Proval CR 300 mg Tablet

Proval CR 300 is a controlled-release tablet containing 300 mg sodium valproate, made by General Pharmaceuticals Ltd. It is used under medical supervision to treat epilepsy and certain mood disorders such as bipolar disorder.

Proval CR 300 300 mg tablet is manufactured by General Pharmaceuticals Ltd. and contains Sodium Valproate, a long-established medicine for epilepsy and for bipolar disorder (mood stabilisation). It is highly effective, but it demands careful medical supervision: it carries a major warning in pregnancy because it can cause serious birth defects and developmental problems, and it requires liver monitoring, especially at the start of treatment.

Sodium Valproate works by increasing GABA, the brain's natural calming chemical, and by stabilising overactive nerve cell membranes. This raises the brain's resistance to the abnormal electrical discharges that cause seizures, and it evens out the extreme mood swings of bipolar disorder.

Doctors prescribe Proval CR 300 for:

• Epilepsy — generalised seizures (including tonic-clonic and absence seizures), myoclonic seizures and many focal seizures, in adults and children
• Bipolar disorder — treatment of manic episodes and long-term mood stabilisation
• Migraine prevention in selected patients, at the specialist's discretion

Treatment is usually long-term and must be planned by a neurologist or psychiatrist. For women and girls who could become pregnant, Proval CR 300 is used only when no other treatment works, and always with a specialist pregnancy-prevention plan.

ChamberBD shows dosing only from the approved product label, with its source named, and no label is on file for Proval CR 300 mg Tablet. Use the dose your doctor prescribed and the instructions in the pack leaflet.

Common side effects of Proval CR 300:

• Nausea, stomach pain, diarrhoea — usually early and settling with food
• Weight gain and increased appetite
• Tremor of the hands
• Drowsiness, dizziness
• Hair thinning (usually temporary; hair may regrow curlier)
• Irregular periods in some women; raised ammonia causing confusion in rare cases

Seek medical help urgently for: persistent vomiting with extreme tiredness, loss of appetite or yellowing of eyes (possible liver damage, highest risk in the first 6 months); severe abdominal pain (pancreatitis); unusual bruising or bleeding (low platelets); or worsening confusion.

Key precautions with Proval CR 300:

• Pregnancy warning: women and girls who could become pregnant must use effective contraception and be under a specialist's pregnancy-prevention programme. Tell your doctor immediately if you plan pregnancy or your period is late.
• Liver monitoring: liver function tests before starting and periodically during the first 6 months; report vomiting, tiredness or jaundice at once.
• Never stop suddenly — risk of severe rebound seizures; taper only under medical supervision.
• Avoid alcohol; it increases drowsiness and liver strain.
• Driving: be cautious until seizures are well controlled and drowsiness has passed — and follow local rules about driving with epilepsy.
• Tell your doctor about any liver disease, metabolic disorders, kidney problems or bleeding tendency; report mood changes or self-harm thoughts.

Tell your doctor about every medicine. Important interactions with Proval CR 300:

• Lamotrigine — valproate raises its level, increasing the risk of serious skin rash; doses must be specialist-adjusted.
• Carbamazepine, phenytoin, phenobarbital — complex two-way interactions; levels may need monitoring.
• Carbapenem antibiotics (meropenem, imipenem) — rapidly lower valproate levels and can let seizures return; combination should be avoided.
• Aspirin and warfarin — increased bleeding tendency and altered valproate levels.
• Other sedatives and alcohol — additive drowsiness.
• Valproate can raise the levels of some antidepressants and antipsychotics.

Proval CR 300 must not be used in:

• Allergy to Sodium Valproate or valproic acid
• Active liver disease or a personal/family history of severe drug-induced liver problems
• Urea cycle disorders and mitochondrial disorders caused by POLG gene mutations
• Known or suspected pregnancy in bipolar disorder, and in epilepsy during pregnancy unless no other treatment is possible
• Porphyria

In women of childbearing age it may only be used within a specialist-supervised pregnancy-prevention programme when other treatments have failed.

Pregnancy — major warning: Sodium Valproate taken in pregnancy causes birth defects in about 10% of babies (including spina bifida) and developmental and learning problems in up to 30–40%. Women and girls who could become pregnant must use reliable contraception and be reviewed regularly by a specialist; if you wish to have a baby, the treatment plan must be changed before conception. Never stop Proval CR 300 suddenly on discovering a pregnancy — uncontrolled seizures also endanger mother and baby. Contact your specialist the same day.

Breastfeeding: small amounts pass into breast milk; breastfeeding is often possible with specialist agreement, watching the baby for unusual sleepiness, poor feeding or bruising.

Store Proval CR 300 below 30°C in a dry place, protected from light and moisture — valproate preparations absorb moisture easily, so keep tablets in their original blister until use. Keep strictly out of the reach of children. Do not use after the expiry date, and return unused medicine to a pharmacy rather than discarding it in household waste.