Product Details

Product Information of Tegretol Syrup 2%

What you need to know before you take Tegretol Syrup

Some people MUST NOT take Tegretol Syrup. Talk to your doctor if: • you think you may be hypersensitive (allergic) to carbamazepine or similar drugs such as oxcarbazepine (Trileptal), 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 Syrup (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 epidermal necrolysis) 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. If you experience dizziness, drowsiness, decrease in blood pressure, confusion, due to Tegretol treatment, this may lead to falls. You should also ask yourself these questions before taking Tegretol Syrup. If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because Tegretol Syrup 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, primidone or phenobarbital? • 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 Syrup 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. There is a risk of harm to the unborn child if Tegretol is used during pregnancy. Women of childbearing age should use effective contraception during treatment with Tegretol and for at least two weeks after the last dose (see the information in Section 2 on pregnancy and breastfeeding). It is important to tell your doctor or pharmacist if you are taking any other medicines for epilepsy at the same time as carbamazepine and you are pregnant, think you may be pregnant, or are planning to have a baby (see also the information in Section 2 on pregnancy and breastfeeding). Tell the doctor if you are taking: • Hormone contraceptives, e.g. pills, patches, injections or implants. Tegretol may affect how hormonal contraceptives work and make them less effective at preventing pregnancy. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while you are taking Tegretol. • 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 (brivaracetam). • 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, breastfeeding and fertility Pregnancy If you are a woman who is able to have a baby and are not planning a pregnancy, you should use effective contraception during treatment with Tegretol. Tegretol may affect how hormonal contraceptives, such as the contraceptive (birth control) pill, work and make them less effective at preventing pregnancy. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while you are taking Tegretol. If treatment with Tegretol is discontinued, you should continue using effective contraception for at least two more weeks following discontinuation. If you are pregnant, or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the epilepsy medicine you are taking might pose to your unborn baby. If you are planning to become pregnant you should discuss your epilepsy treatment with your doctor as early as possible before you become pregnant. You should not stop your treatment without discussing this with your doctor. Suddenly stopping may lead to breakthrough seizures which may harm you and your unborn baby. It is important that your epilepsy remains well controlled. Taking carbamazepine during pregnancy increases the chance that the baby may have a physical birth abnormality (major congenital malformations). Studies with women treated with carbamazepine for epilepsy have shown that on average 4-5 babies in every 100 will have serious physical birth abnormalities. This is compared with 2 to 3 babies in every 100 born to women who do not have epilepsy. These abnormalities can develop early in pregnancy, even before you know you are pregnant. The most common types of major congenital malformations reported for carbamazepine include spina bifida (where the bones of the spine are not properly developed); facial and skull malformations including cleft lip/palate; skeletal, heart, urinary tract and sexual organ malformations. Studies have found that the risk of physical birth abnormalities increases with increasing doses of carbamazepine. Therefore, it is important that where possible you are prescribed the lowest dose to control your epilepsy. Ask your doctor about taking folic acid when trying for a baby and during pregnancy. Folic acid may lower the general risk of serious physical birth abnormalities that exists with all pregnancies. Taking more than one epilepsy medicine at the same time may also increase the risk of physical birth abnormalities. This means that where possible, your doctor should consider using one epilepsy medicine to control your epilepsy. Studies suggest that taking carbamazepine during pregnancy does not increase the risk the child may have difficulties with learning and thinking ability. If you take Tegretol during pregnancy, your baby is also at risk for bleeding problems right after birth. Your doctor may give you and your baby a medicine to prevent this. Breastfeeding Mothers taking Tegretol Syrup 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. Fertility You should use an effective method of contraception throughout your treatment with Tegretol and for a period of 28 days, after discontinuation of treatment. Irregularity of the menstrual period may occur in women taking hormonal contraceptives (birth control medicines) and Tegretol. The hormonal contraceptive may become less effective and you should consider using a different or additional non-hormonal contraceptive method. Ask your doctor about effective contraception. Will there be any problems with driving or using machinery? Tegretol Syrup 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. Tegretol Syrup contains propyl hydroxybenzoate, methyl hydroxybenzoate, sorbitol and propylene glycol: • Propyl hydroxybenzoate (E 216) and methyl hydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). • Sorbitol (E 420): This medicine contains 175 mg sorbitol in each milliliter, which is equivalent to 175 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. • Propylene glycol (E1520): This medicine contains 125 mg propylene glycol in each 100 mg/5ml, which is equivalent to 25 mg/ml. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol. Information about sodium content: This medicine contains less than 1mmol sodium (23mg) per ml, that is to say essentially ‘sodium free’. Other special warnings • 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.