Rasagiline Aurovitas Spain 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rasagilina Aurovitas Spain 1 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Rasagilina Aurovitas Spain is and what it is used for

Rasagilina Aurovitas Spain contains the active substance rasagilina and is indicated for the treatment of Parkinson's disease in adults. It can be used either in combination with levodopa or without it (levodopa is another medicine used to treat Parkinson's disease).

In Parkinson's disease, there is a loss of dopamine-producing cells in the brain. Dopamine is a chemical substance in the brain involved in the control of movement. Rasagilina helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagilina Aurovitas Spain

Do not take Rasagilina Aurovitas Spain

• If you are allergic to rasagiline or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver problems.

Do not take the following medicines while taking rasagiline:

• Monoamine oxidase inhibitors (MAO inhibitors) (e.g., for the treatment of depression or Parkinson's disease, or for other indications), including prescription and non-prescription medicines and natural products, e.g., St. John's wort.
• Meperidine (a strong painkiller).

You must wait at least 14 days after stopping rasagiline before starting treatment with MAO inhibitors or meperidine, and vice versa.

Warnings and precautions

Talk to your doctor before starting to take Rasagilina Aurovitas Spain.

• If you have any liver problems.
• You should speak to your doctor about any suspicious changes in your skin. Treatment with rasagiline may possibly increase the risk of skin cancer.
• If you are taking medicines containing buprenorphine. Using these medicines together with rasagiline may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Rasagilina Aurovitas Spain").

Inform your doctor if you or your family/caregiver notice that you are displaying unusual behaviors in which you cannot resist the impulse, urge, or craving to carry out certain activities that may be harmful to you or others. These are known as impulse control disorders. In patients taking rasagiline and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally increased sex drive or increased sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline may cause drowsiness and cause you to fall asleep suddenly during daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). For further information, see the section "Driving and use of machines".

Children and adolescents

The use of rasagiline in children and adolescents is not relevant. Therefore, rasagiline is not recommended for patients under 18 years of age.

Other medicines and Rasagilina Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor especially if you are taking any of the following medicines:

• Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants).
• The antibiotic ciprofloxacin, used to treat infections.
• The cough suppressant dextromethorphan.
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine.

Some medicines may increase the side effects of rasagiline and, in some cases, may cause very serious reactions. Do not take any other medicine while taking rasagiline without first consulting your doctor, especially:

• Medicines containing buprenorphine. These medicines may interact with rasagiline and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

The use of rasagiline together with antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with rasagiline, you should wait at least 5 weeks after stopping treatment with fluoxetine.

If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping treatment with rasagiline.

Inform your doctor or pharmacist if you smoke or plan to stop smoking. Smoking may decrease the amount of rasagiline in your blood.

Pregnancy, breast-feeding, and fertility

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

You should avoid taking rasagiline if you are pregnant, as the effects of rasagiline on pregnancy and the fetus are unknown.

Driving and use of machines

Talk to your doctor before driving or operating machinery, as both Parkinson's disease and treatment with rasagiline may affect your ability to perform these activities. Rasagiline may cause dizziness or drowsiness, as well as sudden episodes of falling asleep.

This risk may increase if you are taking other medicines to treat symptoms of Parkinson's disease, if you are taking medicines that may cause drowsiness, or if you consume alcohol during treatment with rasagiline. If you have experienced drowsiness and/or sudden episodes of falling asleep before or during treatment with rasagiline, do not drive or operate machinery (see section 2).

3. How to take Rasagilina Aurovitas Spain

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of rasagilina is 1 tablet of 1 mg taken orally once daily. Rasagilina may be taken with or without food.

If you take more Rasagilina Aurovitas Spain than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging/foil of Rasagilina Aurovitas Spain with you to show to the doctor or pharmacist.

Symptoms reported following an overdose of rasagilina include slightly euphoric mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagilina Aurovitas Spain

Do not take a double dose to make up for missed doses. Take the next dose as scheduled.

If you stop taking Rasagilina Aurovitas Spain

Do not stop taking this medicine 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 experiences them.

Contact your doctor immediately if you experience any of the following symptoms. You may require urgent medical treatment or care:

• If you have unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behavior, or abnormally increased sex drive or increased sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome).

Contact your doctor immediately if you notice any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see section 2).

Other adverse effects

Very common (may affect more than 1 in 10 people)

• Involuntary movements (dyskinesia).
• Headache.

Common (may affect up to 1 in 10 people)

• Abdominal pain.
• Falls.
• Allergy.
• Fever.
• Flu (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure upon standing, with symptoms such as dizziness or lightheadedness (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Changes in blood test results (leucopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Numbness and muscle weakness in the hand (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Difficulty with muscle coordination (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Runny nose (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Redness of the eye (conjunctivitis).
• Urinary urgency.

Uncommon (may affect up to 1 in 100 people)

• Stroke (cerebrovascular accident).
• Heart attack (myocardial infarction).
• Blistering rash (vesiculobullous rash).

Frequency not known: cannot be estimated from available data

• High blood pressure.
• Excessive drowsiness.
• Sudden sleep episodes.

Reporting of adverse effects

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

5. Storage of Rasagiline Aurovitas Spain

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

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

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Aurovitas Spain

• The active substance is rasagilina. Each tablet contains 1 mg of rasagilina (as tartrate).
• The other components are microcrystalline cellulose, tartaric acid, corn starch, pregelatinized corn starch, talc and stearic acid.

Appearance of the medicinal product and contents of the container

Rasagilina Aurovitas Spain tablets are presented as white to off-white, oblong tablets (approximately 11.5 mm × 6 mm), biconvex, with the imprint “R9SE” on one side and “1” on the other.

The tablets are available in blister packs containing 7, 10, 28, 30, 50, 90, 100 and 112 tablets.

Only certain 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

Synthon Hispania S.L.

C/ Castelló nº1, Pol. Las Salinas

08830 Sant Boi de Llobregat, Barcelona

Spain

or

Synthon s.r.o.

Brnenska 32 /cp. 597

678 01 Blansko

Czech Republic

or

Synthon BV

Microweg, 22, P.O. Box 7071

6545 CM Nijmegen

Netherlands

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

Germany: Rasagilin PUREN 1 mg Tabletten

Spain: Rasagilina Aurovitas Spain 1 mg comprimidos EFG

Italy: Rasagilina Aurobindo

Netherlands: Rasagiline Aurobindo 1 mg, tabletten

Portugal: Rasagilina Aurovitas

United Kingdom: Rasagiline Milpharm 1 mg tablets

Romania: Rasagilina Aurobindo 1 mg comprimate

Date of the most recent review of this leaflet: March 2021

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/).