SAFINAMIDE VIVANTA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Safinamide Vivanta 50 mg film-coated tablets EFG

Safinamide Vivanta 100 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Safinamide Vivanta and what is it used for
2. What you need to know before taking Safinamide Vivanta
3. How to take Safinamide Vivanta
4. Possible side effects
5. Storage of Safinamide Vivanta
6. Package contents and additional information

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

Safinamide Vivanta is a medication whose active ingredient is safinamide. It acts to increase the level of a substance called dopamine in the brain, which is involved in movement control and is present in reduced amounts in the brain of patients with Parkinson's disease. Safinamide is used for the treatment of Parkinson's disease in adults.

In patients in the mid-to-advanced stage of the disease, who experience sudden changes between "ON", with the ability to move, and "OFF", with difficulty moving, safinamide is added to a stable dose of the medication called levodopa alone or in combination with other medications for Parkinson's disease.

2. What you need to know before taking Safinamide Vivanta

Do not take Safinamida Vivanta

• If you are allergic to safinamide or any of the other components of this medication (listed in section 6).
• If you are taking any of the following medications:
• • Monoamine oxidase inhibitors (MAOIs), such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, and tranylcypromine (e.g., for the treatment of Parkinson's disease or depression or other disorders).
  • Pethidine (a potent analgesic).

You should wait at least 7 days between stopping treatment with safinamide before starting treatment with MAOIs or pethidine.

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

Warnings and precautions

Consult your doctor before starting to take safinamide:

• If you have liver problems.
• Patient and caregivers should be informed that some behavioral symptoms such as compulsions, obsessive thoughts, gambling, increased libido, hypersexuality, impulsive behaviors, and compulsive shopping have been reported with other Parkinson's disease medications.
• Also, involuntary muscle contractions or worsening may occur when safinamide is used with levodopa.

Children and adolescents

Safinamide is not recommended for use in children and adolescents under 18 years of age due to the lack of safety and efficacy data in this population.

Other medications and Safinamide Vivanta

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

• Cough and cold remedies containing dextromethorphan, ephedrine, or pseudoephedrine.
• Medications called selective serotonin reuptake inhibitors (SSRIs) that are normally used to treat anxiety disorders and some personality disorders (e.g., fluoxetine or fluvoxamine).
• Medications called serotonin and norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depression and other mood disorders, such as venlafaxine.
• Cholesterol-lowering medications, such as rosuvastatin, pitavastatin, and pravastatin.
• Fluoroquinolone antibiotics, such as ciprofloxacin.
• Medications that affect the immune system, such as methotrexate.
• Medications for the treatment of metastatic carcinoma, such as topotecan.
• Medications for the treatment of pain and inflammation, such as diclofenac.
• Medications for the treatment of type 2 diabetes, such as gliburide and metformin.
• Medications for the treatment of viral infections, such as acyclovir and ganciclovir.

Pregnancy and breastfeeding

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

Pregnancy

Safinamide should not be used during pregnancy or in women of childbearing age who do not use adequate contraception.

Breastfeeding

It is likely that safinamide will pass into breast milk. Safinamide should not be used during breastfeeding.

Driving and using machines

During treatment with safinamide, drowsiness and dizziness may occur; patients should be cautious when using hazardous machinery or driving until they are sure that safinamide does not affect them in any way.

Consult your doctor before driving or using machines.

3. How to take Safinamide Vivanta

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again.

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

If you have moderate liver impairment, you should not take more than 50 mg per day. Your doctor will confirm if this is the case for you.

If you take more Safinamide Vivanta than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Safinamide Vivanta

Do not take a double dose to make up for missed doses. Skip that dose and take the next dose when you normally would.

If you stop taking Safinamide Vivanta

Do not stop taking safinamide without consulting your doctor first.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side 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, hypertonia, hyperthermia, increased creatine kinase levels in the blood), serotonin syndrome (confusion, hypertension, muscle rigidity, hallucinations), or hypotension.

