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RASAGILINE BRISTOL 1 MG TABLETS

Active substance(s): RASAGILINE HEMITARTRATE

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Package leaflet: Information for the patient

Rasagiline 1 mg tablets
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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what it is used for
This medicine contains active ingredient called Rasagiline, which 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. This medicine helps
to increase and sustain levels of dopamine in the brain.

2. What you need to know before you take this medicine
Do not take this medicine:
• 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 this medicine:
• 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 treatment with this medicine and starting
treatment with MAO inhibitors or pethidine.
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Warnings and precautions
Talk to your doctor, or pharmacist before taking this medicine:
• if you have mild to moderate liver problems
You should speak with your doctor about any suspicious skin changes.
Children and adolescents
This medicine is not recommended for use in Children and adolescents under the age of 18.
Taking other medicines
Tell your doctor or pharmacist if you are taking or 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:
• 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 this medicine together with the antidepressants containing fluoxetine or
fluvoxamine should be avoided.
If you are starting treatment with this medicine, 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 treatment with this medicine.
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 this medicine 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 this medicine with food and drink
This medicine 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 this medicine
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 recommended dose is one tablet of one mg taken by mouth once daily.
• Swallow the tablet whole with a drink of water.
• This medicine may be taken with or without food.
If you take more of this medicine than you should
If you take more of this medicine than you should, talk to a doctor straight away. Take this
medicine with you to show to doctor or pharmacist.
If you forget to take this medicine
If you forget to take a dose, just take your next dose as normal.
Do not take a double dose to make up for a forgotten dose.
If you stop taking this medicine
Do not stop taking your tablets unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Very common (may affect more than 1 in 10 people)
• abnormal movements (dyskinesia)
• headache

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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:

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Common (may affect up to 1 to 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)

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
YellowCard 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 this medicine
• Keep this medicine out of the sight and reach of children.
• For blisters: This medicinal product does not require any special temperature storage
conditions. Store in the original package in order to protect from light.
For bottles: Do not store above 30ºC. Store in the original package in order to protect
from light.
• Do not use this medicine after the expiry date which is stated on the label after EXP.
The expiry date refers to the last day of that month. 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 this medicine contains
• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as hemitartrate).
• The other ingredients are microcrystalline cellulose, pregelatinised maize starch,
colloidal anhydrous silica, magnesium stearate.
What this medicine looks like and contents of the pack
• These tablets are white to off white round, flat with bevelled edges and debossed “1” on
one side.
• This medicine is available in blister packs of 7, 10, 28, 30, 100 or 112 tablets and bottle
packs of 30 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax :
0044 (0)1442 873717
info@bristol-labs.co.uk
E-mail:
Rasagiline 1 mg tablets: PL 17907/0538
This leaflet was last revised in April 2016.

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To request a copy of this leaflet in Braille, large print or audio format, please contact the
licence holder at the address (or telephone, fax, email) above.

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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.

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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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