RASAGILINA 1 мг Таблетка

Содержание инструкции

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

Rasagilina Krka 1 mg tablets

Generic medicine

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 personally. Do not pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• 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 Krka is and what it is used for
• 2. What you need to know before you take Rasagilina Krka
• 3. How to take Rasagilina Krka
• 4. Possible side effects
• 5. How to store Rasagilina Krka
• 6. Contents of the pack and other information

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

Rasagilina Krka is used in the treatment of Parkinson's disease. 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 Krka helps to
increase and maintain constant levels of dopamine in the brain.

2. What you need to know before taking Rasagilina Krka

Do not take Rasagilina Krka:

• 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 combination with Rasagilina Krka:

• 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 Krka before starting treatment with
MAOIs or pethidine.

Warnings and precautions
Take special care with Rasagilina Krka:

• In case of mild to moderate hepatic impairment.
• Consult your doctor if you notice any suspicious skin changes.

Children and adolescents
The use of Rasagilina Krka is not recommended in patients under the age of 18 years.

Taking Rasagilina Krka with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription and if you are a smoker or intend to quit smoking.
Ask your doctor for advice before taking any of the following medicines in combination with
Rasagilina Krka:

• 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 Krka and antidepressants containing fluoxetine or fluvoxamine.
Before starting treatment with Rasagilina Krka, 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 Krka.
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 dangerous or harmful activities for yourself or others. These behaviors are called impulse control disorders. In patients taking Rasagilina Krka 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 an increase in sexual thoughts or desires have been observed. Your doctor may need to adjust
the dose or stop treatment.

Taking Rasagilina Krka with food and drink
Rasagilina Krka can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to
become pregnant, ask your doctor for advice before taking this medicine.

Driving and using machines
Studies regarding the effects on the ability to drive and operate machinery have not been conducted. Ask
your doctor for advice before driving and using machines.

3. How to take Rasagilina Krka

Always take Rasagilina Krka exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
The usual dose of Rasagilina Krka is 1 tablet of 1 mg taken by mouth, once a day.
Rasagilina Krka can be taken with or without food.

If you take more Rasagilina Krka than you should
If you think you have taken more Rasagilina Krka tablets than you should, seek immediate medical
attention or contact your pharmacist. Bring the Rasagilina Krka packaging with you to show the doctor or pharmacist.

If you forget to take Rasagilina Krka
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 Krka
Do not stop taking Rasagilina Krka without first talking to your doctor.
If you have any further questions on the use of Rasagilina Krka, ask your doctor or pharmacist.

4. Possible side effects

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

Very common (may affect more than 1 in 10 people):

• abnormal movements (dyskinesia),
• headache.

Common (may affect up to 1 in 10 people):

• abdominal pain,
• fall,
• allergy,
• fever,
• flu-like syndrome (influenza),
• general feeling of being unwell (malaise),
• neck pain,
• chest pain (angina pectoris),
• reduction in blood pressure when standing up, accompanied by symptoms such as dizziness/lightheadedness (orthostatic hypotension),
• decreased appetite,
• constipation,
• dry mouth,
• nausea and vomiting,
• flatulence,
• abnormalities in 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 (vertigo),
• prolonged muscle contractions (dystonia),
• runny nose (rhinitis),
• skin irritation (dermatitis),
• erythema,
• red eyes (conjunctivitis),
• urinary urgency.
• Not common (may affect up to 1 in 100 people):
• stroke (cerebrovascular accident),
• heart attack (myocardial infarction),
• skin blisters (bullous erythema).

In addition, in controlled clinical studies versus placebo, skin cancer was reported in approximately 1% of patients. Scientific evidence suggests that Parkinson's disease, and not a particular medicine, is associated with an increased risk of skin cancer (not exclusively melanoma). Report any suspicious skin changes to your doctor.
Parkinson's disease is associated with symptoms such as hallucinations and confusion. In post-marketing experience, these symptoms have also been observed in patients with Parkinson's disease treated with
rasagiline.
There have been reports of patients who, while taking one or more medicines to treat
Parkinson's disease, have been unable to resist the urge, desire, or temptation to
perform an action that could be harmful to themselves or others. These behaviors
are called impulse control disorders. In patients taking rasagiline and/or other medicines
used to treat Parkinson's disease, the following behaviors have been observed:

• obsessive thoughts or compulsive behaviors;
• a strong urge to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and behaviors that are significantly concerning to oneself or others, for example, an increase in sexual desire;
• uncontrollable and excessive spending or shopping.

Inform your doctor if you experience any of these behaviors; you will discuss how to manage or reduce
the symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Rasagilina Krka

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 blister and the package after Exp.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original blister pack to protect from moisture.
Medicines should not be disposed of via 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 Krka contains

• The active ingredient is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline hem Tartrate).
• The other ingredients (excipients) are microcrystalline cellulose (E460), pregelatinized starch (type 1500), anhydrous colloidal silica (E551), talc (E553b) and stearic acid.

Description and contents of the pack

• The tablets are white or almost white, round, slightly biconvex, 7 millimeters in diameter, with beveled edges, darker spots which may be visible.
• Rasagilina Krka is available in packs containing: either 14, 15, 28, 30 and 112 tablets in blisters, or 14 x 1, 15 x 1, 28 x 1, 30 x 1 and 112 x 1 tablets in perforated single-dose blisters, or 14 x 1, 15 x 1, 28 x 1, 30 x 1 and 112 x 1 tablets in perforated single-dose blisters with the names of the days (calendar packs).

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Community with the following
names: