Symbicort Turbohaler 200 / 6, inhalation powder

Symbicort Turbohaler 200/6, inhalation powder

budesonide, formoterol fumarate dihydrate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Symbicort Turbohaler is and what it is used for


• 2. Before you use Symbicort Turbohaler


• 3. How to use Symbicort Turbohaler


• 4. Possible side effects


• 5. How to store Symbicort Turbohaler


• 6. Further information

What Symbicort Turbohaler is and what it is used for

Symbicort Turbohaler is an inhaler. It contains two different medicines: budesonide and formoterol fumarate dihydrate.

• Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs.


• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta-agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This helps you to breathe more easily.

Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD).

Asthma

Symbicort Turbohaler can be prescribed for asthma in two different ways.

• 
  a) Some people are prescribed two asthma inhalers: Symbicort Turbohaler and a separate ‘reliever inhaler’.
  

• They use Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening.


• They use their ‘reliever inhaler’ when they get asthma symptoms, to make it easier to breathe again.

• 
  b) Some people are prescribed Symbicort Turbohaler as their only asthma inhaler.
  

• They use Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening.


• They also use Symbicort Turbohaler when they need extra doses for relief of asthma symptoms, to make it easier to breathe again. They do not need a separate inhaler for this.

Chronic obstructive pulmonary disease (COPD)

Symbicort Turbohaler can also be used to treat the symptoms of severe COPD in adults. COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking.

Before you use Symbicort Turbohaler

Do not use Symbicort Turbohaler if:

• You are allergic (hypersensitive) to budesonide, formoterol, or the other ingredient, which is lactose (which contains small amounts of milk proteins).

Take special care with Symbicort Turbohaler

Before you use Symbicort Turbohaler, tell your doctor or pharmacist if:

• You are diabetic.


• You have a lung infection.


• You have high blood pressure or you have ever had a heart problem (including an uneven heart beat, a very fast pulse, narrowing of the arteries or heart failure).


• You have problems with your thyroid or adrenal glands.


• You have low levels of potassium in your blood.


• You have severe liver problems.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eyedrops (such as timolol for glaucoma).


• Medicines for a fast or uneven heart beat (such as quinidine).


• Medicines like digoxin, often used to treat heart failure.


• Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood pressure.


• Steroid medicines that you take by mouth (such as prednisolone).


• Xanthine medicines (such as theophylline or aminophylline). These are often used to treat asthma.


• Other bronchodilators (such as salbutamol).


• Tricyclic anti-depressants (such as amitriptyline).


• Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as phenelzine).


• Phenothiazine medicines (such as chlorpromazine and prochlorperazine).


• Medicines called ‘protease inhibitors’ (such as ritonavir) to treat HIV infection.


• Medicines to treat fungal infections (such as itraconazole and ketoconazole).


• Medicines for Parkinson’s disease (such as leva-dopa).


• Medicines for thyroid problems (such as levo‑thyroxine).

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Symbicort Turbohaler.

Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or for dental work.

Pregnancy and breast-feeding

• If you are pregnant, or planning to get pregnant, talk to your doctor before using Symbicort Turbohaler - do not use Symbicort Turbohaler unless your doctor tells you to.


• If you get pregnant while using Symbicort Turbohaler, do not stop using Symbicort Turbohaler but talk to your doctor immediately.


• If you are breast-feeding, talk to your doctor before using Symbicort Turbohaler.

Driving and using machines

Symbicort Turbohaler is not likely to affect your ability to drive or to use tools or machines.

Important information about some of the ingredients of Symbicort Turbohaler

Symbicort Turbohaler contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. The amount of lactose in this medicine does not normally cause problems in people who are lactose intolerant. The excipient lactose contains small amounts of milk proteins, which may cause an allergic reaction.

How to use Symbicort Turbohaler

• Always use Symbicort Turbohaler exactly as your doctor, nurse or pharmacist has told you. Ask one of them for advice if you are not sure.


• It is important to use Symbicort Turbohaler every day, even if you have no asthma or COPD symptoms at the time.


• If you are using Symbicort Turbohaler for asthma, your doctor will want to regularly check your symptoms.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Symbicort Turbohaler, you should continue to use Symbicort Turbohaler but go to see your doctor as soon as possible, as you may need additional treatment.

Contact your doctor immediately if:

• Your breathing is getting worse or you often wake up at night with asthma.


• Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately.

Asthma

Symbicort Turbohaler can be prescribed for asthma in two different ways. The amount of Symbicort Turbohaler to use and when to use it depends on how it has been prescribed for you.

• a) If you have been prescribed Symbicort Turbohaler and a separate reliever inhaler, read the section called ‘a) Using Symbicort Turbohaler and a separate reliever inhaler’.


• b) If you have been prescribed Symbicort Turbohaler as your only inhaler, read the section called ‘b) Using
  Symbicort Turbohaler as your only asthma inhaler’.

a) Using Symbicort Turbohaler and a separate reliever inhaler

Use your Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening.

Adults (18 years and above)

• The usual dose is 1 or 2 inhalations, twice a day.


• Your doctor may increase this to 4 inhalations, twice a day.


• If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

Adolescents (12 to 17 years)

• The usual dose is 1 or 2 inhalations, twice a day.


• If your symptoms are well controlled, your doctor may ask you to take your medicine once a day.

A lower strength of Symbicort Turbohaler is available for children aged from 6 to 11 years.

Your doctor (or asthma nurse) will help you to manage your asthma. They will adjust the dose of this medicine to the lowest dose that controls your asthma. However, do not adjust the dose without talking to your doctor (or asthma nurse) first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen. Always keep your ‘reliever inhaler’ with you to use when you need it. Do not use Symbicort Turbohaler to treat asthma symptoms - use your reliever inhaler.

b) Using Symbicort Turbohaler as your only asthma inhaler

Only use Symbicort Turbohaler in this way if your doctor has told you to and if you are aged 18 or above.