The following side effects have been reported in patients with Parkinson's disease in the mid-to-advanced stage (patients taking safinamide as an adjunct to levodopa alone or in combination with other medications for Parkinson's disease):

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

Uncommon(may affect up to 1 in 100 people): urinary tract infection, skin cancer, low iron levels in the blood, low white blood cell count, alteration of red blood cells, decreased appetite, high fat levels in the blood, increased appetite, high blood sugar levels, seeing things that are not there, feeling sad, abnormal dreams, fear and worry, confusion, mood changes, increased interest in sex, abnormal perceptions and thoughts, agitation, sleep disorder, numbness, instability, loss of sensation, prolonged abnormal muscle contraction, headache, difficulty speaking, fainting, memory impairment, blurred vision, blind spot, double vision, sensitivity to light, disorders of the light-sensitive layer in the back of the eye, redness of the eyes, increased eye pressure, feeling that the room is spinning, feeling heartbeats, rapid heartbeat, irregular heartbeat, slow heartbeat, high blood pressure, low blood pressure, enlarged and twisted veins, cough, difficulty breathing, nasal discharge, constipation, heartburn, vomiting, dry mouth, diarrhea, abdominal pain, acid reflux, gas, feeling full, drooling, mouth ulcers, sweating, itching, sensitivity to light, skin redness, back pain, joint pain, cramps, stiffness, pain in arms or legs, muscle weakness, feeling heavy, increased urination at night, pain when urinating, difficulty having sex in men, fatigue, feeling weak, unsteady gait, foot swelling, pain, feeling hot, weight loss, weight gain, abnormal blood tests, high fat levels in the blood, high blood sugar levels, abnormal electrocardiogram, abnormal kidney function tests, abnormal urine tests, low blood pressure, high blood pressure, abnormal eye tests, 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, high potassium levels in the blood, uncontrolled impulses, disorientation, distorted image perception, decreased interest in sex, thoughts that cannot be shaken, feeling of being pursued, premature ejaculation, uncontrollable need to sleep, fear of social situations, suicidal thoughts, clumsiness, distractibility, loss of taste, weak or slow reflexes, leg pain that radiates, constant urge to move legs, feeling of sleep, eye abnormalities, progressive vision loss due to diabetes, increased tearing, night blindness, crossed eyes, 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, blistering, skin allergy, skin disorders, bruising, scaly skin, night sweats, skin pain, skin discoloration, psoriasis, flaky skin, inflammatory joint disease due to an autoimmune disease, back pain, joint inflammation, musculoskeletal pain, muscle pain, neck pain, joint pain, joint cyst, uncontrollable need to urinate, increased urination, pus in the urine, difficulty urinating, prostate problems, breast pain, decreased drug effect, drug intolerance, feeling cold, feeling unwell, fever, dryness of the skin, eyes, or mouth, abnormal blood tests, heart murmur, abnormal heart tests, bruising or swelling after trauma, blood vessel blockage due to fat, head trauma, mouth injuries, skeletal injuries, gambling.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Safinamide Vivanta

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister pack after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Return unused medications and packaging to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of unused medications and packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Safinamide Vivanta

The active ingredient is safinamide.

• Each film-coated tablet contains 50 mg or 100 mg of safinamide.
• The other ingredients are:
• • Core of the tablet: 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 package contents

Safinamide Vivanta 50 mg film-coated tablets are orange, round, with a metallic sheen, and engraved with "MS" on one side and "18" on the other side.

Safinamide Vivanta 100 mg film-coated tablets are orange, round, with a metallic sheen, and engraved with "MS" on one side and "19" on the other side.

Safinamide Vivanta is supplied in blister packs of 14, 28, 30, 90, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

You can request more information about this medication from the local representative of the marketing authorization holder:

Local representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Germany:Safinamid Vivanta 50 mg film-coated tablets

Safinamid Vivanta 100 mg film-coated tablets

Croatia:Safinamid MSN 50 mg film-coated tablets

Safinamid MSN 100 mg film-coated tablets

Denmark:Safinamide "Vivanta"

Spain:Safinamida Vivanta 50 mg film-coated tablets EFG

Safinamida Vivanta 100 mg film-coated tablets EFG

Finland:Safinamide Vivanta 50 mg film-coated tablets

Safinamide Vivanta 100 mg film-coated tablets

Norway:Safinamide Vivanta 50 mg

Safinamide Vivanta 100 mg

Netherlands:Safinamide Vivanta 50 mg film-coated tablets

Safinamide Vivanta 100 mg film-coated tablets

Sweden:Safinamide Vivanta 50 mg film-coated tablets

Safinamide Vivanta 100 mg film-coated tablets

Date of the last revision of this package leaflet:March 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es/