RASAGILINA 1 мг Коированная таблетка

Содержание инструкции

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

Rasagilina Teva 1 mg tablets

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

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

Rasagilina Teva contains the active substance 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 Teva
helps to increase and maintain constant levels of dopamine in the brain.

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

Do not take Rasagilina Teva

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

Do not take the following medicines in combination with Rasagilina Teva:

• 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 Teva before starting treatment with MAOIs or pethidine.

Warnings and precautions
Talk to your doctor before taking Rasagilina Teva

• In case of any problems with liver function
• Talk to your trusted doctor if you notice any suspicious skin changes.

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

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

Other medicines and Rasagilina Teva
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)
• 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 Teva and antidepressants containing fluoxetine or fluvoxamine.
Before starting treatment with Rasagilina Teva, 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 Teva.
Tell your doctor or pharmacist if you are a smoker or intend to quit smoking. Smoking may
reduce the amount of Rasagilina Teva in the blood.

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

Driving and using machines
Ask your doctor for advice before driving and using machines, as Parkinson's disease itself as well as treatment with Rasagilina Teva can affect your ability to do so.
Rasagilina Teva can make you feel dizzy and drowsy; it can also cause sudden onset of sleep.
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 Teva. If you have experienced drowsiness and/or sudden onset of sleep
in the past or during treatment with Rasagilina Teva, do not drive or use machines (see
section 2).

3. How to take Rasagilina Teva

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

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

If you stop taking Rasagilina Teva
If you have any questions about 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.
li manifestino.

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 drive 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).
• If you notice suspicious skin changes, because patients with Parkinson’s disease have a higher risk of skin cancer (not only melanoma) (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 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 at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rasagilina Teva

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, bottle or
blister 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 wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rasagilina Teva contains

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

Description of the appearance of Rasagilina Teva and contents of the pack
Rasagilina Teva is presented as white to off-white, round, flat and
bevelled-edge tablets, with a diameter of 8 mm, smooth on one side and bearing the raised inscriptions “GIL” and “1”
on the other.
The tablets are available in packs of 7, 10, 28, 30, 100 and 112 tablets, in packs of 10 x
1, 30 x 1 and 100 x 1 tablets (blister divisible for unit dose) or in bottles of 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazza Luigi Cadorna, 4
20123 Milano
Italy

Manufacturers
Teva Pharmaceutical Europe B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
Teva Operations Poland Sp. zo.o
80 Mogilska Str.
31-546 Krakow
Poland
Pliva Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium Rasagiline Teva 1 mg Tabletten/Comprimés
Croatia Razagilin Teva1 mg tablete
Denmark Rasagiline Teva
Estonia Rasagiline Teva
France Rasagiline Teva 1 mg, comprimé
Germany Rasagilin AbZ 1 mg Tabletten
Ireland Rasagiline Teva 1 mg tablets
Italy Rasagilina Teva
Latvia Rasagiline Teva1 mg tabletes
Malta Rasagiline Teva1 mg tablets
Portugal Rasagilina Teva1 mg comprimidos
Slovenia Razagilin Teva1 mg tablete
Slovakia Razagilin Teva1 mg tablety
Spain Rasagilina Teva 1 mg comprimidos EFG
Sweden Rasagiline Teva
United Kingdom Rasagiline Teva 1 mg tablets