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.
|Published (Last):||7 June 2010|
|PDF File Size:||16.78 Mb|
|ePub File Size:||8.92 Mb|
|Price:||Free* [*Free Regsitration Required]|
It is not recommended for patients with moderate liver problems.
Advise patients to avoid certain food e. Rarely, rasagiline may cause people to have impulsive thoughts or cravings which are difficult ijsert resist. If a doss is missed, the patient should not double the dose.
It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain. Headache Ask your pharmacist or doctor to recommend a suitable painkiller Uncontrolled movements Let your doctor know about this Common rasagiline side-effects – these affect less than 1 in 10 people who take this medicine What can I do if I experience this?
Expand all Collapse all. Do not drive and do not use tools or machines until the dizziness has passed. Thanks for your feedback.
Azilect | European Medicines Agency
Glucuronide conjugation of rasagiline and its metabolites, with subsequent urinary excretion, is the major elimination pathway. The studies lasted 26 and 18 weeks, respectively. Azilect should not be used in people who may be hypersensitive allergic to rasagiline or any of the other ingredients. When a dose of levodopa starts to wear off, the symptoms of Parkinson’s disease can return.
The next dose should be taken at the usual time on the following day. In subjects with moderate hepatic impairment Child-Pugh scoreAUC and Cmax were increased by 7 packagge and 2 fold, respectively, compared to healthy subjects. We will not share your email or personal information. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
Pregnancy Category C Labor and Delivery: Because 1-AI is not an MAO inhibitor, no dose adjustment is needed for patients with mild and moderate renal impairment. Thank you, we just sent a survey email to confirm your preferences. Azilect can only be obtained with a prescription. Very common rasagiline side-effects – these affect more than 1 in 10 people who take this medicine. Initial marketing-authorisation documents List item.
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. It is available as white, round tablets 1 mg. It is also used alongside other treatments which contain a medicine called levodopa. Azilect is a medicine that contains the active substance rasagiline. It must also not be used with pethidine a painkiller.
Advise patients to exercise caution when they are taking other sedating medications, alcohol, or other CNS depressants e. In the first study, two different doses of Azilect taken alone were compared with placebo a dummy treatment in patients with early-stage disease. As your condition improves and your body movements become easier, be careful not to overdo physical activities. International non-proprietary name INN or common name. Why not subscribe to the newsletter?
Rasagiline is rapidly absorbed, reaching peak plasma concentration Cmax in approximately 1 hour. In vitro metabolism studies showed that CYP1A2 was the major enzyme responsible for the metabolism of rasagiline. Azilect must not be used in patients who have severe problems with their liver. Studies in healthy subjects and in Parkinson’s disease patients have shown that rasagiline inhibits platelet MAO-B irreversibly.
It is not known whether this drug is excreted in human milk. Advise patients taking rasagiline as adjunct to levodopa that there is a possibility of dyskinesia or increased dyskinesia. Effect of rasagiline on Other Drugs: Mild impairment, Child-Pugh Class Contact their healthcare provider if elevation of blood pressure occurs. Advise patients that they may experience intense urges to gamble, increased sexual urges, other intense urges, and the inability to control these urges during treatment.
Feeling or being sick, indigestion, tummy abdominal pain, wind Eat simple meals – avoid rich or spicy foods Feeling dizzy when you stand up Try getting up more slowly. How useful was this page? Do not drive and do not use tools or machines until the dizziness has passed Muscle weakness, balance problems, falls If this becomes troublesome, let your doctor know Constipation Eat a well-balanced diet and drink plenty of water each day Dry mouth Try chewing sugar-free gum or sucking sugar-free sweets Chest pains, skin problems Let your doctor know about this ineert Flu-like symptoms, feeling unwell, aches and pains, loss of appetite, feeling depressed, increased urgency to pass urine, conjunctivitis, unusual dreams and thoughts Let your doctor know if any of these become troublesome.
No additional in vivo trials have investigated the effect of rasagiline ailect other drugs metabolized by the cytochrome P enzyme system.
Never give it to other people even if their condition appears to be the paackage as yours. Treatment should be symptomatic and ineert. The mean volume of distribution at steady-state is 87 L, indicating that the tissue binding of rasagiline is in excess of plasma protein binding.
Data are not available for patients aziilect severe renal impairment. A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms. Did you find this information useful? Assess your symptoms online with our free symptom checker. If you have any questions about this medicine ask your pharmacist. In vitro experiments indicate that both routes of rasagiline metabolism are dependent on the cytochrome P CYP system, with CYP1A2 being the major isoenzyme involved in rasagiline metabolism.