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RASAGILINE DR. REDDYS 1MG TABLETS

Active substance(s): RASAGILINE HEMITARTRATE

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Package Leaflet: Information for the User
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).
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 talk to your doctor about any suspicious skin
changes.

Children and adolescents

Ask your doctor for advice before taking any of the
following medicines together with Rasagiline:
 certain antidepressants (selective serotonin
reuptake inhibitors, selective serotoninnorepinephrine 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.
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
Rasagiline may be taken with or without food.

Pregnancy and breast-feeding
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.

Rasagiline is not recommended for use under the age of
18.

The recommended dose is 1 tablet of 1 mg taken by
mouth once daily. Rasagiline may be taken with or
without food.

Other medicines and Rasagiline

If you take more Rasagiline than you should

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without prescription or if
you are smoking or intend to stop smoking.

If you think that you may have taken too many
Rasagiline tablets, contact your doctor or pharmacist
immediately. Take the Rasagiline carton/blister 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 the
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:
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/lightheadedness (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 (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 the 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 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 and blister after EXP. The expiry
date refers to the last day of that month.
This medicine does not require any special storage
conditions.
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 tablets contain



The active substance is rasagiline. Each tablet
contains 1 mg rasagiline (as hemitartrate).
The other ingredients are microcrystalline cellulose,
pregelatinised starch (from maize starch), maize
starch, talc and stearic acid.

What Rasagiline tablets look like and contents
of the pack
The tablets are white to off-white, round, flat, bevel
edged, 8 mm in diameter, debossed with ‘R’ on one side
and ‘1’ on the other side.
Rasagiline tablets are available in pack sizes of 28, 30,
60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 07/2015

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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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