Rasagiline Stada 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rasagilina 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Rasagilina Stada contains the active substance rasagilina and is indicated for the treatment of Parkinson's disease in adults. It can be used with or without Levodopa (another medicine used to treat Parkinson's disease).

In Parkinson's disease, there is a loss of dopamine-producing cells in the brain. Dopamine is a chemical compound in the brain involved in the control of movement. Rasagilina helps to increase and maintain dopamine levels in the brain.

2. What you need to know before starting to take Rasagilina Stada

Do NOT take Rasagilina Stada

• if you are allergic to rasagiline or to 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 (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease, or for other indications), including prescription-free medicines and herbal products, e.g. St. John's Wort.
• Pethidine (a strong painkiller).

You must wait at least 14 days after stopping rasagiline before starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rasagilina Stada.

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

Children and adolescents

Rasagilina Stada is not recommended for children and adolescents under 18 years of age.

Taking Rasagilina Stada with other medicines

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

Seek medical advice before taking any of the following medicines together with rasagiline:

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

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

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

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

Inform your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviours in which you cannot resist the impulse, urge, or craving to carry out certain activities that may be harmful to yourself or others. These are known as impulse control disorders. In patients taking rasagiline or other medicines used to treat Parkinson's disease, such behaviours have been observed, including compulsions, obsessive thoughts, gambling, excessive spending, impulsive behaviour, and abnormally increased sexual drive or increased thoughts or feelings related to sex. Your doctor may need to adjust or discontinue your dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive or use machines. Seek medical advice before driving or using machines.

Rasagilina Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Rasagilina Stada

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of rasagiline is 1 tablet of 1 mg taken orally once daily.

Rasagilina Stada may be taken with or without food.

If you take more Rasagilina Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested. Take the rasagiline packaging along to show to the doctor or pharmacist.

Symptoms reported after overdose of rasagiline included slightly euphoric mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagilina 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 Rasagilina Stada

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

If you have any further questions about 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 everyone gets them.

Contact your doctor immediately if you experience any of the following symptoms.
You may need urgent medical treatment or care:

• If you develop unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour, or abnormally increased sex drive or increased sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome).
• If you notice any suspicious changes in the 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
• Allergy
• Fever
• Flu-like syndrome (influenza)
• Feeling unwell (malaise)
• Neck pain
• Chest pain (angina pectoris)
• Low blood pressure upon standing, with symptoms such as dizziness/spinning sensation (orthostatic hypotension)
• Decreased appetite
• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Changes in blood test results (leucopenia)
• Joint pain (arthralgia)
• Musculoskeletal pain
• Joint swelling (arthritis)
• Numbness and muscle weakness in the hand (carpal tunnel syndrome)
• Weight loss
• Abnormal dreams
• Difficulty with muscle coordination (balance disorder)
• Depression
• Dizziness (vertigo)
• Prolonged muscle contractions (dystonia)
• Runny nose (rhinitis)
• Skin irritation (dermatitis)
• Rash
• Redness of the eye (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 available data):

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

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagilina Stada

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Stada

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

What Rasagilina Stada looks like and contents of the pack

Rasagilina Stada 1 mg tablets are presented as white, round, flat tablets with a diameter of 6 mm.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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-E
4814 NE Breda
Netherlands

or

Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary
Ireland

This medicinal product 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 the latest revision of this leaflet: January 2020

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