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Active substance(s): RASAGILINE TARTRATE

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Package leaflet: Information for the user
Rasagiline 1mg Tablets
Rasagiline tartrate

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.
The full name of this medicine is Rasagiline 1mg Tablets but within the leaflet it will be
referred to as Rasagiline Tablets.
What is in this leaflet
What Rasagiline Tablets are and what they are used for
What you need to know before you take Rasagiline Tablets
How to take Rasagiline Tablets
Possible side effects
How to store Rasagiline Tablets
Contents of the pack and other information


What Rasagiline Tablets are and what they are used for

Rasagiline Tablets contains the active substance rasagiline and it is used for the treatment of
Parkinson’s disease in adults.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 Tablets helps to increase and sustain
levels of dopamine in the brain.


What you need to know before you take Rasagiline Tablets

Do not take Rasagiline Tablets
If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section
If you have severe liver problems.
Do not take the following medicines while taking Rasagiline Tablets:
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 Tablets treatment and starting treatment with
MAO inhibitors or pethidine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rasagiline Tablets

- If you have any liver problems.
- If you have previously experienced somnolence and/or have fallen asleep without warning.
You should speak with your doctor about any suspicious skin changes.
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 Tablets
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 (see section 4).
Rasagiline Tablets may cause drowsiness and may cause you to suddenly fall asleep during day time
activities, especially if you are taking other dopaminergic medicinal products (used for the treatment
of Parkinson’s disease).
Children and adolescents
Rasagiline Tablets are not recommended for use under the age of 18.
Other medicines and Rasagiline Tablets
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. Smoking could decrease the amount of Rasagiline Tablets in the blood.
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 Tablets together with the antidepressants containing fluoxetine or fluvoxamine
should be avoided.
If you are starting treatment with Rasagiline Tablets, 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 Tablets treatment.

Pregnancy, breast-feeding and ferility
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.
You should avoid taking Rasagiline Tablets if you are pregnant, as the effects of Rasagiline Tablets
on pregnancy and the unborn child are not known.

Driving and using machines
Ask your doctor for advice prior to driving or using machines. Parkinson’s disease itself as well as the
treatment with Rasagiline Tablets may influence your ability to drive and operate machines.
Rasagiline Tablets may make you feel dizzy or drowsy and cause episodes of sudden sleep onset.If
you are experiencing somnolence or new episodes of falling asleep without warning during daily
activities, you should not drive or operate machinery.


How to take Rasagiline Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
The recommended dose of Rasagiline Tablets is 1 tablet of 1mg taken by mouth once daily.
Rasagiline Tablets may be taken with or without food.

If you take more Rasagiline Tablets than you should
If you think that you may have taken too many Rasagiline Tablets, contact your doctor or pharmacist
immediately. Take the Rasagiline Tablets carton with you to show the doctor or pharmacist.
Symptoms of overdosing could include: unease, behaviour where patients are unable to resist the
impulse, drive or temptation to perform an action that could be harmful to themselves or others, a
sudden and severe rise in blood pressure, serotonin syndrome including the following: feeling
confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds),
sudden jerks of the muscles or a fast heartbeat.
If you forget to take Rasagiline Tablets
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 Tablets
Do not stop taking Rasagiline Tablets without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact you doctor right away if you notice any of the following symptoms. You may need urgent
medical advice or treatment:
- If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling,
excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase
in sexual thoughts (impulse control disorders) (see section 2).
- If you see or hear things which are not there (hallucinations).
- Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome)
- If you notice any suspicious skin changes because there is a higher risk of skin cancer (not
exclusively melanoma) in patients with Parkinson’s disease (see section 2).
Other side effects
Very common (may affect more than 1 in 10 people)
Involuntary movements (dyskinesia)
Common (may affect up to 1 in 10 people)
Abdominal pain
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
Dry mouth
Nausea and vomiting
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)
Dizziness (vertigo)
Prolonged muscle contractions (dystonia)
Runny nose (rhinitis)
Irritation of the skin (dermatitis)
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).
Not known (frequency cannot be estimated from the available data)
Elevated blood pressure
Excessive drowsiness
Sudden onset of sleep

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website: or search for MHRA Yellow Card in the Google Play or
Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.


How to store Rasagiline Tablets

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 or blister after EXP. The
expiry date refers to the last day of that month.
Store in the original package in order to protect from light.


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.


Contents of the pack and other information

What Rasagiline Tablets contain
The active substance is rasagiline. Each tablet contains 1mg rasagiline (as tartrate).
The other ingredients are: Calcium sulfate dehydrate, Pregelatinised starch (maize), Maize
starch, Stearic acid Talc, Citric acid anhydrous, Silica colloidal anhydrous.
What Rasagiline Tablets look like and contents of the pack
White, round bevel edge, 7mm, debossed with “A486” on one side and plain on the other side.
The tablets are available in blister packs of 28 tablets.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
United Kingdom
Actavis ehf.
Reykjavikurvegur 78

This leaflet was last revised in March 2018

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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.