Leaflet: Information for the user

Rasagilina Aurovitas Spain 1 mg tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Rasagilina Aurovitas Spain

3.How to take Rasagilina Aurovitas Spain

4.Possible side effects

5.Storage of Rasagilina Aurovitas Spain

6.Contents of the pack and additional information

Rasagilina Aurovitas Spain contains the active ingredient rasagilina and is indicated for the treatment of Parkinson's disease in adults. It may be used with or without levodopa (another medication used to treat Parkinson's disease).

With Parkinson's disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a brain chemical involved in the control of movement. Rasagilina helps to increase and maintain dopamine levels in the brain.

Do not take Rasagilina Aurovitas Spain

-If you are allergic to rasagilina or any of the other components of this medication (listed in section 6).

-If you have severe liver problems.

Do not takethe following medications while taking rasagilina:

-Monamine oxidase inhibitors (MAO) (e.g., for the treatment of depression or Parkinson's disease, or for another indication) including medications and natural products without prescription, e.g., St. John's Wort.

-Petidina (potent analgesic).

You should wait at least 14 days after stopping treatment with rasagilina and starting treatment with MAO inhibitors or petidina.

Warnings and precautions

Consult your doctor before starting to take Rasagilina Aurovitas Spain.

-If you have any liver problems.

-You should speak with your doctor about any suspicious changes in your skin. Treatment with rasagilina may possibly increase the risk of skin cancer.

-If you are taking medications containing buprenorphine. The use of these medications together withrasagilinamay lead to the serotonin syndrome, a potentially fatal disease (see “Other medications andRasagilina Aurovitas Spain”).

Inform your doctor if you or your family/caregiver notice that you are presenting unusual behaviors in which you cannot resist the impulse, the urgent need or the anxiety to perform certain harmful or harmful activities for yourself or for others. These are called impulse control disorders. In patients taking rasagilina and/or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, pathological gambling, excessive spending, impulsive behavior, and an abnormally high or increased sexual impulse or thoughts or feelings have been observed. Your doctor may need to adjust or interrupt your dose (see section 4).

Rasagilina may cause drowsiness and make you fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medications (used to treat Parkinson's disease). If you want more information, see the section “Driving and operating machines”.

Children and adolescents

The use of rasagilina in children and adolescents is not relevant. Therefore, rasagilina is not recommended for minors under 18 years.

Other medications and Rasagilina Aurovitas Spain

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor especially if you are taking any of the following medications:

-Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, or tetracyclic antidepressants).

-The antibiotic ciprofloxacin, used against infections.

-The antitussive dextromethorphan.

-Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and anticholinergic medications containing ephedrine or pseudoephedrine.

Some medications may increase the side effects of rasagilina and, in some cases, may cause severe reactions. Do not take any other medication while taking rasagilina without consulting your doctor, especially:

-Medications containing buprenorphine. These medications may interact with rasagilina and you may experience symptoms such as involuntary rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

It should be avoided to use rasagilina together with antidepressants containing fluoxetine or fluvoxamine.

If you are starting your treatment with rasagilina, you should wait at least 5 weeks since the interruption of treatment with fluoxetine.

If you are starting your treatment with fluoxetine or fluvoxamine, you should wait at least 14 days since the interruption of treatment with rasagilina.

Inform your doctor or pharmacist if you smoke or intend to quit smoking. Smoking may decrease the amount of rasagilina in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machines

Consult your doctor before driving or operating machines, as both Parkinson's disease and treatment withrasagilinamay affect your ability to perform these activities.Rasagilinamay cause dizziness or drowsiness, as well as sudden sleep episodes.

This may increase if you are taking other medications to treat the symptoms of Parkinson's disease, if you are taking medications that may cause drowsiness, or if you consume alcohol during treatment withrasagilina. If you have experienced drowsiness and/or sudden sleep episodes before or during treatment withrasagilina, do not drive or operate machines (see section 2).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of rasagilina is 1 tablet of 1 mg taken by mouth, once a day. Rasagilina can 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging/container of Rasagilina Aurovitas Spain to show to your doctor or pharmacist.

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

If you forgot to take Rasagilina Aurovitas Spain

Do not take a double dose to compensate for the missed doses. Take the next regular dose when it is due.

If you interrupt treatment with Rasagilina Aurovitas Spain

Do not stop taking this medication without consulting your doctor first.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

-If you experience unusual behaviors such as, for example, compulsions, obsessive thoughts, compulsive gambling, excessive spending or purchases, impulsive behavior, and an abnormally high or increased sex drive (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)

-Unintentional movements (dyskinesia).

-Headache.

Common(may affect up to 1 in 10 people)

-Abdominal pain.

-Falls.

-Allergy.

-Fever.

-Flu (influenza).

-General discomfort.

-Neck pain.

-Chest pain (angina).

-Low blood pressure when standing with symptoms such as dizziness/dizziness (orthostatic hypotension).

-Decreased appetite.

-Constipation.

-Dry mouth.

-Nausea and vomiting.

-Flatulence.

-Alteration of blood test results (leucopenia).

-Joint pain (arthralgia).

-Musculoskeletal pain.

-Joint inflammation (arthritis).

-Hand numbness and weakness (carpal tunnel syndrome).

-Weight loss.

-Abnormal dreams.

-Muscle coordination disorder (balance disorder).

-Depression.

-Dizziness (vertigo).

-Prolonged muscle contractions (dystonia).

-Nasal discharge (rhinitis).

-Skin irritation (dermatitis).

-Rash.

-Redness of the eyes (conjunctivitis).

-Urgency to urinate.

Rare(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 somnolence.

-Sudden sleep.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box or on the blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Rasagilina Aurovitas Spain

-The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as tartrate).

-The other components are microcrystalline cellulose, tartaric acid, cornstarch, pregelatinized cornstarch, talc, and stearic acid.

Appearance of the product and contents of the package

Rasagilina Aurovitas Spain tablets are presented in the form of white to off-white, oblong (approximately 11.5 mm × 6 mm), biconvex tablets, with the mark “R9SE” on one face and “1” on the other face.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the Marketing Authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible 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 authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: March 2021

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).