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RASAGILINE FLYNN 1 MG TABLETS

Active substance(s): RASAGILINE TARTRATE

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Package leaflet: Information for the user

Rasagiline Flynn
1mg Tablets
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor
or pharmacist.
n 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.
n 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 Flynn is and what it is used for
2. What you need to know before you take
Rasagiline Flynn
3. How to take Rasagiline Flynn
4. Possible side effects
5. How to store Rasagiline Flynn
6. Contents of the pack and other information

1 What Rasagiline Flynn is and
what it is used for
Rasagiline Flynn 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 Flynn helps to increase and sustain levels
of dopamine in the brain.

2 What you need to know before you take
Rasagiline Flynn
Do not take Rasagiline Flynn:
n if you are allergic to rasagiline or any of the other
ingredients of this medicine (listed in section 6).
n if you have severe liver problems
Do not take the following medicines while taking
Rasagiline Flynn:
n 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.
n pethidine (a strong pain killer).
You must wait at least 14 days after stopping
rasagiline treatment and starting treatment with
MAO inhibitors or pethidine.
Take special care with Rasagiline Flynn
n if you have mild to moderate liver problems
n You should speak with your doctor about any
suspicious skin changes.
Children and adolescents
Rasagiline Flynn is not recommended for use under
the age of 18.
Other medicines and Rasagiline Flynn
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines obtained without
a 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 Flynn:
n Certain antidepressants (selective serotonin
reuptake inhibitors, selective serotoninnorepinephrine reuptake inhibitors, tricyclic or
tetracyclic antidepressants)

n the

antibiotic ciprofloxacin used against infections
cough suppressant dextromethorphan
n sympathomimetics such as those present in eye
drops, nasal and oral decongestants and cold
medicine containing ephedrine or pseudoephedrine
The use of Rasagiline Flynn together with the
antidepressants containing fluoxetine or fluvoxamine
should be avoided. If you are starting treatment with
Rasagiline Flynn, 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 Flynn 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 Flynn
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.
n the

Rasagiline Flynn with food and drink
Rasagiline Flynn 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 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 Flynn
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The usual dose of Rasagiline Flynn is 1 tablet of 1mg
taken by mouth once daily. Rasagiline Flynn may be
taken with or without food.
If you take more Rasagiline Flynn than
you should
If you think that you may have taken too many
Rasagiline Flynn tablets, contact your doctor or
pharmacist immediately. Take the carton/bottle with
you to show the doctor or pharmacist.
If you forget to take Rasagiline Flynn
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 Flynn
Do not stop taking Rasagiline Flynn 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:
n Very common (affects more than 1 user in 10)
n Common (affects 1 to 10 users in 100)
n Uncommon (affects 1 to 10 users in 1,000)
n Rare (affects 1 to 10 users in 10,000)
n Very rare (affects less than 1 user in 10,000)
n Not known (frequency cannot be estimated from
the available data)

Very common:
n abnormal movements (dyskinesia)
n headache
Common:
n abdominal pain
n fall
n allergy
n fever
n flu (influenza)
n general feeling of being unwell (malaise)
n neck pain
n chest pain (angina pectoris)
n low blood pressure when rising to a standing
position with symptoms like dizziness/lightheadedness (orthostatic hypotension)
n decreased appetite
n constipation
n dry mouth
n nausea and vomiting
n flatulence
n abnormal results of blood tests (leucopenia)
n joint pain (arthralgia)
n musculoskeletal pain
n joint inflammation (arthritis)
n numbness and muscle weakness of the hand
(carpal tunnel syndrome)
n decreased weight
n abnormal dreams
n difficulty in muscular coordination
(balance disorder)
n depression
n dizziness (vertigo)
n prolonged muscle contractions (dystonia)
n runny nose (rhinitis)
n irritation of the skin (dermatitis)
n rash
n bloodshot eyes (conjunctivitis)
n urinary urgency
Uncommon:
n stroke (cerebrovascular accident)
n heart attack (myocardial infarction)
n 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 Flynn.
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 Flynn and/or other medications
used to treat Parkinson’s disease, the following have
been observed:
n Obsessive thoughts or impulsive behaviour.
n Strong impulse to gamble excessively despite
serious personal or family consequences.
n Altered or increased sexual interest and behaviour
of significant concern to you or to others, for
example, an increased sexual drive.
n 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 in the UK via the Yellow Card
Scheme, (Website: www.mhra.gov.uk/yellowcard)
or in Ireland via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2.
Tel: +353 1 6764971, Fax: +353 1 6762517. Website:
www.hpra.ie e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Rasagiline Flynn
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 after EXP. The expiry date
refers to the last day of that month.
Do not store above 30°C.
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.

6 Contents of the pack and other
information
What Rasagiline Flynn contains
n The active substance is rasagiline. Each tablet
contains 1mg rasagiline (as rasagiline tartrate).
n The other ingredient(s) are mannitol, maize starch,
pregelatinised maize starch, talc, colloidal
anhydrous silica and stearic acid.
What Rasagiline Flynn looks like and
contents of the pack
Rasagiline Flynn tablets are presented as white or
almost white, round, flat and unmarked tablets with
a diameter of 8mm ± 0.8mm.
The tablets are available in blister packs of
7, 10, 28, 30, 100 or 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Flynn Pharma Limited
Alton House,
4 Herbert Street,
Dublin 2,
Republic of Ireland
Manufacturer
Laboratorios Normon SA
Ronda de Valdecarrizo,
6 – 28760 Tres Cantos,
Madrid,
Spain
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Germany
Rasagilin Inresa 1mg Tabletten
Ireland
Rasagiline Flynn 1mg Tablets
United Kingdom Rasagiline Flynn 1mg Tablets
This leaflet was last revised in March 2016.


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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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