Package Insert: Information for the Patient

Rasagilina Combix 1 mg Tablets EFG

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

Rasagilina Combix is indicated for the treatment of Parkinson's disease. It may be used with or without Levodopa (another medication used to treat Parkinson's disease).

With Parkinson's disease, there is a loss of cells that produce dopamine in the brain.

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

Do not take Rasagilina Combix:

• if you are allergic to rasagilina or any of the other ingredients of this medication (listed in section 6).
• if you have severe liver problems.

Do not take the following medications while taking this medication:

• monoamine oxidase inhibitors (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including medications and natural products without a prescription, e.g. St. John's Wort.
• petidina (a potent analgesic).

You must wait at least 14 days after stopping treatment with rasagilina and starting treatment with MAO inhibitors or petidina.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rasagilina.

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

Children and adolescents

Rasagilina is not recommended for minors under 18 years.

Use of Rasagilina Combix with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication or if you smoke or intend to quit smoking.

Seek medical advice before taking any of the following medications with this medication:

• Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, or tetracyclic antidepressants).
• The antibiotic ciprofloxacin used against infections.
• The antitussive dextromethorphan.
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and anticholinergic medications containing ephedrine or pseudoephedrine.

Use of rasagilina with antidepressants containing fluoxetine or fluvoxamine should be avoided.

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

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

Inform your doctor if you or your family/caregiver notice that you are presenting with unusual behaviors in which you cannot resist the urge, the imperative need, or the anxiety to perform certain harmful or detrimental activities for yourself or others. These are known as impulse control disorders. In patients taking rasagilina or other medications used to treat Parkinson's disease, behaviors such as convulsions, obsessive thoughts, compulsive behavior, excessive spending, impulsive behavior, and an abnormally high or increased sexual impulse or thoughts have been observed. Your doctor may need to adjust or discontinue your dose.

Taking Rasagilina Combix with food and drinks

Rasagilina can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No studies have been conducted on the effects on driving or operating machinery.Seek medical advice before driving or operating machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Rasagilina Combix can be taken with or without food.

If you take more Rasagilina Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging/container of rasagilina with you to show to your doctor or pharmacist.

If you forgot to take Rasagilina Combix

Do not take a double dose to compensate for the missed doses. Take the next normal dose when it is time to take it.

If you interrupt treatment with Rasagilina Combix

Do not stop taking rasagilina without consulting your doctor first.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been reported in controlled 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).
• Unknown (the frequency cannot be estimated from available data).

Very common:

• Abnormal movements (dyskinesia).
• Headache.

Common:

• Abdominal pain.
• Falls.
• Allergy.
• Fever.
• Flu-like syndrome.
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing with symptoms such as dizziness/dizziness (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Alteration of blood test results (leucopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Hand numbness and weakness (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Muscle coordination disorder (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urgency to urinate.

Uncommon:

• Stroke (cerebrovascular accident).
• Heart attack (myocardial infarction).
• Wart-like 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 medication, is associated with a higher risk of skin cancer (not exclusively melanoma). You should discuss any suspicious skin changes with your doctor.

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 medications 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 medications used to treat Parkinson's disease, the following disorders have been observed:

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

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttp://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conservation conditions.

Do not use this medication after the expiration date that appears on the packaging, bottle or blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rasagilina Combix

• The active ingredient is rasagilina. Each tablet contains 1,920 mg of rasagilina besilate corresponding to 1 mg of rasagilina.
• The other components are: Calcium hydrogen phosphate anhydrous (E341), pregelatinized cornstarch, microcrystalline cellulose (E460i), anhydrous colloidal silica (E551), and stearic acid.

Appearance of the product and content of the container

Rasagilina Combix is presented in the form of white or off-white, round, flat, and smooth tablets on both sides.

The tablets are presented in oriented polyamide/aluminum/polyethylene-aluminum/polyethylene containers with desiccant or in oriented polyamide/aluminum/PVC-aluminum containers and in high-density polyethylene containers with polypropylene stoppers with or without child-resistant closures in containers of 30 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet: December 2015.

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