Rasagiline Teva-Ratio 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rasagilina Teva-ratio 1 mg tablets EFG

rasagiline

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rasagilina Teva-ratio is and what it is used for
2. What you need to know before taking Rasagilina Teva-ratio
3. How to take Rasagilina Teva-ratio
4. Possible side effects
5. How to store Rasagilina Teva-ratio
6. Contents of the pack and other information

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

Rasagilina Teva-ratio contains the active substance rasagilina and is indicated for the treatment of Parkinson's disease in adults. It can be used with or without levodopa (another medicine used to treat Parkinson's disease).

In Parkinson's disease, there is a loss of dopamine-producing cells in the brain. Dopamine is a chemical compound in the brain involved in the control of movement. Rasagilina Teva-ratio helps increase and maintain dopamine levels in the brain.

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

Do not take Rasagilina Teva-ratio

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

Do not take the following medicines while taking rasagiline:

• Monoamine oxidase inhibitors (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease, or for other indications), including non-prescription medicines and herbal products, such as St. John's wort.
• Pethidine (a strong painkiller).

You must wait at least 14 days after stopping rasagiline before starting treatment with MAO inhibitors or pethidine, and vice versa.

Warnings and precautions

Talk to your doctor before taking Rasagilina Teva-ratio

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

Tell your doctor if you or your family/carer notice that you are displaying unusual behaviours that you cannot resist the impulse, urgent need, or craving to carry out certain activities that may be harmful to you or others. These are known as impulse control disorders. In patients taking rasagiline or other medicines used to treat Parkinson's disease, such behaviours have been observed, including compulsions, obsessive thoughts, gambling, excessive spending, impulsive behaviour, and abnormally high sex drive or increased thoughts or feelings about sex. Your doctor may need to adjust or stop your dose (see section 4).

Rasagilina Teva-ratio may cause drowsiness and cause you to fall asleep suddenly during everyday activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). For further information, see section “Driving and use of machinery”.

Children and adolescents

The use of Rasagilina Teva-ratio in children and adolescents is not appropriate. Therefore, Rasagilina Teva-ratio is not recommended for patients under 18 years of age.

Other medicines and Rasagilina Teva-ratio

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor especially if you are taking any of the following medicines:

• Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).
• The antibiotic ciprofloxacin, used to treat infections.
• The cough medicine dextromethorphan.
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine.

The use of rasagiline together with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with rasagiline, you must wait at least 5 weeks after stopping fluoxetine. If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping rasagiline.

Tell your doctor or pharmacist if you smoke or plan to stop smoking. Smoking may reduce the amount of Rasagilina Teva-ratio in your blood.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should avoid taking Rasagilina Teva-ratio if you are pregnant, as the effects of rasagiline on pregnancy and the unborn baby are unknown.

Driving and use of machinery

Talk to your doctor before driving or operating machinery, 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 falling asleep.

This risk may increase if you take other medicines for the symptoms of Parkinson's disease, if you take medicines that may cause drowsiness, or if you consume alcohol during treatment with rasagiline. If you have experienced drowsiness and/or sudden episodes of falling asleep before or during treatment with Rasagilina Teva-ratio, do not drive or operate machinery (see section 2).

3. How to take Rasagilina Teva-ratio

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Rasagilina Teva-ratio is one 1 mg tablet taken orally once daily. Rasagilina Teva-ratio may be taken with or without food.

If you take more Rasagilina Teva-ratio than you should

If you think you have taken more tablets of Rasagilina Teva-ratio than you should, inform your doctor or pharmacist immediately. Take the pack/blister or bottle of Rasagilina Teva-ratio with you to show to the doctor or pharmacist.

Symptoms reported after an overdose of rasagiline include slightly euphoric mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagilina Teva-ratio

Do not take a double dose to make up for forgotten doses. Take the next dose as scheduled, at the usual time.

If you stop taking Rasagilina Teva-ratio

Do not stop treatment with Rasagilina Teva-ratio without first consulting your doctor.

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

4. Possible side effects

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

Contact your doctor immediately if you experience any of the following symptoms. You may need urgent medical treatment:

• If you have unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour, or abnormally increased sex drive 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, tremor, and sweating (serotonin syndrome).
• Contact your doctor if you notice any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with the use of this medicine (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.
• Allergy.
• Fever.
• Flu (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure upon standing, with symptoms such as dizziness or 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.
• Difficulty with muscle coordination (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Runny nose (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Redness of the eye (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 the available data

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

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline Teva-ratio

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

Do not use this medicine after the expiry date which is stated on the container, bottle, or blister pack after EXP or CAD. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Teva-ratio

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

• The other components are mannitol, anhydrous colloidal silica, maize starch, pregelatinized maize starch, stearic acid, and talc.

Appearance of the product and contents of the pack

Rasagilina Teva-ratio tablets are presented as white or almost white, round, flat, bevelled tablets, 8 mm in diameter, with the embossed inscription "GIL" and "1" on one face and smooth on the other.

The tablets are supplied in blister packs of 7, 10, 28, 30, 100 and 112 tablets, perforated unit-dose blister packs of 10x1, 30x1 and 100x1, or in a bottle containing 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas 28108 Madrid

Spain

Manufacturer

Pliva Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

or

Teva Operations Poland Sp. z o.o.

80 Mogilska Str.

31-546 Krakow

Poland

This medicinal product 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 Teva1 mg tablete

Denmark: Rasagilin Teva 1 mg tabletter

Slovenia: Razagilin Teva1 mg tablete

Spain: Rasagilina Teva-ratio 1 mg comprimidos EFG

Estonia: Rasagiline Teva 1 mg tabletid

France: Rasagiline Teva1 mg comprimé

Ireland: Rasagiline Teva 1 mg tablets

Italy: Rasagilina Teva1 mg compresse

Lithuania: Rasagiline Teva 1mg tabletes

Latvia: Rasagiline Teva1 mg tabletes

Malta: Rasagiline Teva1 mg tablets

Portugal: Rasagilina Teva1 mg comprimidos

United Kingdom: Rasagiline Teva 1 mg tablets

Slovak Republic: Razagilin Teva1 mg tablety

Date of the latest revision of this leaflet: January 2021

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/80470/P_80470.html

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