SAFINAMIDE AUROVITAS 50 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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Safinamide Aurovitas is a medicine 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 medicine called levodopa alone or in combination with other medicines for Parkinson's disease.

2. What you need to know before you take Safinamide Aurovitas

Do not take Safinamide Aurovitas

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

You must 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 severe progressive diabetic retinopathy (progressive loss of vision due to diabetes).

Warnings and precautions

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

• 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 and spending have been reported with other medicines for Parkinson's disease.
• Also, involuntary muscle spasms may 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 due to the lack of data on safety and efficacy in this population.

Other medicines and Safinamide Aurovitas

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

• Cough and cold remedies containing dextromethorphan, ephedrine, or pseudoephedrine.
• Medicines called selective serotonin reuptake inhibitors (SSRIs) that are normally used to treat anxiety disorders and some personality disorders (e.g., fluoxetine or fluvoxamine).
• Medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depression 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 gliburide and metformin.
• Medicines 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

Safinamide is likely to 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 Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor again.

The recommended starting dose of this medicine 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 your case.

If you take more Safinamide Aurovitas than you should

If you have taken too many tablets of this medicine, you may develop high blood pressure, anxiety, confusion, distraction, drowsiness, dizziness, feel sick or vomit, have dilated pupils, or develop involuntary muscle spasms. Contact your doctor immediately and take the safinamide packaging with you.

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

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 take it.

If you stop taking Safinamide Aurovitas

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 medicines):

Common(may affect up to 1 in 10 people): insomnia, difficulty performing voluntary movements, feeling of 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 worry, 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, disorders of the light-sensitive layer at the back of the eye, redness of the eyes, increased eye pressure, feeling that the room is spinning, feeling 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, generalized itching, sensitivity to light, redness of the skin, back pain, joint pain, muscle cramps, stiffness, pain in arms or legs, muscle weakness, feeling of heaviness, increased urination at night, pain when urinating, difficulty urinating, prostate problems, breast pain, decreased drug effect, drug intolerance, feeling of 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, clouding of consciousness, disorientation, misperception 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, ease of distraction, loss of sense of taste, weak or slow reflexes, pain in the legs that radiates, constant urge to move the legs, feeling of drowsiness, 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 of 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Safinamide Aurovitas

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other 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 pack contents

Film-coated tablet.

Safinamide Aurovitas 50 mg film-coated tablets EFG

Orange, round, biconvex film-coated tablets, approximately 7.1 mm, 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, 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.

Avda. 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: November 2024

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