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RASAGILINE HCS 1MG TABLETS

Active substance(s): RASAGILINE HEMITARTRATE / RASAGILINE HEMITARTRATE / RASAGILINE HEMITARTRATE

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NA.RASAGILINE HCS TBL 1MG GB prva stran

Package leaflet: Information for the patient

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

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

Rasagiline HCS 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).

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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
HCS helps to increase and sustain levels of dopamine in
the brain.

2. What you need to know before you
take Rasagiline HCS

Do not take Rasagiline HCS:
• 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 HCS:
• 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
HCS treatment and starting treatment with MAO
inhibitors or pethidine.
Warnings and precautions
Take special care with Rasagiline HCS:
• if you have mild to moderate liver problems
• You should speak with your doctor about any
suspicious skin changes.
Children and adolescents
Rasagiline HCS is not recommended for use under the
age of 18.
Other medicines and Rasagiline HCS
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 HCS:
• 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 HCS together with the
antidepressants containing fluoxetine or fluvoxamine
should be avoided.
If you are starting treatment with Rasagiline HCS, 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 HCS 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 HCS with food and drink and alcohol
Rasagiline HCS 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
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 HCS

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 HCS is 1 tablet of 1 mg
taken by mouth once daily. Rasagiline HCS may be taken
with or without food.
If you take more Rasagiline HCS than you should
If you think that you may have taken too many Rasagiline
HCS tablets, contact your doctor or pharmacist
immediately. Take the Rasagiline HCS carton with you to
show the doctor or pharmacist.
If you forget to take Rasagiline HCS
Do not take a double dose to make up for a forgotten
tablet. Take the next dose normally, when it is time to
take it.
If you stop taking Rasagiline HCS
Do not stop taking Rasagiline HCS without first talking to
your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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NA.RASAGILINE HCS TBL 1MG GB druga stran

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
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
• 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

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• 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.
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.
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 HCS

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 blister and box after EXP. The expiry date
refers to the last day of that month.
Do not store above 30°C.
Store in the original blister in order to protect from moisture.
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 HCS contains
• The active substance is rasagiline. Each tablet contains
1 mg rasagiline (as rasagiline hemitartrate).
• The other ingredients (excipients) are microcrystalline
cellulose (E460), pregelatinised maize starch (type
1500), colloidal anhydrous silica (E551), talc (E553b)
and stearic acid.
What Rasagiline HCS looks like and contents of the
pack
Tablets are white to almost white, round, slightly
biconvex, 7 mm in diameter, with beveled edges, darker
spots may be visible.
Rasagiline HCS is available in boxes containing:
• 14, 15, 28, 30 and 112 tablets in blisters,
• 14 x 1, 15 x 1, 28 x 1, 30 x 1 and 112 x 1 tablets in
perforated unit dose blisters,
• 14 x 1, 15 x 1, 28 x 1, 30 x 1 and 112 x 1 tablets in
perforated unit dose blisters with the names of days
(calendar packs).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
This leaflet was last revised in 08/2016
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4. Possible side effects

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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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