RASAGILINA 1 мг Таблетка

Содержание инструкции

1. RASAGILINA VIATRIS 1 mg tablets
   1. What is RASAGILINA VIATRIS and what it is used for
   2. What you need to know before you take RASAGILINA VIATRIS
   3. How to take RASAGILINA VIATRIS
   4. Possible side effects
   5. How to store RASAGILINA VIATRIS
   6. Package contents and other information

RASAGILINA VIATRIS 1 mg tablets

rasagilina

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is RASAGILINA VIATRIS and what it is used for

RASAGILINA VIATRIS contains the active ingredient rasagiline 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).
With Parkinson's disease, there is a loss of dopaminergic cells in certain areas of the
brain. Dopamine is a brain substance responsible for controlling movements.
RASAGILINA VIATRIS helps to increase and maintain constant levels of dopamine in the brain.

2. What you need to know before you take 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 failure.

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 medicines and herbal products available without a prescription, such as St. John's Wort.
• pethidine (a strong painkiller).

Wait at least 14 days after stopping treatment with RASAGILINA VIATRIS before starting treatment with MAOIs or pethidine.

Warnings and precautions
Talk to your doctor before taking RASAGILINA VIATRIS.

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

Tell your doctor if you, your family members or your caregivers notice that you are developing unusual behaviours that make you unable to resist the impulse, urge or desire to carry out certain activities that are dangerous or harmful to yourself or others. These behaviours are called impulse control disorders. Impulse control disorders such as compulsive gambling, excessive eating, compulsive shopping, sexual urges and/or thoughts have been reported in patients taking RASAGILINA VIATRIS and/or other medicines used to treat Parkinson’s disease. Your doctor may need to adjust your dose or stop your treatment (see section 4).
Rasagilina Viatris can cause drowsiness and may cause you to fall asleep suddenly during the day, especially if you are taking other dopaminergic medicines (used to treat Parkinson’s disease). For further information, please refer to the Driving and operating machinery section.

Children and adolescents
There is no 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:

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

Avoid the concomitant use of RASAGILINA VIATRIS and antidepressants containing fluoxetine or fluvoxamine.
Wait at least five weeks after stopping treatment with fluoxetine before starting treatment with RASAGILINA VIATRIS.
Wait at least 14 days after stopping treatment with RASAGILINA VIATRIS before starting treatment with fluoxetine or fluvoxamine.
Tell your doctor or pharmacist if you are a smoker or intend to stop smoking. Smoking may reduce the amount of Rasagilina Viatris in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking Rasagilina Viatris if you are pregnant, because the effects of Rasagilina Viatris on pregnancy and the foetus are unknown.

Driving and operating machinery
Ask your doctor for advice before driving or operating machinery, as Parkinson’s disease itself as well as treatment with Rasagilina Viatris may affect your ability to do so. Rasagilina Viatris can make you feel dizzy and sleepy; it can also cause sudden episodes of falling asleep.
This may be increased if you are taking other medicines for the treatment of Parkinson’s disease symptoms or if you are taking medicines that can make you feel sleepy, or if you drink alcohol while taking Rasagilina Viatris. If you have experienced sleepiness and/or sudden episodes of falling asleep in the past or during treatment with Rasagilina Viatris, do not drive or operate machinery (see section 2).

3. How to take RASAGILINA VIATRIS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 tablet of 1 mg taken by mouth, once a day.
RASAGILINA VIATRIS can be taken with or without food.

If you take more RASAGILINA VIATRISthan you should
If you think you have taken more RASAGILINA VIATRIS tablets than you should, contact
your doctor or pharmacist immediately. Bring with you the blister/bottle of RASAGILINA VIATRIS
to show to the doctor or pharmacist.
The symptoms reported after an overdose of Rasagilina Viatris included a slightly
euphoric mood (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 a missed tablet. Take the next
dose as normal, when it is time to take it.

If you stop taking RASAGILINA VIATRIS
If you have any questions about the use of RASAGILINA VIATRIS, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediatelyif you notice any of the following symptoms. You may need
immediate medical attention or treatment:

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

Contact your doctorif you notice any suspicious skin changes, because 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
• Allergy
• Fever
• Flu-like illness (influenza)
• General feeling of being unwell (malaise)
• Neck pain
• Chest pain (angina pectoris)
• Low blood pressure when standing up, leading to symptoms such as dizziness or lightheadedness (orthostatic hypotension)
• Decreased appetite
• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Abnormal blood test results (leukopenia)
• Joint pain (arthralgia)
• Musculoskeletal pain
• Joint inflammation (arthritis)
• Numbness and weakness of the hand muscle (carpal tunnel syndrome)
• Weight loss
• Abnormal dreams
• Difficulty with muscle coordination (balance disorders)
• Depression
• Dizziness
• 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)
• Blistering rash (bullous 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 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 through 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 RASAGILINA VIATRIS

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 packaging or the carton
after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What RASAGILINA VIATRIS contains

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

Description of the appearance of RASAGILINA VIATRIS and package contents
Rasagiline tablets are white to off-white in color, oblong (approximately 11.5 mm x 6 mm),
biconvex, with “R9SE” imprinted 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 authorization holder and manufacturer
Marketing authorization holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer
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 on this medicinal product, contact the local representative of the marketing
authorization holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: + 420 222 004 400

Magyarország
Viatris Healthcare Kft
Tel: +36 1 465 2100

Danmark
Mylan Denmark ApS
Tel: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris Norge AS
Tel: + 47 66 75 33 00

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals S.L.U.
Tel: + 34 900 102 712

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Polska
Viatris Healthcare Sp. z.o.o.
Tel: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 21 412 72 00

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 (0) 87 1694982

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 02 612 46921

Suomi/Finland
Viatris Oy Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: + 46 (0) 8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/ .