Degranol 200 mg Tablets

DEGRANOL is an anticonvulsant medicine used to prevent fits. DEGRANOL is also used in the treatment of certain types of pain and to control mood disorders.

Do not take DEGRANOL:

• If you are allergic (hypersensitive) to carbamazepine or similar medicines such as oxcarbazepine, tricyclic antidepressants (amitriptyline or imipramine), or any other ingredients of DEGRANOL (see WHAT DEGRANOL CONTAINS).
• If you have any heart problems.
• If you have ever had problems with your bone marrow.
• If you have a blood disorder called porphyria.
• If you have taken medicines called monoamine oxidase inhibitors (MAOIs), used to treat depression, within the last 14 days.
• If you are pregnant and breastfeeding.
• If you have liver disease.

Take special care with DEGRANOL:

• If you have an inherited allelic variant HLA-B*1502 as you are genetically at greater risk of having serious skin reactions. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians.
• If you have tumours of the liver.
• If you have suicidal tendencies.
• If you have mixed seizures.
• If you have heart, liver or kidney disorders.
• If you have glaucoma (raised pressure in the eye).
• Blood counts and liver function tests should be done before starting treatment with DEGRANOL.
• Tolerance to DEGRANOL may develop and it can be overcome by increasing and adjusting the maintenance dose.
• Do not stop taking DEGRANOL suddenly. DEGRANOL should be withdrawn gradually to minimise the risk of a potential seizure. The change-over period to another antiepileptic medicine should be done in combination with diazepam or a barbiturate.
• Do not take alcohol during treatment with DEGRANOL.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding while taking DEGRANOL, please consult your doctor, pharmacist or other healthcare provider for advice.

Driving and using machinery:

Reaction time may be increased by DEGRANOL. The patient’s safety as a road user or operator of machines may be impaired as a consequence. Do not operate machines or drive whilst taking DEGRANOL, until you know how you will react to it.

Taking other medicines with DEGRANOL:

If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of DEGRANOL with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.

Always use DEGRANOL exactly as your doctor has told you. You must check with your doctor if you are not sure.

The dose of DEGRANOL for trigeminal neuralgia (a nerve disorder that causes a stabbing pain in parts of your face): An initial dose of 200 mg twice daily gradually increasing until a suitable response is obtained. The usual dosage required is one tablet three or four times daily. In elderly or hypersensitive patients an initial dose of half a tablet (100 mg) twice daily is recommended.

Epilepsy:

Dosage for adults: Initially 100 mg to 200 mg once or twice daily, followed by a slow increase until usually, at a level of 400 mg twice or three times daily, the best response is obtained. In some instances 1600 mg in 3 to 4 divided doses may be necessary.

Dosage for children: Administered in several fractional doses, usually 10 to 20 mg/kg per day. 5 to 10 years: 400 to 600 mg (2 to 3 tablets) per day. 10 to 15 years: 600 to 1000 mg (3 to 5 tablets) per day.

Even if you feel better, do not stop taking DEGRANOL without talking to your doctor.

If you take more DEGRANOL than you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison centre.

If you forget to take DEGRANOL:

If you miss a dose of DEGRANOL, take it as soon as you remember. If it is nearly time for the next dose, skip the missed dose and go back to your normal dosing schedule. Do not take a double dose to make up for forgotten individual doses.

Do not stop taking DEGRANOL without talking to your doctor first. Do not stop taking DEGRANOL unless your doctor tells you to. If you suddenly stop taking DEGRANOL you may have a seizure. Even when you feel better, do not stop taking DEGRANOL. Talk to your doctor first. If you have any further questions on the use of DEGRANOL, ask your doctor.

DEGRANOL can cause side effects, although not everybody gets them. Tell your doctor if you experience any of the following symptoms after taking DEGRANOL. If any of the following happens, stop taking DEGRANOL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.
• Yellowing of your skin and eyes (also called jaundice).

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

• Fever, sore throat, rash, sores in your mouth, swollen glands or more easily getting infections (signs of lack of white blood cells).
• Tiredness, headache, being short of breath when exercising, dizziness, looking pale, frequent infections leading to fever, chills, sore throat (lack of all blood cells).
• Serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth, or skin peeling accompanied by fever.

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Not all side effects reported for DEGRANOL are included in this leaflet. Should your general health worsen while taking DEGRANOL or if you notice any side effects not listed in this leaflet, please consult your doctor, pharmacist or other healthcare professional for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C. Protect from moisture. Store in airtight containers. Do not store in a bathroom. Do not use DEGRANOL after the expiry date which is stated on the box after the letters EXP. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). KEEP OUT OF REACH AND SIGHT OF CHILDREN.