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RASAGILINE HBS 1MG TABLETS

Active substance(s): RASAGILINE TARTRATE

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Package leaflet: Information for the user

RASAGILINE 1mg 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 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 or pharmacist before taking RASAGILINE:
• if you have mild to moderate liver problems
• You should speak with your doctor about any suspicious
skin changes.
Children and adolescents
RASAGILINE is not recommended for use in children and
adolescents under the age of 18 years.
Other medicines and RASAGILINE
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.
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.
Developing unusual behaviours (impulse control disorders)
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.
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
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 is 1 tablet of 1mg once daily.
Oral use.
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 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.
Very common side effects (may affect more than 1 in 10
people):
• abnormal movements (dyskinesia)
• headache
Common side effects (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
• 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 side effects (may affect up to 1 in 100 people):
• stroke (cerebrovascular accident)
• heart attack (myocardial infarction)
• blistering rash (vesiculobullous rash)
Other side effects
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 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 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 out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the blister and on the carton. 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 thrown away
medicines you no longer use. These measures will help to
protect the environment.

6. Contents of the pack and other information
What RASAGILINE contains
• The active substance is rasagiline. Each tablet contains
1mg of rasagiline (as tartrate).
• The other ingredients are pregelatinized maize starch,
microcrystalline cellulose, maize starch, silica colloidal
anhydrous, citric acid monohydrate, stearic acid (50), talc.
What RASAGILINE looks like and contents of the pack
RASAGILINE 1 mg tablets are round, biconvex, white or
nearly white. The diameter is 8mm.
They are supplied in blister packs of 7, 10, 28, 30, 100 or
112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
HBS Healthcare Ltd Preston PR1 6AS, UK
Manufacturer:
Ferrer Internacional, S.A., Joan Buscallà1-9,
Sant Cugat del Vallès, Barcelona, 08173, Spain
This leaflet was last revised in February 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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