Leaflet: information for the patient

Devolina 1 mg tablets EFG

Rasagilina

Read this 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 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 Devolina and what it is used for

2. What you need to know before starting to take Devolina

3. How to take Devolina

4. Possible side effects

5. Storage of Devolina

6. Contents of the pack and additional information

Devolina is indicated for the treatment of Parkinson's disease. 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. Devolina helps to increase and maintain dopamine levels in the brain.

Do not take Devolina

-if you are allergic (hypersensitive) 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 a prescription, e.g. St. John's Wort.

- Petidina (strong analgesic).

You must 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 take rasagilina:

-if you have mild to moderate liver problems.

-at any suspicious change in the skin.

Children

Rasagilina is not recommended for minors under 18 years

Other medications and Devolina

Please inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, or if you smoke or intend to quit smoking.

Seek medical advice before taking any of the following medications with rasagilina:

-Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline 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, wait at least 5 weeks since stopping treatment with fluoxetine.

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

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 others. These are known as impulse control disorders. In patients taking rasagilina 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 have been observed. Your doctor may need to adjust or discontinue your dose.

Devolina with food and beverages

Devolina can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No studies have been conducted on the effects on driving or operating machinery.Seekmedical advice before driving or operating machinery.

Devolina contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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

The recommended dose of rasagilina is 1 tablet of 1 mg taken by mouth, once a day. Rasagilina can be taken with or without food.

If you take more Devolina than you should

If you think you have taken more rasagilina tablets than you should, inform your doctor or pharmacist immediately. Bring the packaging/container of this medication with you to show to your doctor or pharmacist.

If you forget to take Devolina

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

If you interrupt treatment with Devolina

Do not stop taking Rasagilina without consulting your doctor first.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been reported in controlled clinical trials with placebo:

The frequency of possible side effects listed below is defined using the following convention:

- Very common (may affect more than 1 in 10 patients).

- Common (may affect up to 1 in 10 patients).

- Uncommon (may affect up to 1 in 100 patients).

- Rare (may affect up to 1 in 1,000 patients).

- Very rare (may affect up to 1 in 10,000 patients).

- Not known (the 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 when standing with symptoms such as dizziness/dizziness (orthostatic hypotension).

-Decreased appetite.

-Constipation.

-Dry mouth.

-Nausea and vomiting.

-Flatulence.

-Alteration of blood test results (leucopenia).

-Joint pain (arthralgia).

-Musculoskeletal pain.

-Joint inflammation (arthritis).

-Hand numbness and weakness (carpal tunnel syndrome).

-Weight loss.

-Abnormal dreams.

-Muscle coordination difficulty (balance disorder).

-Depression.

-Dizziness (vertigo).

-Prolonged muscle contractions (dystonia).

-Nasal discharge (rhinitis).

-Skin irritation (dermatitis).

-Rash.

-Eye redness (conjunctivitis).

-Urgency to urinate.

Uncommon:

-Stroke (cerebrovascular accident).

-Heart attack (myocardial infarction).

-Widespread rash (vesiculobullous rash).

Additionally, in clinical trials compared to placebo, skin cancer was observed in approximately 1% of patients. However, scientific evidence indicates that Parkinson's disease, and not a particular medication, is associated with an increased risk of skin cancer (not exclusively melanoma). You should discuss any suspicious skin changes with your doctor.

Parkinson's disease is associated with hallucinations and confusion symptoms. In post-marketing experience, these symptoms have also been observed in patients with Parkinson's disease treated with rasagilina.

There have been cases of patients who, while taking one or more medications for the treatment of Parkinson's disease, were unable to resist the impulse, desire, or temptation to perform an action that could be harmful to themselves or others. These are known as impulse control disorders. In patients taking rasagilina or other medications used to treat Parkinson's disease, the following disorders have been observed:

• Obsessive thoughts or impulsive behavior.
• Strong impulse to gamble excessively, despite severe personal or family consequences.
• Altered or increased sexual interest and behavior, of particular concern to you or others, for example, an increase in sexual impulse.
• Uncontrolled and excessive spending or purchases.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use,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 after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Devolina

• The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as rasagilina tartrate).

The other components areMicrocrystalline cellulose, Anhydrous colloidal silica, Sodium carboxymethyl starch, Stearic acid fumarate and sodium.

Appearance of the product and content of the packaging

Devolina tablets are presented in the form of white, round, and biconvex tablets.

The tablets are presented in blister packs of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Devon Farmacéutica, S.A.

C/ José Rizal Nº 84

28043 Madrid

Spain

Responsible for manufacturing:

Farmalider, S.A.

Aragoneses, 15

28108 Alcobendas. Madrid

Spain

or

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas. Madrid

Spain

Last review date of this leaflet:September 2016

“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/”)