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RASAGILINE MILPHARM 1 MG TABLETS

Active substance(s): RASAGILINE TARTRATE

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Package leaflet: Information for the user

Very common
abnormal movements (dyskinesia)
• headache

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).

2 What you need to know before you take
Rasagiline
Do not take Rasagiline
- 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: 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.
Children
Rasagiline is not recommended for use under the
age of 18.
Other medicines and Rasagiline
Tell your doctor or pharmacist if you are taking or
have 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

Black

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

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 is 1 tablet of 1 mg taken
by mouth 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)
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The Leaflet can be printed in both sides

The Leaflet can be printed in both sides

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.

The use of Rasagiline together with the
antidepressants containing fluoxetine or
fluvoxamine should be avoided.

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 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. 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 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.
Do not store above 25°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 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
Tablet.
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, 50, 90, 100 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
Synthon Hispania S. L.
Castelló no l
Pol.Las Salinas
Sant Boi de Llobregat
Barcelona 08830
Spain
or
Synthon s.r.o.
Brněnská 32/čp. 597
Blansko 678 01
Czech Republic
or
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
or
APL Swift Services (Malta) Limited
Hf26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 10/2015.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the national
reporting system listed in Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By
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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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