NA. RASAGILINE HCS 1 MG TBL GB pi va stran

Package leaflet: Information for the patient

Rasagiline HCS 1 mg tablets

Rasagiline

Read all of 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 further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Rasagiline HCS is and what it is used for

2.    What you need to know before you take Rasagiline HCS

3.    How to take Rasagiline HCS

4.    Possible side effects

5.    How to store Rasagiline HCS

6.    Contents of the pack and other information

1. What Rasagiline HCS is and what it is used for

Rasagiline HCS is used for the treatment of Parkinson's disease. It can be used together with or without levodopa (another medicine that is used to treat Parkinson's disease).

With Parkinson's disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. Rasagiline HCS helps to increase and sustain levels of dopamine in the brain.

2. What you need to know before you take Rasagiline HCS

Do not take Rasagiline HCS:

•    if you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).

•    if you have severe liver problems.

Do not take the following medicines while taking Rasagiline HCS:

•    monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John's Wort.

•    pethidine (a strong pain killer).

You must wait at least 14 days after stopping Rasagiline HCS treatment and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Take special care with Rasagiline HCS:

•    if you have mild to moderate liver problems

•    You should speak with your doctor about any suspicious skin changes.

Children and adolescents

Rasagiline HCS is not recommended for use under the age of 18.

Other medicines and Rasagiline HCS

Tell your doctor or pharmacist if you are taking, have

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recently taken or might take any other medicines or if you are smoking or intend to stop smoking.

Ask your doctor for advice before taking any of the following medicines together with Rasagiline HCS:

•    Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)

•    the antibiotic ciprofloxacin used against infections

•    the cough suppressant dextromethorphan

•    sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine

The use of Rasagiline HCS together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagiline HCS, you should wait at least 5 weeks after stopping fluoxetine treatment.

If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline HCS treatment.

Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to yourself or others. These are called impulse control disorders. In patients taking rasagiline and/or other medications used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose.

Rasagiline HCS with food and drink and alcohol

Rasagiline HCS may be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Ask your doctor for advice prior to driving or using machines.

3. How to take Rasagiline HCS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of Rasagiline HCS is 1 tablet of 1 mg taken by mouth once daily. Rasagiline HCS may be taken with or without food.

If you take more Rasagiline HCS than you should

If you think that you may have taken too many Rasagiline HCS tablets, contact your doctor or pharmacist immediately. Take the Rasagiline HCS carton with you to show the doctor or pharmacist.

If you forget to take Rasagiline HCS

Do not take a double dose to make up for a forgotten tablet. Take the next dose normally, when it is time to take it.

If you stop taking Rasagiline HCS

Do not stop taking Rasagiline HCS 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.

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 (influenza)

•    general feeling of being unwell (malaise)

•    neck pain

•    chest pain (angina pectoris)

•    low blood pressure when rising to a standing position with symptoms like dizziness/light-headedness (orthostatic hypotension)

•    decreased appetite

•    constipation

•    dry mouth

•    nausea and vomiting

•    flatulence

•    abnormal results of blood tests (leucopenia)

•    joint pain (arthralgia)

•    musculoskeletal pain

•    joint inflammation (arthritis)

•    numbness and muscle weakness of the hand (carpal tunnel syndrome)

•    decreased weight

•    abnormal dreams

•    difficulty in muscular coordination (balance disorder)

•    depression

•    dizziness (vertigo)

•    prolonged muscle contractions (dystonia)

•    runny nose (rhinitis)

•    irritation of the skin (dermatitis)

•    rash

•    bloodshot eyes (conjunctivitis)

•    urinary urgency

Uncommon (may affect up to 1 in 100 people):

•    stroke (cerebrovascular accident)

•    heart attack (myocardial infarction)

•    blistering rash (vesiculobullous rash)

In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials. Nevertheless, scientific evidence suggests that Parkinson's disease, and not any medicine in particular, is associated with a higher risk of skin cancer (not exclusively melanoma). You should speak with your doctor about any suspicious skin changes.

Parkinson's disease is associated with symptoms of hallucinations and confusion.

In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.

There have been cases of patients who, while taking one or more medications for the treatment of Parkinson's disease, were unable to resist the impulse, drive or temptation to perform an action that could be harmful to themselves or others. These are called impulse control disorders. In patients taking rasagiline and/or other medications used to treat Parkinson's disease, the following have been observed:

•    Obsessive thoughts or impulsive behaviour.

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•    Strong impulse to gamble excessively despite serious personal or family consequences.

•    Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.

•    Uncontrollable excessive shopping or spending.

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.

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 via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rasagiline HCS

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 box after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original blister in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Rasagiline HCS contains

•    The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as rasagiline hemitartrate).

•    The other ingredients (excipients) are microcrystalline cellulose (E460), pregelatinised maize starch (type 1500), colloidal anhydrous silica (E551), talc (E553b) and stearic acid.

What Rasagiline HCS looks like and contents of the pack

Tablets are white to almost white, round, slightly biconvex, 7 mm in diameter, with beveled edges, darker spots may be visible.

Rasagiline HCS is available in boxes containing:

•    14,15,28,30 and 112 tablets in blisters,

•    14x1,15x1,28x1,30x1 and 112x1 tablets in perforated unit dose blisters,

•    14x1,15x1,28x1,30x1 and 112x1 tablets in perforated unit dose blisters with the names of days (calendar packs).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Manufacturer

KRKA, d.d., Novo mesto, Smarjeska cesta 6,

8501 Novo mesto, Slovenia

This leaflet was last revised in 08/2016

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