Valeptic CR 300 mg Film-Coated Tablets

VALEPTIC CR belongs to a group of medicines called anticonvulsants or antiepileptics. It is used in the treatment of fits or seizures. It works by controlling the activity of the brain. It is also used to treat certain mental disorders, because of its mood stabilising effect.

Your doctor may therefore prescribe VALEPTIC CR for you:

• To treat partial seizures (fits which affect only one part of your brain).
• To treat generalised seizures (fits which affect the whole or larger part of your brain and may affect your level of consciousness).
• To prevent and treat mania of bipolar disorders (symptoms of great excitement or elation of mood etc. associated with mental illness).

Do not take VALEPTIC CR:

• If you are hypersensitive (allergic) to sodium valproate, to peanuts or soya or to any of the other ingredients used in VALEPTIC CR (see section 6)
• If you are breastfeeding your baby (see Pregnancy and breastfeeding and fertility).
• If you are pregnant.

For the treatment of epilepsy:

• if you are pregnant, unless there is no suitable alternative treatment (see “Pregnancy, breastfeeding and fertility”)
• if you are able to have a baby, unless the conditions of the pregnancy prevention programme are met (see “Pregnancy, breastfeeding and fertility”)

For the treatment of bipolar disorder:

• if you are pregnant
• if you are a woman able to have a baby, unless the conditions of the pregnancy prevention programme are met (see “Pregnancy, breastfeeding and fertility”)
• If you have liver disease such as:
• Inflammation (pain, swelling) of the liver lasting less than six months
• Family history of liver disorders especially if it is due to the use of certain medicines
• Porphyria (enzyme deficiency in the liver that affects the breakdown of components of red blood cells)
• If you have a known metabolic disorder, i.e. a urea cycle disorder
• If you have been told you have a genetic problem caused by a mitochondrial disorder (e.g. Alpers- Huttenlocher syndrome).

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

Always take VALEPTIC CR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

VALEPTIC CR is a controlled release formulation which minimises fluctuations in your blood concentration and ensures a more even concentration throughout the day.

VALEPTIC CR 300 and VALEPTIC CR 500 tablets:

• Should be taken orally
• Should preferably be taken with or after food
• Tablets should be swallowed whole, if necessary with a little water (but not with aerated mineral water)
• Tablets should not be crushed or chewed

Your daily dosage requirements may vary according to your age and body weight. Your dose may be prescribed once or twice daily.

The usual dose of VALEPTIC CR in the treatment of epilepsy is:

• Adults:
• Your dosage should start at 600 mg/day, in divided doses where applicable
• Your dosage should be increased by 5 to 10 mg/kg/day at weekly intervals until your fits or seizures are controlled
• Your dosage should be within the range of 1 000 to 2 000 mg/day
• Your dosage should be increased in stages, to a maximum of 2 500 mg/day, or one other anti-epileptic medicine may be added at a low dosage
• If you are already receiving other therapy, the same pattern should be followed.
• If you experience increased sedation, then your dosage of barbiturates or benzodiazepines (medicines which treat anxiety) should be reduced as that of VALEPTIC CR is increased.
• If you are taking more than one medicine, then your dosage of both VALEPTIC CR and other medicines used should be adjusted, to give optimum control at the lowest possible dose.

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

If any of the following happens, stop taking / using VALEPTIC CR 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 reaction to VALEPTIC CR. 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: These are very serious side effects of VALEPTIC CR. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent:
• nausea
• vomiting
• abdominal pain
• diarrhoea
• hair loss
• redness
• dizziness
• hearing loss
• headache
• excess of ammonia in blood
• low sodium level in blood
• gingival (gum) problems especially overgrowth
• sore mouth, swollen mouth, mouth ulcers and burning feeling of mouth (stomatitis).
• hair loss. When it grows back it may be curlier than before
• weight gain (as your appetite may be increased)
• painful periods
• leaking urine by accident
• aggression, agitation, disturbance in attention
• bleeding of excess of blood from damaged blood vessel
• deficiency of platelets in the blood

Store in a cool, dry place, at or below 25 °C.

Store in the original bottle. Protect from light. Keep the bottle tightly closed to protect from moisture.

Do not store in a bathroom. Do not use after the expiry date stated on the carton/bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicines in drains or sewerage systems (e.g., toilets).

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.