Use your Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening. You can take:

• 1 inhalation in the morning and 1 inhalation in the evening
  or


• 2 inhalations in the morning
  or


• 2 inhalations in the evening.

Your doctor may increase this to 2 inhalations twice a day.

Also use Symbicort Turbohaler as a ‘reliever inhaler’ to treat asthma symptoms when they happen.

• If you get asthma symptoms, take 1 inhalation and wait a few minutes.


• If you do not feel better, take another inhalation.


• Do not take more than 6 inhalations at a single time.

Always keep your Symbicort Turbohaler with you, so you can use it when you need it.

A total daily dose of more than 8 inhalations is not normally needed. However, your doctor may allow you to take up to 12 inhalations a day for a limited period.

If you regularly need to use 8 or more inhalations a day, make an appointment to see your doctor or nurse. They may need to change your treatment.

Do not use more than 12 inhalations in total in 24 hours.

If you are doing exercise and you get asthma symptoms, use Symbicort Turbohaler as described here. However, do not use Symbicort Turbohaler just before exercise to stop asthma symptoms from happening.

Chronic Obstructive Pulmonary Disease (COPD)

• Only to be used by adults (aged 18 years and above).


• The usual dose is 2 inhalations twice a day.

Preparing your new Symbicort Turbohaler

Before using your new Symbicort Turbohaler for the first time, you need to prepare it for use as follows:

• Unscrew the cover and lift it off. You may hear a rattling sound.


• Hold your Turbohaler upright with the red grip at the bottom.

• Turn the red grip as far as it will go in one direction. Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound.

• Do this again, turning the red grip in both directions.


• Your Turbohaler is now ready for use.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions below.

• 1. Unscrew the cover and lift it off. You may hear a rattling sound.


• 
  2. Hold your Turbohaler upright with the red grip at the bottom.


• 3. Do not hold the mouthpiece when you load your Turbohaler. To load your Turbohaler with a dose, turn the red grip as far as it will go in one direction. Then turn it as far as it will go in the other direction (it does not matter which way you turn it first). You should hear a click sound. Your Turbohaler is now loaded and ready to use. Only load your Turbohaler when you need to use it.


• 4. Hold your Turbohaler away from your mouth. Breathe out gently (as far as is comfortable). Do not breathe out through your Turbohaler.


• 5. Place the mouthpiece gently between your teeth. Close your lips. Breathe in as deeply and as hard as you can through your mouth. Do not chew or bite on the mouthpiece.

6. Remove your Turbohaler from your mouth. Then breathe out gently. The amount of medicine that is inhaled is very small. This means you may not be able to taste it after inhalation. If you have followed the instructions, you can still be confident that you have inhaled the dose and the medicine is now in your lungs.

7. If you are to take a second inhalation, repeat steps 2 to 6.

8. Replace the cover tightly after use.

9. Rinse your mouth with water after your daily morning and/or evening doses, and spit it out.

Do not try to remove or twist the mouthpiece. It is fixed to your Turbohaler and must not be taken off. Do not use your
Turbohaler if it has been damaged or if the mouthpiece has come apart from your Turbohaler.

Cleaning your Turbohaler

Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.

When to start using a new Turbohaler

• The dose indicator tells you how many doses (inhalations) are left in your Turbohaler, starting with either 60 or 120 doses when it is full.


• The dose indicator is marked in intervals of 10 doses. Therefore it does not show every dose.


• When you first see a red mark at the edge of the indicator window, there are approximately 20 doses left. For the last 10 doses, the background of the dose indicator is red. When the ‘0’ on the red background has reached the middle of the window, you must start using your new Turbohaler.

Note:

• The grip will still twist and ‘click’ even when your Turbohaler is empty.


• The sound that you hear as you shake your Turbohaler is produced by a drying agent and not the medicine.
  
  Therefore the sound does not tell you how much medicine is left in your Turbohaler.


• If you load your Turbohaler more than once by mistake before taking your dose, you will still only receive one dose. However, the dose indicator will register all the loaded doses.

If you use more Symbicort Turbohaler than you should

If you use more Symbicort Turbohaler than you should, contact your doctor or pharmacist for advice.

The most common symptoms that may occur if you use more Symbicort Turbohaler than you should are trembling, headache or a rapid heart beat.

If you forget to use Symbicort Turbohaler

• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.


• Do not take a double dose to make up for a forgotten dose.

Possible side effects

Like all medicines, Symbicort Turbohaler can cause side effects, although not everybody gets them.

If either of the following happen to you, stop using Symbicort Turbohaler and talk to your doctor immediately:

• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty swallowing) or hives together with difficulty breathing (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction. This happens rarely, affecting less than 1 in 1,000 people.


• Sudden wheezing after inhaling your medicine. This happens very rarely, affecting less than 1 in 10,000 people.

Other possible side effects:

Common (affects less than 1 in 10 people)

• Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use Symbicort Turbohaler.


• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your Turbohaler.


• Mild sore throat, coughing and a hoarse voice.


• Headache.

Uncommon (affects less than 1 in 100 people)

• Feeling restless, nervous or agitated.


• Disturbed sleep.


• Feeling dizzy.


• Nausea (feeling sick).


• Fast heart beat.


• Bruising of the skin.


• Muscle cramps.

Rare (affects less than 1 in 1,000 people)

• Rash, itching.


• Bronchospasm (tightening of the muscles in the airways which causes wheezing). If the wheezing comes on
  suddenly after using Symbicort Turbohaler stop using Symbicort Turbohaler and talk to your doctor immediately.


• Low levels of potassium in your blood.


• Uneven heart beat.

Very rare (affects less than 1 in 10,000 people)

• Depression.


• Changes in behaviour, especially in children.


• Chest pain or tightness in the chest (angina pectoris).


• An increase in the amount of sugar (glucose) in your blood.


• Taste changes, such as an unpleasant taste in the mouth.


• Changes in your blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high
doses for a long time. The effects include:

• changes in bone mineral density (thinning of the bones)


• cataract (clouding of the lens in the eye)


• glaucoma (increased pressure in the eye)


• a slowing of the rate of growth of children and adolescents


• an effect on the adrenal gland (a small gland next to the kidney).

