Leaflet: information for the user

Rasagilina Cinfa 1 mg tablets EFG

Rasagilina tartrate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you

- Keep this leaflet as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Rasagilina Cinfa and what it is used for

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

3. How to take Rasagilina Cinfa

4. Possible side effects

5. Storage of Rasagilina Cinfa

6. Contents of the pack and additional information

Rasagilina Cinfa 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 helps to increase and maintain dopamine levels in the brain

Do not take Rasagilina Cinfa

- 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:

- Monoamine 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.

- 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 starting to takeRasagilina Cinfa

- If you have any liver problems.

- You should talk to your doctor about any suspicious changes in your skin.

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

Rasagilina Cinfa 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 Cinfa in children and adolescents is not relevant. Therefore,Rasagilina Cinfa is not recommended for minors under 18 years old.

Taking Rasagilina Cinfa with other medications

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 taking any 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 stopping treatment with fluoxetine.

If you are starting your treatment with fluoxetine or fluvoxamine, you should wait at least 14 days since stopping treatment with rasagilina.

Inform your doctor or pharmacist if you smoke or intend to quit smoking. Smoking may decrease the amount of rasagilina 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 Cinfa if you are pregnant, as the effects of Rasagilina Cinfa 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 to treat Parkinson's disease symptoms, if you take medications that can cause drowsiness, or if you consume alcohol during rasagilina treatment. If you have experienced drowsiness and/or sudden sleep episodes before or during rasagilina treatment, do not drive or operate machines (see section 2).

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

The recommended dose of Rasagilina Cinfa is 1 tablet of 1 mg taken by mouth, once a day.

Rasagilina Cinfa can be taken with or without food.

If you take more Rasagilina Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the Rasagilina Cinfa packaging with you to show to your doctor or pharmacist.

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

If you forgot to take Rasagilina Cinfa

Do not take a double dose to compensate for the missed doses. Take the next regular dose when it is due.

If you interrupt treatment with Rasagilina Cinfa

Do not stop treatment with Rasagilina Cinfa 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 medicine may 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 sex drive or an increase in 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 the skin, as there is a higher 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.

- Allergy.

- Fever.

- Flu (influenza).

- General discomfort.

- Neck pain.

- Chest pain (angina).

- Low blood pressure when standing with symptoms such as dizziness/head spinning (orthostatic hypotension)

- Decreased appetite.

- Constipation.

- Dry mouth.

- Nausea and vomiting.

- Flatulence.

- Alteration of blood test results (leucopenia).

- Joint pain (arthralgia).

- Muscle and skeletal pain.

- Inflammation of the joints (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).

- Urinary urgency.

Uncommon(may affect up to 1 in 100 people)

- Stroke (cerebrovascular accident).

- Heart attack (myocardial infarction).

- Vesicular bullous eruption (vesiculobullous eruption).

Frequency not known (cannot be estimated from available data)

- High blood pressure.

- Excessive somnolence.

- Sudden sleep.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Usehttps://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 or blister after CAD. The expiration date is the last day of the month indicated.

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

Rasagilina Cinfa Composition

- The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (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 contents of the packaging

Rasagilina Cinfa tablets are presented in the form of white or almost white, round tablets.

The tablets are presented in blister packaging of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta.

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

LACER, S.A.

C/ Boters, 5

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

Spain

Last review date of this leaflet: April 2019

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80951/P_80951.html

QR code to:https://cima.aemps.es/cima/dochtml/p/80951/P_80951.html