Neuromiol 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Neuromiol 1 mg tablets EFG

Rasagiline

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Neuromiol is and what it is used for
2. What you need to know before taking Neuromiol
3. How to take Neuromiol
4. Possible adverse effects
5. How to store Neuromiol
6. Contents of the pack and other information

1. What Neuromiol is and what it is used for

Neuromiol is indicated for the treatment of Parkinson's disease. It may 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 substance in the brain involved in the control of movement.

Rasagiline helps increase and maintain dopamine levels in the brain.

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

Do not take Neuromiol:

• 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) (for example, used to treat depression or Parkinson's disease, or for other indications), including over-the-counter medicines and natural products such as St. John's wort.
• Meperidine (pethidine) (a strong painkiller).

You must wait at least 14 days after stopping rasagiline treatment before starting treatment with MAO inhibitors or meperidine.

Warnings and precautions

Consult your doctor before starting to take this medicine. Inform your doctor if you have or have had any illness or symptom, especially any of the following:

• If you have mild to moderate liver problems.
• You should speak with your doctor about any suspicious changes in the skin.

Children

Neuromiol is not recommended for individuals under 18 years of age.

Use of other medicines

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 together with rasagilina:

• 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.

Concomitant use of this medicine with antidepressants containing fluoxetine or fluvoxamine must 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 if you or your family/caregiver notice that you are exhibiting unusual behaviors in which you cannot resist the impulse, urge, or craving to carry out certain activities that may be harmful or damaging to yourself or others. These are known as impulse control disorders. In patients taking rasagilina or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally increased sex drive or increased sexual thoughts or feelings have been observed. Your doctor may need to adjust or discontinue your dose.

Taking Neuromiol with food and beverages

Neuromiol may be taken with or without food.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will advise you whether you should continue treatment with rasagilina.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive or operate machinery. Seek medical advice before driving or operating machinery.

3. How to take Neuromiol

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual dose of Neuromiol is 1 tablet of 1 mg taken orally, once daily.

Neuromiol may be taken with or without food.

If you take more Neuromiol 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 Neuromiol packaging with you to show to the doctor or pharmacist.

If you forget to take Neuromiol

Do not take a double dose to make up for missed doses. Take the next dose at the usual scheduled time.

If you stop taking Neuromiol

Do not stop taking Neuromiol without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, Neuromiol may have 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 available data).

Very common:

• Abnormal movements (dyskinesia).
• Headache.

Common:

• Abdominal pain.
• Falls.
• Allergy.
• Fever.
• Influenza-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, rather than any specific medication, is associated with an increased risk of skin cancer (not exclusively melanoma). You should speak with your doctor about 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 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 behavior.
• Strong urge to gamble excessively, despite serious personal or family consequences.
• Altered or increased interest in and engagement in sexual behavior, causing concern to you or others, for example increased sex 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Neuromiol

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. If 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:

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other components are microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

Neuromiol tablets are presented as white or almost white, round, flat bevelled tablets, marked with a "1" on one side and with a diameter of 8 mm.

The tablets are supplied in blister packs of 30 tablets.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Genepharm S.A.

18th Marathonos Avenue,

15351 Pallini Attiki

Greece

This leaflet was approved in: February 2016

Detailed and up-to-date 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/