RASABON 1 mg Tablet

Зміст інструкції

1. RASABON 1 mg compresse
   1. HOW TO STORE RASABON

RASABON 1 mg compresse

Rasagiline

Read this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet. 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. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1WHAT RASABON IS AND WHAT IT IS USED FOR
Rasabon is used in the treatment of Parkinson's disease. It can 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 certain areas of the
brain. Dopamine is a brain substance responsible for controlling movements. Rasabon
helps to increase and maintain constant levels of dopamine in the brain.

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

• if you are allergic (hypersensitive) to rasagiline or any of the other ingredientsof this medicine (listed in section 6).
• if you have severe liver 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 medicines and herbal products without a prescription, such as St. John's Wort.

Wait at least 14 days after stopping treatment with Rasabon before starting treatment with MAOIs or selegiline.
petidine(a strong painkiller).

• petidine(a strong painkiller).

Wait at least 14 days after stopping treatment with Rasabon before starting treatment with MAOIs or petidine.

Warnings and precautions
Talk to your doctor before taking Rasabon

Take special care with Rasabon

• If you have mild to moderate liver impairment.
• Contact your doctor if you notice any suspicious skin changes.

Children
Rasabon is not recommended for use in patients under the age of 18 years.

Other medicines and Rasabon
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available 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:

• some antidepressants(selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
• ciprofloxacin, an antibiotic used to treat infections
• dextromethorphan, a medicine used for cough
• sympathomimetics such as those found in eye drops, nasal decongestants and oral decongestants and cold medicines containing ephedrine or pseudoephedrine.Avoid the concomitant use of Rasabon and 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.

Tell 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 temptation to perform certain
activities that are dangerous or harmful to you or others. These behaviors are called
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 an abnormally high sexual drive or an increase in sexual thoughts or desires have been observed. Your doctor may
need to adjust your dose or stop the 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,
ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Studies have not been conducted on the effects on the ability to drive and operate machines. Ask
your doctor for advice before driving or using machines.

3HOW TO TAKE RASABON
Take this medicine exactly as your doctor has told you. If you are unsure, ask your
doctor or pharmacist.
The recommended dose of Rasabon is 1 tablet of 1 mg taken by mouth, once a day.
Rasabon can be taken with or without food.

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

If you forget to take Rasabon
Do not take a double dose to make up for a missed tablet. Take the next
dose normally, when it is due.

If you stop taking Rasabon
Do not stop taking Rasabon without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported during clinical trials controlled against placebo.

The frequency of the possible side effects listed below is defined using the following

conventions:

• 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 the available data).

Very common:

• Abnormal movements (dyskinesia) - headache.

Common:

• abdominal pain - falls - allergy - fever - flu-like illness (influenza) - general feeling of being unwell (malaise) - neck pain - chest pain (angina pectoris) - reduced blood pressure when standing up accompanied by symptoms such as dizziness /lightheadedness (orthostatic hypotension) - loss of 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 of the hand muscle (carpal tunnel syndrome) - weight loss - abnormal dreams - dizziness - prolonged muscle contractions (dystonia) - runny nose (rhinitis) - skin irritation (dermatitis) - redness - red eyes (conjunctivitis) - frequent urination.

Uncommon:

• stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - blistering skin (bullous erythema).

In addition, in clinical trials controlled against placebo, skin cancer was reported in approximately 1% of patients. Scientific evidence suggests that Parkinson's disease, and not a particular medicine,
is associated with a higher 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 occurred of patients who, while taking one or more medicines for the treatment
of Parkinson's disease, have been unable to resist the impulse, urge or
temptation to perform an action that could be harmful to themselves or others.
These behaviors are called 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 compulsive behaviors.
• A strong urge to gamble excessively despite serious personal or family consequences.
• Altered or increased sexual interest and behaviors that are significantly concerning for themselves or others, for example an increased sexual desire.
• Uncontrollable and excessive spending or shopping.

Tell your doctor if any of these behaviors occur; you will discuss how to manage or
reduce the symptoms.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects 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 which is stated on the packaging or blister. The
expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6CONTENTS OF THE PACK AND OTHER INFORMATION
What Rasabon contains

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

Description of the appearance of Rasabon and contents of the pack
Rasabon tablets are white or off-white, oblong (approximately 11.5 mm x 6 mm),
biconvex, with 'R9SE' imprinted on one side and '1' on the other side.

oPA/Al/PVC/Al blister packs of 7, 10, 28, 30, 100 and 112 tablets.

PVC/PVDC/Al blister packs of 7, 10, 28, 30, 100 and 112 tablets.

Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer

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

Manufacturer
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
Netherlands

This medicinal product is authorised in the Member States of the EEA with the following names:
Germany Rasagilin-Glenmark 1 mg Tablets
Finland Rasabon 1 mg tablets
Hungary Razagilin Synthon 1 mg
Iceland Rasagilin WH 1 mg tablets
Italy Rasabon
Croatia Razagilina Makpharm 1 mg tablets
Netherlands Rasagiline Synthon 1 mg, tablets
Poland Rasagilina Synthon
Spain Rasagilina Synthon 1 mg comprimidos EFG
United Kingdom Rasagiline Synthon, 1 mg tablets