RASAGILINE EFARMES 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What is RASAGILINA EFARMES and what is it used for

RASAGILINA EFARMES contains the active substance rasagiline and is indicated for the treatment of Parkinson's disease in adults. 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 RASAGILINA EFARMES

Do not take RASAGILINA EFARMES

• If you are allergic 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 RASAGILINA EFARMES:

• If you have any liver problems.
• You should discuss any suspicious changes in your skin with your doctor.

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 desire to perform certain harmful or dangerous activities for yourself or others. These are called impulse control disorders. In patients taking rasagiline and/or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally high sexual impulse or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or interrupt your dose (see section 4).

RASAGILINA EFARMES may cause drowsiness and make you fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medications (used to treat Parkinson's disease). If you want more information, see the section "Driving and using machines".

Children and adolescents

The use of RASAGILINA EFARMES in children and adolescents is not relevant. Therefore, RASAGILINA EFARMES is not recommended for individuals under 18 years of age.

Taking RASAGILINA EFARMES with other medications

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

Inform your doctor especially if you are taking any of the following medications:

• 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 and oral decongestants, and cough medicines that contain 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.

Inform your doctor or pharmacist if you smoke or intend to quit smoking. Smoking may decrease the amount of rasagiline in your blood.

Pregnancy, breastfeeding, and fertility

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

You should avoid taking RASAGILINA EFARMES if you are pregnant, as the effects of RASAGILINA EFARMES on pregnancy and the fetus are unknown.

Driving and using machines

Consult your doctor before driving or using machines, as both Parkinson's disease and treatment with rasagiline may affect your ability to perform these activities.

Rasagiline may cause dizziness or drowsiness, as well as sudden sleep episodes.

This may increase if you take other medications for treating Parkinson's disease symptoms, if you take medications that may cause drowsiness, or if you consume alcohol during rasagiline treatment. If you have experienced drowsiness and/or sudden sleep episodes before or during rasagiline treatment, do not drive or use machines (see section 2).

3. How to take RASAGILINA EFARMES

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

The recommended dose of RASAGILINA EFARMES is 1 tablet of 1 mg taken orally, once a day.

RASAGILINA EFARMES can be taken with or without food.

If you take more RASAGILINA EFARMES 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 RASAGILINA EFARMES package with you to show to the doctor or pharmacist.

The symptoms reported after a rasagiline overdose were mildly euphoric mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take RASAGILINA EFARMES

Do not take a double dose to make up for forgotten doses. Take the next dose normally, when it is due.

If you stop taking RASAGILINA EFARMES

Do not stop taking RASAGILINA EFARMES 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.

Contact your doctor immediatelyif you experience any of the following symptoms. You may need treatment or urgent medical attention:

• If you exhibit unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally high sexual impulse or increased sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremors, and sweating (serotonin syndrome).
• If you notice any suspicious changes in your skin, as there is an increased risk of skin cancer (not exclusively melanoma) in patients with Parkinson's disease (see section 2).

Other side effects

Very common(may affect more than 1 in 10 people)

• Involuntary movements (dyskinesia).
• Headache.

Common (may affect up to 1 in 10 people)

• Abdominal pain.
• Falls.
• Allergic reactions.
• Fever.
• Flu (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 (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 (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from available data)

• High blood pressure.
• Excessive drowsiness.
• Sudden sleep.

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 Medicines Agency's website https://www.notificaram.es.By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of RASAGILINA EFARMES

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

Do not use this medication after the expiration date stated on the package or blister 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 packages and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of RASAGILINA EFARMES

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other components are mannitol, cornstarch, pregelatinized cornstarch, anhydrous colloidal silica, stearic acid, talc, citric acid, and microcrystalline cellulose.

Appearance of the product and package contents

RASAGILINA EFARMES tablets are presented in the form of white or almost white, round tablets. The tablets are presented in blister packs of 30 tablets.

Marketing authorization holder and manufacturer

LACER, S.A.

C/ Boters, 5

08290 Parc Tecnologic del Vallés (Cerdanyola del Vallés) - Barcelona

Spain

Date of the last revision of this package leaflet: July 2019

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