Europe — EMA
Mysoline (Primidone)
GNH USA supplies Mysoline (Primidone), a barbiturate anticonvulsant for epilepsy, including partial and generalized tonic‑clonic seizures.
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What is Primidone?
Primidone, the active ingredient in Mysoline, is a barbiturate anticonvulsant presented as an oral tablet for oral use. It treats epilepsy, including partial seizures and generalized tonic‑clonic seizures, in adults and children.
GNH USA supplies Mysoline as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Primidone used for?
Primidone is used in the management of seizure disorders within the epilepsy spectrum.
- Partial seizures: reduces the frequency and severity of focal seizure episodes. - Generalized tonic‑clonic seizures: helps control convulsive episodes across the population. - Epilepsy (overall): provides long‑term seizure control as part of an antiepileptic regimen.
What are the side effects of Primidone?
Primidone may cause a range of adverse reactions, from mild to severe.
Common Side Effects: - Drowsiness: feeling unusually sleepy or fatigued. - Dizziness: sensation of light‑headedness or unsteadiness. - Nausea: upset stomach or urge to vomit. - Ataxia: impaired coordination and balance. - Rash: mild skin irritation or redness. - Weight gain: increase in body weight over time.
Serious or Rare Side Effects: - Severe skin reactions: such as Stevens‑Johnson syndrome. - Blood dyscrasias: including agranulocytosis or aplastic anemia. - Hepatic dysfunction: signs of liver injury or elevated enzymes. - Respiratory depression: slowed breathing, especially with other depressants. - Suicidal ideation: emergence of thoughts of self‑harm. - Withdrawal seizures: occurring after abrupt discontinuation.
What precautions apply to Primidone?
When prescribing or dispensing Primidone, several safety considerations are important.
- Monitor blood counts: regular laboratory testing to detect hematologic abnormalities. - Avoid abrupt discontinuation: taper the dose gradually to prevent withdrawal seizures. - Use caution in hepatic impairment: dose adjustments may be required for liver disease. - Pregnancy: consult a healthcare professional; risks and benefits must be weighed. - Store at room temperature: keep in the original container, protect from moisture and direct sunlight.
What does Primidone interact with?
Primidone can interact with other medicines, affecting its efficacy or safety.
Major Interactions (Avoid): - Phenobarbital: additive CNS depression and increased toxicity. - Other central nervous system depressants (e.g., benzodiazepines, opioids): heightened sedative effects. - Alcohol: potentiates drowsiness and respiratory depression.
Moderate Interactions (Monitor Closely): - Valproic acid: may alter plasma levels of both agents. - Carbamazepine: can increase metabolism of Primidone, reducing effectiveness. - Oral contraceptives: Primidone may reduce hormonal contraceptive efficacy, requiring additional contraception methods.



