Rasagiline Mylan - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Rasagiline Mylan 1 mg 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.

What is in this leaflet

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

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

• 3. How to take Rasagiline Mylan

• 4. Possible side effects

• 5. How to store Rasagiline Mylan

• 6. Contents of the pack and other information

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

Rasagiline Mylan contains the active substance rasagiline and it is used for the treatment of Parkinson’s disease in adults. It can be used together with or without levodopa (another medicine that is 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 chemical in the brain involved in movement control. Rasagiline Mylan helps to increase and sustain levels of dopamine in the brain.

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

Do not take 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 (MAO) inhibitors (e.g. for treatment of depression or Parkinson’s di­sease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John's Wort.

• – pethidine (a strong pain killer).

You must wait at least 14 days after stopping Rasagiline Mylan treatment and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Talk to your doctor before taking Rasagiline Mylan.

• – if you have any liver problems

• – if you have any suspicious skin changes. Treatment with Rasagiline Mylan may possibly

increase the risk of skin cancer.

Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to yourself or others. These are called impulse control disorders. In patients taking Rasagiline Mylan and/or other medicines used to treat Parkinson’s di­sease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline Mylan may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson’s di­sease). For further information please refer to section driving and using machines.

Children and adolescents

There is no relevant use of Rasagiline Mylan in children and adolescents. Therefore, Rasagiline Mylan is not recommended for use under the age of 18.

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 together with Rasagiline Mylan:

• – Certain antidepressants (selective serotonin reuptake inhibitors, selective serotoninnore­pinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)

• – the antibiotic ciprofloxacin used against infections

• – the cough suppressant dextromethorphan

• – sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold

medicine containing ephedrine or pseudoephedrine.

The use of Rasagiline Mylan together with the 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 fluoxetine treatment.

If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline Mylan treatment.

Tell your doctor or pharmacist if you are smoking or intend to stop smoking. Smoking could decrease the amount of Rasagiline Mylan in the 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 child are not known.

Driving and using machines

Ask your doctor for advice before you drive and operate machines, since Parkinson’s disease itself as well as the treatment with Rasagiline Mylan may influence your ability to do so. Rasagiline Mylan can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.

This might be enhanced if you take other medicines to treat the symptoms of your Parkinson’s di­sease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking Rasagiline Mylan. If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking Rasagiline Mylan do not drive or operate machinery (see section 2).

3. How to take Rasagiline Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 tablet of 1 mg taken by mouth once daily. Rasagiline Mylan may be taken with or without food.

If you take more Rasagiline Mylan than you should

If you think that you may have taken too many Rasagiline Mylan tablets, contact your doctor or pharmacist immediately. Take the Rasagiline Mylan carton/blister with you to show the doctor or pharmacist.

Symptoms reported following overdose of Rasagiline Mylan included slightly euphoric mood (light form of mania), extremely 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 dose normally, when it is time to take it.

If you stop taking Rasagiline Mylan

Do not stop taking Rasagiline Mylan without first talking to your doctor.

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.

Contact you doctor right away if you notice any of the following symptoms. You may need urgent medical advice or treatment:

• – If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).

• – If you see or hear things which are not there (hallucinations).

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

Contact your doctor if you notice any suspicious skin changes because 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

• – Fall

• – Allergy

• – Fever

• – Flu (influenza)

• – General feeling of being unwell (malaise)

• – Neck pain

• – Chest pain (angina pectoris)

• – Low blood pressure when rising to a standing position with symptoms like dizziness/light-headedness (orthostatic hypotension)

• – Decreased appetite

• – Constipation

• – Dry mouth

• – Nausea and vomiting

• – Flatulence

• – Abnormal results of blood tests (leucopenia)

• – Joint pain (arthralgia)

• – Musculoskeletal pain

• – Joint inflammation (arthritis)

• – Numbness and muscle weakness of the hand (carpal tunnel syndrome)

• – Decreased weight

• – Abnormal dreams

• – Difficulty in muscular coordination (balance disorder)

• – Depression

• – Dizziness (vertigo)

• – Prolonged muscle contractions (dystonia)

• – Runny nose (rhinitis)

• – Irritation of the skin (dermatitis)

• – Rash

• – Bloodshot eyes (conjunctivitis)

• – Urinary urgency

Uncommon (may affect up to 1 in 100 people)

• – Stroke (cerebrovascular accident)

• – Heart attack (myocardial infarction)

• – Blistering rash (vesiculobullous rash)

Not known: frequency cannot be estimated from the available data

• – Elevated blood pressure

• – Excessive drowsiness

• – Sudden onset of sleep

Reporting of side effects

If you get 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. How to store 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 corresponding to 1 mg rasagiline.

• – The other ingredients are microcrystalline cellulose, tartric acid, maize starch, pregelatinized maize starch, talc, stearic acid.

What Rasagiline Mylan looks like and contents of the pack

Rasagiline tablets are presented as white to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with ‘R9SE’ on one side and ‘1’ on the other side.

The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets and in perforated blister packs containing 7 × 1, 10 × 1, 28 × 1, 30 × 1, 100 × 1 and 112 × 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Manufacturer

Synthon Hispania S.L.,

C/ Castelló nol, Pol. Las Salinas,

08830, Sant Boi de Llobregat, Barcelona,

Spain

Mylan Hungary Kft,

Mylan utca 1

H-2900 Komárom

Hungary.

Synthon s.r.o,

Brněnská 32/čp. 597

678 01 Blansko

Czech Republic

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

Tel: + 372 6363 052

This leaflet was last revised in < {MM/YYYY }><{month YYYY }>.

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