Eprolep CR Film-Coated Tablets

EPROLEP CR is used to treat epilepsy (fits) in adults.

Do not take EPROLEP CR if you:

• are hypersensitive (allergic) to sodium valproate or any of the ingredients of EPROLEP CR (signs of allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue).
• are pregnant or breast feeding.
• have liver or pancreas problems or you or your family have a history of liver problems.
• have porphyria (hereditary disorders that may affect the skin or nervous system).
• suffer from blood coagulation (clotting) disorders.
• have “urea cycle disorder” where too much ammonia builds up in the body.
• are taking medicines called monoamine oxidase inhibitors (such as selegiline, phenelzine) – see Taking other medicines with EPROLEP CR.
• are an elderly person.

Do not take EPROLEP CR if any of the above apply to you. If you are not sure, talk to your doctor pharmacist or healthcare professional before taking EPROLEP CR.

Take special care with EPROLEP CR

The presence of other medical problems may affect the use of EPROLEP CR. Talk to your doctor, pharmacist or healthcare professional before taking EPROLEP CR if you:

• have a liver problem (see Liver damage below).
• have kidney problems, as your doctor may give you a lower dose.
• have diabetes, as this medicine may affect the results of urine tests.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking EPROLEP CR. You will need to take extra care in cleaning your teeth to prevent infection.
• have an illness called “systemic lupus erythematosus (SLE)” – a disease of the immune system which affects skin, bones, joints and internal organs.

Always take EPROLEP CR exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of EPROLEP CR is too strong or too weak, you should talk to your doctor or pharmacist.

Do not share medicines prescribed for you with any other person. It is important to take EPROLEP CR every day. Do not discontinue treatment without discussing it with your doctor.

The tablets should be swallowed whole with a little water and must not be crushed. Take EPROLEP CR twice daily with food.

Adults: The starting dose is 600 mg daily. Your doctor will gradually increase this dose by 200 mg every 3 days, depending on your condition and how you respond to treatment.

If you take more EPROLEP CR than you should

You may experience an increase in side effects and their frequency. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

If you forget to take EPROLEP CR

If you miss a dose of EPROLEP CR, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses to make up for a forgotten dose.

EPROLEP CR can have side effects. Not all side effects reported for EPROLEP CR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

If you get any of the following very serious side effects, stop taking EPROLEP CR and tell your doctor immediately, or go to the casualty department at your nearest hospital:

• Allergic reactions (including swelling of the face, eyelids, lips, tongue, throat; difficulty in breathing and swallowing). You may need urgent medical attention. Very serious side effects occur less frequently.

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

• changes in the amount of ammonia in the blood (symptoms are vomiting, problems with balance, feeling less alert);
• liver problems (being nauseous and vomiting many times, being very tired, sleepy and weak, stomach pain, yellowing of the skin or whites of the eye);
• inflammation of the pancreas (acute abdominal pain);
• chest pain; shortness of breath; see also Take special care with EPROLEP CR above.

These are all serious side effects. You may need urgent medical attention. Serious side effects occur less frequently.

Store in the original packaging (keep blisters in the carton in order to protect from light and moisture) at or below 25 °C. Do not store your medicine in the bathroom. Do not take EPROLEP CR after the expiry date printed on the label, container or blister. Return any expired or unused medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.