Epitec Tablets

EPITEC contains the active substance lamotrigine, and belongs to a group of medicines called anticonvulsants or antiepileptics. They are also sometimes called antiseizure medicines.

Epilepsy

EPITEC is used to treat various types of epilepsy (seizures) in adults and children, including seizures associated with Lennox-Gastaut syndrome. EPITEC may be used on its own to treat adults and children over 12 years. EPITEC can also be used in combination with other antiepileptic medicines in both adults and children aged 2 years and over. Sometimes other anti-epileptic medicines may be stopped after EPITEC has been started.

Bipolar disorder

Apart from the treatment of epilepsy (seizures) EPITEC is also indicated for the treatment of bipolar mood disorder in adult patients. Bipolar disorder is a mood disorder characterised by episodes of depression that alternates with episodes of extremely elevated mood (also known as mania). EPITEC should not be used to treat bipolar disorder in children under 18 years of age.

Do not take EPITEC:

• if you are hypersensitive (allergic) to lamotrigine or any of the other ingredients of EPITEC (listed in section 6).
• EPITEC should not be administered to children younger than 2 years of age, since safety and efficacy in this age group have not been demonstrated.

Warnings and precautions

Take special care with EPITEC:

• if you have ever developed a rash after taking EPITEC or other medicines for bipolar disorder or epilepsy
• if you have ever developed meningitis after taking EPITEC (read the description of these symptoms in section 4 of this leaflet: Less frequent side effects)
• if you are already taking medicine that contains lamotrigine
• if you have a history of heart problems or irregular heart beats or any of your family members have any heart problem, including a condition called Brugada syndrome which is a genetic disease that affects the heart
• if you suffer from kidney or liver problems, because you will require adjustments of your EPITEC dosage. Please inform your doctor if you have kidney or liver function impairment
• if you are pregnant or want to become pregnant. If any of these apply to you, tell your doctor, who may decide to lower the dose, or decide that EPITEC is not suitable for you.

Conditions you need to look out for:

• Important information about potentially serious skin reactions: Some people taking EPITEC get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems such as organ failure if they are not treated. These can include Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). You need to know the symptoms to look out for while you are taking EPITEC. This risk may be associated with a variant in genes in people from Asian origin (mainly Han Chinese and Thai). If you are of such origin and have been tested previously carrying this genetic variant (HLA-B* 1502), discuss this with your doctor before taking EPITEC.
• Serious immune system condition (haemophagocytic lymphohistiocytosis or HLH): A serious immune system condition, in which the part of the body that fights disease is overactive. Although it has been reported very rarely in people taking EPITEC, it can be life-threatening. If you have any of the associated symptoms, immediately report them to your doctor.
• Thoughts of harming yourself or suicide: There have been reports of suicidal behaviour (including suicidal thoughts and suicide attempts) in patients being treated with anti-epileptic medicines such as EPITEC. If at any time you have these thoughts, contact your doctor immediately.

Do not share medicines prescribed for you with any other person. Always take EPITEC exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure. The dose your doctor will prescribe for you depends on the indication (epilepsy or bipolar disorder), your age and weight, as well as on whether you are taking other antiepileptic or other psychiatric medicines. This is especially important if you are taking any medicine containing valproate. The dosage will also depend on whether you have normal kidney and liver function.

Your doctor will tell you how long your treatment with EPITEC will last. Do not stop treatment early. The dose of EPITEC must be increased slowly. It may take several weeks or months before your final dosage can be determined by your doctor, based on your response. Do not increase your dose of EPITEC, or take more frequent doses than those prescribed by your doctor.

How to take/use EPITEC tablets: Swallow EPITEC tablets with a little water. Do not chew.

If you take more EPITEC than you should: If you take too much EPITEC you may be more likely to have serious side effects which may be fatal. Possible side effects if you take too much EPITEC include:

• rapid, uncontrollable eye movements (nystagmus)
• clumsiness and lack of co-ordination, affecting your balance (ataxia)
• impaired or loss of consciousness, fits (convulsions) or coma.

If you take too much EPITEC contact your doctor or your nearest hospital emergency department immediately. If possible, show them the EPITEC pack. 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 EPITEC: Always take EPITEC as prescribed by your doctor. If you miss a dose, take it as soon as you remember. However, if you do not remember the missed dose until the next dose is due, skip the missed dose and carry on with your regular dosing schedule. Do not take two doses to make up for forgotten individual dose.

If you stop taking EPITEC: Take EPITEC for as long as your doctor recommends. Do not stop unless your doctor advises you. If you are taking EPITEC for epilepsy: To stop taking EPITEC, it is important that the dose is reduced gradually, over about 2 weeks. If you suddenly stop taking EPITEC, your epilepsy may come back or get worse. Speak to your doctor before stopping EPITEC.

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

If any of the following happens, stop taking EPITEC and tell your doctor immediately or go to the casualty department at your nearest hospital.

• Potentially serious skin reaction: A small number of people taking EPITEC get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. These symptoms are more likely to happen during the first few months of treatment with EPITEC, especially if the dose is too high or if the dose is increased too quickly, or if EPITEC is taken together with a medicine called valproate. Serious skin reactions are more common in children. Isolated cases have occurred after prolonged treatment (e.g. 6 months).
• Serious immune system condition (haemophagocytic lymphohistiocytosis or HLH): A serious immune system condition, in which the part of the body system that fights disease is overactive, has been reported while taking EPITEC. Although, it has been reported very rarely, it can be life-threatening, so it is important that you know the symptoms to look out for.
• Liver and blood problems: These have been reported less frequently while taking EPITEC. The following symptoms may be accompanied by a general feeling of being sick or unwell.

Frequent side effects include:

• headache
• skin rash
• feeling sleepy, clumsiness and lack of co-ordination (ataxia), feeling dizzy
• aggression, agitation or irritability
• feeling drowsy, difficulty sleeping (insomnia), tremors, rapid, uncontrollable eye movements (nystagmus)
• feeling sick (nausea) or being sick (vomiting), diarrhoea
• feeling tired
• pain in your back, joints or elsewhere

Keep EPITEC in a dry place. Store at or below 25 °C. Keep the blister strips in the outer carton until required for use. Store all medicines out of reach of children. In order to protect from moisture, do not store in bathrooms.

Do not use after the expiry date stated on the carton and blister strips. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).