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RASAGILINE SYNTHON 1 MG TABLETS

Active substance(s): RASAGILINE TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER



Rasagiline 1 mg tablets
Rasagiline

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
1. What Rasagiline is and what it is used for
2. What you need to know before you take Rasagiline
3. How to take Rasagiline
4. Possible side effects
5. How to store Rasagiline
6. Contents of the pack and other information

1. WHAT RASAGILINE IS AND WHAT IT IS
USED FOR
Rasagiline is used for the treatment of Parkinson’s disease.
It can be used together with or without Levodopa (another
medicine that is 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 chemical in
the brain involved in movement control. Rasagiline helps to
increase and sustain levels of dopamine in the brain.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE RASAGILINE
Do not take Rasagiline:
• if you are allergic (hypersenstive) to rasagiline or any
of the other ingredients of this medicine (listed in
section 6).
• if you have severe liver problems.
Do not take the following medicines while taking rasagiline:
• monoamine oxidase (MAO) inhibitors (e.g. for
treatment of depression or Parkinson’s disease, or used
for any other indication), including medicinal and natural
products without prescription e.g. St. John’s Wort.
• pethidine (a strong pain killer).
You must wait at least 14 days after stopping Rasagiline
treatment and starting treatment with MAO inhibitors or
pethidine.
Warnings and precautions
Talk to your doctor before taking Rasagiline.
Take special care with Rasagiline
• if you have mild to moderate liver problems
• you should speak with your doctor about any suspicious
skin changes.

recently taken or might take any other medicines, including
medicines obtained without prescription or if you are
smoking or intend to stop smoking.
Ask your doctor for advice before taking any of the following
medicines together 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 present in eye drops,
nasal and oral decongestants and cold medicine
containing ephedrine or pseudoephedrine
The use of Rasagiline together with the antidepressants
containing fluoxetine or fluvoxamine should be avoided.
If you are starting treatment with Rasagiline, you should
wait at least 5 weeks after stopping fluoxetine treatment.
If you are starting treatment with fluoxetine or fluvoxamine,
you should wait at least 14 days after stopping Rasagiline
treatment.
Tell your doctor if you or your family/carer notices that you
are developing unusual behaviours where you cannot resist
the impulse, urges or cravings to carry out certain harmful
or detrimental activities to yourself or others. These are
called impulse control disorders. In patients taking
Rasagiline and/or other medications used to treat
Parkinson’s disease, behaviours such as compulsions,
obsessive thoughts, addictive gambling, excessive spending,
impulsive behaviour and an abnormally high sex drive or an
increase in sexual thoughts or feelings have been observed.
Your doctor may need to adjust or stop your dose.
Rasagiline with food and drink
Rasagiline may be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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
No studies on the effects on the ability to drive and use
machines have been performed. Ask your doctor for
advice prior to driving or using machines.

3. HOW TO TAKE RASAGILINE


Children
Always take this medicine exactly as your doctor has told
Rasagiline is not recommended for use under the age of 18. you. Check with your doctor or pharmacist if you are not
sure.
Other medicines and Rasagiline
The recommended dose is 1 tablet of 1 mg taken by mouth
Tell your doctor or pharmacist if you are taking or have
once daily. Rasagiline may be taken with or without food.

If you take more Rasagiline than you should
If you think that you may have taken too many Rasagiline
tablets, contact your doctor or pharmacist immediately. Take
the Rasagiline carton box with you to show the doctor or
pharmacist.
If you forget to take Rasagiline
Do not take a double dose to make up for a forgotten dose.
Take the next dose normally, when it is time to take it.
If you stop taking Rasagiline
Do not stop taking Rasagiline without first talking to your
doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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

In patients taking Rasagiline and/or other medications used
to treat Parkinson’s disease, the following have been
observed:
• Obsessive thoughts or impulsive behaviour.
• Strong impulse to gamble excessively despite serious
personal or family consequences.
• Altered or increased sexual interest and behaviour of
significant concern to you or to others, for example, an
increased sexual drive.
• Uncontrollable excessive shopping or spending.
Tell your doctor if you experience any of these behaviours;
they will discuss ways of managing or reducing the
symptoms.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this leaflet. You can
also report side effects directly via Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety
of this medicine.

5. HOW TO STORE RASAGILINE
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 carton or blister. The expiry date refers to the
last day of that month.

Very common
• abnormal movements (dyskinesia) • headache

Do not store above 25°C.

Common

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

• abdominal pain • fall • allergy • fever • flu (influenza)
• general feeling of being unwell (malaise) • neck pain
• chest pain (angina pectoris) • low blood pressure when

rising to a standing position with symptoms like dizziness/
light-headedness (orthostatic hypotension) • decreased
appetite • constipation • dry mouth • nausea and vomiting
• flatulence • abnormal results of blood tests (leucopenia)
• joint pain (arthralgia) • musculoskeletal pain • joint
inflammation (arthritis) • numbness and muscle weakness
of the hand (carpal tunnel syndrome) • decreased weight
• abnormal dreams • difficulty in muscular coordination
(balance disorder) • depression • dizziness (vertigo)
• prolonged muscle contractions (dystonia) • runny nose
(rhinitis) • irritation of the skin (dermatitis) • rash
• bloodshot eyes (conjunctivitis) • urinary urgency
Uncommon
• stroke (cerebrovascular accident) • heart attack
(myocardial infarction) • blistering rash (vesiculobullous
rash)
In addition, skin cancer was reported in around 1% of
patients in the placebo controlled clinical trials.
Nevertheless, scientific evidence suggests that Parkinson’s
disease, and not any medicine in particular, is associated
with a higher risk of skin cancer (not exclusively melanoma).
You should speak with your doctor about any suspicious
skin changes.
Parkinson’s disease is associated with symptoms of
hallucinations and confusion.
In post marketing experience these symptoms have also
been observed in Parkinson’s disease patients 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, drive or temptation to
perform an action that could be harmful to themselves or
others. These are called impulse control disorders.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Rasagiline contains
• The active substance is Rasagiline. Each tablet contains
1 mg Rasagiline (as tartrate).
• The other ingredients are microcrystalline cellulose,
tartric acid, maize starch, pregelatinized starch, talc,
stearic acid.
What Rasagiline looks like and contents of the pack
Rasagiline tablets are presented as white to off-white,
oblong (approximately 11.5 mm x 6 mm), bioconvex
tablets, debossed with ”R9SE” on one side and ‘1’ on the
other side.
The tablets are available in blister packs of 7, 10, 28, 30,
100 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Synthon BV, Microweg 22, 6545 CM Nijmegen,
The Netherlands
Manufacturer:
Synthon Hispania, S.L., C/Castelló, 1 - Polígono Las Salinas,
08830 Sant Boi de Llobregat, Barcelona, Spain
Distributed by:
Consilient Health (UK) Ltd., No. 1 Church Road,
Richmond upon Thames, Surrey. TW9 2QE.

This leaflet was last revised in September 2015
P0360

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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