RASAGILINE TEVA-RATIO 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline Teva-ratio 1 mg tablets EFG

rasagiline

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

1. What is Rasagiline Teva-ratio and what is it used for

Rasagiline Teva-ratio 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 Teva-ratio helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagiline Teva-ratio

Do nottake Rasagiline Teva-ratio

• 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 treatment with rasagiline and before starting treatment with MAOIs or pethidine.

Warnings and precautions

Consult your doctor before taking Rasagiline Teva-ratio

• If you have any liver problems.
• You should discuss any suspicious changes in your skin with your doctor. Treatment with rasagiline may possibly increase the risk of skin cancer.

Inform your doctor if you or your family/caregiver notice that you are presenting 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 shopping, 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).

Rasagiline Teva-ratio 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 Rasagiline Teva-ratio in children and adolescents is not appropriate. Therefore, Rasagiline Teva-ratio is not recommended for individuals under 18 years of age.

Other medications and Rasagiline Teva-ratio

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 decongestants, and oral and anti-cough medications 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 Teva-ratio 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 Rasagiline Teva-ratio if you are pregnant, as the effects of rasagiline 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 episodes of sleep.

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

3. How to take Rasagiline Teva-ratio

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

The recommended dose of Rasagiline Teva-ratio is one 1 mg tablet taken orally, once a day. Rasagiline Teva-ratio can be taken with or without food.

If you take more Rasagiline Teva-ratio than you should

If you think you have taken more tablets of Rasagiline Teva-ratio than you should, inform your doctor or pharmacist immediately. Bring the package/blisters or bottle of Rasagiline Teva-ratio with you to show the doctor or pharmacist.

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

If you forget to take Rasagiline Teva-ratio

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 Rasagiline Teva-ratio

Do not stop taking Rasagiline Teva-ratio without consulting your doctor first.

If you have any other 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 gets them.

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

• If you experience unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and abnormally high sexual impulse or increased sexual thoughts and feelings (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).
• Contact your doctorif you notice any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with the use of this medication (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/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 (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 Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Rasagiline Teva-ratio

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package, bottle, or blister after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in 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 Rasagiline Teva-ratio

• The active substance is rasagiline (as mesylate). Each tablet contains rasagiline mesylate equivalent to 1 mg of rasagiline.

The other components are mannitol, colloidal anhydrous silica, cornstarch, pregelatinized cornstarch, stearic acid, and talc.

Appearance of the product and package contents

Rasagiline Teva-ratio tablets are presented in the form of white or almost white, round, flat, and beveled tablets with a diameter of 8 mm, with the inscription "GIL" and "1" in relief on the lower part of one face and smooth on the other face.

The tablets are presented in blister packs of 7, 10, 28, 30, 100, and 112 tablets, single-dose blister packs of 10x1, 30x1, and 100x1, or in a bottle with 30 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas 28108 Madrid

Spain

Manufacturer

Pliva Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

or

Teva Operations Poland Sp.zo.o

80 Mogilska Str.

31-546 Krakow

Poland

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Rasagilin AbZ 1 mg Tabletten

Belgium: Rasagiline Teva 1 mg Tabletten/Comprimés

Croatia: Razagilin Teva 1 mg tablete

Denmark: Rasagilin Teva 1 mg tabletter

Slovenia: Razagilin Teva 1 mg tablete

Spain: Rasagilina Teva-ratio 1 mg comprimidos EFG

Estonia: Rasagiline Teva 1 mg tabletid

France: Rasagiline Teva 1 mg comprimé

Ireland: Rasagiline Teva 1 mg tablets

Italy: Rasagilina Teva 1 mg compresse

Lithuania: Rasagiline Teva 1mg tabletes

Latvia: Rasagiline Teva 1 mg tabletes

Malta: Rasagiline Teva 1 mg tablets

Portugal: Rasagilina Teva 1 mg comprimidos

United Kingdom: Rasagiline Teva 1 mg tablets

Slovak Republic: Razagilin Teva 1 mg tablety

Date of last revision of this package leaflet: January 2021

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80470/P_80470.html

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