Tegretol 100mg/5ml Liquid
1. What Tegretol Liquid is and what it's used for
2. Things to consider before you start to take Tegretol Liquid
3. How to take Tegretol Liquid
PACKAGE LEAFLET: INFORMATION FOR THE USER TEGRETOL® LIQUID 100mg/5ml
(carbamazepine)
This product will be referred to as Tegretol Liquid throughout the remainder of this leaflet.
What you need to know about Tegretol Liquid
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you don't understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be 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 Tegretol Liquid is and what it's used for
2. Things to consider before you start to take Tegretol Liquid
3. How to take Tegretol Liquid
4. Possible side effects
5. How to store Tegretol Liquid
6. Further information
Tegretol Liquid is a white suspension tasting of caramel. Carbamazepine, the active ingredient in Tegretol Liquid, can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders.
Tegretol is used
• To treat some forms of epilepsy
• To treat a painful condition of the face called trigeminal neuralgia
• To help control serious mood disorders when some other medicines don't work.
Some people MUST NOT take Tegretol Liquid. Talk to your
doctor if:
• you think you may be hypersensitive (allergic) to carbamazepine or similar drugs such as oxcarbazepine (T rileptal), or to any of a related group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine). If you are allergic to carbamazepine there is a one in four (25%) chance that you could also have an allergic reaction to oxcarbazepine.
• you think you may be allergic to any of the other ingredients of Tegretol Liquid (these are listed at the end of the leaflet). Signs of a hypersensitivity reaction include swelling of the face or mouth (angioedema), breathing problems, runny nose, skin rash, blistering or peeling.
• you have any heart problems,
• you have ever had problems with your bone marrow,
• you have a blood disorder called porphyria,
• you have taken drugs called monoamine oxidase inhibitors (MAOIs), used to treat depression, within the last 14 days.
A small number of people being treated with anti-epileptics such as carbamazepine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Serious skin rashes (Stevens- Johnson syndrome, toxic epidermalnecrolysis) have been reported with the use of carbamazepine.
Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza-like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first months of treatment.
These serious skin reactions can be more common in people from some Asian countries. The risk of these reactions in patients of Han Chinese or Thai origin may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking carbamazepine.
If you develop a rash or these skin symptoms, stop taking carbamazepine and contact your doctor immediately.
You should also ask yourself these questions before taking Tegretol Liquid. If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because Tegretol Liquid might not be the right medicine for you.
• Are you pregnant or planning to become pregnant?
• Are you breastfeeding?
• Do you suffer from the sort of epilepsy where you get mixed seizures which include absences?
• Do you have any mental illness?
• Are you allergic to an epilepsy medicine called phenytoin?
• Do you have liver problems?
• Do you have kidney problems associated with low sodium blood level or do you have kidney problems and you are taking certain medicines that lower sodium blood levels (diuretics such as hydrochlorothiazide, furosemide)?
• Are you elderly?
• Do you have any eye problems such as glaucoma (increased pressure in the eye) or do you have difficulty retaining your urine?
• Do you have an intolerance to some sugars? (Tegretol Liquid contains sorbitol).
Are you taking other medicines?
Because of the way that Tegretol works, it can affect, and be affected by, lots of other things that you might be eating or medicines that you are taking. It is very important to make sure that your doctor knows all about what else you are taking, including anything that you have bought from a chemist or health food shop. It may be necessary to change the dose of some medicines, or stop taking something altogether.
Tell the doctor if you are taking:
• Hormone contraceptives, e.g. pills, patches, injections or implants. Tegretol affects the way the contraceptive works in your body, and you may get breakthrough bleeding or spotting. It may also make the contraceptive less effective and there will be a risk of getting pregnant. Your doctor will be able to advise you about this, and you should think about using other contraceptives.
• Hormone Replacement Therapy (HRT). Tegretol can make HRT less effective.
• Any medicines for depression or anxiety.
• Corticosteroids ('steroids'). You might be taking these for inflammatory conditions such as asthma, inflammatory bowel disease, muscle and joint pains.
• Anticoagulants to stop your blood clotting.
• Antibiotics to treat infections including skin infections and TB (e.g. ciprofloxacillin).
• Antifungals to treat fungal infections.
• Painkillers containing paracetamol, dextropropoxyphene, tramadol, methadone or buprenorphine.
• Other medicines to treat epilepsy.
• Medicines for high blood pressure or heart problems.
• Antihistamines (medicines to treat allergy such as hayfever, itch, etc).
• Diuretics (water tablets).
• Cimetidine or omeprazole (medicines to treat gastric ulcers).
• Isotretinoin (a medicine for the treatment of acne).
• Metoclopramide or aprepitant (anti-sickness medications).
• Acetazolamide (a medicine to treat glaucoma - increased pressure in the eye).
• Danazol or gestrinone (treatments for endometriosis).
• Theophylline or aminophylline (used in the treatment of asthma).
• Ciclosporin, tacrolimus or sirolimus (immunosuppressants, used after transplant operations, but also sometimes in the treatment of arthritis or psoriasis).
• Drugs to treat schizophrenia (e.g. paliperidone, aripiprazole).
• Cancer drugs (e.g. temsirolimus, cyclophasphamide, lapatinib).
• The anti-malarial drug, mefloquine.
• Drugs to treat HIV.
• Levothyroxine (used to treat hypothyroidism).
• Tadalafil (used to treat impotence).
• Albendazole (used to treat worms).
• Bupropion (used to help stop smoking).
• A herbal remedy called St John's Wort or Hypericum.
• Drugs or supplements containing Vitamin B (nicotinamide).
Pregnancy and breastfeeding
You must discuss your epilepsy treatment with your doctor well before you become pregnant. If you do get pregnant while you're taking Tegretol Liquid you must tell the doctor straightaway. It is important that your epilepsy remains well controlled, but, as with other anti-epilepsy treatments, there is a risk of harm to the foetus. Make sure you are very clear about the risks and the benefits of taking Tegretol Liquid.
Mothers taking Tegretol Liquid can breastfeed their babies, but you must tell the doctor as soon as possible if you think that the baby is suffering side effects such as excessive sleepiness, skin reaction or yellow skin and eyes, dark urine or pale stools.
Will there be any problems with driving or using machinery?
Tegretol Liquid can make you feel dizzy or drowsy, or may cause blurred vision, double vision, or you may have a lack of muscular coordination, especially at the start of treatment or when the dose is changed. If you are affected in this way, or if your eyesight is affected, you should not drive or operate machinery.
Other special warnings
• Tegretol Liquid contains parahydroxybenzoates as preservative. These may cause allergic reactions, which may not appear immediately.
• Drinking alcohol may affect you more than usual. Discuss whether you should stop drinking with your doctor.
• Eating grapefruit, or drinking grapefruit juice, may increase your chance of experiencing side effects.
• Your doctor may want you to have a number of blood tests before you start taking Tegretol and from time to time during your treatment. This is quite usual and nothing to worry about.
The doctor will tell you how much Tegretol Liquid to take and when to take it. Always follow his/her instructions carefully. The dose will be on the pharmacist's label. Check the label carefully. It is important to take the liquid at the right times. If you are not sure, ask your doctor or pharmacist. Keep taking your medicine for as long as you have been told, unless you have any problems. In that case, check with your doctor.
