RASAGILINE COMBIX 1 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

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

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

Do not take Rasagiline Combix:

• if you are allergic 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 this medicine:

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting rasagiline.

• If you have mild to moderate liver problems.
• You should talk to your doctor if you notice any suspicious changes in your skin.

Children and adolescents

Rasagiline is not recommended for children under 18 years.

Using Rasagiline Combix with other medicines

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

Ask your doctor for advice before taking any of the following medicines with this medicine:

• 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.

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

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/carer notice that you are developing unusual behaviours where 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 or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, pathological gambling, excessive shopping, impulsive behaviour and an abnormally high or increased sexual desire or drive have been observed. Your doctor may need to adjust or stop your dose.

Taking Rasagiline Combix with food and drink

Rasagiline can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 Combix

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

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

Rasagiline Combix can be taken with or without food.

If you take more Rasagiline Combix than you should

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken. Bring the package/ bottle of rasagiline to show to your doctor or pharmacist.

If you forget to take Rasagiline Combix

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 Combix

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

If you have any further questions on 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:

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).
• Rare (may affect up to 1 in 1,000 people).
• Very rare (may affect up to 1 in 10,000 people).
• Not known (frequency cannot be estimated from the available data).

Very common:

• Abnormal movements (dyskinesia).
• Headache.

Common:

• 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 (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 difficulties (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urinary urgency.

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 if you notice 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, urge or temptation to perform certain actions 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 impulse control disorders have been observed:

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

Tell your doctor if you experience any of these behaviours; 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 via the Spanish Medicines Agency's website at http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline Combix

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton, bottle or blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Rasagiline Combix

• The active substance is rasagiline. Each tablet contains 1.920 mg of rasagiline besylate which corresponds to 1 mg of rasagiline.
• The other ingredients are: Anhydrous calcium hydrogen phosphate (E341), pregelatinized maize starch, microcrystalline cellulose (E460i), anhydrous colloidal silica (E551) and stearic acid.

Appearance and packaging of the product

Rasagiline Combix is presented as white or white-greyish, round, flat tablets with smooth surfaces on both sides.

The tablets are presented in blister packs of Oriented Polyamide/Aluminium/Polyethylene-Aluminium/Polyethylene with desiccant or Oriented Polyamide/Aluminium/PVC-Aluminium and in bottles of high-density polyethylene with a polypropylene cap with or without a child-resistant closure in packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of last revision of this package leaflet: December 2015.

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