RASAGILINE MABO 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline MABO 1 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Rasagiline MABO is indicated for the treatment of Parkinson's disease. 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 cells that produce dopamine in the brain.

Dopamine is a brain chemical involved in controlling movement. Rasagiline MABO helps to increase and maintain dopamine levels in the brain.

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

Do not take Rasagiline MABO

• 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 MABO:

• Monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medicines and natural products, e.g. St. John's Wort.
• Pethidine (a strong painkiller).

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

Warnings and precautions

Talk to your doctor before taking this medicine. Tell your doctor if you have or have had any disease or symptoms, especially any of the following:

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

Children and adolescents

Rasagiline MABO is not recommended for children under 18 years.

Using Rasagiline MABO with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those bought without a prescription, 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 cough and cold medicines containing ephedrine or pseudoephedrine.

Avoid using this medicine with antidepressants that contain fluoxetine or fluvoxamine. If you are starting treatment with Rasagiline MABO, 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 MABO.

Tell your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviors in which you cannot resist the impulse, urge, or temptation to perform certain harmful or dangerous activities for yourself or others. These are called impulse control disorders. In patients taking Rasagiline MABO or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally high or increased sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose.

Taking Rasagiline MABO with food, drinks, and alcohol

Rasagiline MABO can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will tell you whether you should continue treatment with rasagiline.

Driving and using machines

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

3. How to take Rasagiline MABO

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again if you have any doubts.

The normal dose of Rasagiline MABO is 1 tablet of 1 mg taken by mouth, once a day.

Rasagiline MABO can be taken with or without food.

If you take more Rasagiline MABO than you should

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

If you forget to take Rasagiline MABO

Do not take a double dose to make up for forgotten doses. Take the next normal dose when it is due.

If you stop taking Rasagiline MABO

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

If you have any other 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 everybody gets them.

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

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

• Abnormal movements (dyskinesia).
• Headache.

Common side effects (affect between 1 and 10 in 100 people):

• Abdominal pain.
• Falls.
• Allergic reactions.
• Fever.
• Flu-like symptoms (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing up with symptoms such as dizziness/ lightheadedness (orthostatic hypotension).
• Decreased 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 discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urinary urgency.

Uncommon side effects (affect between 1 and 10 in 1,000 people):

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

In addition, in clinical trials compared to placebo, skin cancer was observed in around 1% of patients. However, scientific evidence indicates that Parkinson's disease, and not a particular medicine, is associated with a higher risk of skin cancer (not exclusively melanoma). You should talk to your doctor about any suspicious changes in your skin.

Parkinson's disease is associated with symptoms of hallucinations and confusion. In post-marketing experience, these symptoms have also been observed in patients with Parkinson's disease treated with Rasagiline MABO.

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

• Obsessive thoughts or impulsive behavior.
• Strong impulse to gamble excessively, despite serious personal or family consequences.
• Altered or increased sexual interest or behavior, of special concern to you or others, for example, an increased sexual impulse.
• Uncontrolled or excessive shopping or spending.

Tell your doctor if you experience any of these behaviors; they will consider ways to treat or reduce the symptoms.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the 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 MABO

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

Store below 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rasagiline MABO

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other ingredients (excipients) are: microcrystalline cellulose (E-460i), tartaric acid, corn starch, pregelatinized corn starch, talc (E-553b), and stearic acid (E-570).

Appearance of the product and pack contents

Rasagiline MABO tablets are presented as white or almost white, biconvex, oblong tablets, engraved with 'R9SE' on one side and "1" on the other.

The tablets are presented in blister packs of 30 tablets.

Marketing authorisation holder

MABO-FARMA, S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

Synthon Hispania, S.L.

Castelló 1, Polígono Las Salinas.

08830, Sant Boi de Llobregat, Spain.

or

Synthon s.r.o.

Brnenska 32/cp. 597

678 01 Blansko

Czech Republic,

or

Synthon BV

Microweg 22,

6545 CM Nijmegen

Netherlands.

Date of last revision of this package leaflet: October 2015

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