Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Onstryv (Safinamide).
Abnormal heart rhythms: Onstryv (Safinamide) can cause abnormal heart rhythms. Certain medications may increase this risk. If you have an irregular heartbeat or are taking other medications that affect the heartbeat, discuss with your doctor how Onstryv (Safinamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onstryv (Safinamide), and whether any special monitoring is needed.
Antidepressant medication: Severe reactions are possible when Onstryv (Safinamide) is combined with medications and natural products used to treat Depression. Avoid combining Onstryv (Safinamide) and antidepressants. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are also possible.
If you have taken antidepressants recently, discuss with your doctor how Onstryv (Safinamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onstryv (Safinamide), and whether any special monitoring is needed.
Blood pressure: Onstryv (Safinamide) may cause increased blood pressure. If you have high blood pressure or take medications to control blood pressure, discuss with your doctor how Onstryv (Safinamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onstryv (Safinamide), and whether any special monitoring is needed.
Impulse control: People taking Onstryv (Safinamide) have experienced abnormal behaviour such as compulsive gambling, compulsive shopping, hypersexuality, and binge eating. If you experience these symptoms or any other behaviour change while taking Onstryv (Safinamide), contact your doctor immediately.
Liver function impairment: Liver disease or reduced liver function may cause Onstryv (Safinamide) to build up in the body, causing side effects. If you have reduced liver function or liver disease, discuss with your doctor how Onstryv (Safinamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onstryv (Safinamide), and whether any special monitoring is needed. Do not take Onstryv (Safinamide) if you have moderate or severe liver function impairment.
Melanoma: People with Parkinson's disease may be at increased risk of developing melanoma (a type of Skin Cancer). It is not known if this increased risk is due to Parkinson's disease or to the medications used to treat Parkinson's disease. You and your doctor should check your skin regularly for signs of skin cancer (e.g., moles that have an irregular shape or border, moles that change colour, or moles that are larger than 6 mm). Talk to your doctor if you have any concerns.
Mental health: Medications that affect dopamine may make behavior and thought disturbances worse for people who have psychotic conditions. Rarely, they may also cause symptoms of psychosis and mania to develop in people who have not had these symptoms before. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking Onstryv (Safinamide), contact your doctor as soon as possible.
Neuroleptic malignant syndrome (NMS): Rarely, Onstryv (Safinamide) can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.
Sudden onset of sleep: As with other medication to treat Parkinson's disease, Onstryv (Safinamide) can cause the sudden, unpredictable onset of sleep. This can happen while participating in the daily activities of living, including driving or operating machinery. This effect may occur at any point while taking the medication. You should use caution if driving or operating machinery while taking Onstryv (Safinamide). If you experience drowsiness or sudden onset of sleep, do not drive or operate machinery, and contact your doctor as soon as possible.
Uncontrolled movements: Onstryv (Safinamide) may cause an increase in irregular, jerky movements or uncontrolled body movements when it is taken with levodopa. If you notice movement problems worsening, contact your doctor as soon as possible.
Vision problems: Onstryv (Safinamide) may have an effect on the retina of the eye, particularly for people who already have certain vision problems. If you notice any changes to your vision, contact your doctor as soon as possible. People with eye problems involving the retina should not use Onstryv (Safinamide).
Pregnancy: Onstryv (Safinamide) should not be used during pregnancy. If you become pregnant while taking Onstryv (Safinamide), contact your doctor immediately.
Breast-feeding: It is not known if Onstryv (Safinamide) passes into breast milk. If you are a breast-feeding mother and are taking Onstryv (Safinamide), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Onstryv (Safinamide) have not been established for children.
