Tegretol ® 200 mg Tablets

What TEGRETOL is

The active substance of TEGRETOL is carbamazepine. TEGRETOL belongs to a group of medicines called antiepileptics (medicine for seizures). TEGRETOL is used to treat certain types of seizures (epilepsy). It is also used to treat some neurological diseases (such as a painful condition of the face called ‘trigeminal neuralgia’) as well as certain psychiatric conditions (mania episodes of bipolar mood disorders and a certain type of depression).

The risk of serious skin reactions in patients of Han Chinese or Thai origin associated with carbamazepine or chemically related compounds 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 TEGRETOL.

Do not take TEGRETOL:

• If you think you may be hypersensitive (allergic) to carbamazepine or similar medicines such as oxcarbazepine (Trileptal), or to any of a related group of medicines 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.
• If you are allergic (hypersensitive) to carbamazepine or to any of the other ingredients of TEGRETOL listed in this leaflet. Signs of a hypersensitivity reaction include swelling of the face or mouth (angioedema), breathing problems, runny nose, skin rash, blistering or peeling.
• If you have severe heart disease.
• If you have had serious blood illnesses in the past.
• If you have a disturbance in the production of porphyrin, a pigment important for liver function and blood formation (also called ‘porphyria’).
• If you have taken medicines belonging to a group of antidepressants called monoamine-oxidase inhibitors (MAOIs), within the last 14 days.
• Do not breastfeed your baby if you are taking TEGRETOL.
• If you previously developed a serious skin rash (Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). If this applies to you, tell your doctor before taking TEGRETOL. If you think you may be allergic, ask your doctor for advice.

Warnings and Precautions: Take special care with TEGRETOL:

• If you have blood illnesses (including those caused by other medicines).
• If you have ever shown unusual sensitivity (rash or any other signs of allergy) to carbamazepine, oxcarbazepine or to any other medicines. It is important to note that if you are allergic to carbamazepine, the chances are approximately 1 in 4 (25 %) that you could also have an allergic reaction to oxcarbazepine.
• If you have or have had heart, liver or kidney disease in the past.
• If you have increased pressure in the eye (glaucoma) or if you have difficulty or pain when passing urine.
• If you were told by your medical practitioner that you suffer from a mental disorder called psychosis that may be accompanied by confusion or agitation.
• If you are a female of childbearing age, you should use an effective method of contraception throughout your treatment and for 2 weeks after your last dose. If you are taking a hormonal contraceptive (birth control medicine), TEGRETOL may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking TEGRETOL.
• Tell your doctor at once if you get irregular vaginal bleeding or spotting. If you have any questions about this, ask your doctor or health professional.
• Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss with you the potential risk of taking TEGRETOL during pregnancy since it may cause harm or abnormalities in the unborn child (see section “Pregnancy”).

Do not share medicines prescribed for you with any other person.

Always take TEGRETOL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. This will help you to get the best results and reduce the chance of serious side-effects. Do not take extra unprescribed doses of TEGRETOL, do not take it more often, and do not take it for a longer time than your doctor tells you. Your doctor will tell you how long your treatment with TEGRETOL will last. If you are taking TEGRETOL, do not suddenly stop taking it without first checking with your doctor. If you have the impression that the effect of TEGRETOL is too strong or too weak, tell your doctor or pharmacist.

Treatment of epilepsy with all forms of tablets and oral suspension is usually started at 100 to 200 mg once or twice a day in adults. The dosage is then gradually increased to 800 to 1 200 mg a day (in some patients 1600 mg a day may be needed), divided in 2 or 3 intakes. Treatment in children is usually started at 100 to 200 mg day (based on 10 to 20 mg/kg body weight daily) and kept at 400 to 600 mg a day. Adolescents may receive between 600 and 1 000 mg a day. For trigeminal neuralgia the starting dosage of 200 to 400 mg a day is slowly raised until there is no pain (usually 200 mg 3 to 4 times a day). For elderly patients a lower starting dose, 100 mg twice a day, is recommended. For acute mania and maintenance treatment of bipolar affective disorders the usual dosage is 400 to 600 mg a day (dosage range: about 400 to 1 600 mg a day). Your doctor will tell you exactly how many doses of TEGRETOL to take.

TEGRETOL is always (except possibly on the first day) given in divided daily doses, i.e. 2 to 4 times a day, depending on your medical condition. The dose prescribed by your doctor may be different from those listed above. In this case follow your doctor’s instructions. Take TEGRETOL during or after a meal. Swallow the tablets with some liquid; if necessary, the tablets may be broken in half along the line.

