RASAGILINE FERRER 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline Ferrer 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 Ferrer and what is it used for
2. What you need to know before you take Rasagiline Ferrer
3. How to take Rasagiline Ferrer
4. Possible side effects
5. Storage of Rasagiline Ferrer
6. Package contents and further information

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

Rasagiline 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 helps to increase and maintain dopamine levels in the brain.

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

Do not take Rasagiline Ferrer

• 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:

• 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 before starting treatment with MAOIs or pethidine.

Warnings and precautions

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

• 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 is not recommended for children under 18 years.

Using rasagiline with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, or if you smoke or plan 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 decongestants, and oral and anti-cough medicines containing ephedrine or pseudoephedrine.

You should avoid taking this medicine with antidepressants that contain fluoxetine or fluvoxamine.

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/caregiver notice that you are presenting with strange behaviors in which you cannot resist the impulse, the need, or the anxiety to perform certain activities that are harmful to you or others. These are called impulse control disorders. In patients taking Rasagiline Ferrer 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 Ferrer with food and drinks

Rasagiline can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor 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 performed 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 Ferrer

Follow the instructions for taking Rasagiline Ferrer exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist again.

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

Rasagiline Ferrer can be taken with or without food.

If you take more Rasagiline Ferrer 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 ingested. Bring the Rasagiline Ferrer packaging with you to show the doctor or pharmacist.

If you forget to take Rasagiline Ferrer

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 Ferrer

Do not stop taking rasagiline without talking to your doctor first.

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 everybody gets them.

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

• Very common (may affect more than 1 in 10 people).
• Common (may affect up to 1 in 10 people).
• Uncommon (may affect up to 1 in 100 people).

The very common side effects that may affect more than 1 in 10 people are:

• Abnormal movements (dyskinesia).
• Headache.

The common side effects that may affect up to 1 in 10 people are:

• 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/spinning sensation (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.

The uncommon side effects that may affect up to 1 in 100 people are:

• 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.

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, the desire, or the 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; he will explain how 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 through the Spanish Medicines and Healthcare Products Agency's 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 Ferrer

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.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Package contents and further information

Composition of Rasagiline Ferrer

The active ingredient is Rasagiline.

Each tablet contains 1 mg of rasagiline (as tartrate).

The other ingredients are microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, corn starch, citric acid monohydrate, stearic acid, and talc.

Appearance of the product and package contents

Rasagiline Ferrer tablets are presented as white or almost white, round, biconvex tablets.

The tablets are presented in blister packs of 30 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173-Sant Cugat del Vallès (Barcelona)

This package leaflet was approved in: October 2015

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/.