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RASAGILINE TEVA 1 MG TABLETS

Active substance(s): RASAGILINE MESYLATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE 1 mg TABLETS
Read all of this leaflet carefully before you start taking this medicine.
 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. Do not pass it on to others. It may harm them, even if their
symptoms 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.
IN THIS LEAFLET:
1. What Rasagiline is and what it is used for
2. Before you take Rasagiline
3. How to take Rasagiline
4. Possible side effects
5. How to store Rasagiline
6. Further 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.

BEFORE YOU TAKE RASAGILINE

Do not take Rasagiline if you:
 are allergic (hypersensitive) to rasagiline or any of the other ingredients of Rasagiline
 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.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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.
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.
Taking Rasagiline with food and drink
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 Rasagiline exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose of Rasagiline 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/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 product, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Rasagiline 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)
 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 at
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 Rasagiline after the expiry date which is stated on the carton, bottle or blister after
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Rasagiline contains
 The active substance is rasagiline (as mesilate). Each tablet contains rasagiline mesilate equivalent to 1
mg rasagiline.
 The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize
starch, stearic acid, talc.
What Rasagiline looks like and contents of the pack
Rasagiline tablets are presented as white to off-white, round, flat, bevelled tablets of 8 mm diameter,
debossed with “GIL” and “1” underneath on one side and plain on the other side.
The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 30
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer:
TEVA Pharmaceuticals Europe B.V. , Swensweg 5, 2031 GA Haarlem, Netherlands
This leaflet was last revised in 11/2015
PL 00289/2006

* Only the actual site of batch release will appear on the printed version of the leaflet

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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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