Rasagiline Viatris 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rasagilina Mylan 1 mg tablets EFG

rasagiline

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it could 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 Mylan is and what it is used for
2. What you need to know before taking Rasagilina Mylan
3. How to take Rasagilina Mylan
4. Possible side effects
5. How to store Rasagilina Mylan
6. Contents of the pack and other information

1. What Rasagilina Mylan is and what it is used for

Rasagilina Mylan 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 to treat Parkinson's disease).

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

2. What you need to know before taking Rasagilina Mylan

Do not take Rasagilina Mylan:

• 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 Rasagilina Mylan:

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

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

Warnings and precautions

Talk to your doctor before taking Rasagilina Mylan.

• If you have any liver problems.
• If you notice any suspicious changes in your skin. Treatment with Rasagilina Mylan may increase the risk of skin cancer.

Inform 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 you or others. These are known as impulse control disorders. In patients taking Rasagilina Mylan or other medicines used to treat Parkinson’s disease, such behaviors have been observed, including compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally increased sexual drive or increased sexual thoughts or feelings. Your doctor may need to adjust or stop your dose (see section 4).

Rasagilina Mylan may cause drowsiness and may cause you to fall asleep suddenly during everyday 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 Rasagilina Mylan in children and adolescents is not appropriate. Therefore, Rasagilina Mylan is not recommended for patients under 18 years of age.

Other medicines and Rasagilina Mylan

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

Seek medical advice before taking any of the following medicines with Rasagilina Mylan:

• Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline 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.

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

If you are starting treatment with Rasagilina Mylan, 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 Mylan.

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

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

3. How to take Rasagilina Mylan

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

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

If you take more Rasagilina Mylan than you should

If you think you have taken more tablets of Rasagilina Mylan than you should, inform your doctor or pharmacist immediately. Take the packaging/blister of Rasagilina Mylan with you to show to the doctor or pharmacist.

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

If you forget to take Rasagilina Mylan

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

If you stop taking Rasagilina Mylan

Do not stop taking Rasagilina Mylan 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.

The following adverse effects have been reported in placebo-controlled clinical trials:

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

• Unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour, abnormally increased sex drive, or increased sexual thoughts (impulse control disorders) (see section 2).
• Seeing or hearing things that are not there (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 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/spinning sensation (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 sleepiness.
• Sudden onset of sleep.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagilina Mylan

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

Do not use this medicine after the expiry date stated on the packaging or blister. 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. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Mylan

• The active substance is rasagiline. Each tablet contains rasagiline tartrate equivalent to 1 mg of rasagiline.
• The other components are microcrystalline cellulose, tartaric acid, corn starch, pregelatinized corn starch, talc, stearic acid.

Appearance of the product and contents of the pack

Rasagilina Mylan is presented as white or almost white, elongated (approximately 11.5 mm × 6 mm), biconvex tablets, with the raised inscription “R9SE” on one side and “1” on the other.

The tablets are packed in blister packs containing 7, 10, 28, 30, 100 and 112 tablets or in single-dose perforated blisters with 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 or 112 x 1 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

Mylan Hungary Kft
Mylan utca 1
H-2900 Komárom
Hungary

Synthon Hispania S.L.
C/Castelló No. 1, Pol. Las Salinas
08830 Sant Boi de Llobregat, Barcelona
Spain

Synthon s.r.o.
Brnenská 32/cp. 597
678 01 Blansko
Czech Republic

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

Date of the last review of this leaflet: