Valeptic 200 mg/5 ml Syrup

Sodium Valproate, the active ingredient in VALEPTIC SYRUP, belongs to a group of medicines called anti-convulsants or anti-epileptics. VALEPTIC SYRUP is used in the treatment of epilepsy (fits) or seizures. It works by controlling the activity of the brain.

Do not take VALEPTIC SYRUP:

• if you are hypersensitive (allergic) to sodium valproate or any of the other ingredients of VALEPTIC SYRUP (listed in section 6).
• If you are a woman able to have a baby, you must not take VALEPTIC SYRUP unless you use an effective method of birth control (contraception) at all times during your treatment with VALEPTIC SYRUP. Do not stop taking VALEPTIC SYRUP or your contraception until you have discussed this with your doctor. Your doctor will advise you further (see below under ‘Pregnancy, breast- feeding and fertility – Important advice for women’).
• if you are pregnant or breastfeeding (see Pregnancy, Breastfeeding and fertility).
• if you have liver disease such as: inflammation (pain, swelling) of the liver, family history of liver disorders.
• if you have a known metabolic disorder, i.e a urea cycle disorder.
• if you have a rare illness called porphyria (enzyme deficiency in the liver that affects the breakdown of components of red blood cells).
• if you are taking medicines that are part of a class of medicines known as Monoamine Oxidase Inhibitors (MAOI) used to treat depression.
• if you have a genetic problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome).

Warnings and precautions

Take special care with VALEPTIC SYRUP:

• VALEPTIC SYRUP can cause severe liver damage and can result in death. You are most at risk if you are an infant or a young child under the age of 3 with severe disorders particularly those with brain damage, reduced mental abilities and (or) diseases present since birth. After the age of 3, the incidence of occurrence is reduced and decreases with age. In most cases, such liver damage occurs during the first 6 months of therapy.
• If you have any of the following symptoms or notice any of the following symptoms in your child contact your doctor or healthcare professional immediately.
• Sudden onset of feeling of weakness, loss of appetite, tiredness, oedema and drowsiness which are sometimes associated with repeated vomiting and abdominal pain.
• If you are suffering from epilepsy (fits), you may experience a recurrence of seizures.
• Investigations including clinical examination and biological assessment of the liver function will be undertaken immediately by your doctor. Liver function tests will be performed before treatment and then will periodically be monitored during the first 6 months of therapy. Your doctor will then decide whether to continue your treatment with VALEPTIC SYRUP.
• If you are using salicylates (medicines such as aspirin) with VALEPTIC SYRUP these will be discontinued.
• You may experience severe pancreatitis (swelling and constant pain in the abdomen or reaching to the back and other areas) and death may even result. If you are a young child you are at particular risk. This risk is decreased with increasing age. If you suffer from severe fits, neurological (nerve) damage, or are taking medicines for fits you may be at risk to develop pancreatitis (swelling and constant pain in the abdomen or reaching to the back and other areas). Liver failure with pancreatitis (swelling and constant pain in the abdomen or reaching to the back and other areas) increases the risk of death.
• If you experience sudden stomach pain contact your doctor or healthcare practitioner immediately. If you are diagnosed with pancreatitis (swelling and constant pain in the abdomen, or reaching to the back and other areas) VALEPTIC SYRUP should be discontinued.

Do not share medicines prescribed for you with any other person. Always take VALEPTIC SYRUP exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you sure.

• Your doctor will decide how much VALEPTIC SYRUP to give you or your child depending on the child’s body weight.
• VALEPTIC SYRUP should be taken by mouth.
• Take VALEPTIC SYRUP in 2 separate doses. The usual dose of VALEPTIC SYRUP is:

Adults:

Initially 600 mg/day, in divided doses. Your doctor may increase it by 200 mg/day at three day intervals until control is achieved; this is generally within the range of 1000 to 2 000 mg/day. If adequate control has not been achieved after two weeks, your doctor may further increase the dose in stages, to a maximum of 2 500 mg/day, or one other medication used for fits may be added at a low dosage.

Children weighing more than 20 kg:

Initial dosage is 400 mg/day. The doctor may increase the dose gradually until control is achieved. This is usually within the range of 20 to 30 mg/kg of body mass per day. If adequate control is not achieved within this range, your doctor may increase the dose to 35 mg/kg body mass per day.

Children weighing less than 20 kg:

The usual dose is 20 mg/kg of body mass per day in severe cases. Your doctor may increase this dose.

Elderly patients

– If you are old you may be given a lower dosage of VALEPTIC SYRUP. Your doctor will tell you how long your treatment with VALEPTIC SYRUP will last. Do not stop treatment early. If you have the impression that the effect of VALEPTIC SYRUP is too strong or too weak, tell your doctor or pharmacist.

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

If any of the following happens, stop taking VALEPTIC SYRUP 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
• sudden life-threatening severe allergic reactions which may cause difficulty in swallowing and breathing

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

• Group of disorders caused by blood cells that are poorly formed or don’t work properly (myelodysplastic syndrome).
• a disease in which the functioning of the brain is affected by some agent or condition (such as viral infection or toxins in the blood) (encephalopathy in patients with urea cycle disorders).
• difficult breathing (dyspnoea)
• Pancreatitis (swelling and constant pain in the abdomen, or reaching to the back and other areas). This condition can result in death.
• Liver failure. This may show as a sudden illness which may happen in the first six months of treatment. This happens in a small number of people taking VALEPTIC SYRUP. It includes feeling sick being very tired, sleepy and weak. You may have stomach pain including very bad upper stomach pain, jaundice (yellowing of the skin or whites of the eyes), loss of appetite, swelling (especially of the legs and feet but may include other parts of the body), worsening of your fits or general feelings of being unwell.

Store all medicines out of reach of children. Store in a dry place at or below 25 ºC, away from direct sunlight. Protect from light. Do not use after the expiry date stated on the pack. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).