NAVARIN XR

This medicine contains the active ingredient sodium valproate. This medicine belongs to a group of antiepileptic (anticonvulsants) medicines. These medicines are used to treat epilepsy by stabilizing the abnormal electrical activity in the brain. This unusual electrical brain activity can cause fits or seizures in epilepsy (symptoms like abnormal muscle movements, twitches, visual and taste disturbances, unresponsiveness, loss of consciousness). Sodium valproate is prescribed for the treatment of epilepsy and manic episodes (sudden outbursts of excitement, agitation, irritability or hyperactivity).

Is Sodium valproate suitable for me?

Sodium valproate is not suitable for everyone. Do not use it

• if you are allergic to sodium valproate, or other ingredients of this medicine
• if you have porphyria (blood condition)
• if you have a history of drug or alcohol addiction
• if you have serious kidney or liver disease
• if you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
• if you are under 18 years of age

In particular, you must tell the doctor if you:

• are pregnant or breastfeeding
• have kidney problems
• have fits (epilepsy), brain disease or a metabolic condition affecting your brain
• have a ‘urea cycle disorder’ where too much ammonia builds up in the body
• have an underlying condition called Carnitine palmitoyltransferase type II deficiency
• have an inflammatory condition called systemic lupus erythematosus

Sodium valproate interacts with other medicines. It is most important that you tell the doctor all the medications and herbal supplements that you are currently taking.

See the package leaflet for a complete list of possible contraindications and warnings.

How should I take Sodium valproate?

This medicine is available in form of a prolonged release tablet.

You should take sodium valproate exactly as instructed by your doctor or pharmacist. The dose will be prescribed according to your age, condition and needs.

• For the treatment of mania: the usual starting daily dose is 750 mg. The usual maintenance daily doses are between 1000 mg and 2000 mg.
• For the treatment of epilepsy: the usual starting dose is 600 mg daily. The usual maintenance dose is between 1000 mg and 2000 mg. The maximum dose is 2500 mg.

Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor instructed. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day. Do not take two doses together if you miss a dose.

Read the information leaflet provided with your medication for additional information. Talk to your doctor if you have any additional questions.

What are Sodium valproate side effects?

Like all medicines sodium valproate can cause side effects, including:

• nausea, vomiting
• red, swollen or bleeding gums
• swollen mouth or lips
• stomach ache or diarrhea
• fainting
• nausea
• sedation
• extrapyramidal disorders
• hearing loss
• skin problems such as rashes
• hair loss
• skin rash caused by narrow or blocked blood vessels (vasculitis)
• changes in women’s periods
• increased hair growth in women, acne or excessively oily skin
• breast enlargement in men
• male infertility
• swelling of the feet and legs (edema)
• weight gain
• kidney problems
• headache
• aggression, agitation, disturbance in attention
• abnormal behavior, restlessness, hyperactivity and learning disorder
• tingling or numbness in the hands and feet
• sore muscles and darkened urine
• feeling cold, cold or pale skin, feeling listless and tired (hyperthermia)

Consult a doctor if the side effects are severe. See the package leaflet for a complete list of side effects.