RASAGILINE KERN PHARMA 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline Kern Pharma 1 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet:

1. What is Rasagiline Kern Pharma and what is it used for
2. What you need to know before taking Rasagiline Kern Pharma
3. How to take Rasagiline Kern Pharma
4. Possible side effects
5. Storage of Rasagiline Kern Pharma
6. Package contents and additional information

1. What is Rasagiline Kern Pharma 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 medication 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 movement control. Rasagiline helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagiline Kern Pharma

Do not take Rasagiline Kern Pharma

• If you are allergic (hypersensitive) to rasagiline or any of the other components of this medication (listed in section 6).
• If you have severe liver problems.

Do not take the following medications while taking rasagiline:

• Monoamine oxidase inhibitors (MAOIs) (e.g., for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medications and natural products, e.g., St. John's Wort.
• Pethidine (a potent analgesic).

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

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 skin changes.

Children and adolescents

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

Use of other medications

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

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

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine 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 medications and cough medicines containing ephedrine or pseudoephedrine.

Rasagiline should be avoided with antidepressants containing 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.

Inform your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviors in which you cannot resist the impulse, need, or urge to perform certain harmful or dangerous activities for yourself or others. These are called impulse control disorders. In patients taking rasagiline or other medications 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 discontinue your dose.

Taking Rasagiline Kern Pharma with food and drinks

Rasagiline can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will advise you whether to continue treatment with rasagiline.

Driving and using machines

No studies have been conducted on the effects on driving ability or machine use. Seek medical advice before driving or using machines.

3. How to take Rasagiline Kern Pharma

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

The normal dose of rasagiline is 1 tablet of 1 mg taken orally, once a day.

This medication can be taken with or without food.

If you take more Rasagiline Kern Pharma 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 medication and the amount ingested. Bring the rasagiline packaging with you to show to the doctor or pharmacist.

If you forget to take Rasagiline Kern Pharma

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 Kern Pharma

Do not stop taking rasagiline without consulting your doctor first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

• Abnormal movements (dyskinesia).
• Headache.

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

• 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/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.
• 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 side effects (affecting between 1 and 10 in 1,000 people):

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

In addition, in clinical trials compared to placebo, skin cancer was observed in approximately 1% of patients. However, scientific evidence indicates that Parkinson's disease, and not a particular medication, is associated with an increased 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 urge to perform certain actions 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 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.

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

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for human use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Rasagiline Kern Pharma

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 stated on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Rasagiline Kern Pharma

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

Appearance of the product and package contents

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

The tablets are presented in blister packs of 30 tablets.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173-Sant Cugat del Vallès - Barcelona

Spain

Date of the last revision of this package leaflet: October 2015

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