Rasagiline Viatri

Package leaflet: Information for the patient

RASAGILINA VIATRIS 1 mg tablets

rasagiline
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What RASAGILINA VIATRIS is and what it is used for

RASAGILINA VIATRIS contains the active substance rasagilina and is used in 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, dopaminergic nerve cells are lost in certain areas of the
brain. Dopamine is a substance in the brain responsible for controlling movement.
RASAGILINA VIATRIS helps increase and maintain stable levels of dopamine in the brain.

2. What you need to know before taking RASAGILINA VIATRIS

Do not take RASAGILINA VIATRIS:

• 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 impairment.

Do not take the following medicines in combination with RASAGILINA VIATRIS:

• monoamine oxidase inhibitors (MAOIs) (used as antidepressants, for the treatment of Parkinson's disease, or for any other indication), including over-the-counter medicines and herbal products such as St. John’s wort.
• meperidine (pethidine) (a strong painkiller).

Wait at least 14 days after stopping treatment with RASAGILINA VIATRIS before starting treatment with MAO inhibitors or meperidine.
Warnings and precautions
Talk to your doctor before taking RASAGILINA VIATRIS.

• If you have any liver function problems.
• if you have any suspicious skin lesions. Treatment with RASAGILINA VIATRIS may increase the risk of skin cancer.

Inform your doctor if you, your family members, or caregivers notice that you are developing unusual behaviours that make you unable to resist the impulse, drive, or urge to carry out certain activities that may be harmful to yourself or others. These behaviours are known as impulse control disorders. In patients taking RASAGILINA VIATRIS and/or other medicines used to treat Parkinson’s disease, such behaviours have been observed, including compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviours, and abnormally increased sexual desire or an increase in sexual thoughts or urges. Your doctor may need to adjust your dose or discontinue your treatment (see section 4).
Rasagilina Viatris may cause drowsiness and may cause you to fall asleep suddenly during daytime activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson’s disease). For further information, refer to the section on Driving and use of machines.
Children and adolescents
There is no indication for the specific use of Rasagilina Viatris in children and adolescents. Therefore, the use of Rasagilina Viatris is not recommended in children and adolescents under 18 years of age.
Other medicines and RASAGILINA VIATRIS
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 in combination with RASAGILINA VIATRIS:

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

Avoid concomitant use of RASAGILINA VIATRIS and antidepressants containing fluoxetine or fluvoxamine.
Before starting treatment with RASAGILINA VIATRIS, wait at least five weeks after stopping treatment with fluoxetine.
Before starting treatment with fluoxetine or fluvoxamine, wait at least 14 days after stopping treatment with RASAGILINA VIATRIS.
Inform your doctor or pharmacist if you are a smoker or plan to stop smoking. Smoking may reduce the amount of Rasagilina Viatris in your blood.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Avoid taking Rasagilina Viatris during pregnancy, as the effects of Rasagilina Viatris on pregnancy and the fetus are unknown.
Driving and use of machines
Ask your doctor for advice before driving or operating machinery, as both Parkinson’s disease itself and treatment with Rasagilina Viatris may affect your ability to do so. Rasagilina Viatris may cause dizziness and drowsiness; it may also cause sudden episodes of falling asleep.
This effect may be increased if you are taking other medicines for the symptoms of Parkinson’s disease, or if you are taking medicines that cause drowsiness, or if you drink alcohol while taking Rasagilina Viatris. If you have previously experienced drowsiness and/or sudden episodes of falling asleep, either before or during treatment with Rasagilina Viatris, do not drive or operate machinery (see section 2).

3. How to take RASAGILINA VIATRIS

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet of 1 mg taken orally once daily.
RASAGILINA VIATRIS may be taken with or without food.
If you take more RASAGILINA VIATRIS than you should
If you think you have taken more tablets of RASAGILINA VIATRIS than you should, contact your doctor or pharmacist immediately. Take the RASAGILINA VIATRIS blister pack/bottle with you to show to the doctor or pharmacist.
Symptoms reported after overdose of Rasagilina Viatris have included slightly euphoric mood (a mild form of mania), extremely high blood pressure, and serotonin syndrome (see section 4).
If you forget to take RASAGILINA VIATRIS
Do not take a double dose to make up for the forgotten tablet. Take the next dose at the usual time.
If you stop taking RASAGILINA VIATRIS
If you have any doubts about using RASAGILINA VIATRIS, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you notice any of the following symptoms. You may need
immediate medical advice or treatment:

• If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling addiction, excessive shopping or spending, impulsive behaviour, abnormally increased sex drive or an increase in sexual thoughts (impulse control disorders) (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 suspicious skin changes, as the risk of skin cancer (melanoma) may increase 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
• Falls
• Allergic reaction
• Fever
• Flu-like symptoms (influenza)
• General feeling of being unwell (malaise)
• Neck pain
• Chest pain (angina pectoris)
• Low blood pressure when standing up, with symptoms such as dizziness/light-headedness (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 weakness in the hand muscle (carpal tunnel syndrome)
• Loss of body weight
• Abnormal dreams
• Difficulty with muscle coordination (balance disorders)
• 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 people)

• Stroke (cerebrovascular accident)
• Heart attack (myocardial infarction)
• Rash with blisters (vesiculobullous erythema)

Not known: frequency cannot be estimated from the available data

• High blood pressure
• Excessive sleepiness
• Sudden onset of sleep

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store RASAGILINA VIATRIS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack or carton after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RASAGILINA VIATRIS contains

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

Description of the appearance of RASAGILINA VIATRIS and package contents
Rasagiline tablets are white to off-white, oblong (approximately 11.5 mm x 6 mm),
biconvex, with "R9SE" engraved on one side and "1" on the other.
The tablets are available in packs of 7, 10, 28, 30, 100 and 112, and in perforated blisters containing
7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 and 112 x 1.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturers
Synthon Hispania S.L.,
C/ Castelló no1, 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft
Tel: + 420 222 004 400 Tel: +36 1 465 2100

Danmark Malta
Mylan Denmark ApS V.J. Salomone Pharma Ltd
Tel: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris Norge AS
Tel: + 372 6363 052 Tel: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals S.L.U. Viatris Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 (0) 87 1694982 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy Puh/Tel: +358 20 720 9555
Tel: + 39 02 612 46921

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0) 8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/