Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
Agomelatine
Servier Laboratories (Australia) Pty Ltd
Medicine Registered
VALDOXAN ® 25MG _Agomelatine (pronounced a-go-mel-a-tin)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VALDOXAN. It does not contain all the available information. You can obtain more information about VALDOXAN by talking to your doctor or pharmacist. All medications have risks and benefits. Your doctor has weighed the risks of you taking VALDOXAN against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT VALDOXAN IS USED FOR VALDOXAN is used in the treatment of depression or to help prevent depression returning, and is only available with a doctor's prescription. The symptoms of depression vary from one person to another, but commonly include persistent sadness, loss of interest in favourite activities, feelings of worthlessness, sleep problems, feeling of being slowed down, feelings of anxiety or changes in appetite and weight. Changes in your daily sleep and appetite patterns are examples of disturbances of your 'body clock' that occur commonly in depression. VALDOXAN can help regulate your 'body clock' (circadian rhythm) with positive benefits on mood and sleep in depression. VALDOXAN is not addictive. VALDOXAN is not recommended for children or adolescents (under 18 years old). Your doctor may prescribe VALDOXAN for another purpose. Ask your doctor if you have any questions about why VALDOXAN has been prescribed for you. BEFORE YOU TAKE VALDOXAN There are some people who shouldn't take VALDOXAN. Please read the list below. If you think any of these situations apply to you or you have any questions, please see your doctor. _WHEN YOU MUST NOT TAKE_ _VALDOXAN_ DO NOT TAKE VALDOXAN IF: • YOU SUFFER FROM LIVER DISEASE OR YOU KNOW YOUR LIVER DOES NOT WORK PROPERLY (HEPATIC IMPAIRMENT). • YOU ARE CURRENTLY TAKING FLUVOXAMINE (A DRUG USED IN THE TREATMENT OF DEPRESSION) OR CIPR Olvassa el a teljes dokumentumot
VALDOXAN _®_ – PRODUCT INFORMATION 1 (16) Version 13a _VALDOXAN_ _®_ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE _VALDOXAN _ Agomelatine 25mg DESCRIPTION The active component of VALDOXAN is agomelatine which has the chemical name: N-[2-(7- methoxy-1-naphthyl)ethyl] acetamide. Agomelatine is practically insoluble in purified water (<0.1 mg/mL) but freely soluble (>100 mg/mL) in various organic solvents (96% ethanol, methanol, methylene chloride). Agomelatine has no asymmetric carbon atom. CAS Registry Number_: _ _138112-76-2_ _ _ _ _ _Molecular formula_: C 15 H 17 NO 2 (MW = 243.3). _Chemical structure_: _Excipients:_ Lactose, starch - maize, povidone, sodium starch glycollate, stearic acid, magnesium stearate, silica - colloidal anhydrous, hypromellose, iron oxide yellow (CI77492), glycerol, macrogol 6000, and titanium dioxide (CI77891), shellac, indigo carmine (CI73015), propylene glycol. PHARMACOLOGY PHARMACODYNAMICS Pharmacotherapeutic group: Other antidepressants (ATC-code: NO6AX22) VALDOXAN (agomelatine) is a melatonin receptor (MT 1 and MT 2 ) agonist and 5-HT 2C receptor antagonist. VALDOXAN (agomelatine) has shown an antidepressant-like effect in animal models of depression (learned helplessness test, despair test, chronic mild stress), in models with circadian rhythm desynchronisation and in models related to stress and anxiety. In vitro studies indicate that VALDOXAN (agomelatine) has no effect on monoamine uptake and no affinity for or adrenergic, histaminergic, cholinergic, dopaminergic, or benzodiazepine recept Olvassa el a teljes dokumentumot