Rasagiline Krka

Package leaflet: Information for the patient

Rasagilina Krka 1 mg tablets

Equivalent medicine
Please read 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effect, including those not listed in this leaflet, contact 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 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

1. What Rasagilina Krka is and what it is 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).
In Parkinson's disease, dopaminergic neurons are lost in certain areas of the brain. Dopamine is a substance in the brain responsible for controlling movement. Rasagilina Krka helps increase and maintain stable 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 to any of the other excipients of this medicine (listed in section 6);
• if you have severe liver impairment.

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

• monoamine oxidase inhibitors (MAO inhibitors) (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 (a strong analgesic).

Wait at least 14 days after stopping treatment with Rasagilina Krka before starting therapy with MAO inhibitors or meperidine.
Warnings and precautions
Exercise particular caution with Rasagilina Krka:

• If you have mild to moderate liver 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 18 years of age.
Taking Rasagilina Krka with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
including over-the-counter medicines, and if you are a smoker or plan to stop smoking.
Ask your doctor for advice before taking any of the following medicines in combination with
Rasagilina Krka:

• 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 Krka with 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.
Inform your doctor if you, your family members, or caregivers notice that you are developing unusual behaviors that make you unable to resist the impulse, urge, or desire to carry out certain activities that may be dangerous or harmful to you or others. These behaviors are known as impulse control disorders. In patients treated with 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 abnormally increased sexual desire or increased sexual thoughts or urges have been observed. Your doctor may need to adjust your dose or discontinue 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, think you might be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
Driving and using machines
No studies have been conducted regarding the effects on the ability to drive and use machinery. Ask your doctor for advice before driving or operating machinery.

3. How to take Rasagilina Krka

Always take Rasagilina Krka exactly as your doctor has instructed you. If you are in any doubt, consult your doctor or pharmacist.
The usual dose of Rasagilina Krka is 1 tablet of 1 mg taken orally once daily.
Rasagilina Krka may be taken with or without food.
If you take more Rasagilina Krka than you should
If you think you have taken more tablets of Rasagilina Krka than you should, contact your doctor or pharmacist immediately. Take 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 the forgotten tablet. Take the next dose as scheduled, at the usual time.
If you stop taking Rasagilina Krka
Do not stop taking Rasagilina Krka without first talking to your doctor.
If you have any doubts about how to use Rasagilina Krka, consult 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/light-headedness (orthostatic hypotension),
• decreased appetite,
• constipation,
• dry mouth,
• nausea and vomiting,
• flatulence,
• abnormalities in blood test results (leucopenia),
• joint pain (arthralgia),
• musculoskeletal pain,
• inflammation of the joints (arthritis),
• numbness and weakness of the hand muscle (carpal tunnel syndrome),
• loss of body weight,
• abnormal dreams,
• difficulty in muscle coordination (balance disorders),
• depression,
• dizziness (vertigo),
• 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),
• skin blisters (vesiculobullous erythema).

In addition, in placebo-controlled clinical trials, skin cancer was reported in approximately 1% of patients. Scientific evidence suggests that Parkinson's disease, and not any particular medicine, is associated with a higher 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.

Cases have been reported of patients, while taking one or more medicines for the treatment of Parkinson’s disease, being unable to resist the impulse, desire, or temptation to carry out an action that could be harmful to themselves or others. These behaviours are known as impulse control disorders. The following behaviours have been observed in patients taking rasagiline and/or other medicines used to treat Parkinson’s disease:

• obsessive thoughts or impulsive behaviours;
• strong urge to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and behaviours significantly concerning to themselves or others, for example increased sexual desire;
• uncontrollable and excessive spending or shopping.

Inform your doctor if any of these behaviours occur; you will discuss ways to manage or reduce the symptoms.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 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 carton after "Exp".
The expiry date refers to the last day of the month.
Do not store above 30°C.
Keep in the original blister to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rasagilina Krka contains

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

Description and content of the container

• The tablets are white or almost white, round, slightly biconvex, 7 mm in diameter, with bevelled edges, and dark specks which may be visible.
• Rasagilina Krka is available in boxes 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 unit dose blisters, or 14 x 1, 15 x 1, 28 x 1, 30 x 1 and 112 x 1 tablets in perforated unit dose blisters with day names (calendar packs).

Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the Member States of the European Community under the following
names :

This leaflet was last reviewed on