Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Azilect (rasagiline). 21/06/ Azilect – EMEA/H/C/ – IA//G. List item. Azilect: EPAR – Product Information (PDF/ KB) of the marketing authorisation; Annex IIIA – Labelling; Annex IIIB – Package leaflet. PACKAGE LEAFLET: INFORMATION FOR THE USER. AZILECT 1 mg tablets. Rasagiline. Read all of this leaflet carefully before you start.
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If you need more information about your medical condition or your treatment, read the package leaflet also part of the EPAR or contact your doctor or pharmacist. Azilect is a medicine that contains the active substance rasagiline.
It is available as white, round tablets 1 mg. It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain. Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
The patients then lose their ability to control their movements reliably. In the first study, two different doses of Azilect taken alone were compared with placebo a dummy treatment in patients with early-stage disease. The studies lasted 26 and 18 weeks, respectively.
Azilect was more effective than placebo in all of the studies. In the study where Azilect was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0. This was compared with a rise of 4. A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.
The most common side effect with Azilect seen in more than 1 patient in 10 is headache. For the full list of all side effects reported with Azilect, see the package leaflet. Azilect should not be used in people who may be hypersensitive allergic to rasagiline or any of the other ingredients. It must also not be used with pethidine a painkiller.
There should be at least 14 days between stopping treatment with Azilect and starting treatment with another monoamine-oxidase inhibitor or with pethidine.
Azilect must not be used in patients who have severe problems with their liver. It is not recommended for patients with moderate liver problems. Patients with mild liver aziect should use Azilect with caution and should stop treatment if their liver problems get worse.
The Committee recommended that Azilect be given marketing authorisation. The marketing authorisation was renewed on 21 February More detail azilevt available in the summary of product characteristics. Azilect is indicated for the treatment of idiopathic Parkinson’s disease PD as monotherapy without levodopa or as adjunct therapy with levodopa in patients with end-of-dose fluctuations.
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Azilect | European Medicines Agency
Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Table of contents Overview Authorisation details Product information Assessment history. Expand all Collapse all.
Azilect can only be obtained with a prescription.
The standard dose of Azilect is one tablet once a day, taken with or without food. Product details Name Azilect. Swensweg 5 GA Haarlem Netherlands.
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International non-proprietary name INN or common name. Anatomical therapeutic chemical ATC code. Date of issue of marketing authorisation valid throughout the European Union.