DEVOLINA 1 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Devolina 1 mg tablets EFG

Rasagiline

Read the entire summary of product characteristics 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Devolina and what is it used for
2. What you need to know before you take Devolina
3. How to take Devolina
4. Possible side effects
5. Storage of Devolina
6. Contents of the pack and further information

1. What is Devolina and what is it 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 cells that produce dopamine in the brain.

Dopamine is a brain chemical involved in controlling movement. Devolina helps to increase and maintain dopamine levels in the brain.

2. What you need to know before you take Devolina

Do not take Devolina

• if you are allergic (hypersensitive) 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 rasagiline treatment before starting treatment with MAOIs or pethidine.

Warnings and precautions

Talk to your doctor before starting rasagiline:

• If you have mild to moderate liver problems.
• If you have any suspicious changes in your skin.

Children

Rasagiline is not recommended for children under 18 years of age.

Other medicines and Devolina

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, or if you smoke or plan to stop smoking.

Ask your doctor for advice before taking any of the following medicines with rasagiline:

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin and 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 containing ephedrine or pseudoephedrine.

Rasagiline should not be used with antidepressants that contain fluoxetine or fluvoxamine. 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 if you or your family/caregiver notice that you are presenting with unusual behaviors that you cannot resist the impulse, urge, or temptation to perform certain activities that are harmful to you or others. These are called 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 high or increased sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose.

Taking Devolina with food and drink

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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Ask your doctor for advice before driving or using machines.

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 of your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

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

If you take more Devolina than you should

If you think you have taken more tablets of rasagiline than you should, tell your doctor or pharmacist immediately. Bring the pack/container of this medicine with you to show 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 talking to your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in 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 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.
• Allergic reactions.
• Fever.
• Flu-like symptoms (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 (leucopenia).
• 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:

• Stroke (cerebrovascular accident).
• Heart attack (myocardial infarction).
• Blistering rash (vesiculobullous rash).

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

Parkinson's disease is associated with symptoms of 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 perform certain actions that could be harmful to themselves or others. These are called impulse control disorders. In patients taking rasagiline or other medicines used to treat Parkinson's disease, the following impulse control 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 or behavior, of special concern to you or others, for example, an increased sexual impulse.
• Uncontrolled and excessive shopping or spending.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es. By reporting side 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 pack after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

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 further information

Composition of Devolina

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).

The other ingredients are microcrystalline cellulose, anhydrous colloidal silica, sodium starch glycolate, and sodium stearyl fumarate.

Appearance and pack contents

Devolina tablets are white, round, and biconvex.

The tablets are available in blister packs of 30 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet:September 2016

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