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RASAGILINE ARISTO 1 MG TABLETS

Active substance(s): RASAGILINE TARTRATE

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Package leaflet: Information for the user

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

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

2. What you need to know
before you take Rasagiline
Aristo
Do not take Rasagiline Aristo:
• if you are allergic (hypersensitive) 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 Aristo:
• 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 Aristo treatment and
starting treatment with MAO inhibitors or
pethidine.
Warnings and precautions
Talk to you doctor or pharmacist before
taking Rasagiline Aristo:
• if you have mild to moderate liver
problems
• You should speak with your doctor about
any suspicious skin changes.
• 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 Aristo 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.
Children and adolescents
Rasagiline Aristo is not recommended for
use under the age of 18.

Other medicines and Rasagiline
Aristo
Tell your doctor or pharmacist if you
are taking or have recently taken 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
Aristo:
• Certain antidepressants (selective
serotonin reuptake inhibitors,
selective serotonin-norepinephrine
reuptake inhibitors, tricyclic or
tetracyclic antidepressants)
• the antibiotic ciprofloxacin used
against infections
• the cough suppressant dextrome-
thorphan
• sympathomimetics such as those
present in eye drops, nasal and
oral decongestants and cold
medicine containing ephedrine or
pseudoephedrine
The use of Rasagiline Aristo together
with the antidepressants containing
fluoxetine or fluvoxamine should be
avoided.
If you are starting treatment with
Rasagiline Aristo, 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 Aristo treatment.
Rasagiline Aristo with food and
drink
Rasagiline Aristo 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
Aristo
Always take Rasagiline Aristo exactly
as your doctor has told you. Check
with your doctor or pharmacist if you
are not sure.
The recommended dose of Rasagiline
Aristo is 1 tablet of 1 mg taken by
mouth once daily.
Rasagiline Aristo may be taken with
or without food.
If you take more Rasagiline Aristo
than you should
If you think that you may have taken
too many Rasagiline Aristo tablets,
contact your doctor or pharmacist immediately. Take the Rasagiline Aristo

carton/blister with you to show the
doctor or pharmacist.

Parkinson's disease patients treated
with Rasagiline Aristo.

If you forget to take Rasagiline Aristo
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.

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 Aristo and/or other
medications used to treat Parkinson’s
disease, the following have been
observed:
• Obsessive thoughts or impulsive
behaviour.
• Strong impulse to gamble exces sively 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.

If you stop taking Rasagiline Aristo
Do not stop taking Rasagiline Aristo 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, Rasagiline Aristo 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 user in 10)
Common
(may affect 1 to 10 users in 100)
Uncommon
(may affect 1 to 10 users in 1,000)
Rare
(may affect 1 to 10 users in 10,000)
Very rare
(may affect less than 1 user in 10,000)
Not known
(frequency cannot be estimated from the
available data)
Very common:
• abnormal movements (dyskinesia)
• headache
Common:
• 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

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 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
Aristo
Keep this medicine out of the sight
and reach of children.
Do not use Rasagiline Aristo after the
expiry date which is stated on the
carton or blister after “Expiry date:”.
The expiry date refers to the last day
of that month.
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 Aristo contains
• The active substance is rasagiline.
Each tablet contains 1 mg
rasagiline (as tartrate).
• The other ingredients are glyceryl
behenate, starch, pregelatinised,
sodium starch glycoloate, citric
acid, anhydrous, cellulose,
microcrystalline.
What Rasagiline Aristo looks like
and contents of the pack
Rasagiline Aristo tablets are
presented as round, white and
biconvex tablets.
The tablets are available in blister
packs of 10, 28 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8 – 10
13435 Berlin
Germany
Manufacturer
Laboratorios Medicamentos
Internationales, S.A. (Medinsa)
C/ Solana, 26, Torrejón de Ardoz,
28850 Madrid
Spain
or

Aristo Pharma GmbH
Wallenroder Straße 8 – 10
13435 Berlin
Germany
This medicinal product is authorised
in the Member States of the EEA
under the following names:
Austria: Rasagilin Aristo 1 mg Tabletten
Italy: Rasagilina Aristo
Portugal: Rasagilina Aristo
Spain: Rasagilina Aristo 1 mg comprimidos
EFG
United Kingdom: Rasagiline Arsito 1 mg
tablets
PL 40546/0018
This leaflet was last revised in July 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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