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RASAGILINE ACCORD 1MG TABLETS

Active substance(s): RASAGILINE TARTRATE

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Pre-Folded Leaflet H x W mm (300 x 200 mm)
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Read all of this leaflet carefully before you start taking this
medicine cause 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 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 Accord is and what it is used for
2. What you need to know before you take Rasagiline Accord
3. How to take Rasagiline Accord
4. Possible side effects
5. How to store Rasagiline Accord
6. Contents of the pack and other information

1. What Rasagiline Accord is and what it is
used for

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Rasagiline Accord 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 Accord ]helps to
increase and sustain levels of dopamine in the brain.

2. What you need to know before you
take Rasagiline Accord
Do not take Rasagiline Accord
- if you are allergic 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
Accord :
- 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 Accord
treatment and starting treatment with MAO inhibitors or pethidine.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Rasagiline Accord
- if you have mild to moderate liver problems
- You should speak with your doctor about any suspicious skin
changes.
Children and adolescents
Rasagiline Accord is not recommended for use in children
and adolescents under the age of 18 years.
Other medicines and Rasagiline Accord
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines or if you are smoking
or intend to stop smoking.

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Ask your doctor for advice before taking any of the following
medicines together with Rasagiline Accord :
- 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

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.

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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 this 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 Accord
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose of Rasagiline Accord is 1 tablet of 1
mg once daily. Oral use.
Rasagiline Accord may be taken with or without food.
If you take more Rasagiline Accord than you should
If you think that you may have taken too many Rasagiline
Accord tablets, contact your doctor or pharmacist
immediately. Take the Rasagiline Accord carton with you to
show the doctor or pharmacist.
If you forget to take Rasagiline Accord
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 Accord
Do not stop taking Rasagiline Accord 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:
Very common (may affect more than 1 in 10 people)
- abnormal movements (dyskinesia)
- headache
Common (may affect up to 1 in 10 people):
- 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

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Rasagiline

Laetus bars

Package leaflet: Information for the user

Rasagiline Accord 1mg tablets

The use of Rasagiline Accord together with the
antidepressants containing fluoxetine or fluvoxamine should
be avoided.
If you are starting treatment with Rasagiline Accord , 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
Accord treatment.

- 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 (may affect up to 1 in 100 people):
- 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 Accord .
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. In patients
taking Rasagiline Accord 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.
Reporting of side effects
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 via the national
reporting system (see contact details below). By reporting
side effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie

5. How to store Rasagiline Accord
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, tablet container or blister. The expiry date refers
to the last day of that month.

This medicinal product does not require any special storage
conditions.
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 to
protect the environment.

6. Contents of the pack and other
information
What Rasagiline Accord contains
- The active substance is rasagiline. Each tablet contains 1
mg rasagiline (as rasagiline tartrate).
- The other ingredients are Cellulose, Microcrystalline; Maize
starch; Starch, Pregalatinised (from maize); Talc; Sodium
Stearyl Fumarate.
What Rasagiline Accord looks like and contents of the pack
Rasagiline Accord tablets are presented as white to off-white,
round, flat, bevelled tablets (6.5 mm).
Pack sizes of 7, 10 , 28, 30, 60, 100, 112 tablets in blisters
Pack sizes of 30 tablets in tablet containers with child-resistant
screw caps containing desiccant (silica gel). The desiccant,
used to keep the tablets dry, should not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF, United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF, United Kingdom
Delorbis Pharmaceuticals Ltd
17 Athinon Street, Ergates Industrial Area,
2643 Ergates Lefkosia, Cyprus
Iberfar – Indústria Farmaĉeutica, S.A.
Rua Consiglieri Pedroso, no. 121-123
Queluz de Baixo, Barcarena, Portugal
Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias – Alto do Colaride, Cacém ,Portugal
This medicinal product is authorised in the Member
States of the EEA under the following names:
Name of the
Member State
Germany
Austria
Bulgaria
Denmark
Estonia
Finland
France
Ireland
Italy
Lithuania
Latvia
Norway
Poland
Sweden
Slovak Republic
United Kingdom

Name of the medicinal product
Rasagilin Accord 1mg Tabletten
Rasagilin Accord 1mg Tabletten
Rasagiline Accord 1mg таблетки
Rasagilin Accord
Rasagiline Accord
Rasagiline Accord 1mg Tabletti
Rasagiline Accord 1mg comprimé
Rasagiline Accord 1mg tablets
Rasagilina Accord
Rasagiline Accord 1mg tabletės
Rasagiline Accord 1mg tabletes
Rasagilin Accord 1mg tabletter
Rasagiline Accord
Rasagiline Accord 1mg tabletter
Rasagiline Accord 1mg tablety
Rasagiline Accord 1mg tablets

This leaflet was last revised in 10/2015.

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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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