Package Insert: Information for the User

Rasagilina Qualigen 1 mg Tablets EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isRasagilina Qualigenand what is it used for

2. What you need to know before starting to takeRasagilina Qualigen

3. How to takeRasagilina Qualigen

4. Possible adverse effects

5. Storage ofRasagilina Qualigen

6. Contents of the package and additional information

Rasagilina 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.

Rasagilina helps to increase and maintain dopamine levels in the brain.

Do not take Rasagilina Qualigen:

• If you are allergic (hypersensitive) to rasagilina or to 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:

• Monamine oxidase inhibitors (MAO) (for example for the treatment of depression or Parkinson's disease, or for another indication) including medications and natural products without a prescription, for example 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 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 must speak with your doctor about any suspicious changes in the skin.

Children

Rasagilina is not recommended for minors under 18 years.

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 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.

It is recommended to avoid the use of this medication with antidepressants containing fluoxetine or fluvoxamine.If you are starting your treatment with rasagilina, you must wait at least 5 weeks since the interruption of treatment with fluoxetine.

If you are starting your treatment with fluoxetine or fluvoxamine, you must wait at least 14 days since the interruption of treatment with rasagilina.

Inform your doctor if you or your family/caregiver notice that you are presenting rare behaviors in which you cannot resist the impulse, the urgent need, or the anxiety to perform certain harmful or harmful activities for yourself or for 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, pathological gambling, 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.

Administration of Rasagilina Qualigen with food and beverages

Rasagilina can be taken with or without food.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. Your doctor will indicate whether you should continue treatment with rasagilina.

Driving and operating machinery

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

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

The usual dose of Rasagilina Qualigen is 1 tablet of 1 mg taken by mouth, once a day.Rasagilina Qualigen may be taken with or without food.

If you take more Rasagilina Qualigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the Rasagilina Qualigen packaging with you to show to your doctor or pharmacist.

If you forgot to take Rasagilina Qualigen

Do not take a double dose to compensate for the missed doses. Take the next regular dose when it is time to take it.

If you interrupt treatment with Rasagilina Qualigen

Do not stop taking rasagilina without consulting your doctor first.

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

Like all medicines, Rasagilina Qualigen may 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:

Common:

(Orthostatic hypotension).

Uncommon:

• Stroke (cerebrovascular accident).
• Heart attack (myocardial infarction).
• Wart-like rash (vesiculobullous rash).

In addition, in clinical trials compared to placebo, skin cancer was observed in about 1% of patients. However, scientific evidence indicates that Parkinson's disease, and not a particular medication, is associated with a higher 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 symptoms of hallucinations and confusion. 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 impulse control disorders have been observed:

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 about 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 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 drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition:

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

Appearance of the product and content of the container

Rasagilina Qualigen tablets are presented in the form of white or off-white, round, flat bisected tablets, marked with a “1” on one face and with a diameter of 8 mm.

The tablets are presented in blister packs of 30 tablets.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturing

Genepharm S.A.

18th Marathonos Avenue,

15351 Pallini Attiki

Greece

This leaflet was approved in: November 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/