If you take more TEGRETOL than you should

If you experience difficulty in breathing, a fast and irregular heartbeat, loss of consciousness, fainting, shakiness, sickness and/or vomiting, your dose may be too high. Stop taking your medicine and inform your doctor without delay. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take TEGRETOL

If you forget to take a dose, take it as soon as possible. However, if it is almost time for your next dose, do not take the missed one; just go back to your regular dosing timetable. Do not double the dose to make up for the forgotten dose.

TEGRETOL can have side-effects. Not all side effects reported for TEGRETOL are included in this leaflet. Should your general health worsen while taking TEGRETOL, please consult your health care provider for advice.

If any of the following happens, stop taking TEGRETOL and tell your doctor immediately or go to the casualty department at your nearest hospital: They may be early signs of serious damage to your blood, liver, kidneys or other organs and may urgently need medical treatment.

• If you have swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives and generalised itching, rash, fever, abdominal cramps, chest discomfort or tightness, difficulty breathing, unconsciousness (signs of angioedema and severe allergic reactions).
• If you have fever, sore throat, rash, ulcers in the mouth, swollen glands or more easily getting infections (signs of lack of white blood cells).
• If you have tiredness, headache, being short of breath when exercising, dizziness, looking pale, frequent infections leading to fever, chills, sore throat or mouth ulcers; bleeding or bruising more easily than normal, nose bleeds (lack of all blood cells).
• If you have red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of systemic lupus erythematosus).
• If you have any yellowing of the white of your eyes or your skin (signs of hepatitis).
• If you have darkening of urine (signs of porphyria or hepatitis).
• If you have severe decreased urine output due to kidney disorders, blood in the urine.
• If you have severe upper abdominal pain, vomiting, loss of appetite (signs of pancreatitis).
• If you have skin rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, accompanied by fever, chills, headache, cough, body aches (signs of serious skin reactions).
• If you have lethargy, confusion, muscular twitching or significant worsening of convulsions (symptoms that may be linked to low sodium levels in the blood).
• If you have fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light (signs of meningitis).
• If you have muscular stiffness, high fever, altered consciousness, high blood pressure, excessive salvation (signs of neuroleptic malignant syndrome).
• If you have irregular heartbeat, chest pain.
• If you have disturbed consciousness, fainting.
• If you have diarrhoea, abdominal pain and fever (signs of an inflammation of the colon). The frequency of this side effect is not known.
• If you experience a fall due to dizziness, drowsiness, decrease in blood pressure, confusion. These are all very serious side-effects. If you have them, you may have had a serious allergic reaction to TEGRETOL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Frequent: loss of muscle coordination, allergic skin reactions
• Less frequent: swelling of the ankles, feet or lower legs (oedema), changes in behaviour, confusion, weakness, increase in seizures (fits, due to insufficient amount of sodium in your body), blurred vision, double vision, itching with redness and swelling of the eye (conjunctivitis), feeling pressure/pain in the eye (signs of increased pressure in the eye), trembling, uncontrolled body movements, muscle spasms, uncontrolled eye movements, itching, swollen glands, agitation or hostility (especially in the elderly), fainting, difficulty in speaking or slurred speech, depression with restlessness, nervousness or other mood or mental changes, hallucinations (seeing/hearing things that are not there), ringing or other unexplained sounds in the ears, decreased hearing, troubled breathing, chest pain, fast or unusually slow heartbeat, numbness, tingling in hands and feet, frequent urination, sudden decrease in amount of urine, taste disturbances, unusual secretion of breast milk, breast enlargement in men, swelling and redness along a vein which is extremely tender when touched, often experienced as painful (thrombophlebitis), increased sensitivity of the skin to sun, softening or thinning or weakening of bones causing an increased risk of broken bones (lack of vitamin D, osteoporosis).

Some side effects are of unknown frequency: reactivation of herpes virus infection (can be serious when the immune system is depressed), complete loss of the nails, bone fracture, decrease in the bone density. These are all serious side-effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects: vomiting, nausea, dizziness, sleepiness, unsteadiness, weight gain.
• Less frequent side effects: headache, dry mouth, constipation, diarrhoea, abdominal pain, aching joints or muscles, increased sweating, loss of appetite, loss of hair, sexual disturbances, male infertility, red and sore tongue, mouth sores, alterations in skin pigmentation, acne.
• Some side effects are of not known frequency: drowsiness, memory loss, purple or reddish-purple bumps that may be itchy.

If any of these affects you severely, tell your doctor. If you notice any side-effects not mentioned in this leaflet, please inform your doctor or pharmacist.

TEGRETOL ® 200 Store at or below 30 °C and protect from moisture. TEGRETOL CR ® 200 and TEGRETOL ® CR 400 Store at or below 30 °C and protect from moisture. TEGRETOL ® S Store below 30 °C and protect from light. Store all medicines out of the reach of children. Return any unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).