Devolina 1 mg tablets EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Devolina 1 mg tablets EFG
Rasagiline
Read this 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you personally. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Devolina is and what it is used for
- What you need to know before taking Devolina
- How to take Devolina
- Possible side effects
- How to store Devolina
- Contents of the pack and other information
1. What Devolina is and what it is used for
Devolina 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. Devolina helps increase and maintain dopamine levels in the brain.
2. What you need to know before taking Devolina
Do not take Devolina
- if you are allergic (hypersensitive) to rasagiline 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 rasagiline:
- 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, e.g. St. John's wort.
- Meperidine (a strong painkiller).
You must wait at least 14 days after stopping rasagiline before starting treatment with MAO inhibitors or meperidine.
Warnings and precautions
Talk to your doctor before starting rasagiline:
- If you have mild to moderate liver problems.
- If you notice any suspicious changes in your skin.
Children
Rasagiline is not recommended for patients under 18 years of age.
Other medicines and Devolina
Please inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, or if you smoke or intend to stop smoking.
Seek medical advice before taking any of the following medicines with rasagiline:
- 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 decongestants, oral decongestants, and cold remedies containing ephedrine or pseudoephedrine.
The use of rasagiline together with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with rasagiline, you must wait at least 5 weeks after stopping fluoxetine treatment.
If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping rasagiline treatment.
Inform your doctor if you or your family/caregiver notice unusual behaviors in which you cannot resist the impulse, urge, or craving to carry out certain harmful or dangerous activities. These are known as impulse control disorders. In patients taking rasagiline or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally increased sexual drive or increased sexual thoughts or feelings have been observed. Your doctor may need to adjust or discontinue your dose.
Taking Devolina with food and drinks
Devolina can be taken with or without food.
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.
Driving and using 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.
Devolina contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
3. How to take Devolina
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose of rasagiline is 1 tablet of 1 mg taken by mouth once daily. Rasagiline may be taken with or without food.
If you take more Devolina than you should
If you think you have taken more rasagiline tablets than you should, inform your doctor or pharmacist immediately. Take the packaging/bottle of this medicine with you to show to the doctor or pharmacist.
If you forget to take Devolina
Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.
If you stop taking Devolina
Do not stop taking rasagiline without first consulting your doctor.
If you have any further questions about the use of this product, 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:
The frequency of the possible side effects listed below is defined using the following convention:
- Very common (may affect more than 1 in 10 people).
- Common (may affect up to 1 in 10 people).
- Uncommon (may affect up to 1 in 100 people).
- Rare (may affect up to 1 in 1,000 people).
- Very rare (may affect up to 1 in 10,000 people).
- Not known (frequency cannot be estimated from the available data).
Very common:
- Abnormal movements (dyskinesia).
- Headache.
Common:
- 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 (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).
- Runny nose (rhinitis).
- Skin irritation (dermatitis).
- Rash.
- Redness of the eye (conjunctivitis).
- Urinary urgency.
Uncommon:
- Stroke (cerebrovascular accident).
- Heart attack (myocardial infarction).
- Blistering rash (vesiculobullous rash).
Additionally, in placebo-controlled clinical trials, skin cancer was observed in approximately 1% of patients. However, scientific evidence indicates that Parkinson's disease, and not any particular medicine, is associated with an increased risk of skin cancer (not exclusively melanoma). You should speak with your doctor about any suspicious changes in the 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 rasagiline.
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 behaviour.
- Strong urge to gamble excessively, despite serious personal or family consequences.
- Altered or increased sexual interest and behaviour, causing concern for you or others, for example increased sex drive.
- Uncontrollable and excessive spending or shopping.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Devolina
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 packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
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. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Devolina
- The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
The other components are microcrystalline cellulose, anhydrous colloidal silica, sodium carboxymethyl starch from potato, stearic fumarate and sodium.
Appearance of the product and contents of the pack
Devolina tablets are presented as white, round, biconvex tablets.
The tablets are packaged in blister packs of 30 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Devon Farmacéutica, S.A.
C/ José Rizal Nº 84
28043 Madrid
Spain
Manufacturer:
Farmalider, S.A.
Aragoneses, 15
28108 Alcobendas, Madrid
Spain
or
Toll Manufacturing Services, S.L.
Aragoneses, 2
28108 Alcobendas, Madrid
Spain
Date of the most recent revision of this leaflet: September 2016
“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/)”