SAFINAMIDE AUROVITAS 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Safinamide Aurovitas 50 mg film-coated tablets EFG

Safinamide Aurovitas 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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Safinamide Aurovitas and what is it used for
2. What you need to know before taking Safinamide Aurovitas
3. How to take Safinamide Aurovitas
4. Possible side effects
5. Storage of Safinamide Aurovitas
6. Contents of the pack and further information

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

Safinamide Aurovitas is a medication whose active substance is safinamide. It works to increase the level of a substance called dopamine in the brain, which is involved in the control of movement and is present in reduced amounts in the brain of patients with Parkinson's disease. Safinamide is used to treat 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 Aurovitas

Do not take Safinamide Aurovitas

• 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 at 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 at the back of the eye), or uveitis (inflammation inside the eye), inherited retinopathy (inherited vision disorders) or progressive severe diabetic retinopathy (progressive loss of vision due to diabetes).

Warnings and precautions

Consult your doctor or pharmacist before starting to take safinamide, especially:

• If you have liver problems.
• Patient and caregivers should be informed that some behavioral symptoms such as compulsion, obsessive thoughts, gambling, increased libido, hypersexuality, impulsive behavior, and compulsive shopping have been reported with other medications for Parkinson's disease.
• Involuntary spasmodic movements may also occur or worsen if 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 data on safety and efficacy in this population.

Other medications and Safinamide Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or may 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.
• Medications for high cholesterol, 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 or pharmacist 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 passes 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 Aurovitas

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor again.

The recommended starting dose of this medication 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.

If you take more Safinamide Aurovitas than you should

If you have taken too many tablets of this medication, you may develop high blood pressure, anxiety, confusion, distraction, drowsiness, dizziness, nausea, or vomiting, dilated pupils, or develop involuntary spasmodic movements. Contact your doctor immediately and take the package of safinamide 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 Aurovitas

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

If you stop taking Safinamide Aurovitas

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets 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 clinical trials with placebo in patients with mid-to-advanced Parkinson's disease (patients taking safinamide as an adjunct to levodopa alone or in combination with other antiparkinsonian medications):

Common(may affect up to 1 in 10 people): insomnia, difficulty performing voluntary movements, drowsiness, 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 anxiety, confusion, mood changes, increased interest in sex, abnormal perceptions and thoughts, agitation, sleep disorders, instability, numbness, loss of sensation, prolonged muscle contraction, headache, difficulty speaking, fainting, abnormal memory, blurred vision, blind spot, double vision, sensitivity to light, eye disorders, increased eye pressure, feeling that the room is spinning, sensation of strong heartbeat, rapid heartbeat, irregular heartbeat, slow heartbeat, high blood pressure, low blood pressure, enlarged and twisted veins, cough, difficulty breathing, runny nose, 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, muscle cramps, stiffness, pain in the arms or legs, muscle weakness, feeling heavy, increased urination at night, pain when urinating, difficulty urinating, prostate problems, breast pain, decreased drug effect, drug intolerance, feeling cold, discomfort, fever, dryness of the skin, eyes, or mouth, abnormal blood tests, heart murmur, abnormal heart tests, bruising or swelling after trauma, blockage of blood vessels due to fat, head trauma, mouth injuries, skeletal injuries, gambling.

Rare(may affect up to 1 in 1000 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, confusion, disorientation, incorrect perception of images, 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, pain in the legs that radiates, constant urge to move the legs, feeling of sleep, eye abnormalities, progressive loss of vision due to diabetes, increased tearing, night blindness, crossed eyes, heart attack, contraction or narrowing of blood vessels, 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, inflammation of the spine joints 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, discomfort, fever, dryness of the skin, eyes, or mouth, abnormal blood tests, heart murmur, abnormal heart tests, bruising or swelling after trauma, blockage of blood vessels due to fat, head trauma, mouth injuries, skeletal injuries, gambling.

Reporting of 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 (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Safinamide Aurovitas

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and blister 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 the packaging and any unused medication to the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Safinamide Aurovitas

• The active substance is safinamide mesylate.
  • Each film-coated tablet contains 50 mg equivalent to 65.9 mg of safinamide mesylate.
  • Each film-coated tablet contains 100 mg equivalent to 131.8 mg of safinamide mesylate.

• The other ingredients are:
  • Core of the tablet: microcrystalline cellulose (grade 200), crospovidone (type A), colloidal anhydrous silica, and magnesium stearate.
  • Coating material: hypromellose 2910 (3 mPa·s & 6 mPa·s), aluminum silicate and potassium/titanium dioxide/iron oxide, macrogol 6000, iron oxide red, titanium dioxide.

Appearance of the product and packaging contents

Film-coated tablet.

Safinamide Aurovitas 50 mg film-coated tablets EFG

Orange, round, biconvex film-coated tablets, approximately 7.1 mm in diameter, engraved with "SA" on one side and "50" on the other side.

Safinamide Aurovitas 100 mg film-coated tablets EFG

Orange, round, biconvex film-coated tablets, approximately 9.1 mm in diameter, engraved with "SA" on one side and "100" on the other side.

Safinamide Aurovitas 50 mg and 100 mg film-coated tablets are available in blister packs.

Blister pack: 10, 14, 20, 28, 30, 40, 50, 60, 70, 80, 90, 98, 100, and 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this package leaflet: November 2024

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