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RASAGILINE ZYDUS 1 MG TABLETS

Active substance(s): RASAGILINE BESYLATE

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CONFIDENTIAL
Module 1.3.1.4

Package Leaflet – Procedure version

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 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.
2.
3.
4.
5.
6.

1.

What Rasagiline is and what it is used for
What you need to know before you take Rasagiline
How to take Rasagiline
Possible side effects
How to store Rasagiline
Contents of the pack and other information

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 (for example for treatment of depression or Parkinson’s
disease, or used for any other indication), including medicinal and natural products without
prescription (for example 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.

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CONFIDENTIAL
Module 1.3.1.4

Package Leaflet – Procedure version

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 use 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.
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 has told you. Check with your doctor or pharmacist if
you are not sure.
The usual dose of Rasagiline is 1 tablet of 1 mg once daily.
Oral use.
Rasagiline may be taken with or without food.
If you take more Rasagiline than you should

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CONFIDENTIAL
Module 1.3.1.4

Package Leaflet – Procedure version

If you think that you may have taken too many Rasagiline tablets, contact your doctor or pharmacist
immediately. Take the Rasagiline carton/bottle 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:
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;
dizziness (vertigo);
prolonged muscle contractions (dystonia);
runny nose (rhinitis);
irritation of the skin (dermatitis);

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Module 1.3.1.4
-

Package Leaflet – Procedure version

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. 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

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, bottle or blister. 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 . Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

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CONFIDENTIAL
Module 1.3.1.4

6.

Package Leaflet – Procedure version

Contents of the pack and other information

What Rasagiline contains
The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as rasagiline besylate).
-

The other ingredients are calcium hydrogen phosphate (anhydrous), pregelatinised starch (maize
starch), cellulose microcrystalline, silica colloidal anhydrous, stearic acid 95.

What Rasagiline looks like and contents of the pack
Rasagiline tablets are white or greyish-white, round, flat tablets with an approximate diameter of 8.0 mm,
plain on both sides.
The tablets are available in blisters of 7, 10, 28, 30, 100 and 112 tablets or in bottles with or without childresistant cap containing 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zydus France
Zac Des Hautes Patures
25, rue des Peupliers
92000 Nanterre
France
Telephone: 01 41 19 18 50
Fax: 01 46 49 30 72
E-Mail: francoise.goulley-mothe@zydusfrance.com

Manufacturer
Centre Specialites Pharmaceutiques
76-78 avenue du Midi
63800 COURNON D’AUVERGNE
France
Telephone: 04 73 69 98 93
Fax: 04 73 69 89 93
E-Mail: pguittard@csp-epl.com
Idifarma Desarrollo Farmaceutico, S.L.
Poligono Mocholi, C/Noain, Nº 1, Noain
31110, Navarra
Spain
Telephone: +34 948 214 023
Fax: + 34 948 312 359
E-Mail: info@idifarma.com

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CONFIDENTIAL
Module 1.3.1.4

Package Leaflet – Procedure version

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria

Rasagilin Zydus 1 mg Tabletten

Belgium

Rasagilin Zydus 1 mg Tabletten

France

Rasagiline Zydus 1 mg, comprimé

Greece

Rasagiline Zydus 1 mg Tablets

Germany

Rasagilin Zydus 1 mg Tabletten

Italy

Rasagilina Zydus

Romania

Rasagilină Zydus 1 mg comprimate

Spain

Rasagilin Zydus 1 mg Tabletten

Slovak Republic

Rasagiline Zydus 1 mg Tablets

United Kingdom

Rasagiline Zydus 1 mg Tablets

This leaflet was last revised in February2016

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Mod. 1.3.1.4, Page 6

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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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