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Azilect^®

Azilect^® is registered for use in the following countries

• 
  Austria
• 
  Belgium
• 
  Brazil
• 
  Canada
• 
  Croatia
• 
  Denmark
• 
  Estonia
• 
  Finland
• 
  Germany
• 
  Greece
• 
  Hungary
• 
  Iceland
• 
  Ireland
• 
  Israel
• 
  Italy
• 
  Lithuania
• 
  Luxembourg
• 
  Malta
• 
  Mexico
• 
  Netherlands
• 
  Norway
• 
  Poland
• 
  Romania
• 
  Slovakia
• 
  Slovenia
• 
  Spain
• 
  Sweden
• 
  Switzerland
• 
  Turkey
• 
  United Kingdom
• 
  USA

Availability - Formulation

Azilect^® 1 mg tablets

What Does It Contain?

• The active ingredient in Azilect^® is rasagiline mesilate. Other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.

Therapeutic Indication (Who Is It For?)

Azilect^® is a medicine for the treatment of Parkinson’s disease. It belongs to a class of treatments called monoamine oxidase Type B (MAOB) inhibitors.

Azilect^® works by blocking the breakdown of dopamine by the enzyme Monoamine Oxidase-B in the brain, keeping it ‘available’ for longer. Azilect^® can be taken early in Parkinson’s disease on its own (as ‘monotherapy’) to help boost dopamine still being produced by the brain, and/or later in the disease, to boost the effect of levodopa (as ‘adjunct therapy’).

Contra-indications (When Not To Use)

Most people can take Azilect^®, but you should be sure to tell your doctor if:

• you take antidepressants, unselective MAO inhibitors or the painkiller pethidine
• have liver problems, or
• if you are allergic to any of the ingredients of Azilect^®.

Special Warning & Precautions For Use

• Most people can take Azilect^®, but you should be sure to tell your doctor if you take antidepressants or the painkiller pethidine, have liver problems, could become pregnant, or if you are allergic to any of the ingredients of Azilect^®.
• Most medicines can be taken along with Azilect^®, but do tell any doctor or pharmacist that you are taking this treatment, as there are some medicines that need special consideration. You should tell your doctor about all medicines that you are currently taking, even those obtained without prescription such as cough suppressants, nasal and oral decongestants, and natural products such as St John's Wort etc..

How To Take Azilect^®

• Like all medicines, Azilect^® should be taken as instructed by your doctor. The dose is one tablet taken once a day with or without food.
• If you forget to take a dose, make sure you take the next one at the usual time. Do not take a double dose to cover the one you missed.
• Azilect^® should be taken for as long as your doctor believes it is necessary. Your doctor will monitor your progress on Azilect^® and assess how long you need to continue. Always report any concerns you may have about your treatment, as this will help your doctor to understand how you are getting on, and how to manage your treatment most effectively.

Interaction With Other Medicinal Products & Other Forms of Interaction

• Rasagiline should not be administered along with other MAO inhibitors as there may be a risk of non-selective MAO inhibition that may lead to hypertensive crises.
• The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided. With MAO inhibitors as well as with another selective MAO-B inhibitor there have been reports of drug interactions with the concomitant use of sympathomimetic medicinal products. Therefore, in view of the MAO inhibitory activity of rasagiline, concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medications, containing ephedrine or pseudoephedrine, is not recommended.
• There have been reports of drug interactions with the concomitant use of dextromethorphan and non-selective MAO inhibitors. Therefore, in view of the MAO inhibitory activity of rasagiline, the concomitant administration of rasagiline and dextromethorphan is not recommended.
• Serious adverse reactions have been reported with the concomitant use of selective serotonin reuptake inhibitors (SSRIs), tricyclic, tetracyclic antidepressants and MAO inhibitors as well as with another selective MAO-B inhibitor. Therefore, in view of the MAO inhibitory activity of rasagiline, antidepressants should be administered with caution and in close consultation with your physician.
• Tyramine/rasagiline interaction: there have been no reports of tyramine/rasagiline interaction in clinical studies conducted without tyramine restriction, indicating that rasagiline can be used safely without dietary tyramine restrictions. Tyramine is broken down by the enzyme MAO-A. If Azilect^® was not a selective inhibitor for the enzyme MAO-B and inhibited MAO-A as well, there would be a risk for hypertensive crisis. Administration should be carried out with caution (see above)

Pregnancy and Lactation

• No clinical data are available. Caution should be exercised when administered to a breast feeding mother.

Effects on Ability to Drive & Use Machines

No studies on Azilect^® and the effects on the ability to drive and use machines have been performed. However, Azilect^® is not known to cause drowsiness, so you should be able to continue driving, or operate machinery, as normal. However, if you do experience any problems in these areas you are advised to speak to your doctor.

Possible Undesirable Effects of Azilect^®

Although Azilect^® is generally well tolerated, as with all medicines there can be side effects. When people have taken Azilect^® on its own (without levodopa), the most commonly reported side effects have been headache, aching joints, indigestion, flu-like symptoms and depression.When taken with levodopa, the most common reports were of uncontrolled movements and accidental falls. These effects may be due to the increase in dopamine caused by Azilect^®, so always report such problems to your doctor. They may be able to tailor your other treatments to relieve the problem.

Overdose

• If you think that you, or anyone else, may have taken too many Azilect^® tablets, contact your doctor or pharmacist immediately. If follow-up action is required, take the Azilect^® carton with you to show the doctor or pharmacist.

Pharmacological Properties of Azilect^®

Azilect^® is a potent, irreversible MAO-B selective inhibitor. Azilect^® blocks the breakdown of dopamine in the brain and hence increases the levels of dopamine available. Azilect^®, when used in combination with levodopa treatment increases the availability of dopamine by preventing the levodopa-derived dopamine from being broken down.

Pharmaceutical Particulars of Azilect^®

Shelf Life

• Azilect^® should not be used after the expiry date on the carton.

Special precautions for storage

• Azilect^® should be stored in its original package and not above 25°C. This is best achieved in a cupboard to avoid the pack getting hot in direct sunlight.
• Always keep Azilect^® out of reach and sight of children.

Product Information Downloads

Patient Information

Azilect 1mg Patient Information Leaflet (UK & Ireland) (21 February 2005)

Azilect^® patient Brochure (June 2005)

Useful Links & References

• www.azilect.com (aimed a tHealthcare Professionals)
• www.tevaneuro.com
• www.lundbeck.com

Further Information

Teva Pharmaceuticals Ltd
The Gate House
Gatehouse Way
Aylesbury
Bucks
HP19 8DB
UK

Telephone:  +44 (0)1296 719 768
Facsimile:  +44 (0)1296 719 769
Medical Information e-mail: Med.info@tevapharma.co.uk

Marketing Authorisation Holder

Teva Pharma GmbH
Kandelstr 10
D-79199 Kirchzarten
Germany