RASAGILINA 1 mg Tablet

Зміст інструкції

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

Rasagilina ratiopharm 1 mg tablets

rasagilina

Read this leaflet carefully before you start taking this medicine as 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 ratiopharm is and what it is used for
• 2. What you need to know before you take Rasagilina ratiopharm
• 3. How to take Rasagilina ratiopharm
• 4. Possible side effects
• 5. How to store Rasagilina ratiopharm
• 6. Contents of the pack and other information

1. What is Rasagilina ratiopharm and what is it used for

Rasagilina ratiopharm contains the active ingredient rasagiline and is used for 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 ratiopharm helps to increase and maintain constant levels of dopamine in the brain.

2. What you need to know before you take Rasagilina ratiopharm

Do not take Rasagilina ratiopharm:

• If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from severe hepatic insufficiency.

Do not take the following medicines in association with Rasagilina ratiopharm:

• Monoamine oxidase inhibitors (MAOIs) (used as antidepressants, for the treatment of Parkinson's disease or for any other indication), including medicines and herbal products without a prescription, such as St. John's Wort.
• Pethidine (a strong painkiller).

Wait at least 14 days after stopping treatment with Rasagilina ratiopharm before starting
treatment with MAOIs or pethidine.

Warnings and precautions
Talk to your doctor before taking Rasagilina ratiopharm

• If you have any problems with liver function.
• Talk to your trusted doctor if you notice any suspicious skin changes. Treatment with Rasagilina ratiopharm may increase the risk of skin cancer.

Tell your doctor if you, your family members or your caregiver notice that you are developing
unusual behaviors that make you unable to resist the impulse, urge or desire to
perform certain activities that are dangerous or harmful to you or others. These behaviors are called
impulse control disorders. In patients taking Rasagilina ratiopharm and/or other
medicines used to treat Parkinson's disease, behaviors such as
compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviors and an abnormally high sexual desire or increased sexual thoughts or urges have been observed.
Your doctor may need to adjust the dose or stop treatment (see section 4).
Rasagilina ratiopharm can cause drowsiness and may make you fall asleep suddenly during
daytime activities, especially if you are taking other dopaminergic medicines (used for the treatment
of Parkinson's disease). For further information, refer to the Driving and using machines section.

Children and adolescents
There is no indication for specific use of Rasagilina ratiopharm in children and
adolescents. Therefore, the use of Rasagilina ratiopharm is not recommended in patients under 18
years of age.

Other medicines and Rasagilina ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Especially tell your doctor if you are taking any of the following medicines:

• Some antidepressants (selective serotonin reuptake inhibitors, selective serotonin and 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 the concomitant use of Rasagilina ratiopharm and antidepressants containing fluoxetine or fluvoxamine. Wait at least five weeks after stopping treatment with fluoxetine before starting treatment with Rasagilina ratiopharm. Wait at least 14 days after stopping treatment with Rasagilina ratiopharm before starting treatment with fluoxetine or fluvoxamine.

Tell your doctor or pharmacist if you are a smoker or intend to quit smoking. Smoking may
reduce the amount of Rasagilina ratiopharm in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are 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 ratiopharm if you are pregnant, because the effects of Rasagilina
ratiopharm on pregnancy and the fetus are unknown.

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

3. How to take Rasagilina ratiopharm

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose of Rasagilina ratiopharm is 1 tablet of 1 mg taken orally, once a
day.
Rasagilina ratiopharm can be taken with or without food.

If you take more Rasagilina ratiopharm than you should
If you think you have taken more Rasagilina ratiopharm tablets than you should, contact your
doctor or pharmacist immediately. Bring with you the carton/blister or bottle of Rasagilina ratiopharm to
show to the doctor or pharmacist.
Symptoms reported after an overdose of Rasagilina ratiopharm 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 ratiopharm
Do not take a double dose to make up for the missed tablet. Take the next
dose as normal, when it is time to take it.

If you stop taking Rasagilina ratiopharm
Do not stop taking Rasagilina ratiopharm 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.

Seek immediate medical attentionif 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, excessive shopping or spending, impulsive behaviour and an abnormally increased sexual drive or increased 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)
• Reduced blood pressure when getting up from a sitting or lying position, accompanied by symptoms such as dizziness/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)
• Erythema
• Red eyes (conjunctivitis)
• Urinary urgency.

Uncommon (may affect up to 1 in 100 people)

• Stroke (cerebrovascular accident)
• Heart attack (myocardial infarction)
• Blisters (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 Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rasagilina ratiopharm

Keep Rasagilina ratiopharm out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging, bottle or
pack after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 ratiopharm contains

• The active ingredient is rasagiline. Each tablet contains 1 mg of rasagiline (as mesylate).
• The other ingredients are mannitol, anhydrous colloidal silica, corn starch, pregelatinized corn starch, stearic acid, talc.

Description of the appearance of Rasagilina ratiopharm and contents of the pack
Rasagilina ratiopharm is presented as white to off-white, round, flat
tablets with beveled edges, smooth on one side and with the embossed markings “GIL” and “1” on the other.
The tablets are available in packs of 7, 10, 28, 30, 100 and 112 tablets, in perforated blisters
containing unit doses, packs of 10 x 1, 30 x 1 and 100 x 1 tablets or in bottles of 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers
Teva Pharmaceutical Europe B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Pliva Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
Teva Operations Poland Sp.z o.o.
ul. Mogilska 80
31-546 Krakow
Poland
For further information on this medicinal product, please contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tel/Tél: +32 3 820 73 73

Lietuva
UAB “Sicor Biotech”
Tel: +370 5 266 02 03

България
Тева Фармасютикълс България ЕООД
Teл: +359 2 489 95 82

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG, Belgium
Tel/Tél: +32 3 820 73 73

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 1 288 64 00

Malta
Teva Pharmaceuticals Ireland
Ireland
Tel: +353 51 321 740

Deutschland
ratiopharm GmbH
Tel: +49 731 402 02

Danmark
Teva Denmark A/S
Tlf: +45 44 98 55 11

Nederland
Teva Nederland B.V.
Tel: +31 800 0228 400

Eesti
Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Tel: +372 661 0801

Norge
Teva Norway AS
Tlf: +47 6677 55 90

Ελλάδα
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099

Österreich
ratiopharm Arzneimittel Vertriebs GmbH
Tel: +43 1 97007 0

España
Laboratorios Davur, S.L.U.
Tél: +34 91 387 32 80

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 22 345 93 00

France
Teva Santé
Tél: +33 1 55 91 7800

Portugal
Teva Pharma - Produtos Farmacêuticos Lda
Tel: +351 21 476 75 50

Hrvatska
Pliva Hrvatska d.o.o
Tel: + 385 1 37 20 000

Ireland
Teva Pharmaceuticals Ireland
Tel: +353 51 321 740

România
Teva Pharmaceuticals S.R.L
Tel: +4021 230 6524

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390

Ísland
Actavis Pharmaceuticals Iceland ehf.
Simi: +354 550 3300

Slovenská republika
Teva Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 5726 7911

Italia
Teva Italia S.r.l.
Tel: +39 028 917 981

Suomi/Finland
ratiopharm Oy
Puh/Tel: +358 20 180 5900

Κύπρος
Teva Ελλάς Α.Ε., Ελλάδα
Τηλ: +30 210 72 79 099

Sverige
Teva Sweden AB
Tel: +46 42 12 11 00

Latvija
Sicor Biotech filiāle Latvijā
Tel: +371 67 323 666