RASAGILINE VISO FARMACEUTICA 1 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

RasagilineViso Pharmaceutical1 mg EFG tablets

Rasagiline

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

1. What is Rasagiline Viso Pharmaceutical and what is it used for

Rasagiline Viso Pharmaceutical contains the active substance rasagiline and is indicated for the treatment of Parkinson's disease in adults. It can be used with or without Levodopa (another medicine used for Parkinson's disease).

Parkinson's disease causes a loss of cells that produce dopamine in the brain. Dopamine is a brain chemical involved in controlling movement. Rasagiline Viso Pharmaceutical helps to increase and maintain dopamine levels in the brain.

2. What you need to know before you take Rasagiline Viso Pharmaceutical

Do not takeRasagiline Viso Pharmaceutical

• If you are allergicto 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 being treated with Rasagiline Viso Pharmaceutical:

• Monoamine oxidase inhibitors (MAOIs) (for the treatment of depression or Parkinson's disease, or for any other indication), including non-prescription medicines and natural products, e.g. St. John's Wort.
• Pethidine (a potent pain reliever).

You must wait at least 14 daysafter stopping treatment with Rasagiline Viso Pharmaceutical before starting treatment with MAOIs or pethidine.

Warnings and precautions

Consult your doctor before taking Rasagiline Viso Pharmaceutical:

• If you have any liver problems

You should discuss with your doctor any suspicious changes in your skin. Treatment with Rasagiline Viso Pharmaceutical may possibly increase the risk of skin cancer (melanoma).

Tell your doctorif you or your family/caregiver notice that you are presenting unusual behaviors in which you cannot resist the urge, need, or cravingto perform certain harmful or hazardous activities for yourself or others. This is known as impulse control disorders. In patients taking Rasagiline Viso Pharmaceutical or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behavior, or an abnormally high sexual desire, or an increase in sexual thoughts or desires have been observed. Your doctor may need to adjust or interrupt the dose (see section 4).

Rasagiline Viso Pharmaceutical may cause drowsiness and make you fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease).

Children and adolescents

The use of Rasagiline Viso Pharmaceutical in children and adolescents is not relevant. Therefore, Rasagiline Viso Pharmaceutical is not recommended for individuals under 18 years of age.

Other medicines and Rasagiline Viso Pharmaceutical

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

Consult your doctor before taking any of the following medicines with Rasagiline Viso Pharmaceutical:

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine 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 cough and cold medicines that contain ephedrine or pseudoephedrine

The use of Rasagiline Viso Pharmaceutical with antidepressants that contain fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagiline Viso Pharmaceutical, 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 Viso Pharmaceutical.

Tell your doctor or pharmacist if you smoke or plan to quit smoking. Smoking may decrease the amount of Rasagiline Viso Pharmaceutical in your blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should avoid taking Rasagiline Viso Pharmaceutical if you are pregnant, as the effects of Rasagiline Viso Pharmaceutical 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 Viso Pharmaceutical may affect your ability to perform these activities. Rasagiline Viso Pharmaceutical may cause dizziness or drowsiness, as well as sudden episodes of sleep.

This may be increased if you take other medicines for Parkinson's disease symptoms, or if you take medicines that may cause drowsiness, or if you drink alcohol while taking Rasagiline Viso Pharmaceutical. If you have experienced drowsiness and/or sudden sleep episodes before or while taking Rasagiline Viso Pharmaceutical, do not drive or use machines (see section 2).

3. How to take Rasagiline Viso Pharmaceutical

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

The recommended dose of Rasagiline Viso Pharmaceutical is one 1 mg tablet taken orally once a day.

Rasagiline Viso Pharmaceutical can be taken with or without food.

If you take more Rasagiline Viso Pharmaceutical than you should

If you think you have taken more Rasagiline Viso Pharmaceutical than you should, inform your doctor or pharmacist immediately. Bring the pack or blister or bottle of Rasagiline Viso Pharmaceutical with you to show the doctor or pharmacist.

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

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 medicine and the amount ingested.

If you forget to take Rasagiline Viso Pharmaceutical

Do not take a double dose to make up for forgotten doses. Take the next normal dose when it is due.

If you stop taking Rasagiline Viso Pharmaceutical

Do not stop treatment with Rasagiline Viso Pharmaceutical without consulting your doctor first.

If you have any other questions about 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 treatment or urgent medical attention:

• If you experience unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behavior, or an abnormally high sexual desire, or an increase in 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 doctorif 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
• General malaise
• Neck pain
• Chest pain (angina pectoris)
• Low blood pressure when standing up, with symptoms such as dizziness/fainting (orthostatic hypotension)
• Decreased appetite
• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Abnormal blood test results (leukopenia)
• 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 congestion (rhinitis)
• Skin irritation (dermatitis)
• Rash
• Red eyes (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 sleep

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 through the Spanish Pharmacovigilance System for Human Use http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline Viso Pharmaceutical

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 or bottle after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

Bottle only

Shelf life after opening: 2 months

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

Contents of Rasagiline Viso Pharmaceutical

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
• The other ingredients are microcrystalline cellulose, citric acid, pregelatinized starch (maize), colloidal anhydrous silica, stearic acid, talc

Appearance of Rasagiline Viso Pharmaceutical and contents of the pack

Rasagiline Viso Pharmaceutical is presented as white to off-white, flat, circular tablets, approximately 8 mm in diameter, with the number "771" engraved on one side and a "G" on the other.

The tablets are available in PVC/Aluminum/OPA-Aluminum blisters of 7, 10, 28, 30, 60, 100, and 112 tablets, or in a white HDPE bottle with and without a child-resistant cap, of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibíchova 143

56617 Vysoké Mýto

Czech Republic

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park, Croxley Green

Hertfordshire, WD18 8YA

United Kingdom

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Date of last revision of this leaflet:July 2021.

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