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About SAFINAMIDE

SAFINAMIDE belongs to a class of drugs called antiparkinson agents, which are used in combination with other drugs for the treatment of the signs and symptoms of Parkinson's disease. Parkinson’s disease is a disorder of the central nervous system that affects movement and locomotion. It causes stiffness, shaking, and difficulty in walking, coordination and balance. 

SAFINAMIDE contains 'safinamide', belonging to the group of medications called monoamine oxidase type B (MAO-B) inhibitors. It works by increasing the amount of dopamine (a natural substance that is needed to control movement) in the brain.

SAFINAMIDE may cause common side effects like cough, depression, indigestion, flu-like symptoms, insomnia (difficulty sleeping), joint pain, and peripheral oedema. Most of these side effects of  SAFINAMIDE do not require medical attention and gradually resolve over time. However, if the side effects persist or worsen, please consult your doctor.

If you are known to be allergic to SAFINAMIDE or any other medicines, please tell your doctor. Please inform your doctor if you are using any medications other than SAFINAMIDE. If you are pregnant or breastfeeding, it is advised to inform your doctor. SAFINAMIDE is not recommended in albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy. SAFINAMIDE should be used with caution in patients like schizophrenia (a mental illness that causes disturbed thinking, loss of interest in life, and strong or unusual emotions), bipolar disorder (mood that changes from depressed to abnormally excited), or psychosis; or if you have high or low blood pressure; dyskinesia (abnormal movements); or sleep problems. SAFINAMIDE may cause serotonin syndrome when used with MAO inhibitors, antidepressants, or opioid drugs.

Uses of SAFINAMIDE

Parkinson's disease

Medicinal Benefits

SAFINAMIDE belongs to a class of drugs called antiparkinson agents, which are used in combination with other drugs for the treatment of the signs and symptoms of Parkinson's disease. It works by increasing the amount of dopamine (a natural substance needed to control movement) in the brain. Thereby improving the symptoms of Parkinson’s disease.

Directions for Use

Swallow SAFINAMIDE as a whole with water. Do not chew, crush or break it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of SAFINAMIDE

  • Cough
  • Depression
  • Indigestion
  • Flu-like symptoms
  • Insomnia (difficulty in sleeping)
  • Joint pain
  • Peripheral oedema

In-Depth Precautions and Warning

Drug Warnings

If you are known to be allergic to SAFINAMIDE or any other medicines, please tell your doctor. Please inform your doctor if you are using any medications other than SAFINAMIDE. If you are pregnant or breastfeeding, it is advised to inform your doctor. SAFINAMIDE is not recommended in albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy. SAFINAMIDE should be used with caution in patients like schizophrenia (a mental illness that causes disturbed thinking, loss of interest in life, and strong or unusual emotions), bipolar disorder (mood that changes from depressed to abnormally excited), or psychosis; or if you have high or low blood pressure; dyskinesia (abnormal movements); or sleep problems. SAFINAMIDE should be used caution with liver diseases. SAFINAMIDE may cause serotonin syndrome when used with MAO inhibitors, antidepressants or opioid drugs. A combination of MAOIs and dextromethorphan has been reported to cause episodes of psychosis or abnormal behaviour.

Drug Interactions

Drug-Drug Interaction: SAFINAMIDE may interact with other medicines like pain killers (diclofenac, tramadol), antidepressant medications (fluoxetine, bupropion, amitryptiline), antibiotics (balofloxacin, ciprofloxacin), anti-epileptics (carbamazepine), statins (rosuvastatin, pitavastatin, pravastatin), anti-cancer (methotrexate, topotecan), antidiabetic (glyburide), antitussive (dextromethorphan), opioid-medications (meperidine, methadone, propoxyphene), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine),

Drug-Food Interaction: SAFINAMIDE may interact with foods that are high in tyramine, such as aged cheeses, fava beans, soy sauce, herring, pickled or processed meats, fish, and meats that are aged, dried, smoked, or fermented. Eating tyramine while taking this drug can raise your blood pressure which could cause life-threatening side effects. It may also interact with alcohol and St. John's wort.

Drug-Disease Interaction: The use of SAFINAMIDE is strictly restricted if a patient is already dealing with liver diseases, albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy.

