RASAGILINE STADA 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline STADA 1 mg tablets EFG

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.

Contents of the pack:

1. What is Rasagiline Stada and what is it used for
2. What you need to know before you take Rasagiline Stada
3. How to take Rasagiline Stada
4. Possible side effects
5. Storage of Rasagiline Stada
6. Contents of the pack and other information

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

Rasagiline Stada contains the active substance rasagiline and is indicated for the treatment of Parkinson's disease in adults. It can be used alone or in combination with Levodopa (another medicine used to treat Parkinson's disease).

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

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

Do not take Rasagiline Stada

• 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:

• monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medicinal products, e.g. St. John's Wort.
• Pethidine (a strong pain killer).

You should wait at least 14 days after stopping treatment with rasagiline before starting treatment with MAOIs or pethidine.

Warnings and precautions

Consult your doctor or pharmacist before starting Rasagiline Stada.

• If you have mild to moderate liver problems.
• You should talk to your doctor about any suspicious changes in your skin.

Children and adolescents

Rasagiline Stada is not recommended for children and adolescents under 18 years.

Taking Rasagiline Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, or if you smoke or intend to stop smoking.

Ask your doctor for advice before taking any of the following medicines with rasagiline:

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).
• The antibiotic ciprofloxacin used against infections.
• The cough suppressant dextromethorphan.
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants and anti-cold medicines containing ephedrine or pseudoephedrine.

The use of rasagiline with antidepressants containing fluoxetine or fluvoxamine should be avoided.

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

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

Tell your doctor if you or your family/carer notice that you are developing unusual behaviours where you cannot resist the impulse, urge or temptation to perform certain harmful or dangerous activities to yourself or others. These are called impulse control disorders. In patients taking rasagiline or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour and an abnormally high sexual drive or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or stop your dose.

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 before driving or using machines.

Rasagiline Stada contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially 'sodium-free'.

3. How to take Rasagiline Stada

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of rasagiline is 1 tablet of 1 mg taken by mouth, once a day.

Rasagiline Stada can be taken with or without food.

If you take more Rasagiline Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Take the rasagiline packaging with you to show to your doctor or pharmacist.

The symptoms reported after an overdose of rasagiline were mildly euphoric mood (a mild form of mania), very high blood pressure and serotonin syndrome (see section 4).

If you forget to take Rasagiline Stada

Do not take a double dose to make up for forgotten doses.

Take the next dose at the usual time.

If you stop taking Rasagiline Stada

Do not stop taking Rasagiline Stada without consulting your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Seek immediate medical attentionif you experience any of the following symptoms.

You may need urgent medical treatment:

• If you experience unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour and an abnormally high sexual drive or increased sexual thoughts and feelings (impulse control disorders) (see section 2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, agitation, tremor and sweating (serotonin syndrome).
• If you notice any suspicious changes in your skin, as there is an increased risk of skin cancer (not exclusively melanoma) in patients with Parkinson's disease (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
• Allergic reactions
• Fever
• Flu-like symptoms (influenza)
• Feeling unwell (malaise)
• Neck pain
• Chest pain (angina pectoris)
• Low blood pressure when standing up with symptoms such as dizziness/lightheadedness (orthostatic hypotension)
• Loss of appetite
• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Abnormal blood test results (leucopenia)
• Joint pain (arthralgia)
• Musculoskeletal pain
• Joint inflammation (arthritis)
• Numbness and muscle weakness in the hand (carpal tunnel syndrome)
• Weight loss
• Abnormal dreams
• Muscle coordination problems (balance disorder)
• Depression
• Dizziness (vertigo)
• Prolonged muscle contractions (dystonia)
• Nasal congestion (rhinitis)
• Skin irritation (dermatitis)
• Rash
• Eye redness (conjunctivitis)
• Urinary urgency

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

• Stroke (cerebrovascular accident)
• Heart attack (myocardial infarction)
• Blistering rash (vesiculobullous rash)

Frequency not known(cannot be estimated from the available data)

• High blood pressure.
• Excessive sleepiness.
• Sudden sleep onset.

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 the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline Stada

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 carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rasagiline Stada contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other ingredients are microcrystalline cellulose, anhydrous colloidal silica, sodium carboxymethyl starch (type A) (potato), povidone K30, phosphoric acid, stearic acid.

Appearance and packaging

Rasagiline Stada 1 mg tablets are white, round and flat with a diameter of 6 mm.

The tablets are packaged in blister packs of 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, 140, 168 and 180 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratorio Stada S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

Stada Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E4814 NE Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany Rasagilin AL 1 mg Tabletten

Austria Rasagilin Stada 1 mg Tabletten

Belgium Rasagiline EG 1mg tabletten

Denmark Rasagilin Stada Arzneimittel AG

Slovenia Razagilin Stada 1 mg tablete

Spain Rasagilina Stada 1 mg comprimidos EFG

France RASAGILINE EG 1 mg, comprimé

Croatia Razagilin Stada 1 mg tablete

Netherlands Rasagiline CF 1 mg, tabletten

Hungary Rasagiline Stada 1 mg tabletta

Ireland Rasagiline Clonmel 1 mg tablets

Italy RASAGILINA EG

Luxembourg Rasagiline EG 1mg comprimés

Portugal Rasagilina Ciclum

Slovak Republic Rasagiline

Date of last revision of this leaflet:January 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/