RASAGILINE QUALIGEN 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What is Rasagiline Qualigen 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 Qualigen

Do not take Rasagiline Qualigen:

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

You should wait at least 14 days after stopping treatment with rasagiline and 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

Rasagiline is not recommended for children under 18 years.

Use of other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, even 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 decongestants and oral and anti-cold 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 unusual behaviors in which you cannot resist the impulse, the need or the urge to perform certain harmful or dangerous activities for yourself or others. These are called impulse control disorders. In patients taking rasagiline 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 Qualigen with food and drinks

Rasagiline can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, 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 Qualigen

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The normal dose of Rasagiline Qualigen is 1 tablet of 1 mg taken by mouth, once a day. Rasagiline Qualigen can be taken with or without food.

If you take more Rasagiline Qualigen 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 Qualigen packaging with you to show to the doctor or pharmacist.

If you forget to take Rasagiline Qualigen

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 Qualigen

Do not stop taking rasagiline without consulting 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, Rasagiline Qualigen can cause side effects, although not everybody gets them.

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

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

• Very common (affects more than 1 in 10 patients).
• Common (affects between 1 and 10 in 100 patients).
• Uncommon (affects between 1 and 10 in 1,000 patients).
• Rare (affects between 1 and 10 in 10,000 patients).
• Very rare (affects less than 1 in 10,000 patients).
• Not known (frequency cannot be estimated from the available data).

Very common:

• Abnormal movements (dyskinesia).
• Headache.

Common:

• Abdominal pain.
• Falls.
• Allergy.
• 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).

Uncommon:

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

In addition, in clinical trials compared to placebo, skin cancer was observed in about 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 and 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 through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline Qualigen

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 blister. The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature. Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition:

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other ingredients are microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and pack contents

Rasagiline Qualigen tablets are presented as white or almost white, round, flat, beveled tablets, marked with a "1" on one face and with a diameter of 8 mm.

The tablets are presented in blister packs of 30 tablets.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Genepharm S.A.

18th Marathonos Avenue,

15351 Pallini Attiki

Greece

This package leaflet was approved in: November 2015

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