These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Symbicort Turbohaler

• Keep out of the reach and sight of children.


• Do not store above 30°C.


• When not in use, Symbicort Turbohaler should be stored with the cover tightened, in order to protect from moisture.


• Do not use Symbicort Turbohaler after the expiry date printed on the carton or on the label of your Turbohaler. The expiry date refers to the last day of that month.


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.

Further information

What Symbicort Turbohaler 200/6 contains

The active substances are budesonide and formoterol.

Each inhaled dose contains 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.

The other ingredient is lactose monohydrate (which contains milk proteins).

What Symbicort Turbohaler 200/6 looks like and contents of the pack

Symbicort Turbohaler 200/6 is an inhaler containing your medicine. The inhalation powder is white in colour.

Each Turbohaler contains either 60 or 120 doses and has a white body with a red turning grip.

Symbicort Turbohaler 200/6 is available in packs of 1, 2, 3, 10 or 18 Turbohalers.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Symbicort Turbohaler 200/6 is held by

AstraZeneca UK Ltd

600 Capability Green

Luton

LU1 3LU

UK

Symbicort Turbohaler 200/6 is manufactured by

AstraZeneca AB

S-151 85 Södertälje

Sweden

Symbicort Turbohaler is authorised in the Member States of the EEA under the following names:

Symbicort Turbohaler and Symbicort Turbuhaler. In some countries, the dosage strength refers to the metered dose
(200/6), in others the delivered dose (160/4.5).

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name

Symbicort Turbohaler 200/6

Reference number

17901/0092

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last approved in February 2010

© AstraZeneca 2010

Symbicort and Turbohaler are trade marks of the AstraZeneca group of companies.

RSP 10 0005

6804034.28

Strepsils Extra Citrus Menthol Lozenges (Reckitt Benckiser Healthcare (UK) Ltd)

1. Name Of The Medicinal Product

Strepsils Extra Citrus Menthol Lozenges

STREPSILS Extra Strength Lemon Menthol Lozenges

2. Qualitative And Quantitative Composition

Hexylresorcinol Ph Eur 2.4mg

For excipients, see 6.1.

3. Pharmaceutical Form

Lozenge.

4. Clinical Particulars

4.1 Therapeutic Indications

As an antiseptic and local anaesthetic for the relief of sore throat and its associated pain.

4.2 Posology And Method Of Administration

For oral administration.

Adults, the elderly and children 6 years and over: One lozenge dissolved slowly in the mouth every three hours or as required.

Do not take more than 12 lozenges in 24 hours.

Not to be given to children under 6 years.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The label will convey:

Do not exceed the stated dose.

Keep out of the reach of children.

Not to be given to children under 6 years.

This product is unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrose-isomaltase deficiency.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is a lack of evidence of safety of the product in human pregnancy, but hexylresorcinol has been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

None known.

4.9 Overdose

Hexylresorcinol overdosage may cause minor gastrointestinal irritation. Treatment would be withdrawal of the product and symptomatic measures as appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Hexylresorcinol is a local anaesthetic for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.

The product base has a demulcent action.

5.2 Pharmacokinetic Properties

Pharmacokinetic considerations do not arise since the pharmacological action is local to the oro-pharangeal cavity.

5.3 Preclinical Safety Data

There are no pre-clinical data available specific to the product.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid Sucrose,

Liquid Glucose,

Propylene Glycol,

Levomenthol,

Lemon Flavour,

Quinoline Yellow (E104),

Indigo Carmine (E132).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original packaging. Keep in the outer carton.

6.5 Nature And Contents Of Container

Blister packs of 250 micron PVC coated 40 gsm PVDC with 20 micron hard temper aluminium foil, heat sealed to the PVC/PVDC blister containing 6, 8, 10, 12, 16, 20, 24, 32 or 36 lozenges in a carton.

6.6 Special Precautions For Disposal And Other Handling

None specific to the product/pack.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 3UH

8. Marketing Authorisation Number(S)

PL 00063/0394

9. Date Of First Authorisation/Renewal Of The Authorisation

6^th April 2010

10. Date Of Revision Of The Text

April 2010

Supralip 160mg

1. Name Of The Medicinal Product

Supralip^® 160 mg, film-coated tablet.

2. Qualitative And Quantitative Composition

Each tablet contains 160.0 mg fenofibrate.

For excipients, see 6.1.

3. Pharmaceutical Form

Film coated tablet.

White, oblong, film-coated tablets engraved “160” on one side and “Fournier logo” on the other side.

4. Clinical Particulars

4.1 Therapeutic Indications

Supralip^® 160mg is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

- Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.

- Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

- Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

4.2 Posology And Method Of Administration

Posology:

Adults: The recommended dose is one tablet containing 160 mg fenofibrate taken once daily. Patients currently taking one Lipantil Micro 200mg capsule can be changed to one Supralip 160 mg tablet without further dose adjustment.

Elderly patients: The usual adult dose is recommended.

Patients with renal impairment: Dosage reduction is required in patients with renal impairment. The use of dosage forms containing a lower dose of active ingredient (67 mg micronised fenofibrate capsules or 100 mg standard fenofibrate capsules) is recommended in these patients.

Children: The use of the 160 mg dosage form is contraindicated in children.

Hepatic disease: Patients with hepatic disease have not been studied.

Dietary measures initiated before therapy should be continued.

If after several months of fenofibrate administration (e.g. 3 months) serum lipid levels have not been reduced satisfactorily, complementary or different therapeutic measures should be considered.

Method of administration: Tablet should be swallowed whole during a meal.

4.3 Contraindications

• hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality e.g. persistent elevations in serum transaminases)

• renal insufficiency

• children (age below 18 years)

• hypersensitivity to the active substance or to any of the excipients

• known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen

• gallbladder disease

• chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia

• Supralip 160mg should not be taken in patients allergic to peanut or arachis oil or soya lecithin or related products due to the risk of hypersensitivity reactions.

