RASAGILINE CINFA 1 mg TABLETS

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

Do not take Rasagilina Cinfa

• If you are allergic to rasagiline 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 rasagiline:

• Monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medicines and natural products, e.g. St. John's Wort.
• Pethidine (a strong painkiller).

You should wait at least 14 days after stopping treatment with rasagiline and before starting treatment with MAOIs or pethidine.

Warnings and precautions

Talk to your doctor before starting Rasagilina Cinfa

• If you have any liver problems.
• You should talk to your doctor if you notice any suspicious changes in your skin.

Tell your doctor if you or your family/caregiver notice that you are developing unusual behaviors where you cannot resist the impulse, urge, or temptation to perform certain harmful or dangerous activities for yourself or others. These are called impulse control disorders. In patients taking rasagiline and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and abnormally high sexual impulses or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or stop 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 medicines (used to treat Parkinson's disease). If you want more information, see the section "Driving and using machines".

Children and adolescents

The use of Rasagilina Cinfa in children and adolescents is not relevant. Therefore, Rasagilina Cinfa is not recommended for children under 18 years of age.

Taking Rasagilina Cinfa with other medicines

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

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

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-noradrenaline 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 and oral decongestants, and cough and cold medicines 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.

Tell your doctor or pharmacist if you smoke or plan to stop smoking. Smoking could decrease the amount of rasagiline in your blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 using machines

Talk to your doctor before driving or using machines, as both Parkinson's disease and treatment with rasagiline can affect your ability to perform these activities.

Rasagilina may cause dizziness or drowsiness, as well as sudden episodes of sleepiness.

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

3. How to take Rasagilina Cinfa

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Bring the Rasagilina Cinfa packaging with you to show the doctor or pharmacist.

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

If you forget to take Rasagilina Cinfa

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

If you stop taking Rasagilina Cinfa

Do not stop taking Rasagilina Cinfa without talking to your doctor first.

If you have any further questions on 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 everybody gets them.

Seek medical help immediatelyif you have any of the following symptoms. You may need urgent medical treatment:

• If you develop unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behavior, and abnormally high sexual impulses 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, agitation, tremor, and sweating (serotonin syndrome).
• If you notice any suspicious changes in your skin, as there is an increased 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.
• 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 problems (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 the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagilina Cinfa

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 carton or blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Rasagilina Cinfa

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other ingredients are mannitol, corn starch, pregelatinized corn starch, colloidal anhydrous silica, stearic acid, talc, citric acid, and microcrystalline cellulose.

Appearance and packaging of the product

Rasagilina Cinfa tablets are presented as white or almost white, round tablets.

The tablets are presented in blister packs of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Manufacturer

LACER, S.A.

C/ Boters, 5

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

Spain

Date of last revision of this leaflet: April 2019

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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