Rasagiline CINFA 1 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Rasagilina Cinfa 1 mg tablets EFG
Rasagiline tartrate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
- Keep this leaflet. 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 they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Rasagilina Cinfa is and what it is used for
- What you need to know before taking Rasagilina Cinfa
- How to take Rasagilina Cinfa
- Possible side effects
- How to store Rasagilina Cinfa
- Contents of the pack and other information
1. What Rasagilina Cinfa is and what it is used for
Rasagilina Cinfa contains the active substance rasagilina and is indicated for the treatment of Parkinson's disease in adults. It can be used either in combination 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 helps to increase and maintain dopamine levels in the brain.
2. What you need to know before taking Rasagilina Cinfa
Do not take Rasagilina Cinfa
- If you are allergic to rasagilina 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 rasagilina:
- Monoamine oxidase inhibitors (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease, or for other indications), including over-the-counter medicines and natural products such as St. John's wort.
- Pethidine (a strong painkiller).
You must wait at least 14 days after stopping rasagilina before starting treatment with MAO inhibitors or pethidine.
Warnings and precautions
Talk to your doctor before starting Rasagilina Cinfa
- If you have any liver problems.
- You should discuss with your doctor any suspicious changes in your skin.
Inform your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviors in which you cannot resist the impulse, urgent need, or craving to carry out certain harmful or damaging activities. These are known as impulse control disorders. In patients taking rasagilina and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, pathological gambling, excessive spending, impulsive behavior, and abnormally increased sexual urges or increased thoughts or feelings of sexuality have been observed. Your doctor may need to adjust or stop your dose (see section 4).
Rasagilina Cinfa may cause drowsiness and may 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 the section "Driving and use of machines".
Children and adolescents
The use of Rasagilina Cinfa in children and adolescents is not relevant. Therefore, Rasagilina Cinfa is not recommended for patients 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 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 suppressant dextromethorphan.
- Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine.
The use of rasagilina together with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with rasagilina, you must wait at least 5 weeks after stopping treatment with fluoxetine.
If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with rasagilina.
Inform your doctor or pharmacist if you smoke or if you plan to stop smoking. Smoking may reduce the amount of rasagilina in your blood.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, 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 Cinfa if you are pregnant, as the effects of Rasagilina Cinfa on pregnancy and the fetus are unknown.
Driving and use of machines
Talk to your doctor before driving or operating machinery, 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 episodes of falling asleep.
This risk may increase if you are taking other medicines to treat symptoms of Parkinson's disease, if you are taking medicines that may cause drowsiness, or if you consume alcohol during treatment with rasagilina. If you have experienced drowsiness and/or sudden episodes of falling asleep before or during treatment with rasagilina, do not drive or operate machinery (see section 2).
3. How to take Rasagilina Cinfa
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose of Rasagilina Cinfa is 1 tablet of 1 mg taken orally once daily.
Rasagilina Cinfa may be taken with or without food.
If you take more Rasagilina Cinfa than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested. Take the Rasagilina Cinfa packaging with you to show to the doctor or pharmacist.
Symptoms reported after overdose with Rasagilina Cinfa included slightly euphoric mood (a mild form of 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 treatment with Rasagilina Cinfa 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 or attention:
- If you have unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive spending or shopping, 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).
- If you notice any suspicious changes in the 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.
- Allergy.
- Fever.
- Flu (influenza).
- General malaise.
- Neck pain.
- Chest pain (angina pectoris).
- Low blood pressure when standing, with symptoms such as dizziness/spinning sensation (orthostatic hypotension).
- Decreased appetite.
- Constipation.
- Dry mouth.
- Nausea and vomiting.
- Flatulence.
- Changes in blood test results (leucopenia).
- Joint pain (arthralgia).
- Musculoskeletal 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).
- 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 eruption).
Frequency not known (cannot be estimated from available data)
- High blood pressure.
- Excessive sleepiness.
- Sudden sleep onset.
Reporting of side effects
If you experience any 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 at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Rasagiline Cinfa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister after EXP. The expiry date refers to the last day of the month indicated.
Medicines must 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 properly dispose of unused containers and medicines. This 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 components are mannitol, corn starch, pregelatinized corn starch, colloidal anhydrous silica, stearic acid, talc, citric acid, and microcrystalline cellulose.
Appearance of the product and contents of the pack
Rasagilina Cinfa tablets are presented as white or almost white, round tablets.
The tablets are packed 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 the most recent review of this leaflet: April 2019
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer 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 link: https://cima.aemps.es/cima/dochtml/p/80951/P_80951.html