Rasagiline Combix 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rasagilina Combix 1 mg tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Rasagilina 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 dopamine-producing cells in the brain.

Dopamine is a chemical substance in the brain involved in the control of movement. Rasagilina Combix helps increase and maintain dopamine levels in the brain.

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

Do not take Rasagilina Combix:

• if you are allergic to rasagiline or to 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 (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease, or for other indications), including non-prescription medicines and natural products, e.g. St. John's wort.
• Pethidine (a strong painkiller).

You must wait at least 14 days after stopping treatment with rasagiline before starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take rasagiline.

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

Children and adolescents

Rasagiline is not recommended for patients under 18 years of age.

Use of Rasagilina Combix with other medicines

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

Seek medical advice before taking any of the following medicines together with this medicine:

• Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).
• The antibiotic ciprofloxacin used for infections.
• The cough suppressant dextromethorphan.
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine.

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

If you are starting treatment with rasagiline, you must wait at least 5 weeks after stopping treatment with fluoxetine.

If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with rasagiline.

Inform your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviors in which you cannot resist the impulse, urge, or craving to carry out certain harmful or damaging activities. These are known as impulse control disorders. In patients taking rasagiline or other medicines used to treat Parkinson's disease, behaviors such as compulsive gambling, compulsive shopping, excessive spending, compulsive eating, hypersexuality, or an abnormally increased sex drive or increased thoughts or feelings about sex have been observed. Your doctor may need to adjust or stop your dose.

Taking Rasagilina Combix with food and drink

Rasagiline may be taken with or without food.

Pregnancy and breastfeeding

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

Driving and use of machines

No studies have been conducted on the effects on the ability to drive or use machines. Seek medical advice before driving or operating machinery.

3. How to take Rasagilina Combix

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose of Rasagilina Combix is 1 tablet of 1 mg taken orally, once daily.

Rasagilina Combix may be taken with or without food.

If you take more Rasagilina Combix than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Take the rasagilina packaging/bottle with you to show to the doctor or pharmacist.

If you forget to take Rasagilina Combix

Do not take a double dose to make up for missed doses. Take the next dose at the usual time.

If you stop taking Rasagilina Combix

Do not stop taking rasagilina without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported in placebo-controlled clinical trials:

The frequency of the possible adverse 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 reaction.
• Fever.
• Influenza-like syndrome (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure upon standing, with symptoms such as dizziness/lightheadedness (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Abnormal blood test results (leukopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Numbness and muscle weakness in the hand (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Difficulty with muscle coordination (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Runny nose (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urinary urgency.

Uncommon:

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

Additionally, in placebo-controlled clinical trials, skin cancer was observed in approximately 1% of patients. However, scientific evidence indicates that Parkinson's disease itself, rather than any specific medicine, is associated with an increased risk of skin cancer (not exclusively melanoma). You should speak with your doctor about any suspicious changes in the skin.

Hallucinations and confusion are symptoms associated with Parkinson's disease. 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, desire, or temptation to carry out an action that could be harmful to themselves or others. These are known as impulse control disorders. The following disorders have been observed in patients taking rasagiline or other medicines used to treat Parkinson's disease:

• Obsessive thoughts or impulsive behavior.
• Strong urge to gamble excessively, despite serious personal or family consequences.
• Altered or increased sexual interest and behavior, causing concern to the patient or others, for example increased sexual drive.
• Uncontrollable and excessive shopping or spending.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagilina 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 stated on the container, vial, or blister pack, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Combix

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

Appearance of the product and contents of the pack

Rasagilina Combix is available as white or whitish-grey, round, flat, and smooth tablets on both sides.

The tablets are supplied in blisters made of oriented polyamide/aluminum/polyethylene-aluminum/polyethylene with desiccant or oriented polyamide/aluminum/PVC-aluminum, or in high-density polyethylene bottles with polypropylene caps with or without child-resistant closures, in pack sizes of 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 latest review of this leaflet: December 2015.

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