4.4 Special Warnings And Precautions For Use

Liver function: As with other lipid lowering agents, increases have been reported in transaminase levels in some patients. In the majority of cases these elevations were transient, minor and asymptomatic. It is recommended that transaminase levels are monitored every 3 months during the first 12 months of treatment and thereafter periodically. Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if ASAT (SGOT) and ALAT (SGPT) levels increase to more than 3 times the upper limit of the normal range. When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus), laboratory tests are to be conducted for verification and discontinuation of fenofibrate therapy may be considered.

Pancreas: Pancreatitis has been reported in patients taking fenofibrate (see sections 4.3 and 4.8). This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct.

Muscle: Muscle toxicity, including very rare cases of rhabdomyolysis, has been reported with administration of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminaemia and previous renal insufficiency. Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscular cramps and weakness and/or marked increases in CPK (levels exceeding 5 times the normal range). In such cases treatment with fenofibrate should be stopped.

Patients with pre-disposing factors for myopathy and/or rhabdomyolysis, including age above 70 years old, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may be at an increased risk of developing rhabdomyolysis. For these patients, the putative benefits and risks of fenofibrate therapy should be carefully weighed up.

The risk of muscle toxicity may be increased if the drug is administered with another fibrate or an HMG-CoA reductase inhibitor, especially in cases of pre-existing muscular disease. Consequently, the co-prescription of fenofibrate with a statin should be reserved to patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease. This combination therapy should be used with caution and patients should be monitored closely for signs of muscle toxicity.

For hyperlipidaemic patients taking oestrogens or contraceptives containing oestrogens it should be ascertained whether the hyperlipidaemia is of primary or secondary nature (possible elevation of lipid values caused by oral oestrogen).

This medicinal product contains lactose. Therefore patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Renal function: Treatment should be interrupted in case of an increase in creatinine levels > 50% ULN (upper limit of normal).

It is recommended that creatinine is measured during the first 3 months after initiation of treatment and thereafter periodically (for dose recommendations, see section 4.2).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Oral anticoagulants: Fenofibrate enhances oral anticoagulant effect and may increase risk of bleeding. It is recommended that the dose of anticoagulants is reduced by about one third at the start of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring. Therefore, this combination is not recommended.

Cyclosporin: Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and cyclosporin. The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.

HMG-CoA reductase inhibitors and other fibrates:

The risk of serious muscle toxicity is increased if fenofibrate is used concomitantly with HMG-CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity (See section 4.4).

Cytochrome P450 enzymes: In vitro studies using human liver microsomes indicate that fenofibrate and fenofibric acid are not inhibitors of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. They are weak inhibitors of CYP2C19 and CYP2A6, and mild-to-moderate inhibitors of CYP2C9 at therapeutic concentrations.

Patients co-administered fenofibrate and CYP2C19, CYP2A6, and especially CYP2C9 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.

4.6 Pregnancy And Lactation

There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effects. Embryotoxic effects have been shown at doses in the range of maternal toxicity (see section 5.3). The potential risk for humans is unknown. Therefore, Supralip 160mg film-coated tablet should only be used during pregnancy after a careful benefit/risk assessment.

There are no data on the excretion of fenofibrate and/or its metabolites into breast milk.

Consequently Supralip 160mg film-coated tablet should not be used in nursing mother.

4.7 Effects On Ability To Drive And Use Machines

Supralip 160mg, Film-coated tablet has no influence on the ability to drive and use machines.

4.8 Undesirable Effects

The most commonly reported ADRs during fenofibrate therapy are digestive, gastric or intestinal disorders.

The following undesirable effects have been observed during placebo-controlled clinical trials (n=2344) with the below indicated frequencies:

MedDRA system organ class	Common >1/100, <1/10	Uncommon >1/1,000, <1/100	Rare >1/10,000, <1/1,000	Very rare <1/10,000 incl. isolated reports	Not knowna
Blood and lymphatic system disorders			Haemoglobin decreased White blood cell count decreased
Immune system disorders			Hypersensitivity
Nervous system disorders		Headache
Vascular disorders		Thromboembolism (pulmonary embolism, deep vein thrombosis)*
Respiratory, thoracic and mediastinal disorders					Interstitial pneumopathies
Gastrointestinal disorders	Gastrointestinal signs and symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence) Moderate in severity	Pancreatitis*
Hepatobiliary disorders	Transaminases increased (see section 4.4)	Cholelithiasis	Hepatitis (see section 4.4)
Skin and subcutaneous tissue disorders		Cutaneous hypersensitivity (e.g. Rashes, pruritus, urticaria)	Alopecia Photosensitivity reactions
Musculoskeletal, connective tissue and bone disorders		Muscle disorder (e.g. myalgia, myositis, muscular spasms and weakness)			Rhabdomyolysis
Reproductive system and breast disorders		Sexual dysfunction
Investigations		Blood creatinine increased	Blood urea increased

*: In the FIELD-study, a randomized placebo-controlled trial performed in 9,795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031). In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0% [48/4,900 patients] versus fenofibrate 1.4% [67/4,895 patients]; p = 0.074).

^a: In addition to those events reported during clinical trials, the following side effects have been reported spontaneously during postmarketing use of Supralip 160mg. A precise frequency cannot be estimated from the available data and is therefore classified as “not known”.

- Respiratory, thoracic and mediastinal disorders: Interstitial lung disease.

- Musculoskeletal, connective tissue and bone disorders: Rhabdomyolysis.

4.9 Overdose

Only anecdotal cases of fenofibrate overdosage have been received. In the majority of cases no overdose symptoms were reported.

No specific antidote is known. If an overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Serum Lipid Reducing Agents / Cholesterol and Triglycerides Reducers / Fibrates.

ATC code: C10 AB 05

Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα).

Through activation of PPARα, fenofibrate increases the lipolysis and elimination of atherogenic triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein CIII. Activation of PPARα also induces an increase in the synthesis of apoproteins AI and AII.

The above stated effects of fenofibrate on lipoproteins lead to a reduction in very low- and low density fractions (VLDL and LDL) containing apoprotein B and an increase in the high density lipoprotein fraction (HDL) containing apoprotein AI and AII.

In addition, through modulation of the synthesis and the catabolism of VLDL fractions fenofibrate increases the LDL clearance and reduces small dense LDL, the levels of which are elevated in the atherogenic lipoprotein phenotype, a common disorder in patients at risk for coronary heart disease.

During clinical trials with fenofibrate, total cholesterol was reduced by 20 to 25%, triglycerides by 40 to 55% and HDL cholesterol was increased by 10 to 30%.

In hypercholesterolaemic patients, where LDL cholesterol levels are reduced by 20 to 35%, the overall effect on cholesterol results in a decrease in the ratios of total cholesterol to HDL cholesterol, LDL cholesterol to HDL cholesterol, or Apo B to Apo AI, all of which are markers of atherogenic risk.

Because of its significant effect on LDL cholesterol and triglycerides, treatment with fenofibrate should be beneficial in hypercholesterolaemic patients with or without hypertriglyceridaemia, including secondary hyperlipoproteinaemia such as type 2 diabetes mellitus.

There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin. Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32; absolute risk reduction: 0.74%). In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (

Extravascular deposits of cholesterol (tendinous and tuberous xanthoma) may be markedly reduced or even entirely eliminated during fenofibrate therapy.

Patients with raised levels of fibrinogen treated with fenofibrate have shown significant reductions in this parameter, as have those with raised levels of Lp(a). Other inflammatory markers such as C Reactive Protein are reduced with fenofibrate treatment.

The uricosuric effect of fenofibrate leading to reduction in uric acid levels of approximately 25% should be of additional benefit in those dyslipidaemic patients with hyperuricaemia.

Fenofibrate has been shown to possess an anti-aggregatory effect on platelets in animals and in a clinical study, which showed a reduction in platelet aggregation induced by ADP, arachidonic acid and epinephrine.

5.2 Pharmacokinetic Properties

Supralip 160 mg is a film-coated tablet containing 160 mg of micronised fenofibrate and is suprabioavailable (larger bioavailability) compared to the previous formulations.

Absorption: Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration. Plasma concentrations are stable during continuous treatment in any given individual.

The absorption of fenofibrate is increased when administered with food.

Distribution: Fenofibric acid is strongly bound to plasma albumin (more than 99%).

Plasma half-life: The plasma elimination half-life of fenofibric acid is approximately 20 hours.

Metabolism and excretion: No unchanged fenofibrate can be detected in the plasma where the principal metabolite is fenofibric acid. The drug is excreted mainly in the urine. Practically all the drug is eliminated within 6 days. Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate. In elderly patients, the fenofibric acid apparent total plasma clearance is not modified.

Kinetic studies following the administration of a single dose and continuous treatment have demonstrated that the drug does not accumulate. Fenofibric acid is not eliminated by haemodialysis.

5.3 Preclinical Safety Data

Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.

Studies on mutagenicity of fenofibrate have been negative.

In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation. These changes are specific to small rodents and have not been observed in other animal species. This is of no relevance to therapeutic use in man.

Studies in mice, rats and rabbits did not reveal any teratogenic effect. Embryotoxic effects were observed at doses in the range of maternal toxicity. Prolongation of the gestation period and difficulties during delivery were observed at high doses. No sign of any effect on fertility has been detected.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium laurilsulfate

Lactose monohydrate

Povidone

Crospovidone

Microcrystalline cellulose

Silica colloidal anhydrous

Sodium stearyl fumarate

Composition of the coating:

Opadry®:

- polyvinyl alcohol

- titanium dioxide (E171)

- talc

- soybean lecithin

- xanthan gum.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Store in the original package in order to protect from moisture.

Do not store above 30°C.

6.5 Nature And Contents Of Container

Thermoformed blister strips (PVC/PE/PVDC) of 10 or 14 tablets each.

Boxes of 10, 20, 28, 30, 50, 84, 90, 98 and 100 tablets.

Hospital pack sizes: 280 (10 x 28) and 300 (10 x 30) tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Abbott Healthcare Products Ltd

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

8. Marketing Authorisation Number(S)

PL 00512/0389

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: September 2000

Date of last renewal: 4 November 2004

10. Date Of Revision Of The Text

March 2011

11. Legal category

POM

Stesolid Rectal Tubes 5mg (Actavis UK Ltd)

1. Name Of The Medicinal Product

Stesolid® rectal tubes 5 mg.

2. Qualitative And Quantitative Composition

Diazepam 2 mg/ml.

3. Pharmaceutical Form

Enema.

4. Clinical Particulars

4.1 Therapeutic Indications

Diazepam has anticonvulsant, sedative, and muscle relaxant properties. It is used in the treatment of severe anxiety and tension states, as a sedative and premedication, in the control of muscle spasm, and in the management of alcohol withdrawal symptoms.

Stesolid rectal tubes 5 mg may be used in acute severe anxiety and agitation, epileptic and febrile convulsions, tetanus, as a sedative in minor surgical and dental procedures, or in other circumstances in which a rapid effect is required but where intravenous injection is impracticable or undesirable.

Stesolid rectal tubes 5 mg may be of particular value for the immediate treatment of convulsions in infants and children.

4.2 Posology And Method Of Administration

Sensitivity to diazepam varies with age.

Children above 1 year of age: 0.5 mg/kg body weight

Adults: 0.5 mg/kg body weight

Elderly patients: 0.25 mg/kg body weight

A maximum dose of 30 mg diazepam is recommended, unless adequate medical supervision and monitoring are available.

4.3 Contraindications

Myasthenia gravis, hypersensitivity to benzodiazepines, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency and porphyria.

4.4 Special Warnings And Precautions For Use

Tolerance

Some loss of efficacy to the hypnotic effects of diazepam may develop after repeated use for a few weeks.

