NEUROMIOL 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Neuromiol 1 mg Tablets EFG

Rasagiline

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Neuromiol and what is it used for
2. What you need to know before taking Neuromiol
3. How to take Neuromiol
4. Possible side effects
5. Storage of Neuromiol
6. Package Contents and Additional Information

1. What is Neuromiol and what is it used for

Neuromiol is indicated for the treatment of Parkinson's disease. It can be used with or without levodopa (another medication 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.

Rasagiline helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Neuromiol

Do not take Neuromiol:

• If you are allergic (hypersensitive) to rasagiline or any of the other ingredients of this medication (listed in section 6).
• If you have severe liver problems.

Do not take the following medications 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 medications and natural products, such as St. John's Wort.
• Pethidine (a potent analgesic).

You should wait at least 14 days after stopping rasagiline treatment and before starting treatment with MAOIs or pethidine.

Warnings and Precautions

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

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

Children

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

Use of Other Medications

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 rasagiline:

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine 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 decongestants, and oral medications, and cough medicines containing ephedrine or pseudoephedrine.

The use of this medication with antidepressants containing fluoxetine or fluvoxamine should be avoided. 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.

Inform your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviors in which you cannot resist the impulse, need, or urge to perform certain harmful or dangerous activities for yourself or others. These are called impulse control disorders. In patients taking rasagiline or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behavior, and abnormally high sexual impulse or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or interrupt your dose.

Taking Neuromiol with Food and Drinks

Neuromiol can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will advise you whether to continue treatment with rasagiline.

Driving and Using Machines

No studies have been conducted on the effects on driving ability or use of machines. Seek medical advice before driving or using machines.

3. How to Take Neuromiol

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The normal dose of Neuromiol is 1 tablet of 1 mg taken orally, once a day.

Neuromiol can be taken with or without food.

If you take more Neuromiol than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring 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 forgotten doses. Take the next normal dose when it is due.

If you stop taking Neuromiol

Do not stop taking Neuromiol without consulting your doctor first.

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

4. Possible Side Effects

Like all medications, Neuromiol can have side effects, although not everyone will experience 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 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 (frequency cannot be estimated from 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).

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 indicates that Parkinson's disease, and not a particular medication, 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 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 called impulse control disorders. In patients taking rasagiline 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 serious personal or family consequences.
• Altered or increased sexual interest or behavior, of special concern to you or others, such as an increased sexual impulse.
• Uncontrolled and excessive shopping or spending.

Inform your doctor if you experience any of these behaviors; they will consider ways to treat or reduce the symptoms.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System: www.notificaram.es.

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

5. Storage of Neuromiol

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

Do not use this medication after the expiration date stated on the blister pack. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication at the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition:

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

Appearance of the Product and Package Contents

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

The tablets are presented 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 package leaflet was approved in: February 2016

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