País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
agomelatine-citric acid, Quantity: 44.739 mg (Equivalent: agomelatine, Qty mg)
Southern Cross Pharma Pty Ltd
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; povidone; sodium stearylfumarate; mannitol; crospovidone; silicified microcrystalline cellulose; magnesium stearate; stearic acid; hypromellose; macrogol 6000; titanium dioxide; purified talc; iron oxide yellow
Oral
28 tablets
(S4) Prescription Only Medicine
Treatment of major depression in adults including prevention of relapse.
Visual Identification: yellow, oblong biconvex film coated tablet; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-06-26
AGOMELATINE SANDOZ 1 AGOMELATINE SANDOZ _Agomelatine-citric acid _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AGOMELATINE SANDOZ. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking AGOMELATINE SANDOZ against the benefits they expect it will 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 AGOMELATINE SANDOZ IS USED FOR AGOMELATINE SANDOZ is used to treat depression or to help prevent depression returning. 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. AGOMELATINE SANDOZ can help regulate your 'body clock' (circadian rhythm) with positive benefits on mood and sleep in depression. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is only available with a doctor's prescription. In clinical studies AGOMELATINE SANDOZ had no effect on sexual function. AGOMELATINE SANDOZ is not recommended for children, adolescents (under 18 years old) or elderly patients aged 75 or older. BEFORE YOU TAKE AGOMELATINE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE AGOMELATINE SANDOZ IF: • you suffer from liver disease or you know your liver does not work properly (hepatic impairment) • your routine blood tests show levels of liver enzymes have increased to more than 3 times the upper limit of normal • yo Llegiu el document complet
AUSTRALIAN PRODUCT INFORMATION AGOMELATINE SANDOZ, (AGOMELATINE-CITRIC ACID) _ _ 1. NAME OF THE MEDICINE Agomelatine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AGOMELATINE SANDOZ film-coated tablets contain 44.74 mg agomelatine-citric acid (equivalent to 25 mg agomelatine). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM AGOMELATINE SANDOZ 25 mg are yellow, oblong biconvex film coated tablet. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of major depression in adults including prevention of relapse. 4.2. DOSE AND METHOD OF ADMINISTRATION The recommended daily dose is one tablet taken orally at bedtime. After two weeks of treatment, if there is no improvement in symptoms, the dose may be increased to 50 mg once daily, taken as a single dose of two tablets at bedtime. The maximum recommended dose should not be exceeded. Dose escalation has been associated with an increased incidence of serum transaminase elevations. Dose increases to 50 mg should only occur following an assessment of the benefits and risk and assessment of liver function. Liver function tests should be performed in all patients before initiation of treatment and before a dose increase to 50 mg. Treatment with AGOMELATINE SANDOZ should not be initiated if serum transaminase levels are > 3 times the upper limit of normal range, see Section 4.3 CONTRAINDICATIONS and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. During treatment transaminases should be monitored periodically after around 3, 6 (end of acute phase), 12, and 24 (end of maintenance phase) weeks with regimen to be repeated following dose increase to 50 mg and thereafter when clinically indicated, see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. Treatment should be discontinued if serum transaminase levels are > 3 times the upper limit of the normal range, see Section 4.3 CONTRAINDICATIONS and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE. TREATMENT DURATION Patients with depression should be treated for a Llegiu el document complet