Prospect: Information for the user

Rasagilina Teva-ratio 1 mg tablets EFG

rasagilina

Read this prospect carefully before starting to take the medicine, as 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 only for you, and you must not give it to other people, even if they have the same symptoms as you, 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 section4.

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

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

3.How to take Rasagilina Teva-ratio

4.Possible adverse effects

5.Storage of Rasagilina Teva-ratio

6.Contents of the package and additional information

Rasagilina Teva-ratio contains the active ingredient rasagilina and is indicated for the treatment of Parkinson's disease in adults. 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 Teva-ratio helps to increase and maintain dopamine levels in the brain.

Do not take Rasagilina Teva-ratio

-If you are allergic to rasagilina or 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 rasagilina:

• Inhibitors of monoamine oxidase (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including medicines and natural products without prescription, e.g. St. John's Wort.
• Petidina (strong analgesic).

You should 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 taking Rasagilina Teva-ratio

- If you have any liver problems.

- You should talk to your doctor about any suspicious changes in your skin. Treatment with rasagilina may possibly increase the risk of skin cancer.

Inform your doctor if you or your family/caregiver notice that you are presenting impulsive behaviors in which you cannot resist the urge, the imperative need or the anxiety to perform certain harmful or detrimental activities to yourself or others. These are known as impulse control disorders. In patients taking rasagilina or other medicines used to treat Parkinson's disease, such behaviors have been observed, such as compulsions, obsessive thoughts, ludopathy, excessive spending, impulsive behavior, and an abnormally high or increased sexual impulse or thoughts or feelings. Your doctor may need to adjust or interrupt your dose (see section 4).

Rasagilina Teva-ratio may cause drowsiness and make you fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). If you want more information, see the section “Driving and operating machines”.

Children and adolescents

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

Other medicines and Rasagilina Teva-ratio

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

Inform your doctor especially if you are takingany of the following medicines:

-Certain antidepressants(selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, tricyclic antidepressants or tetracyclic antidepressants).

-The antibiotic ciprofloxacino used against infections.

-The antitussive dextrometorfano.

-Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and anticholinergic medicines containing efedrina or pseudoefedrina.

You should avoid using rasagilina with antidepressants containing fluoxetina or fluvoxamina. If you are starting your treatment with rasagilina, you should wait at least 5 weeks since the interruption of treatment with fluoxetina. If you are starting your treatment with fluoxetina or fluvoxamina, you should wait at least 14 days since the interruption of treatment with rasagilina.

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend 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 rasagilina on pregnancy and the fetus are unknown.

Driving and operating machines

Consult your doctor before driving or operating machines, as both Parkinson's disease and treatment with rasagilina may affect your ability to perform these activities. Rasagilina may cause dizziness or drowsiness, as well as sudden sleep episodes.

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

Follow exactly the administration instructions for this medication as indicated 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 by mouth, once a day. 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 Rasagilina Teva-ratio tablets than you should, inform your doctor or pharmacist immediately. Bring the box/blister or bottle of Rasagilina Teva-ratio with you to show to your doctor or pharmacist.

The symptoms reported after a rasagilina overdose were mildly euphoric mood (mild 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 the missed dose. Take the next dose normally, when it is due.

If you interrupt treatment with Rasagilina Teva-ratio

Do not stop treatment with Rasagilina Teva-ratio 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 medicinecan cause side effects, although not everyone will experience them.

Immediately contact your doctorif you experience any of the following symptoms. You may need treatment or urgent medical attention:

• If you experience unusual behaviors such as, for example, compulsions, obsessive thoughts, compulsive gambling, excessive purchases or spending, impulsive behavior, and an abnormally high or increased sex drive (impulse control disorders) (see section2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremors, and sweating (serotonin syndrome).
• Immediately 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 medicine (see section2).

Other side effects

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

-Uncontrollable movements (dyskinesia).

-Headache.

Common (may affect up to 1 in 10people)

-Abdominal pain.

-Falls.

-Allergy.

-Fever.

-Flu (influenza).

-General discomfort.

-Neck pain.

-Chest pain (angina).

-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).

-Hand numbness and weakness (carpal tunnel syndrome).

-Weight loss.

-Abnormal dreams.

-Muscle coordination disorder (balance disorder).

-Depression.

-Dizziness (vertigo).

-Prolonged muscle contractions (dystonia).

-Nasal discharge (rhinitis).

-Skin irritation (dermatitis).

-Rash.

-Eye redness (conjunctivitis).

-Urgency to urinate.

Uncommon (may affect up to 1 in 100people)

-Stroke (cerebrovascular accident).

-Heart attack (myocardial infarction).

-Blistering rash (vesiculobullous eruption).

Frequency not known: cannot be estimated from available data

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rasagilina Teva

- The active ingredient is rasagilina (as mesilate). Each tablet contains rasagilina mesilate equivalent to 1mg of rasagilina.

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

Appearance of the product and contents of the package

Rasagilina Teva tablets are presented in the form of white or off-white, round, flat, and beveled tablets of 8mm in diameter, with the inscription in relief “GIL” and “1”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, perforated single-dose blister packs of 10x1, 30x1, and 100x1, or in a bottle with 30 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

Alcobendas 28108 Madrid

Spain

Responsible 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 medicine is authorized in the member states of the European Economic Area with 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 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

Last revision date of this leaflet: January 2021