Rasagiline Mabo 1 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Rasagilina MABO 1 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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 must not pass it on 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 effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Rasagilina MABO is and what it is used for
- What you need to know before taking Rasagilina MABO
- How to take Rasagilina MABO
- Possible adverse effects
- How to store Rasagilina MABO
- Contents of the pack and other information
1. What Rasagilina MABO is and what it is used for
Rasagilina MABO is indicated for the treatment of Parkinson's disease. It can be used 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 MABO helps increase and maintain dopamine levels in the brain.
2. What you need to know before taking Rasagilina MABO
Do not take Rasagilina MABO
- If you are allergic (hypersensitive) to rasagiline or to any of the other components of this medicine (listed in section 6).
- If you have severe liver problems.
Do not take the following medications while taking Rasagilina MABO:
- Monoamine oxidase inhibitors (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease, or for other indications), including non-prescription medicines and herbal products, e.g. St. John’s wort.
- Pethidine (a strong painkiller).
You must wait at least 14 days after stopping treatment with rasagiline before starting treatment with MAO inhibitors or pethidine.
Warnings and precautions
Consult your doctor before taking this medicine. Inform your doctor if you have or have had any illness or symptoms, especially any of the following:
- You have mild to moderate liver problems.
- You should speak with your doctor about any suspicious changes in the skin.
Children and adolescents
Rasagilina MABO is not recommended for patients under 18 years of age.
Use of Rasagilina MABO with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription, or if you smoke or intend to quit smoking.
Seek medical advice before taking any of the following medicines together with rasagiline:
- Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).
- The antibiotic ciprofloxacin used for 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 this medicine together with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with Rasagilina MABO, 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 MABO.
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 activities that may be harmful to yourself or others. These are known as impulse control disorders. In patients taking Rasagilina MABO or other medicines used to treat Parkinson’s disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally high sexual drive or increased thoughts or feelings about sex have been observed. Your doctor may need to adjust or discontinue your dose.
Taking Rasagilina MABO with food, drinks and alcohol
Rasagilina MABO can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will advise you whether you should continue treatment with rasagiline.
Driving and use of machines
No studies have been conducted on the effects on the ability to drive or use machines. Seek medical advice before driving or operating machinery.
3. How to take Rasagilina MABO
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again if you have any questions.
The usual dose of Rasagilina MABO is 1 tablet of 1 mg taken orally, once daily.
Rasagilina MABO may be taken with or without food.
If you take more Rasagilina MABO 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, indicating the medicine and the amount ingested. Take the Rasagilina MABO packaging with you to show to the doctor or pharmacist.
If you forget to take Rasagilina MABO
Do not take a double dose to make up for missed doses. Take the next dose at the usual time, as scheduled.
If you stop taking Rasagilina MABO
Do not stop taking Rasagilina MABO without consulting your doctor first.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported in placebo-controlled clinical trials:
Very common adverse effects (may affect more than 1 in 10 people):
- Abnormal movements (dyskinesia).
- Headache.
Common adverse effects (may affect between 1 and 10 in 100 people):
- Abdominal pain.
- Falls.
- Allergy.
- Fever.
- Flu-like syndrome (influenza).
- General malaise.
- Neck pain.
- Chest pain (angina pectoris).
- Low blood pressure upon standing, with symptoms such as dizziness/spinning sensation (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.
- 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 adverse effects (may affect between 1 and 10 in 1,000 people):
- Stroke (cerebrovascular accident).
- Heart attack (myocardial infarction).
- Blistering rash (vesiculobullous rash).
Additionally, in placebo-comparative clinical trials, skin cancer was observed in approximately 1% of patients. However, scientific evidence indicates that Parkinson's disease itself, rather than any specific medication, is associated with an increased risk of skin cancer (not exclusively melanoma). You should consult your doctor if you notice any suspicious changes in your skin.
Parkinson's disease is associated with hallucinations and confusion. In post-marketing experience, these symptoms have also been observed in patients with Parkinson's disease treated with Rasagilina MABO.
There have been cases of patients who, while taking one or more medicines for the treatment of Parkinson's disease, were unable to resist the impulse, desire, or temptation to carry out an action that could be harmful to themselves or others. These are known as impulse control disorders. The following disorders have been observed in patients taking rasagiline or other medicines used to treat Parkinson's disease:
- Obsessive thoughts or impulsive behavior.
- Strong urge to gamble excessively, despite serious personal or family consequences.
- Altered or increased sexual interest and behavior, causing concern to the patient or others, for example increased sexual drive.
- Uncontrollable and excessive spending or shopping.
Inform your doctor if you experience any of these behaviors; they will consider ways to manage or reduce the symptoms.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Rasagiline MABO
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging 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 medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rasagilina MABO
- The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
- The other components (excipients) are: microcrystalline cellulose (E-460i), tartaric acid, corn starch, pregelatinized corn starch, talc (E-553b) and stearic acid (E-570).
Appearance of the product and contents of the pack
Rasagilina MABO tablets are presented as white or almost white, biconvex, oblong tablets, engraved with 'R9SE' on one side and "1" on the other.
The tablets are supplied in blister packs of 30 tablets.
Marketing Authorization Holder
MABO-FARMA, S.A.
Calle Vía de los Poblados 3,
Edificio 6, 28033, Madrid,
Spain.
Manufacturer
Synthon Hispania, S.L.
Castelló 1, Polígono Las Salinas.
08830, Sant Boi de Llobregat, Spain.
or
Synthon s.r.o.
Brnenska 32/cp. 597
678 01 Blansko
Czech Republic,
or
Synthon BV
Microweg 22,
6545 CM Nijmegen
The Netherlands.
Date of the most recent revision of this leaflet: October 2015
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es