Package Leaflet: Information for the User

Rasagilina MABO 1 mg tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

Do not take Rasagilina MABO

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

Do not take the following medications while taking Rasagilina MABO:

• Monamine oxidase inhibitors (MAO) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including medications and natural products without 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 taking this medication.Inform your doctor if you have or have had any disease or symptom, especially any of the following:

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

Children and adolescents

Rasagilina MABO is not recommended for minors under 18 years.

Use of Rasagilina MABO with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication, even those acquired 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-norepinephrine 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 this medication with antidepressants containing fluoxetine or fluvoxamine. If you are starting your treatment with Rasagilina MABO, you must wait at least 5 weeks since stopping treatment with fluoxetine.

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

Inform your doctor if you or your family/caregiver notice that you are presenting unusual behaviors in which you cannot resist the urge, the imperative need, or the anxiety to perform certain activities that are harmful or detrimental to yourself or others. These are known as impulse control disorders. In patients taking Rasagilina MABO 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.

Taking Rasagilina MABO with food, drinks, and alcohol

Rasagilina MABO can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.Your doctor will tell you if 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 or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The normal dose of Rasagilina MABOis 1 tablet of 1 mg taken by mouth, once a day.

Rasagilina MABOcan be taken with or without food.

If you take more Rasagilina MABOthan 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 MABOpackage with you to show to your doctor or pharmacist.

If you forgot to take Rasagilina MABO

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 the treatment with Rasagilina MABO

Do not stop taking Rasagilina MABOwithout consulting your doctor first.

If you have any other questions about the use of this medication, 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:

Very common side effects (affect more than 1 in 10 people):

• Abnormal movements (dyskinesia).
• Headache.

Common side effects (affect between 1 and 10 in 100 people):

• Abdominal pain.
• Falls.
• Allergy.
• Fever.
• Flu-like syndrome (influenza).
• General discomfort.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing with symptoms such as dizziness/vertigo (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).
• Numbness and muscle weakness of the hand (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Muscle coordination disorder (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urgency to urinate.

Uncommon side effects (affect between 1 and 10 in 1,000 people):

• 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 MABO.

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 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 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://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.

Store below 25°C.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Rasagilina CompositionMABO

• The active ingredient is rasagilina. Each tablet contains 1 mg of rasagilina (as tartrate).
• The other components (excipients) are:microcrystalline cellulose (E-460i), tartaric acid, cornstarch, pregelatinized cornstarch, talc (E-553b), and stearic acid (E-570).

Appearance of the product and contents of the packaging

Rasagilina MABO tablets are presented in the form of white or almost white, biconvex, oblong, tablets engraved with 'R9SE' on one side and "1" on the other.

The tablets are presented in blister packaging of 30 tablets.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Rejas 2, 1st floor28821, Coslada, Madrid.

Responsible for Manufacturing

Synthon Hispania, S.L.

Castelló 1, Las Salinas Industrial Estate.

08830, Sant Boi de Llobregat, Spain.

or

Synthon s.r.o.

Brnenska 32/cp. 597

678 01 Blansko

Republic of Czechia,

or

Synthon BV

Microweg 22,

6545 CM Nijmegen

Netherlands.

Last review date of this leaflet: October 2015

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