Prospect: Information for the user

Rasagilina STADA 1 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Rasagilina Stada

4.Possible adverse effects

5.Storage of Rasagilina Stada

6.Contents of the package and additional information

Rasagilina Stadacontains the active ingredient rasagilina andis indicated for the treatment of Parkinson's disease in adults. It may be used with or without Levodopa (another medication 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 brain chemical involved in the control of movement. Rasagilina helps to increase and maintain dopamine levels in the brain.

Do not take Rasagilina Stada

• if you are allergic to rasagilina or any of the other ingredients of this medication (listed in section 6).
• if you have severe liver problems.

Do not takethe following medications while taking rasagilina:

• monoamine oxidase inhibitors (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including medications and natural products without prescription e.g. St. John's Wort.
• petidina (strong analgesic).

You must wait at least 14 days after stopping treatment with rasagilina and starting treatment with MAO inhibitors or petidina.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeRasagilina Stada.

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

Children and adolescents

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

Taking Rasagilina Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication or if you smoke or intend to quit smoking.

Seek medical advicebefore taking any of the following medications with rasagilina:

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

You should avoid using rasagilina with antidepressants containing fluoxetine or fluvoxamine.

If you are starting your treatment with rasagilina, you must wait at least 5 weeks since the interruption of treatment with fluoxetine.

If you are starting your treatment with fluoxetine or fluvoxamine, you must wait at least 14 days since the interruption of treatment with rasagilina.

Inform your doctor if you or your family/caregiver notice that you are presenting rare behaviors in which you cannot resist the impulse, the imperative need or the anxiety to perform certain activities that are harmful or detrimental to yourself or others. These are known as impulse control disorders. In patients taking rasagilina or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, pathological gambling, excessive spending, impulsive behavior and an abnormally high or increased sexual impulse or thoughts or feelings have been observed. Your doctor may need to adjust or discontinue your dose.

Pregnancy and breastfeeding

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

Driving and operating machinery

No studies have been conducted on the effects on driving or operating machinery.Seek medical advice before driving or operating machinery.

Rasagilina Stadacontains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Rasagilina Stada can be taken with or without food.

If you take more Rasagilina Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the rasagilina packaging with you to show to your doctor or pharmacist.

The symptoms reported after a rasagilina overdose were mildly euphoric mood (mild mania), very high blood pressure, and serotonin syndrome (see section4).

If you forgot to take Rasagilina Stada

Do not take a double dose to compensate for the missed doses.

Take the next regular dose when it is due.

If you interrupt treatment with Rasagilina Stada

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctorif you experience any of the following symptoms.

You may need treatment or urgent medical attention:

• If you experience unusual behaviors such as, for example, compulsions, obsessive thoughts, compulsive gambling, excessive purchases or spending, impulsive behavior, and an abnormally high or increased sex drive (impulse control disorders) (see section2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremors, and sweating (serotonin syndrome).
• If you notice any suspicious changes in the skin, as there is a higher risk of skin cancer (not exclusively melanoma) in patients with Parkinson's disease (see section2).

Other side effects

Very common(may affect more than 1 in 10 people):

-Unintentional movements (dyskinesia)

-Headache

Common(may affect up to 1 in 10 people):

-Abdominal pain

-Falls

-Allergy

-Fever

-Flu-like syndrome

-Feeling unwell

-Neck pain

-Chest pain (angina pectoris)

-Low blood pressure when standing with symptoms such as dizziness/dizziness (orthostatic hypotension)

-Decreased appetite

-Constipation

-Dry mouth

-Nausea and vomiting

-Flatulence

-Alteration of blood test results (leucopenia)

-Joint pain (arthralgia)

-Musculoskeletal pain

-Arthritis

-Hand numbness and weakness (carpal tunnel syndrome)

-Weight loss

-Abnormal dreams

-Muscle coordination disorder (balance disorder)

-Depression

-Dizziness (vertigo)

-Prolonged muscle contractions (dystonia)

-Nasal discharge (rhinitis)

-Skin irritation (dermatitis)

-Rash

-Redness of the eyes (conjunctivitis)

-Urgency to urinate

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

-Stroke (cerebrovascular accident)

-Heart attack (myocardial infarction)

-Wart-like rash (vesiculobullous rash)

Unknown frequency(cannot be estimated from available data)

-High blood pressure.

-Excessive somnolence.

-Sudden sleep.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rasagilina Stada

-The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as tartrate).

-The other components are microcrystalline cellulose, anhydrous colloidal silica, sodium carboxymethylcellulose (type A) (from potato), povidone K30, phosphoric acid, and stearic acid.

Appearance of the product and contents of the package

Rasagilina Stada 1 mg tablets are presented in the form of white, round, and flat tablets with a diameter of 6 mm.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Stada S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

Stada Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

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 medicine is authorized in the Member States of the European Economic Area with the following names:

GermanyRasagilin AL 1 mg Tabletten

AustriaRasagilin Stada 1 mg Tabletten

BelgiumRasagiline EG 1mg tabletten

DenmarkRasagilin Stada Arzneimittel AG

SloveniaRazagilin Stada 1 mg tablete

SpainRasagilina Stada 1 mg comprimidos EFG

FranceRASAGILINE EG 1 mg, comprimé

CroatiaRazagilin Stada 1 mg tablete

NetherlandsRasagiline CF 1 mg, tabletten

HungaryRasagiline Stada 1 mg tabletta

IrelandRasagiline Clonmel 1 mg tablets

ItalyRASAGILINA EG

LuxembourgRasagiline EG 1mg comprimés

PortugalRasagilina Ciclum

Slovak RepublicRasagiline

Date of the last review of this prospectus:January 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/