Safinamide

Is the main active ingredient.

Treatment of Parkinson's disease, specifically as an addon therapy to levodopa in patients experiencing “off” periods (fluctuations in motor control).

Zafimove 100mg Tab (Safinamide) is a selective, reversible inhibitor of monoamine oxidase type B (MAO-B). By inhibiting MAO-B, it increases the levels of dopamine in the brain. It also has a secondary mechanism of action, which involves the modulation of glutamate release, contributing to its overall therapeutic effect in Parkinson's disease.

Store at room temperature (below 25°C), away from moisture and direct sunlight. Keep out of reach of children.

Dosage should be determined by a physician and may vary depending on individual needs and response.

Typically starts with a low dose, gradually increasing as tolerated.

Usually taken once daily, with or without food.

Nausea

Dizziness

Headache

Insomnia

Fatigue

Constipation

Falls (increased risk in Parkinson's patients)

Hypotension (low blood pressure)

Hallucinations (rare)

Alcohol Consumption

Avoid excessive alcohol consumption as it may increase the risk of side effects, particularly dizziness and hypotension.



While Driving or operating Machinery

Safinamide may cause dizziness and drowsiness; avoid driving or operating machinery until you know how it affects you.



Pregnant & Breastfeeding Women

Safinamide is not recommended for pregnant or breastfeeding women unless the potential benefits outweigh the risks. Consult with your doctor.



Children

Safinamide is not approved for use in children.



Kidney

Dosage adjustment may be necessary in patients with impaired kidney function. Consult with your doctor.



Liver

Dosage adjustment may be needed in patients with impaired liver function. Consult with your doctor.

Consult your physician or pharmacist for detailed information and to access the drug's official prescribing information (SmPC).