Package leaflet: Information for the user

Rasagiline Aristo 1 mg tablets

Rasagiline

What is in this leaflet:

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

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

3.    How to take Rasagiline Aristo

4.    Possible side effects

5.    How to store Rasagiline Aristo

6.    Contents of the pack and other information

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

Rasagiline Aristo 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 Aristo helps to increase and sustain levels of dopamine in the brain.

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

Do not take Rasagiline Aristo:

•    if you are allergic (hypersensitive) 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 Aristo:

•    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 Aristo treatment and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Talk to you doctor or pharmacist before taking Rasagiline Aristo:

•    if you have mild to moderate liver problems

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

•    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 Aristo 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.

Children and adolescents

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

Other medicines and Rasagiline Aristo

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription 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 Aristo:

•    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 Aristo together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagiline Aristo, 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 Aristo treatment.

Rasagiline Aristo with food and drink

Rasagiline Aristo 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 or pharmacist 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 Aristo

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

The recommended dose of Rasagiline Aristo is 1 tablet of 1 mg taken by mouth once daily.

Rasagiline Aristo may be taken with or without food.

If you take more Rasagiline Aristo than you should

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

If you forget to take Rasagiline Aristo

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

If you stop taking Rasagiline Aristo

Do not stop taking Rasagiline Aristo 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, Rasagiline Aristo can cause side effects, although not everybody gets them.

The following side effects have been reported in placebo controlled clinical trials:

The frequency of possible side effects listed below is defined using the following convention:

Very common

(may affect more than 1 user in 10) Common

(may affect 1 to 10 users in 100) Uncommon

(may affect 1 to 10 users in 1,000)

Rare

(may affect 1 to 10 users in 10,000)

Very rare

(may affect less than 1 user in 10,000)

Not known

(frequency cannot be estimated from the available data)

Very common:

•    abnormal movements (dyskinesia)

•    headache

Common:

•    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:

•    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 Aristo.

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 Aristo and/or other medications used to treat Parkinson's disease, the following have been observed:

•    Obsessive thoughts or impulsive behaviour.

•    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 Aristo

Keep this medicine out of the sight and reach of children.

Do not use Rasagiline Aristo after the expiry date which is stated on the carton or blister after "Expiry date:". The expiry date refers to the last day of that month.

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 to protect the environment.

6. Contents of the pack and other information

What Rasagiline Aristo contains

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

•    The other ingredients are glyceryl behenate, starch, pregelatinised, sodium starch glycoloate, citric acid, anhydrous, cellulose, microcrystalline.

What Rasagiline Aristo looks like and contents of the pack

Rasagiline Aristo tablets are presented as round, white and biconvex tablets.

The tablets are available in blister packs of 10, 28 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aristo Pharma GmbH Wallenroder StraGe 8 - 10 13435 Berlin Germany

Manufacturer

Laboratorios Medicamentos Internationales, S.A. (Medinsa)

C/ Solana, 26, Torrejon de Ardoz,

28850 Madrid

Spain

or

Aristo Pharma GmbH Wallenroder StraGe 8 - 10 13435 Berlin Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Rasagilin Aristo 1 mg Tabletten

Italy: Rasagilina Aristo

Portugal: Rasagilina Aristo

Spain: Rasagilina Aristo 1 mg comprimidos

EFG

United Kingdom: Rasagiline Arsito 1 mg tablets

PL 40546/0018

This leaflet was last revised in July 2016