Salofalk Enema 2g

SALOFALKENEMA 2g

MESALAZINE

Please read this leaflet carefully before you start to take your medicine. It does not contain complete information about your treatment but if you have any questions or are not sure about anything ask your doctor or pharmacist (chemist). Keep this leaflet until you have finished all your treatment. You may want to read it again.

If you are helping someone else to take this medicine, please read this leaflet before you give the first dose.

The name of this medicine is SalofalkEnema 2g. The active ingredient is mesalazine and each enema contains 2grams of this ingredient in 59ml of suspension. The enemas also contain carbomer, potassium acetate (E261), potassium metabisulphite (E224), purified water, sodium benzoate (E211) disodium edetate (total sodium content 17mg) and xanthan gum (E415).

Each box of SalofalkEnema 2g contains 7enemas.

Mesalazine is used to treat diseases in the lower bowel.

Product Licence Holder:

Dr Falk Pharma UK Ltd

Unit K

Bourne End Business Park

Cores End Road

Bourne End

Bucks

SL8 5AS

UK

Manufactured by:

Dr. Falk Pharma GmbH

D-79041 Freiburg

Germany

SalofalkEnema 2g may be used to treat the following:

• Inflammation of the large intestine (colon) and rectum (back passage) known by doctors as ulcerative colitis.

Before using SalofalkEnema 2g

• If you are pregnant, think you might be pregnant, trying to become pregnant or breast-feeding, you should tell your doctor.

If the answer to any of the following questions is yes, tell your doctor or pharmacist.

• Do you suffer from kidney or liver disease?


• Do you have or have you ever had a stomach or duodenal ulcer?


• Do you tend to bleed easily or have you ever been told that there is a problem with the clotting of your blood?


• Are you or have you ever been told you are allergic to aspirin or other salicylates?


• Are you taking any medicines for thrombosis or to thin your blood?


• Are you taking any medicines for the treatment of gout, heart problems, psoriasis, arthritis, leukaemia, tuberculosis?


• Are you taking any anti-inflammatory agents, pain relief drugs or any other medicines which your doctor does not know about?

Using SalofalkEnema 2g

It is important to take your medicine as directed by your doctor. The usual dose is one enema a day at bedtime although the dispensing label will tell you how many to use and how often. If it does not or you are unsure ask your doctor or pharmacist.

• This medicine should not be swallowed.


• Empty your bowels if necessary and wash your hands. Shake the bottle for 30 seconds then remove the protective cap from the applicator and hold the bottle by its upper end. Lie down on your left side with the left leg outstretched and the right leg bent (this aids the action of the enema). Guide the applicator deep into the rectum and whilst holding the bottle obliquely, squeeze slowly. Remove the applicator from the rectum when the bottle is empty but maintain this position for at least 30minutes to allow the enema to spread throughout the lower part of the large intestine. Wash your hands again and try not to empty your bowels again until the next morning.


• If you forget to take your medicine continue with the next dose as instructed on the label.


• If you go into hospital or visit a dentist or another doctor tell them you are taking this medicine.

After using SalofalkEnema 2g

Like all medicines, SalofalkEnema 2g may occasionally cause side-effects in some people. Normally these effects are mild and rare but if you experience any of the following effects severely, stop using the enemas and tell your doctor as soon as possible.

• Fever, sore throat, bleeding, bruising and anaemia.


• Skin rash, inflammation, blistering and peeling skin (sometimes severe).


• Chest tightness or shortage of breath.


• Headache, nausea, diarrhoea or hair loss.


• Numbness or tingling in the hands or feet.


• Swelling of ankles, feet or lower leg.


• Very rarely, liver problems and jaundice, and pancreatitis might occur.


• If you become dehydrated (lose too much water) which can occur with severe or prolonged vomiting and/or diarrhoea, high fever or excess sweating, contact your doctor or pharmacist for advice. Adequate fluid replacement is important in preventing kidney problems.

If you experience any other undesirable effects then tell your doctor or pharmacist, particularly if they are severe or persistent.

Benzoic acid is a mild irritant to the skin, eyes and mucous membrane (e.g. mouth). This product may be harmful to people on a low sodium diet. E224 can cause allergic-type reactions such as rash, shortness of breath or wheezing, or swollen face in susceptible people, especially those with a history of asthma or allergy.

Storing SalofalkEnema 2g

• Store the enemas at room temperature (15-25°C) in their original packaging but keep them in a place where they cannot be reached by children, your medicine could harm them.


• Check the expiry date on the carton or bottle and do not use the enemas if this date has been passed.


• If your doctor decides to stop treatment, return any left over enemas to the pharmacist. Only keep them if the doctor tells you to.


• If the enemas look to be deteriorating in any way, do not use but return them to the pharmacist.


• Protect from light.

Date leaflet prepared: May 2010

PL 10341/0008

This leaflet provides a summary of the information available on your medicine.

This information applies only to SalofalkEnema 2g. If you have any questions or are not sure of anything, ask your doctor or pharmacist who have access to additional information.

REMEMBER: This medicine is yours. Never give it to others.

It may not be suitable for them even if their symptoms are the same as yours.

Dr Falk Pharma UK Ltd

Unit K

Bourne End Business Park

Cores End Road

Bourne End

Bucks

SL8 5AS

UK