Rasagiline Viso Farmaceutica 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Rasagilina Viso Farmacéutica 1 mg tablets EFG

Rasagiline

Read all of 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, 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 could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What is Rasagilina Viso Farmacéutica and what is it used for

Rasagilina Viso Farmacéutica contains the active substance rasagilina 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 loss of dopamine-producing brain cells. Dopamine is a chemical substance in the brain involved in movement control. Rasagilina Viso Farmacéutica helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagilina Viso Farmacéutica

Do not take Rasagilina Viso Farmacéutica

• 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 during treatment with Rasagilina Viso Farmacéutica:

• Monoamine oxidase inhibitors (MAOIs) (used to treat depression or Parkinson's disease, or for any other indication), including over-the-counter medicines and natural products, e.g., St. John’s wort.
• Meperidine (a strong painkiller).

You must wait at least 14 days after stopping treatment with Rasagilina Viso Farmacéutica before starting treatment with MAO inhibitors or meperidine.

Warnings and precautions

Talk to your doctor before taking Rasagilina Viso Farmacéutica:

• If you have any liver problems.

You should speak with your doctor about any suspicious changes in your skin. Treatment with Rasagilina Viso Farmacéutica might possibly increase the risk of skin cancer. Tell your doctor if you or your family/caregiver notice that you are developing unusual behaviors in which you cannot resist the impulse, urge, or craving to carry out certain activities that may be harmful to yourself or others. This is known as impulse control disorders. In patients taking Rasagilina Viso Farmacéutica or other medicines used to treat Parkinson’s disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, abnormally increased sex drive, or increased sexual thoughts or desires have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagilina Viso Farmacéutica may cause drowsiness and may cause you to fall asleep suddenly during daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson’s disease). For more information, see the section “Driving and use of machines”.

Children and adolescents

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

Other medicines and Rasagilina Viso Farmacéutica

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

Consult your doctor before taking any of the following medicines together with Rasagilina Viso Farmacéutica:

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

The use of Rasagilina Viso Farmacéutica together with antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagilina Viso Farmacéutica, you must wait at least 5 weeks after stopping treatment with fluoxetine.

If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with Rasagilina Viso Farmacéutica.

Tell your doctor or pharmacist if you smoke or plan to stop smoking. Smoking may reduce the amount of Rasagilina Viso Farmacéutica 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 Rasagilina Viso Farmacéutica if you are pregnant, as the effects of Rasagilina Viso Farmacéutica 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 Rasagilina Viso Farmacéutica may affect your ability to perform these activities. Rasagilina Viso Farmacéutica may cause dizziness or drowsiness, as well as sudden episodes of falling asleep.

This effect may be increased if you take other medicines to treat symptoms of Parkinson’s disease, if you take medicines that may cause drowsiness, or if you drink alcohol while taking Rasagilina Viso Farmacéutica. If you have previously experienced drowsiness and/or sudden onset of sleep while taking Rasagilina Viso Farmacéutica, do not drive or operate machinery (see section 2).

3. How to take Rasagilina Viso Farmacéutica

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Rasagilina Viso Farmacéutica is one 1 mg tablet taken orally once daily.

Rasagilina Viso Farmacéutica may be taken with or without food.

If you take more Rasagilina Viso Farmacéutica than you should

If you think you have taken too much Rasagilina Viso Farmacéutica, inform your doctor or pharmacist immediately. Take the pack/blister or bottle of Rasagilina Viso Farmacéutica with you to show to the doctor or pharmacist.

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

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

If you forget to take Rasagilina Viso Farmacéutica

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

If you stop taking Rasagilina Viso Farmacéutica

Do not stop treatment with Rasagilina Viso Farmacéutica without first consulting your doctor.

If you have any further questions about the use of this medicine, consult 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 display unusual behaviors such as compulsions, obsessive thoughts, gambling addiction, excessive shopping or spending, impulsive behavior, or abnormally increased sexual desire or increased sexual thoughts (impulse control disorder) (see section 2).

• If you see or hear things that are not real (hallucinations).

• Any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome).

Contact your doctor 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 patients):

• Involuntary movements (dyskinesia)
• Headache

Common (may affect up to 1 in 10 patients):

• Abdominal pain
• Falls
• Allergic reaction
• Fever
• Flu-like symptoms
• General malaise
• Neck pain
• Chest pain (angina pectoris)
• Low blood pressure upon standing, with symptoms such as dizziness/feeling faint (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
• Problems with muscle coordination (balance disorder)
• Depression
• Dizziness (vertigo)
• Prolonged muscle contractions (dystonia)
• Runny nose (rhinitis)
• Skin irritation (dermatitis)
• Rash
• Red eyes (conjunctivitis)
• Urinary urgency

Uncommon (may affect up to 1 in 100 patients):

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

Frequency not known: cannot be estimated from available data

• High blood pressure
• Excessive sleepiness
• Sudden sleep onset

Reporting of adverse effects

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

5. Storage of Rasagilina Viso Farmacéutica

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

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

Do not store above 25°C.

Bottle only

Validity period after first opening: 2 months

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Contents of Rasagilina Viso Farmacéutica

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

Appearance of Rasagilina Viso Farmacéutica and contents of the pack

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

The tablets are packaged in PVC/Aluminum/OPA-Aluminum blisters containing 7, 10, 28, 30, 60, 100 and 112 tablets, or in white HDPE bottles, with or without child-resistant caps, containing 30 tablets.

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

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

Date of the most recent review of this leaflet: July 2021.

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