Prospecto: Information for the User

Rasagilina 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 ratio and what it is used for

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

3.How to take Rasagilina ratio

4.Possible adverse effects

5.Storage of Rasagilina ratio

6.Contents of the package and additional information

Rasagilina 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 ratio helps to increase and maintain dopamine levels in the brain.

Do not take Rasagilina ratio

-If you are allergic to rasagilina 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 rasagilina:

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

You should wait at least 14 days after stopping treatment with rasagilina and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Consult your doctor before taking Rasagilina ratio

-If you have any liver problems.

-You should speak with your doctor about any suspicious changes in your skin.The 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 for yourself or for others. These are known as impulse control disorders. In patients taking rasagilina or other medications used to treat Parkinson's disease, such behaviors have been observed, such as compulsions, obsessive thoughts, pathological gambling, 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 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 operating machines”.

Children and adolescents

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

Other medications and Rasagilina ratio

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

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

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

-The antibiotic ciprofloxacin used against infections.

-The antitussive dextromethorphan.

-Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and anticholinergic medications containing ephedrine or pseudoephedrine.

Avoid using rasagilina with antidepressants containing fluoxetine or fluvoxamine. If you are starting your treatment with rasagilina, you should wait at least 5 weeks since the interruption of treatment with fluoxetine. If you are starting your treatment with fluoxetine or fluvoxamine, 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 ratio in the blood.

Pregnancy, breastfeeding, and fertility

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

You should avoid taking Rasagilina 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 medications for treating Parkinson's disease symptoms, if you take medications that may cause drowsiness, or if you consume alcohol during treatment with rasagilina. If you have experienced drowsiness and/or sudden sleep episodes before or during treatment with Rasagilina 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 ratio is one 1 mg tablet taken by mouth, once a day. Rasagilina ratio may be taken with or without food.

If you take more Rasagilina ratio than you should

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

Do not take a double dose to make up for the missed dose. Take the next scheduled dose normally.

If you interrupt treatment with Rasagilina ratio

Do not stop treatment with Rasagilina 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 spending or purchases, 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).

-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).

-Nasal discharge (rhinitis).

-Skin irritation (dermatitis).

-Rash.

-Redness of the eyes (conjunctivitis).

-Urgency to urinate.

Uncommon (may affect up to 1 in 100people)

-Stroke (cerebrovascular accident).

-Heart attack (myocardial infarction).

-Herpes zoster (shingles).

Frequency not known: cannot be estimated from available data

• High blood pressure.
• Excessive sleepiness.
• 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rasagilina ratio

- 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 packaging

Rasagilina ratio tablets are presented in the form of white or off-white, round, flat, and bisected 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 sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas 28108 Madrid

Spain

Responsible for manufacturing

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:

Spain:Rasagilina ratio 1 mg tablets EFG

Sweden:Rasagiline ratio

Last review date of this leaflet: January 2021