Safina 100

Indications

Safinamide is used in adults with Parkinson's disease who are already taking Levodopa (alone or with other Parkinson's medicines) and who have "off" episodes, times when symptoms such as slowness, stiffness and tremor return before the next dose is due. It is an add-on treatment, not a replacement for levodopa.

How It Works

Safinamide blocks an enzyme called monoamine oxidase B (MAO-B), which breaks down dopamine in the brain. Keeping more dopamine available helps levodopa work for longer. It also has effects on sodium channels and on the release of glutamate, a brain messenger, which may add to its benefit.

Dosage and Administration

Take exactly as prescribed by a specialist. Treatment usually starts at 50 mg once daily, and the doctor may increase it to 100 mg once daily depending on response. Take it at the same time each day with water, with or without food. People with moderate liver problems should not take more than 50 mg a day. Do not stop suddenly without medical advice.

Interactions

Do not take it with other MAO inhibitors (such as Selegiline, Rasagiline, Linezolid or Moclobemide) or with Pethidine. Use great caution with antidepressants (SSRIs such as Fluoxetine, SNRIs, tricyclics) and with Dextromethorphan, Tramadol or St John's wort, because of the risk of serotonin syndrome. Avoid decongestants and stimulants such as Pseudoephedrine or Ephedrine, which can raise blood pressure. Safinamide can increase levels of Rosuvastatin, Methotrexate and some other medicines. Very large amounts of tyramine-rich foods (aged cheese, cured meats, fermented products) are best avoided.

Contraindications

Do not take safinamide if you are allergic to it, have severe liver impairment, are taking another MAO inhibitor or Pethidine, or have certain eye conditions affecting the retina (such as albinism, retinal degeneration, uveitis, inherited retinal disease or severe progressive diabetic retinopathy).

Side Effects

Common side effects include:

• Dyskinesia (uncontrolled jerky movements)
• Sleepiness, difficulty sleeping, dizziness and headache
• Nausea
• Low blood pressure on standing, which can cause falls
• Cataract or other eye changes

Some people develop hallucinations, confusion or impulse control problems such as gambling, overeating, compulsive shopping or increased sexual urges; tell your doctor if you or your family notice these.

Get urgent medical help if you have a sudden severe headache with very high blood pressure, high fever with muscle stiffness, agitation and sweating (possible serotonin syndrome), sudden episodes of falling asleep, changes in vision, or signs of a serious allergic reaction.

Pregnancy and Lactation

Safinamide should not be used during pregnancy, and women who could become pregnant should use effective contraception. It should not be used while breastfeeding, as it may pass into breast milk and may reduce milk production.

Precautions and Warnings

Do not drive or use machines if you feel sleepy or have sudden sleep episodes. Tell your doctor about any eye disease; regular eye checks may be advised. The doctor may lower the levodopa dose if dyskinesia increases. Watch for mood or behaviour changes. Use with care in liver disease.

Overdose

Overdose may cause high blood pressure, low blood pressure on standing, hallucinations, involuntary movements, vomiting and serotonin-like symptoms. Seek emergency medical help; treatment is supportive.

Therapeutic Class

Antiparkinson agent; selective monoamine oxidase B (MAO-B) inhibitor.

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.