RASAGILINE AUROVITAS SPAIN 1 mg TABLETS

2. What you need to know before you take Rasagiline Aurovitas Spain

Do not take Rasagiline Aurovitas Spain

• If you are allergic to rasagiline or 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 (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medicines and natural products, e.g. St. John's Wort.
• Pethidine (a strong painkiller).

You should wait at least 14 days after stopping treatment with rasagiline and before starting treatment with MAOIs or pethidine.

Warnings and precautions

Consult your doctor before starting to take Rasagiline Aurovitas Spain.

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

Tell your doctor if you or your family/caregiver notice that you are presenting with unusual behaviors in which you cannot resist the impulse, urge, or desire to perform certain harmful or dangerous activities for yourself or others. These are called 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 shopping, impulsive behavior, and abnormally high sexual impulse or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or interrupt your dose (see section 4).

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

Children and adolescents

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

Other medicines and Rasagiline Aurovitas Spain

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin and noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).
• The antibiotic ciprofloxacin, used against infections.
• The cough suppressant dextromethorphan.
• Sympathomimetics such as those found in eye drops, nasal decongestants, and oral and cough medicines that contain 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 muscle contractions, including the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

The use of rasagiline 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.

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

Pregnancy, breastfeeding, and fertility

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.

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

Driving and using machines

Consult your doctor before driving or using machines, as both Parkinson's disease and treatment with rasagiline may affect your ability to perform these activities. Rasagiline may cause you to feel dizzy or drowsy, as well as sudden episodes of sleepiness.

This may increase if you take other medicines for Parkinson's disease symptoms, if you take medicines that may cause drowsiness, or if you consume alcohol during treatment with rasagiline. If you have experienced drowsiness and/or sudden episodes of sleepiness before or during treatment with rasagiline, do not drive or use machines (see section 2).

3. How to take Rasagiline Aurovitas Spain

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of rasagiline is 1 tablet of 1 mg taken by mouth, once a day. Rasagiline can be taken with or without food.

If you take more Rasagiline Aurovitas Spain than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Bring the packaging/blister of Rasagiline Aurovitas Spain with you to show to the doctor or pharmacist.

The symptoms reported after an overdose of rasagiline were mildly euphoric mood (mild mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagiline Aurovitas Spain

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you stop taking Rasagiline Aurovitas Spain

Do not stop taking this medicine 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.

Contact your doctor immediatelyif you experience any of the following symptoms. You may need urgent medical treatment:

• If you experience unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and abnormally high sexual impulse or increased sexual thoughts and feelings (impulse control disorders) (see section 2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremors, 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 side 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.
• Allergic reactions.
• Fever.
• Flu (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing up with symptoms such as dizziness/spinning (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Abnormal 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.
• Muscle coordination problems (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (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 the available data

• High blood pressure.
• Excessive drowsiness.
• Sudden sleepiness.

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 to the Spanish Medicines Vigilance System for Human Use: www.notificaram.es. By reporting side 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 which is stated on the carton or blister after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

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 Rasagiline Aurovitas Spain

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

Appearance and packaging

Rasagiline Aurovitas Spain tablets are white to off-white, oblong (approximately 11.5 mm x 6 mm), biconvex, with the mark "R9SE" on one face and "1" on the other face.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing Authorisation 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 medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Rasagilin PUREN 1 mg Tabletten

Spain: Rasagilina Aurovitas Spain 1 mg tablets EFG

Italy: Rasagilina Aurobindo

Netherlands: Rasagiline Aurobindo 1 mg, tablets

Portugal: Rasagilina Aurovitas

United Kingdom: Rasagiline Milpharm 1 mg tablets

Romania: Rasagilina Aurobindo 1 mg tablets

Date of last revision of this leaflet: March 2021

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