RASAGILINE VIATRIS 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Rasagiline Mylan contains the active substance rasagiline and is indicated for the treatment of Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine used to treat Parkinson's disease).

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

2. What you need to know before you take Rasagiline Mylan

Do nottake Rasagiline Mylan:

• 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 Mylan:

• Monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication), including non-prescription medicines and products, e.g. St. John's Wort.
• Pethidine (a strong painkiller).

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

Warnings and precautions

Consult your doctor before starting Rasagiline Mylan.

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

Tell your doctor if you or your family/caregiver notice that you are developing unusual behaviours where you cannot resist the impulse, urge or temptation to perform certain harmful or dangerous activities for yourself or others. These are called impulse control disorders. In patients taking Rasagiline Mylan or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour, and an abnormally high sexual drive or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline Mylan may cause you to feel drowsy or fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). If you need more information, see the section “Driving and using machines”.

This could increase if you take other medicines that may cause drowsiness or if you drink alcohol during treatment with Rasagiline Mylan. If you have experienced drowsiness or sudden sleep episodes before or during treatment with Rasagiline Mylan, do not drive or use machines (see section 2).

Children and adolescents

The use of Rasagiline Mylan in children and adolescents is not appropriate. Therefore, Rasagiline Mylan is not recommended for people under 18 years of age.

Other medicines and Rasagiline Mylan

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

Ask your doctor for advice before taking any of the following medicines with Rasagiline Mylan:

• 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 and oral decongestants, and cough and cold medicines containing ephedrine or pseudoephedrine.

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

If you are starting treatment with Rasagiline Mylan, 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 Mylan.

Tell your doctor or pharmacist if you smoke or intend to stop smoking. Smoking could decrease the amount of Rasagiline 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should avoid taking Rasagiline Mylan if you are pregnant, as the effects of Rasagiline Mylan on pregnancy and the unborn baby are not known.

Driving and using machines

Consult your doctor before driving or using machines, as both Parkinson's disease and treatment with Rasagiline Mylan may affect your ability to perform these activities. Rasagiline Mylan may cause dizziness or drowsiness, as well as sudden sleep episodes.

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

3. How to take Rasagiline Mylan

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

If you take more Rasagiline Mylan than you should

If you think you have taken more tablets of Rasagiline Mylan than you should, tell your doctor or pharmacist immediately. Bring the Rasagiline Mylan pack/blister with you to show the doctor or pharmacist.

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

If you forget to take Rasagiline Mylan

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

If you stop taking Rasagiline Mylan

Do not stop taking Rasagiline Mylan 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.

The following side effects have been reported in controlled clinical trials with placebo:

Get medical help immediatelyif you have any of the following symptoms. You may need treatment or urgent medical attention:

• If you develop unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour, and an abnormally high sexual drive or increased sexual thoughts and feelings (impulse control disorders) (see section 2).
• If you see or hear things that are not there (hallucinations).
• Any combination of hallucinations, fever, agitation, tremor, and sweating (serotonin syndrome).

Tell your doctorif you notice any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with 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/lightheadedness (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 sleep episodes.

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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline Mylan

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 refers to the last day of that month.

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

What Rasagiline Mylan contains

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

Appearance and packaging

Rasagiline Mylan is presented as white or almost white, elongated (approximately 11.5 mm x 6 mm), biconvex tablets with the inscription "R9SE" on one side and "1" on the other side.

The tablets are presented in blister packs of 7, 10, 28, 30, 100, and 112 tablets or perforated unit dose blisters of 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 authorisation 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 n.º 1, Pol. Las Salinas

08830 Sant Boi de Llobregat, Barcelona

Spain

Synthon s.r.o.,

Brnenská 32/cp. 597

678 01 Blansko

Czech Republic

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: