Safinamide Vivanta 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Safinamida Vivanta 50 mg film-coated tablets EFG

Safinamida Vivanta 100 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Safinamida Vivanta is and what it is used for
2. What you need to know before taking Safinamida Vivanta
3. How to take Safinamida Vivanta
4. Possible adverse effects
5. How to store Safinamida Vivanta
6. Contents of the pack and other information

1. What Safinamida Vivanta is and what it is used for

Safinamida Vivanta is a medicine whose active substance is safinamida. It works by increasing the level of a substance called dopamine in the brain, which plays a role in movement control and is present in reduced amounts in the brains of patients with Parkinson's disease. Safinamida is used for the treatment of Parkinson's disease in adults.

In patients at a moderate to advanced stage of the disease who experience sudden fluctuations between "ON" periods, during which they can move, and "OFF" periods, during which they have difficulty moving, safinamida is added to a stable dose of the medicine called levodopa, either alone or in combination with other Parkinson's disease medications.

2. What you need to know before taking Safinamida Vivanta

Do not take Safinamida Vivanta

• If you are allergic to safinamide or to any of the other ingredients of this medicine
  (listed in section 6).
• If you are taking any of the following medicines:
  • Monoamine oxidase inhibitors (MAO inhibitors), such as selegiline, rasagiline, moclobemide, phenelzine, isocarbazide, or tranylcypromine (for example, used to treat Parkinson’s disease, depression, or other disorders).
  • Pethidine (a strong painkiller).

You must wait at least 7 days after stopping safinamide treatment before starting treatment with MAO inhibitors or pethidine.

• If you have been diagnosed with severe liver disorders.
• If you have an eye disorder that may put you at risk of possible damage to the retina (the light-sensitive layers at the back of the eyes), for example, albinism (lack of pigmentation in the skin or eyes), retinal degeneration (loss of cells in the light-sensitive layer at the back of the eye), uveitis (inflammation inside the eye), inherited retinopathy (inherited vision disorders), or severe progressive diabetic retinopathy (progressive loss of vision due to diabetes).

Warnings and precautions

Talk to your doctor before taking safinamide:

• If you have liver problems.
• Patients and caregivers should be informed that behavioral symptoms such as compulsions, obsessive thoughts, gambling disorder, increased libido, hypersexuality, impulsive behaviors, and compulsive buying or spending have been reported with other Parkinson’s disease medications.
• Involuntary spasmodic movements may also occur or worsen when safinamide is used together with levodopa.

Children and adolescents

The use of safinamide is not recommended in children and adolescents under 18 years of age due to lack of data on safety and efficacy in this population.

Other medicines and Safinamida Vivanta

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Consult your doctor before taking the following medicines with safinamide:

• Cough and cold remedies containing dextromethorphan, ephedrine, or pseudoephedrine.
• Medicines known as selective serotonin reuptake inhibitors (SSRIs), commonly used to treat anxiety disorders and certain personality disorders (e.g., fluoxetine or fluvoxamine).
• Medicines known as serotonin-norepinephrine reuptake inhibitors (SNRIs), used to treat major depressive disorder and other mood disorders, such as venlafaxine.
• Medicines for high cholesterol, such as rosuvastatin, pitavastatin, and pravastatin.
• Fluoroquinolone antibiotics, such as ciprofloxacin.
• Medicines that affect the immune system, such as methotrexate.
• Medicines for the treatment of metastatic carcinoma, such as topotecan.
• Medicines for the treatment of pain and inflammation, such as diclofenac.
• Medicines for the treatment of type 2 diabetes, such as glibenclamide and metformin.
• Medicines for the treatment of viral infections, such as acyclovir and ganciclovir.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

Safinamide must not be used during pregnancy or in women of childbearing potential who are not using an adequate method of contraception.

Breastfeeding

Safinamide is likely to pass into breast milk. Safinamide must not be used during breastfeeding.

Driving and use of machines

Safinamide may cause drowsiness and dizziness during treatment; patients should exercise caution when operating dangerous machinery or driving until they are certain that safinamide does not affect them in any way.

Consult your doctor before driving or operating machinery.

3. How to take Safinamida Vivanta

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

The recommended starting dose of safinamide is one 50 mg tablet, which may be increased to one 100 mg tablet, taken once daily, preferably in the morning, orally with water. Safinamida may be taken with or without food.

If you have moderate hepatic impairment, you must not take more than 50 mg per day. Your doctor will confirm whether this applies to you.

If you take more Safinamida Vivanta than you should

If you have taken too many safinamide tablets, you may develop high blood pressure, anxiety, confusion, memory lapses, drowsiness, dizziness, nausea or vomiting, dilated pupils, or involuntary spasmodic movements. Contact your doctor immediately and bring the safinamide packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Safinamida Vivanta

Do not take a double dose to make up for missed doses. Skip the missed dose and take the next dose at your usual time.

If you stop taking Safinamida Vivanta

Do not stop treatment with safinamide without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Seek medical attention if you experience hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, increased blood levels of the enzyme creatine kinase), serotonin syndrome (confusion, high blood pressure, muscle stiffness, hallucinations), or hypotension.

The following adverse effects have been reported in patients with moderately advanced Parkinson's disease (patients taking safinamide as an add-on to levodopa alone or in combination with other Parkinson's disease medications):

Common (may affect up to 1 in 10 people): insomnia, difficulty performing voluntary movements, drowsiness, dizziness, headache, worsening of Parkinson's disease, lens opacity, low blood pressure upon standing, nausea, and falls.

Uncommon (may affect up to 1 in 100 people): urinary tract infection, skin cancer, low iron levels in blood, low white blood cell count, red blood cell disorders, decreased appetite, elevated blood fat levels, increased appetite, high blood sugar levels, seeing things that are not there, feeling of sadness, abnormal dreams, fear and anxiety, confusion, mood changes, increased interest in sex, abnormal perceptions and thoughts, agitation, sleep disorders, numbness, instability, loss of sensation, prolonged abnormal muscle contractions, headache, speech difficulties, fainting, memory impairment, blurred vision, blind spot, double vision, light sensitivity, disorders of the light-sensitive layer at the back of the eye, eye redness, increased eye pressure, sensation that the room is spinning, awareness of heartbeat, rapid heartbeat, irregular heartbeat, slow heartbeat, high blood pressure, low blood pressure, enlarged and twisted veins, cough, breathing difficulty, nasal discharge, constipation, heartburn, vomiting, dry mouth, diarrhea, abdominal pain, acid reflux, gas, feeling full, drooling, mouth ulcers, sweating, itching, light sensitivity, skin redness, back pain, joint pain, cramps, stiffness, pain in arms or legs, muscle weakness, heaviness sensation, increased nighttime urination, painful urination, difficulty with sexual performance in men, fatigue, feeling of weakness, unsteady gait, swelling of feet, pain, sensation of heat, weight loss, weight gain, abnormal blood tests, increased blood fat levels, increased blood sugar levels, abnormal electrocardiogram, abnormal kidney function test, abnormal urine tests, decreased blood pressure, increased blood pressure, abnormal eye examination, foot fracture.

Rare (may affect up to 1 in 1,000 people): pneumonia, skin infection, sore throat, nasal allergy, dental infection, viral infection, non-cancerous skin growths/disorders, white blood cell abnormalities, severe weight loss and weakness, increased potassium levels in blood, uncontrollable impulses, mental clouding, disorientation, visual perception disturbances, decreased interest in sex, persistent intrusive thoughts, feeling that someone is pursuing you, premature ejaculation, irresistible need to sleep, fear of social situations, suicidal thoughts, clumsiness, easy distractibility, loss of taste sensation, weak or slow reflexes, radiating leg pain, persistent urge to move legs, drowsiness, eye abnormalities, progressive vision loss due to diabetes, increased tear production, night blindness, squint, heart attack, blood vessel constriction or narrowing, very high blood pressure, chest tightness, difficulty speaking, difficulty or pain when swallowing, gastroduodenal ulcer, nausea, stomach bleeding, jaundice, hair loss, blister formation, skin allergy, skin disorders, bruising, scaly skin, night sweats, skin pain, skin discoloration, psoriasis, peeling skin, inflammation of spinal joints due to autoimmune disease, back pain, joint inflammation, musculoskeletal pain, muscle pain, neck pain, joint pain, joint cyst, uncontrollable need to urinate, increased urination, pus in urine, difficulty urinating, prostate problems, breast pain, reduced drug effect, drug intolerance, feeling cold, feeling unwell, fever, dryness of the skin, eyes or mouth, abnormal blood tests, heart murmur, abnormal cardiac tests, bruising or swelling after injury, fat-induced blockage of blood vessels, head injury, oral injuries, skeletal injuries, gambling.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Safinamida Vivanta

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Safinamida Vivanta

The active substance is safinamide.

• Each film-coated tablet contains 50 mg or 100 mg of safinamide.
• The other components are:
  • Tablet core: microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, and magnesium stearate.
  • Coating material: hypromellose (E464), macrogol 6000 (E1521), mica (E555), titanium dioxide (E171), and red iron oxide (E172).

Appearance of the product and contents of the pack

Safinamida Vivanta 50 mg film-coated tablets are orange-coloured, round, with a metallic sheen, and marked with “MS” on one side and “18” on the other.

Safinamida Vivanta 100 mg film-coated tablets are orange-coloured, round, with a metallic sheen, and marked with “MS” on one side and “19” on the other.

Safinamida Vivanta is supplied in blisters containing 14, 28, 30, 90, or 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Vivanta Generics s.r.o
Trtinová 260/1, Cakovice
19600 Prague 9
Czech Republic

Manufacturer

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola, PLA3000,
Malta

Or

MSN Labs Europe Limited
KW20A Corradino Park,
Paola, PLA3000,
Malta

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Local representative:

Mabo-Farma S.A.
Calle Vía de los Poblados 3, Edificio 6
28033 Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Safinamid Vivanta 50 mg Filmtabletten
Safinamid Vivanta 100 mg Filmtabletten

Croatia: Safinamid MSN 50 mg filmom obložene tablete
Safinamid MSN 100 mg filmom obložene tablete

Denmark: Safinamide “Vivanta”

Spain: Safinamida Vivanta 50 mg comprimidos recubiertos con película EFG
Safinamida Vivanta 100 mg comprimidos recubiertos con película EFG

Finland: Safinamide Vivanta 50 mg kalvopäällysteiset tabletit
Safinamide Vivanta 100 mg kalvopäällysteiset tabletit

Norway: Safinamide Vivanta 50 mg
Safinamide Vivanta 100 mg

Netherlands: Safinamide Vivanta 50 mg filmomhulde tabletten
Safinamide Vivanta 100 mg filmomhulde tabletten

Sweden: Safinamide Vivanta 50 mg filmdragarade tabletter
Safinamide Vivanta 100 mg filmdragarade tabletter

Date of the most recent review of this leaflet: March 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/