Dependence

Use of benzodiazepines may lead to development of physical and psychic dependence upon these products. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse.

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

Rebound insomnia and anxiety: a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.

Psychiatric and paradoxical reactions

Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychosis, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this occur, use of the medicinal product should be discontinued.

They are more likely to occur in children and the elderly.

Specific patient groups

Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum. Elderly should be given a reduced dose (see posology). A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy.

Benzodiazepines are not recommended for the primary treatment of psychotic illness.

Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients).

In common with other benzodiazepines, the use of diazepam may be associated with amnesia and should not be used in cases of loss or bereavement as psychological adjustment may be inhibited.

Stesolid rectal tubes 5 mg should not be used in phobic or obsessional states, as there is insufficient evidence of efficacy and safety in such conditions.

Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

- Not recommended: concomitant intake with alcohol.

The sedative effects may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machines.

- Take into account: combination with CNS depressants.

Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic products, anaesthetics and sedative antihistamines.

In the case of narcotic analgesics enhancement of the euphoria may also occur leading to an increase in psychic dependence.

Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines. To a lesser degree this also applies to benzodiazepines that are metabolised only by conjugation.

4.6 Pregnancy And Lactation

In animal studies administration of benzodiazepines during gestation has lead to cleft palate, CNS malformation and permanent functional disturbances in the offspring.

There is no evidence as to the safety of diazepam in human pregnancy. It should not be used, especially during the first and last trimesters, unless the benefit is considered to outweigh the potential risk.

In labour, high single doses or repeated low doses have been reported to produce hypotonia, poor sucking, and hyperthermia in the neonate, and irregularities in the foetal heart.

If benzodiazepines are prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant.

If, for compelling medical reasons, the product is administered during the late phase of pregnancy, or during labour at high doses, effects on neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.

Infants born to mothers who took benzodiazepines chronically during the later states of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.

Since benzodiazepines are found in breast milk, benzodiazepines should not be given to breast feeding mothers.

4.7 Effects On Ability To Drive And Use Machines

Sedation, amnesia, impaired muscular function may adversely affect the ability to drive or use machines. If insufficient sleep occurs, the likelihood of impaired alertness may be increased (see also Interactions).

4.8 Undesirable Effects

The side effects of diazepam are usually mild and infrequent.

The most common side effects are drowsiness, light-headedness, unsteadiness, and ataxia. Elderly patients are particularly susceptible to these effects.

Rare side effects include hypotension, apnoea, gastrointestinal and visual disturbances, skin rashes, urinary retention, headache, confusion, vertigo, changes in libido, blood dyscrasias, jaundice and respiratory depression.

Paradoxical reactions to the benzodiazepines, provoking excitement instead of sedation, have been reported.

4.9 Overdose

As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol).

In the management of overdose with any medical product, it should be borne in mind that multiple agents might have been taken.

Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.

Emergency procedure is to secure adequate airway maintenance. Otherwise, the treatment is symptomatic. Intravenous fluids may be administered and Flumazenil may be useful as an antidote.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Diazepam has anticonvulsant, sedative, and muscle relaxant properties.

5.2 Pharmacokinetic Properties

Absorption: Diazepam is quickly absorbed from the rectal mucosa. The maximum serum concentration is reached within 17 minutes. Absorption is 100% compared with that of intravenous injection of diazepam.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzoic acid

Ethanol

Propylene glycol

Sodium benzoate

Benzyl alcohol

Purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

30 months at 25°C.

6.4 Special Precautions For Storage

The storage temperature must not exceed 25°C.

6.5 Nature And Contents Of Container

Carton containing sealed low density polyethylene tubes, single packed in aluminium laminated bags.

Package size: 5 x 2.5 ml

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfjordur

Iceland

8. Marketing Authorisation Number(S)

PL 30306/0040

9. Date Of First Authorisation/Renewal Of The Authorisation

01/06/2007

10. Date Of Revision Of The Text

31/07/2007

Synagis 50mg

SYNAGIS 50 mg

powder and solvent for solution for injection

Palivizumab

Read all of this leaflet carefully because it contains important information for you and your child.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as those of your child.


• If any of the side effects get serious, or if you notice that your child has any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What SYNAGIS is and what it is used for


• 2. Before SYNAGIS is given to your child


• 3. How will my child receive SYNAGIS


• 4. Possible side effects


• 5. How to store SYNAGIS


• 6. Further information

What Synagis Is And What It Is Used For

SYNAGIS contains an active ingredient called palivizumab which is an antibody that works specifically against a virus called respiratory syncytial virus, RSV.

Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV). SYNAGIS is a medicine to help protect your child from getting severe RSV illness.

Before Synagis Is Given To Your Child

Your child should not be given SYNAGIS

• if he/she has ever had an allergic (hypersensitive) reaction to the active ingredient of SYNAGIS (palivizumab) or to any of the other ingredients of SYNAGIS (see a full list of ingredients in Section 6)

Take special care with SYNAGIS

• if your child is unwell. Please tell your doctor if your child is unwell, as the use of SYNAGIS may need to be delayed.


• if your child has any bleeding disorders as SYNAGIS is usually injected into the thigh.

Taking other medicines

SYNAGIS is not known to interact with other medicines. However, you should inform your doctor of all medicines your child is currently taking before starting SYNAGIS.

How Will My Child Receive Synagis

Instructions for proper use

How often will SYNAGIS be given to my child?

SYNAGIS should be given to your child at a dose of 15 mg/kg body weight once a month for as long as the risk of RSV infection remains.

For your child’s best protection, it is necessary to take the doctor’s advice about when to return for additional doses of SYNAGIS.

If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of SYNAGIS after the operation.

Your child can then go back to the original planned injection.

How will my child receive SYNAGIS?

SYNAGIS will be given by injection to your child into a muscle, usually in the outer part of the thigh.

What should you do if you feel that your child has become ill while being treated with SYNAGIS?

If your child becomes ill, please contact your doctor immediately.

