Stesolid Rectal Tubes 5mg and 10mg
(diazepam)
Read all of this leaflet carefully before you start using 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 Stesolid rectal tubes are and what they are used for
2 Before you use
3 How to use
4 Possible side effects
5 How to store
6 Further information
What Stesolid rectal tubes are and what they are used for
Stesolid rectal tubes contain diazepam which belongs to a group of medicines called benzodiazepines. Diazepam is used to treat:
- severe anxiety and agitation
- muscle spasms
- epilepsy or febrile convulsions
- symptoms of alcohol withdrawal
Stesolid rectal tubes can also be used to cause relaxation and sleepiness before an operation or dental procedure.
Before you use
Do not use Stesolid rectal tubes and tell your doctor if you have
- an allergy (hypersensitivity) to diazepam, other benzodiazepine medicines or to any of the other ingredients (see section 6)
severe breathing problems
myasthenia gravis (a condition which causes muscle weakness)
sleep apnoea (a condition where you stop breathing whilst asleep)
severe liver disorders
porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders).
Check with your doctor or pharmacist before using Stesolid rectal tubes if you
- have a phobia (a fear of a particular object or situation) or other mental illness
- have a history of alcoholism or drug abuse
- have someone close to you who has recently died
- are elderly (as there is an increased risk of side effects).
Warnings about stopping treatment
Withdrawal symptoms
There is a risk of becoming dependent on this medicine, particularly with high doses, continued use or if you have a history of alcoholism or drug abuse.
If dependence has developed, withdrawal symptoms will occur if you suddenly stop treatment. Withdrawal symptoms include: headaches, muscle pain, anxiety, tension, restlessness confusion and irritability and in severe cases: feelings of things being unreal or strange or that your mind is separated from your body, numbness and tingling in the hands and feet, hallucinations, fits or sensitivity to light, noise or touch.
Rebound sleeplessness and anxiety
When you stop taking this type of medicine, some of the symptoms that led to treatment can return more intensely than before, such as sleep disturbances, anxiety, restlessness or mood changes. The risk of this is greater if you stop suddenly.
To avoid these things happening, treatment should be stopped gradually under the advice of a doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Especially:
- antidepressants or antipsychotics (to treat mental problems)
- sedative antihistamines (to treat allergies)
- general anaesthetics
- hypnotics (to help you sleep)
- strong pain killers
- medicines for epilepsy.
Alcohol
Do not drink alcohol while you are using Stesolid rectal tubes. Alcohol may increase the sedative effects of diazepam and make you very sleepy.
Pregnancy and breastfeeding
You should not use Stesolid rectal tubes if you are pregnant, planning to become pregnant or are breast feeding. If you use Stesolid rectal tubes late in your pregnancy or during labour, your baby might have a low body temperature, floppiness, and breathing difficulties.
Your baby may also develop withdrawal symptoms.
Driving and using machines
Stesolid rectal tubes may affect your muscles or may make you feel sleepy or forgetful (especially if you don’t have enough sleep). If you are affected in this way, do not drive or use any tools or machinery.
How to use
Always use Stesolid rectal tubes exactly as your doctor has told you.
The tubes are inserted into the anus using the nozzle provided.
Instructions for inserting the tubes are on the folded label on each bag. Please read the instructions very carefully before using your medicine.
Doses
Adults and children above 1 year of age: 0.5mg per kg of body weight
Elderly: 0.25mg per kg of body weight
If you have breathing problems you may be given a lower dose.
After giving into the anus, the medicine is quickly absorbed and will start to take effect within 5 minutes.
If you don’t feel better
If your symptoms or the fit are not brought under control with Stesolid rectal tubes, contact a doctor for advice. Further doses should only be given after consulting a doctor. The maximum dose is 30mg.
If you use more Stesolid rectal tubes than you should
If you (or someone else) use a lot of medicine at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include drowsiness, confusion , tiredness or in severe cases, loss of coordination, low blood pressure, breathing difficulties or coma.
If you forget to use Stesolid rectal tubes
If you forget to use a dose, use it as soon as you remember it and then use the next dose at the right time. Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Stesolid rectal tubes can cause side effects, although not everybody gets them.
Contact your doctor at once if you notice any of the following effects:
- restlessness, agitation, irritability, aggressivness, delusions, rages, nightmares, hallucinations or unusual behaviour.
Tell your doctor or pharmacist if you notice any of the following side effects or notice any other effects not listed:
Common (occurs in less than 1 in 10 users): light-headedness, drowsiness, unsteadiness, loss of co-ordination, memory loss, muscle weakness, speech problems, tremors
Rare (occurs in less than 1 in 1,000 users): low blood pressure, breathing difficulties, visual disturbances, stomach upsets, skin rashes, difficulty passing urine, inability to control bladder, confusion, headache, ‘spinning’ sensation, blood disorders, changes in sex drive, yellowing of the skin or whites of the eyes (jaundice), excitement.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Stesolid rectal tubes after the expiry date stated on the label/carton/bottle. 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 Stesolid rectal tubes contain:
- The active substance (the ingredient that makes the medicine work) is diazepam.
Each rectal tube contains either 5mg or 10mg of diazepam. - The other ingredients are benzoic acid, ethanol, propylene glycol, sodium benzoate, benzyl alcohol, water.
What Stesolid rectal tubes look like and contents of the pack
Stesolid rectal tubes contains a clear, colourless to yellowish liquid in a yellow polyethylene tube.
Pack size of 5 x 2.5ml, singly packed in aluminium foil.
Marketing Authorisation Holder and Manufacturer:
Manufacturer
Distributor
Date of Revision: November 2009
21193-31
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