Rasabon

PACKAGE LEAFLET: INFORMATION FOR THE USER

RASABON 1 mg tablets

Rasagiline
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1 WHAT RASABON IS AND WHAT IT IS USED FOR
Rasabon is used in 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, dopaminergic neurons are lost in certain areas of the
brain. Dopamine is a brain substance responsible for controlling movement. Rasabon
helps increase and maintain stable dopamine levels in the brain.

2 WHAT YOU NEED TO KNOW BEFORE TAKING RASABON
Do not take Rasabon

• if you are allergic (hypersensitive) to rasagiline or to any of the excipients of this medicine (listed in section 6).

• if you have severe hepatic impairment.

• Do not take the following medicines in combination with Rasabon: monoamine oxidase inhibitors (MAOIs) (used as antidepressants, for the treatment of Parkinson's disease, or for any other indication), including medicinal products and natural products available without prescription, such as St. John's wort.

• meperidine (a strong analgesic).

Wait at least 14 days after stopping treatment with Rasabon before starting therapy with
MAO inhibitors or meperidine.

Warnings and precautions
Consult your doctor before taking Rasabon
Exercise particular caution with Rasabon

• In case of mild to moderate hepatic impairment.
• Consult your trusted doctor if you notice any suspicious skin changes.

Children
Use of Rasabon is not recommended in patients under 18 years of age.

Other medicines and Rasabon
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription, and if you are a smoker or intend to quit
smoking.
Ask your doctor for advice before taking any of the following medicines in combination with
Rasabon:

• certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
• the antibiotic ciprofloxacin used to treat infections
• dextromethorphan, a medicine used for cough
• sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine. Avoid concomitant use of Rasabon with antidepressants containing fluoxetine or fluvoxamine. Before starting treatment with Rasabon, wait at least five weeks after stopping treatment with fluoxetine. Before starting treatment with fluoxetine or fluvoxamine, wait at least 14 days after stopping treatment with Rasabon.

Inform your doctor if you, your family members, or caregivers notice that you are developing
unusual behaviors that make you unable to resist the impulse, urge, or desire to perform certain
activities that may be dangerous or harmful to yourself or others. These behaviors are known as
impulse control disorders. In patients taking Rasabon and/or other medicines used to treat
Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling addiction,
excessive spending, impulsive behaviors, and abnormally increased sexual desire or increased
sexual thoughts or desires have been observed. Your doctor may need to adjust the dose or
discontinue treatment.

Rasabon with food and drink
Rasabon can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby,
consult your doctor or pharmacist before taking any medicine.

Driving and using machines
No studies have been conducted on the effects on the ability to drive and use machines. Consult
your doctor before driving or operating machinery.

3 HOW TO TAKE RASABON
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose of Rasabon is 1 tablet of 1 mg taken orally once daily.
Rasabon may be taken with or without food.

If you take more Rasabon than you should
If you think you have taken more Rasabon tablets than prescribed, contact your
doctor or pharmacist immediately. Bring the Rasabon packaging with you to show the doctor or pharmacist.

If you forget to take Rasabon
Do not take a double dose to make up for the missed tablet. Take the next dose at the usual time.

If you stop taking Rasabon
Do not stop taking Rasabon without first discussing it with your doctor.

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

4 POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported in placebo-controlled clinical trials.
The frequency of the possible side effects listed below is defined using the following
conventions:

• Very common (more than 1 in 10 patients)
• Common (1 to 10 in 100 patients)
• Uncommon (1 to 10 in 1,000 patients)
• Rare (1 to 10 in 10,000 patients)
• Very rare (less than 1 in 10,000 patients)
• Not known (frequency cannot be estimated from available data).

Very common:

• Abnormal movements (dyskinesia) - headache.

Common:

• abdominal pain - falls - allergy - fever - influenza-like illness (influenza) - general feeling of being unwell (malaise) - neck pain - chest pain (angina pectoris) - reduction in blood pressure upon standing, accompanied by symptoms such as dizziness/light-headedness (orthostatic hypotension) - decreased appetite - constipation - dry mouth - nausea and vomiting - flatulence - abnormalities in blood test results (leucopenia) - joint pain (arthralgia) - musculoskeletal pain - joint inflammation (arthritis) - numbness and weakness in hand muscles (carpal tunnel syndrome) - weight loss - abnormal dreams - difficulty in muscle coordination (balance disorders) - depression - dizziness - prolonged muscle contractions (dystonia) - runny nose (rhinitis) - skin irritation (dermatitis) - erythema - red eyes (conjunctivitis) - urinary urgency.

Uncommon:

• stroke (cerebrovascular accident) - heart attack (myocardial infarction) - skin blisters (bullous exanthema).

Additionally, in placebo-controlled clinical trials, skin cancer was reported in approximately 1% of patients. Scientific evidence suggests that Parkinson's disease, rather than a specific medicine, is associated with an increased risk of skin cancer (not exclusively melanoma). Report any suspicious skin changes to your doctor.
Parkinson's disease is associated with symptoms such as hallucinations and confusion. In post-marketing experience, these symptoms have also been observed in patients with Parkinson's disease treated with rasagiline.
Cases have been reported of patients, while taking one or more medicines for the treatment of Parkinson's disease, being unable to resist the impulse, desire, or temptation to perform an action that could be harmful to themselves or others. These behaviors are known as impulse control disorders. The following behaviors have been observed in patients taking rasagiline and/or other medicines used to treat Parkinson's disease:

• Obsessive thoughts or impulsive behaviors.
• Strong urge to gamble excessively despite serious personal or family consequences.
• Altered or increased sexual interest and behaviors significantly concerning to themselves or others, for example increased sexual desire.
• Uncontrollable and excessive spending or shopping.

Inform your doctor if any of these behaviors occur; you will discuss ways to manage or reduce the symptoms.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of suspected adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RASABON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister.
The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6 CONTENT OF THE PACKAGE AND OTHER INFORMATION

What Rasabon contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The excipients are microcrystalline cellulose, tartaric acid, maize starch, pregelatinized maize starch, talc, stearic acid.

Description of the appearance of Rasabon and contents of the pack
Rasabon tablets are white or almost white, oblong (approximately 11.5 mm x 6 mm),
biconvex, with 'R9SE' engraved on one side and '1' on the other.
PVC/Al/PVDC/Al blisters containing 7, 10, 28, 30, 100 and 112 tablets.
PVC/PVDC/Al blisters containing 7, 10, 28, 30, 100 and 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
FB Health S.p.A.
Via dei Sabini, 28
63100 Ascoli Piceno
Italy

Manufacturers
Synthon Hispania S.L.
C/Castelló n°1,
Pol. Las Salinas
08830 Sant Boi de Llobregat
Spain
Synthon s.r.o. Blansko
Brnenska 32/c.p.597
678 01 Blansko
Czech Republic
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

This medicine is authorised in EEA Member States under the following names:
Germany Rasagilin-Glenmark 1 mg Tabletten
Finland Rasabon 1 mg tabletti
Hungary Razagilin Synthon 1 mg
Iceland Rasagilin WH 1 mg töflur
Italy Rasabon
Croatia Razagilina Makpharm 1 mg tablete
The Netherlands Rasagiline Synthon 1 mg, tabletten
Poland Rasagilina Synthon
Spain Rasagilina Synthon 1 mg comprimidos EFG
United Kingdom Rasagiline Synthon, 1 mg tablets

This patient information leaflet was last approved on MM/YYYY.