What should you do if your child misses an injection of SYNAGIS?

If your child misses an injection, you should contact your doctor as soon as possible. Each injection of SYNAGIS can only help protect your child for about one month before another injection is needed.

If you have any further questions on how this product will be given to your child, ask your doctor or pharmacist.

Synagis 50mg Side Effects

Like all medicines, SYNAGIS can cause side effects, although not everybody gets them.

What side effects may occur while taking SYNAGIS?

Common (affects 1 to 10 users in 100):

• fever;


• nervousness;


• redness or swelling at the injection site;


• diarrhoea.

Uncommon (affects 1 to 10 users in 1000):

• colds;


• coughs;


• runny nose;


• wheeze;


• vomiting


• rash;


• pain;


• viral infection;


• bleeding;


• weakness;


• constipation;


• drowsiness;


• hyperactivity;


• decrease in white blood cell counts;


• increase in liver function tests which will be seen in blood tests;


• upper respiratory infection.

Not Known (occurrence cannot be estimated):

• fits;


• reduced platelet count (cells that are needed for blood clotting);


• a pause in breathing or other breathing difficulties;


• severe allergic reactions.

What should you do if side effects occur?

If your child shows any side effects after receiving SYNAGIS you should contact your doctor. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, contact your doctor.

How To Store Synagis

Keep out of the reach and sight of children.

Do not use SYNAGIS after the expiry date which is stated on the label.

After reconsititution use within 3 hours.

Store in a refrigerator (2°C-8°C)

Do not freeze.

Store in the original container

Further Information

What SYNAGIS contains

• The active substance is palivizumab. 50 mg per vial, providing 100 mg/ml of palivizumab when reconstituted as recommended.


• The other ingredients are,
  
  
  • for the powder: histidine, glycine and mannitol.
  • for the solvent: water for injections.

What SYNAGIS looks like and contents of the pack

SYNAGIS is presented as a powder and solvent for solution for injection (50 mg of powder in vial) + 1ml of solvent in ampoule - Pack size of 1.

SYNAGIS is a white to off-white cake.

Marketing Authorisation holder

Abbott Laboratories, Limited

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

UK

Manufacturer

Abbott SRL

I 04011

Campoverde di Aprilia, (Latina)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom

Abbott Laboratories Ltd

Tel:+ 44 (0) 1628 773355

This leaflet was last approved in December 2009

Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/

131-020-19

Strepsils Honey and Lemon (Reckitt Benckiser Healthcare (UK) Ltd)

1. Name Of The Medicinal Product

Strepsils Honey and Lemon

2. Qualitative And Quantitative Composition

Amylmetacresol BP 0.6mg

2,4

For excipients, see 6.1

3. Pharmaceutical Form

A yellow circular lozenge

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of mouth and throat infections.

4.2 Posology And Method Of Administration

For oral administration.

Adults and children (over 6 years old):

One lozenge to be dissolved slowly in the mouth every 2

Not suitable for children under 6 years.

Elderly:

There is no need for dosage reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach of children.

If symptoms persist consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions are known.

4.6 Pregnancy And Lactation

The safety of Strepsils Honey and Lemon during pregnancy and lactation has not been established, but it is not considered to constitute a hazard during these periods.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects are known.

4.8 Undesirable Effects

Occasionally hypersensitivity reactions.

4.9 Overdose

Overdosage should not present a problem other than gastrointestinal discomfort.

Treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

2,4

5.2 Pharmacokinetic Properties

None available.

5.3 Preclinical Safety Data

None available.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Honey

Tartaric acid

Peppermint oil

Terpeneless lemon oil

Quinoline yellow

Liquid sugar

Liquid glucose

6.2 Incompatibilities

Not applicable.

.

6.3 Shelf Life

36 months for lozenges packed in blister strips within a carton.

36 months for lozenges packed in polypropylene tube, with an in use shelf-life of 'use within 3 months of opening'.

18 months for blister packs attached to a stencilled card.

6.4 Special Precautions For Storage

Carton or Stencilled card - Do not store above 25°C.

Polypropylene tube – No storage restrictions

6.5 Nature And Contents Of Container

A blister push through pack consisting of hard temper aluminium foil heat

Sample packs consisting of two, four or six individual lozenge blister strips attached to a card.

A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of 8 lozenges in a wrap around cardboard carton with tamper-evident seal.

An injection moulded white pigmented polypropylene tube with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).

The tube contains 10 lozenges.

20 lozenges consisting of a bundled pack of 2 tubes of 10 lozenges each.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 3UH

8. Marketing Authorisation Number(S)

PL 00063/0397

9. Date Of First Authorisation/Renewal Of The Authorisation

19^th March 2010

10. Date Of Revision Of The Text

March 2010

Stilnoct 5mg

Stilnoct 5 mg Tablets

zolpidem tartrate

Is this leaflet hard to see or read?

Phone 01483 505515 for help

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Stilnoct is and what it is used for


• 2. Before you take Stilnoct


• 3. How to take Stilnoct


• 4. Possible side effects


• 5. How to store Stilnoc


• 6. Further information

What Stilnoct is and what it is used for

The name of your medicine is Stilnoct 5 mg Tablets (called Stilnoct in this leaflet). Stilnoct contains a medicine called zolpidem tartrate. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep.

Stilnoct is used for temporary sleep problems that are causing you severe distress or that are affecting your every day life. This includes sleep problems such as:

• Difficulty falling asleep


• Waking in the middle of the night


• Waking too early

Stilnoct is not meant to be used every day for long periods of time. Ask your doctor for advice if you are unsure.

Before you take Stilnoct

Do not take this medicine and tell your doctor if:

• You are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of Stilnoct (listed in Section 6 below)
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue


• Your lungs do not work properly (respiratory failure)


• You have severe liver problems


• You have a problem where you stop breathing for short periods at night (sleep apnoea)


• You have a problem that causes severe muscle weakness (myasthenia gravis)


• You have been told by a doctor that you have a mental illness (psychosis)


• You are under the age of 18

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Stilnoct.

Take special care with Stilnoct

Check with your doctor or pharmacist before taking your medicine if:

• You have a history of alcohol or drug abuse


• You have liver problems


• You have depression or have had another mental illnesses in the past


• You have recently taken Stilnoct or other similar medicines for more than four weeks


• You are elderly

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Stilnoct.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Stilnoct can affect the way some other medicines work. Also some medicines can affect the way Stilnoct works.

Tell your doctor if you are taking any of the following medicines:

Stilnoct may increase the effect of the following medicines:

• Medicines for some mental health problems (antipsychotics)


• Medicines for depression such as sertraline


• Medicines for epilepsy (anticonvulsants)


• Medicines used in surgery (anaesthetics)


• Medicines to calm or reduce anxiety or for sleep problems


• Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine


• Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol

The following medicines can increase the chance of you getting side effects when taken with Stilnoct. To make this less likely, your doctor may decide to lower your dose of Stilnoct:

• Some antibiotics such as clarithromycin or erythromycin


• Some medicines for fungal infections such as ketaconazole and itraconazole


• Ritonavir (a protease inhibitor) - for HIV infections

The following medicines can make Stilnoct work less well:

• Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin


• Rifampicin (an antibiotic) - for infections


• St John’s Wort (a herbal medicine) - for mood swings and depression

Taking Stilnoct with food and drink

• Do not drink alcohol while you are taking Stilnoct. Alcohol can increase the effects of Stilnoct and make you sleep very deeply so that you do not breathe properly or have difficulty waking.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Taking Stilnoct during pregnancy may harm your baby.

You should not breast-feed if you are taking Stilnoct. This is because small amounts may pass into mother’s milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

On the day after taking Stilnoct, do not drive or use machinery or tools if you feel sleepy, dizzy or confused.For more information about possible side effects which could affect your driving see section 4 of this leaflet.

Important information about some of the ingredients of Stilnoct

Stilnoct contains:

• Lactose. This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine

How to take Stilnoct

Always take Stilnoct exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth


• Swallow the tablet whole with a drink of water


• Take just before bedtime. Make sure you have at least 7-8 hours for sleep after taking this medicine


• The usual length of treatment is 2 days to 4 weeks

Adults

The usual dose is two Stilnoct tablets (10 mg) just before bedtime.

Elderly

The usual dose is one tablet (5mg) just before bedtime.

Patients with liver problems

The usual starting dose is one tablet (5mg) just before bedtime. Your doctor may decide to increase this to two tablets (10mg) if it is safe to do so.

Children and Adolescents

Stilnoct should not be used in people under 18 years old.

If you take more Stilnoct than you should

If you take more Stilnoct than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you.

This is so the doctor knows what you have taken.

Taking too much Stilnoct can be very dangerous. The following effects may happen:

• Feeling drowsy, confused, sleeping deeply and possibly falling into a fatal coma.

If you forget to take Stilnoct

Stilnoct must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Stilnoct

Keep taking Stilnoct until your doctor tells you to stop. Do not stop taking Stilnoct suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time.

If you stop taking Stilnoct suddenly, your sleep problems may come back and you may get a ‘withdrawal effect’. If this happens you may get some of the effects listed below.

See a doctor straight away if you get any of the following effects:

• Feeling anxious, restless, irritable or confused


• Headache


• Faster heartbeat or uneven heartbeat (palpitations)


• Nightmares, seeing or hearing things that are not real (hallucinations)


• Being more sensitive to light, noise and touch than normal


• Relaxed grip on reality


• Feeling distant from your body or feeling ‘puppet-like’


• Numbness and tingling in your hands and feet


• Aching muscles


• Stomach problems


• Sleep problems come back worse than before

In rare cases fits (seizures) may also occur.

Stilnoct 5mg Side Effects

Like all medicines, Stilnoct can cause side effects, although not everybody gets them.

Stop taking Stilnoct and see a doctor or go to a hospital straight away if:

• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Tell your doctor as soon as possible if you have any of the following side effects:

Common (affects less than 1 in 10 people)

• Poor memory while taking Stilnoct (amnesia) and strange behaviour during this time. This is more likely to affect you in the few hours after you take this medicine. By having 7-8 hours sleep after taking Stilnoct, this is less likely to cause you a problem.


• Sleeping problems that get worse after taking this medicine


• Seeing or hearing things that are not real (hallucinations)

Uncommon (affects less than 1 in 100 people)

• Blurred eyesight or ‘seeing double’

Frequency unknown

• Being less aware of your environment


• Falling, especially in the elderly

Sleep-Driving and other strange behaviour

There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine. This includes sleep-driving, sleep walking and having sex. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Common (affects less than 1 in 10 people)

• Diarrhoea


• Headache


• Feeling tired or agitated


• Nightmares

Uncommon (affects less than 1 in 100 people)

• Feeling confused or irratable

Frequency unknown

• Itching skin or skin rash


• Weak muscles


• Feeling restless, aggressive, angry or showing unusual behaviour


• Thinking things that are not true (delusions)


• Changes in sex drive (libido)


• Change in the amount of liver enzymes – shown up in the results of blood tests


• Changes in the way you walk


• Stilnoct having less effect than normal

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

How to store Stilnoct

Store below 30°C. Keep the blister strip in the carton in order to protect from moisture.

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Stilnoct after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Stilnoct contains

• Each tablet of Stilnoct contains 5 mg of the active substance zolpidem tartrate


• Other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, titanium dioxide (E171), sodium starch glycollate, magnesium stearate and macrogol 400.

What Stilnoct looks like and contents of the pack

Stilnoct is a round white film-coated tablet contained within PVC/ foil blisters in cartons containing 4, 14, 28 or 56 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

Tel:01483 505515

Fax:01483 535432

email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Sanofi Winthrop Industrie

30 – 36 avenue

Gustave Eiffel

37 000 Tours

France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 08/2008

© sanofi-aventis, 1993 - 2008

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