Drug-Drug Interactions Checker List:

  • DICLOFENAC
  • TRAMADOL
  • FLUOXETINE
  • BUPROPION
  • AMITRIPTYLINE
  • BALOFLOXACIN
  • CIPROFLOXACIN
  • CARBAMAZEPINE
  • ROSUVASTATIN
  • PITAVASTATIN
  • PRAVASTATIN
  • METHOTREXATE
  • GLYBURIDE
  • MEPERIDINE
  • METHADONE
  • PROPOXYPHENE
  • ISOCARBOXAZID
  • LINEZOLID
  • METHYLENE BLUE
  • MOCLOBEMIDE
  • PHENELZINE
  • PROCARBAZINE
  • RASAGILINE
  • SELEGILINE
  • TRANYLCYPROMINE
  • DEXTROMETHORPHAN
  • TOPOTECAN
  • Safety Advice

    • Safety Warning

      Alcohol

      caution

      SAFINAMIDE may cause excessive drowsiness with alcohol, decreasing alertness and affecting your vision.

    • Safety Warning

      Pregnancy

      unsafe

      SAFINAMIDE may be unsafe to use during pregnancy. Your doctor will weigh the benefits and potential risks before prescribing SAFINAMIDE. Please consult your doctor before taking SAFINAMIDE.

    • Safety Warning

      Breast Feeding

      unsafe

      SAFINAMIDE may be unsafe to use in breastfeeding mothers. Your doctor will weigh the benefits and potential risks before prescribing SAFINAMIDE. Please consult your doctor before taking SAFINAMIDE.

    • Safety Warning

      Driving

      caution

      SAFINAMIDE may decrease alertness, affect your vision or make you sleepy and dizzy. Do not drive if these symptoms occur.

    • Safety Warning

      Liver

      caution

      SAFINAMIDE should be used with caution in patients with liver disease. A dose adjustment of SAFINAMIDE may be needed. So please consult your doctor before taking SAFINAMIDE.

    • Safety Warning

      Kidney

      caution

      SAFINAMIDE should be used with caution in patients with kidney disease. A dose adjustment of SAFINAMIDE may be needed. So please consult your doctor before taking SAFINAMIDE.

    • Safety Warning

      Children

      unsafe

      SAFINAMIDE is not recommended for use in children under 12 years.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • A balanced diet is essential to show improvement in Parkinson's disease, including grains and leafy foods, as this food is rich in vitamins, fibres, and minerals. With this food, one should also include dairy items, protein-rich nourishments, for example, meat and beans, and solid fats found in nuts, olive oil, fish, and eggs in their diet. However, limit the consumption of sugar.
    • Avoid intake of high-protein foods like soy protein, fish, eggs, chicken, beef, and pork. Eat more whole-grain foods such as whole wheat bread, oatmeal, brown rice or pasta.
    • Eat more fibre-rich foods to ease constipation.
    • Drink plenty of water to avoid headaches due to dehydration.
    • Avoid the consumption of alcohol as it may increase drowsiness.

    Special Advise

    • Talk to your doctor if you develop hallucinations or other changes in your behaviour.

    Patients Concern

    Disease/Condition Glossary

    Parkinson’s disease: It is a disorder of the central nervous system that affects movement due to damage of nerve cells in the brain which reduces the levels of dopamine and leads to symptoms such as stiffness, tremor in one hand, shaking, difficulty in walking, coordination and balance. This condition can last for many years or life-long. Treatment with medicines and physiotherapy may help control the symptoms and provide a quality life for as long as possible.

    FAQs

    How does SAFINAMIDE work?

    SAFINAMIDE works by increasing the amount of dopamine (a natural substance needed to control movement) in the brain. Thereby improving the symptoms of Parkinson’s disease.

    What should I do if I miss a dose of SAFINAMIDE?

    Do not double the dosage to compensate for a missed one. One can skip the missed portion and take the next dosage at the standard time of the following day.

    Are there any specific contraindications associated with SAFINAMIDE?

    Yes, SAFINAMIDE is not recommended in albinism (an inherited condition that causes a lack of colour in the skin, hair and eyes), retinal degeneration, uveitis (inflammation of the middle layer of the eye (uvea)), inherited retinopathy or severe progressive diabetic retinopathy.

    Can i stop SAFINAMIDE abruptly?

    Do not stop SAFINAMIDE suddenly; it may cause side effects like confusion, stiff muscles and a high fever. So please consult your doctor before stopping the medicine.

    Available Medicines for

    SAFINAMIDE