Prospect: Information for the user

Rasagilina Kern Pharma 1 mg tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed to you alone and should not be given to other people, even if they have the same symptoms, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Rasagilina Kern Pharma and what is it used for

2.What you need to know before starting to take Rasagilina Kern Pharma

3.How to take Rasagilina Kern Pharma

4.Possible adverse effects

5.Storage of Rasagilina Kern Pharma

6.Contents of the package and additional information

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

Do not take Rasagilina Kern Pharma

-If you are allergic (hypersensitive) to rasagilina or to any of the other components of this medication (including those listed in section 6).

-If you have severe liver problems.

Do not take the following medications while taking rasagilina:

-Monamine oxidase inhibitors (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including medications and natural products without prescription e.g. St. John's Wort.

-Petidina (strong 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 before starting to take this medication. Inform your doctor if you have or have had any disease or symptom, especially any of the following:

• Mild to moderate liver problems.
• Any suspicious change in the skin.

Children and adolescents

Rasagilina is not recommended for minors under 18 years.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription or if you smoke or intend to quit smoking.

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

-Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline 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.

Avoid using rasagilina with antidepressants containing fluoxetine or fluvoxamine. If you are starting your treatment with rasagilina, you must wait at least 5 weeks since the interruption of treatment with fluoxetine.

If you are starting your treatment with fluoxetine or fluvoxamine, you must wait at least 14 days since the interruption of treatment with rasagilina.

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

Taking Rasagilina Kern Pharma with food and drinks

Rasagilina can be taken with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication. Your doctor will indicate if you should continue treatment with rasagilina.

Driving and operating machines

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

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

The usual dose of rasagilina is 1 tablet of 1 mg taken by mouth, once a day.

This medication can be taken with or without food.

If you take more Rasagilina Kern Pharma 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 rasagilina packaging with you to show it to your doctor or pharmacist.

If you forgot to take Rasagilina Kern Pharma

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

If you interrupt treatment with Rasagilina Kern Pharma

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:

Very common side effects (affect more than 1 in 10 people):

• Abnormal movements (dyskinesia).
• Headache.

Common side effects (affect between 1 and 10 in 100 people):

• Abdominal pain.
• Falls.
• Allergy.
• Fever.
• Flu-like syndrome (influenza).
• General discomfort.
• 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).
• Numbness and muscle weakness of the hand (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Muscle coordination difficulty (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urgency to urinate.

Uncommon side effects (affect between 1 and 10 in 1,000 people):

• 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 talk to your doctor about any suspicious changes in your skin.

Parkinson's disease is associated with hallucinations and confusion symptoms. In post-marketing experience, these symptoms have also been observed in patients with Parkinson's disease treated with rasagilina.

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 rasagilina 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 purchases or spending.

Inform your doctor if you experience any of these behaviors; he will explain how to treat or reduce the symptoms.

Reporting side effects:

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

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box 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 packaging and medications you no longer need at the SIGRE collection point of the Pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Rasagilina Kern Pharma Composition

• The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as tartrate).
• The other components are microcrystalline cellulose (E-460i), cornstarch, pregelatinized cornstarch, anhydrous colloidal silica, citric acid monohydrate (E-330), stearic acid (E-570), and talc (E-553b).

Appearance of the product and content of the packaging

This medication is presented in the form of white or off-white, round, and biconvex tablets.

The tablets are presented in blister packaging of 30 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173-Sant Cugat del Vallès - Barcelona

Spain

Last Review Date of this leaflet: October 2015

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS) http://www.aemps.gob.es/