Leaflet: information for the user

Rasagilina Mylan 1 mg tablets EFG

rasagilina

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Rasagilina Mylan contains the active ingredient rasagilina and is indicated for the treatment of Parkinson's disease in adults. It may be used with or without levodopa (another medication 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 brain chemical involved in the control of movement. Rasagilina Mylan helps to increase and maintain dopamine levels in the brain.

Do not take Rasagilina Mylan:Rasagilina Mylan:

• If you are allergic to rasagilina or any of the other ingredients of this medication (listed in section 6).
• If you have severe liver problems.

Do not take the following medications while taking Rasagilina Mylan:Rasagilina Mylan:

• Monamine oxidase inhibitors (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for another indication), including medications and natural products without a prescription, e.g. St. John's Wort.
• Petidina (a potent analgesic).

You should wait at least 14 days after stopping treatment with Rasagilina Mylan and starting treatment with MAO inhibitors or petidina.

Warnings and precautions:

Consult your doctor before starting to take Rasagilina Mylan.

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

Inform your doctor if you or your family/caregiver notice that you are experiencing unusual behaviors in which you cannot resist the impulse, the urgent need or the anxiety to perform certain harmful or harmful activities for yourself or for others. These are called impulse control disorders. In patients taking Rasagilina Mylan or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, ludomania, excessive spending, impulsive behavior, and an abnormally high or increased sexual impulse or thoughts or feelings have been observed. Your doctor may need to adjust or interrupt your dose (see section 4).

Rasagilina Mylan may cause drowsiness and make you fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medications (used to treat Parkinson's disease). If you want more information, see the section "Driving and operating machines".

Children and adolescents:

The use of Rasagilina Mylan in children and adolescents is not appropriate. Therefore, Rasagilina Mylan is not recommended for minors under 18 years old.

Other medications and Rasagilina Mylan:

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

• Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants or tetracyclic antidepressants).
• The antibiotic ciprofloxacino, used against infections.
• The antitussive dextrometorfano.
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and anticholinergic medications containing efedrina or pseudoefedrina.

The use of Rasagilina Mylan should be avoided with antidepressants containing fluoxetina or fluvoxamina.

If you are starting your treatment with Rasagilina Mylan, you should wait at least 5 weeks since the interruption of treatment with fluoxetina.

If you are starting your treatment with fluoxetina or fluvoxamina, you should wait at least 14 days since the interruption of treatment with Rasagilina Mylan.

Inform your doctor or pharmacist if you smoke or intend to quit smoking. Smoking may decrease the amount of Rasagilina Mylan in the blood.

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 operating machines:

Consult your doctor before driving or operating machines, 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 sleep episodes.

This may increase if you take other medications to treat Parkinson's disease symptoms, if you take medications 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 machines (see section 2).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 1 mg tablet taken by mouth, once a day. Rasagilina Mylan can be taken with or without food.

If you take more Rasagilina Mylan than you should

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

The symptoms reported after a Rasagilina Mylan overdose were mildly euphoric mood (mild 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 the missed dose. Take the next regular dose when it is due.

If you interrupt treatment with Rasagilina Mylan

Do not stop taking Rasagilina Mylan without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Immediately contact your doctorif you experience any of the following symptoms. You may need treatment or urgent medical attention:

• If you experience unusual behaviors such as, for example, compulsions, obsessive thoughts, compulsive gambling, excessive spending or purchases, impulsive behavior, and an abnormally high or increased sex drive (impulse control disorders) (see section 2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremors, and sweating (serotonin syndrome).

Contact your doctorif you observe any suspicious changes in the 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)

• Unintentional movements (dyskinesia).
• Headache.

Common (may affect up to 1 in 10 people)

• Abdominal pain.
• Falls.
• Allergy.
• Fever.
• Flu (influenza).
• General discomfort.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing with symptoms such as dizziness/dizziness (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Alteration of blood test results (leucopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Hand numbness and weakness (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Muscle coordination difficulty (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urgent urination.

Rare (may affect up to 1 in 100 people)

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

Frequency not known: cannot be estimated from available data

• High blood pressure.
• Excessive somnolence.
• Sudden sleep.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly throughthe national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Rasagilina Mylan

• The active ingredient is rasagilina. Each tablet contains the rasagilina tartrate corresponding to 1 mg of rasagilina.
• The other components are microcrystalline cellulose, tartaric acid, cornstarch, pregelatinized cornstarch, talc, and stearic acid.

Appearance of the product and contents of the package

Rasagilina Mylan is presented in the form of white or off-white, elongated tablets (approximately 11.5 mm × 6 mm), biconvex with the inscription in relief “R9SE” on one face and “1” on the other face.

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

Marketing Authorization Holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

DUBLIN

Ireland

Responsible for manufacturing

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

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: