Bio – Carbamazepine Tablets

Carbamazepine, the active ingredient in BIO - CARBAMAZEPINE 200, can affect the body in several different ways. It is an anti - convulsant medicine (prevents fits). It can also modify some types of pain.

BIO - CARBAMAZEPINE 200 is used:

• To treat some forms of epilepsy.
• To treat a painful condition of the face called trigeminal neuralgia.
• To treat a painful condition occurring in the back of the throat, tongue and ear called idiopathic glossopharyngeal neuralgia.

Do not take BIO - CARBAMAZEPINE 200:

• If you are allergic (hypersensitive) to carbamazepine, similar medicines such as tricyclic antidepressants (used to treat mood disorders) or to any of the other ingredients of BIO - CARBAMAZEPINE 200 (listed in section 6).
• If you have ever had problems with your bone marrow.
• If you have a heart problem called heart block.
• If you have taken medicines called monoamine oxidase inhibitors (MAOIs), used to treat depression, within the last 14 days.
• If you have a blood disorder called porphyria.
• If you are breastfeeding (see Pregnancy and breastfeeding).
• If you have a history of one of the following severe skin conditions:

• Stevens - Johnson syndrome (SJS)
• toxic epidermal necrolysis (TEN).

If you are not sure if any of the above applies to you, please talk to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist or pharmacist before taking BIO - CARBAMAZEPINE 200:

• A small number of people being treated with anti - epileptics such as BIO - CARBAMAZEPINE 200 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 BIO - CARBAMAZEPINE 200 (see section 4). 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 BIO - CARBAMAZEPINE 200.
• If you develop a rash or these skin symptoms, stop taking BIO - CARBAMAZEPINE 200 and contact your doctor immediately.
• If you experience dizziness, drowsiness, decrease in blood pressure, confusion, due to BIO - CARBAMAZEPINE 200 treatment, this may lead to falls.
• Your doctor may want you to have a number of blood tests before you start taking BIO - CARBAMAZEPINE 200 and from time to time during your treatment. This is quite usual and nothing to worry about.

Talk to your doctor before taking BIO - CARBAMAZEPINE if any of the following applies to you. BIO - CARBAMAZEPINE 200 might not be the right medicine for you:

• You are pregnant or planning to become pregnant.
• You suffer from the sort of epilepsy where you get mixed seizures which include absences.
• You have any mental illness.
• You are allergic to an epilepsy medicine called phenytoin, primidone or phenobarbital.
• You have liver problems.
• You have kidney problems associated with low sodium blood level or you have kidney problems and you are taking certain medicines called diuretics that lower sodium blood levels (such as hydrochlorothiazide, furosemide).
• You are an elderly person.
• You have eye problems such as glaucoma (increased pressure in the eye) or you have difficulty retaining your urine.

Do not share medicines prescribed for you with any other person. Always take BIO - CARBAMAZEPINE 200 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

To treat epilepsy the usual doses are:

• Adults: 800 – 1 200 mg a day, although higher doses may be necessary. If you are elderly, you might require a lower dose.
• Children: Aged up to 1 year: 100 – 200 mg a day. Aged 1 – 5 years: 200 – 400 mg a day. Aged 5 – 10 years: 400 – 600 mg a day. Aged 10 – 15 years: 600 – 1 000 mg a day.

To treat trigeminal neuralgia the usual dose is: 400 – 800 mg a day. The maximum dose is 1 600 mg a day. If you are elderly, you might require a lower dose.

Your doctor will tell you how long your treatment with BIO - CARBAMAZEPINE 200 will last. Do not stop treatment early because it may cause your condition to worsen.

If you have the impression that the effect of BIO - CARBAMAZEPINE 200 is too strong or too weak, talk to your doctor or pharmacist.

If you take more BIO - CARBAMAZEPINE 200 than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and any remaining tablets with you, so that your doctor knows what you have taken.

If you forget to take BIO - CARBAMAZEPINE 200

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and then go on as before. Do not take two dosages at the same time.

BIO - CARBAMAZEPINE 200 can have side effects. Not all side effects reported for BIO - CARBAMAZEPINE 200 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BIO - CARBAMAZEPINE 200, please consult your health care provider for advice.

If any of the following happens, stop taking BIO - CARBAMAZEPINE 200 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BIO - CARBAMAZEPINE 200. 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:

• Mouth ulcers or unexplained bruising or bleeding.
• Sore throat or fever - high temperature, or both.
• Jaundice (yellowing of the skin and eyes, dark urine, and tiredness), which may be symptoms of liver problems.
• Swollen ankles, feet or lower legs (oedema).
• Any signs of nervous illness (depression, restlessness, agitation, aggression) or confusion.
• Lupus erythematosus (pain in your joints and muscles, a rash across the bridge of the nose and cheeks and problems with breathing).
• multi - organ sensitivity disorder (fever, skin rash, joint pain, and abnormalities in blood and liver function tests).
• abdominal pain (pain in the area near the stomach).
• you experience a fall due to dizziness, drowsiness, decrease in blood pressure, confusion.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• Leucopenia (a reduced number of the cells which fight infection making it easier to catch infections).
• Dizziness and tiredness.
• Feeling unsteady or finding it difficult to control movements.
• Feeling sick (nausea) or being sick (vomiting).
• Changes in liver enzyme levels (usually without any symptoms).
• Skin reactions which may be severe.
• Changes in the blood including an increased tendency to bruise or bleed.
• Fluid retention and swelling.
• Increase in body weight.
• Low sodium in the blood which might result in confusion.
• Headache.
• Blurred vision or other vision problems.
• Dry mouth and throat.

The following side effects have been reported less frequently:

• Abnormal involuntary movements including tremor or tics.
• Abnormal eye movements.
• Constipation or diarrhoea.
• Disease of the lymph glands.
• Folic acid deficiency.
• Hallucinations.
• Loss of appetite.
• Speech disorders.
• Numbness or tingling in the hands and feet.

• Store all medicines out of reach of children.

• Store at or below 25 °C. Keep well closed and protect from moisture.

• Do not store in your bathroom, to limit the contact with moisture in the surrounding air.

• Do not take your tablets after the expiry date stated on the container or outer carton.

• Please return all unused or expired medicines to your pharmacist and do not dispose of these medicines in drains or sewerage systems (via wastewater or household waste).