Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
duloxetine hydrochloride, Quantity: 33.65 mg
Arrotex Pharmaceuticals Pty Ltd
Duloxetine hydrochloride
Capsule, enteric
Excipient Ingredients: hypromellose phthalate; triethyl citrate; brilliant blue FCF; purified talc; hypromellose; Gelatin; titanium dioxide; sucrose; maize starch; propylene glycol; ethanol; indigo carmine; butan-1-ol; isopropyl alcohol; iron oxide yellow; Shellac; strong ammonia solution
Oral
28 capsules
(S4) Prescription Only Medicine
Duloxetine capsules are indicated for the treatment of major depressive disorder (MDD). Treatment of Generalised Anxiety Disorder (GAD).
Visual Identification: Opaque blue/white hard gelatin capsule '157' on body and 'A' on cap with green ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2014-02-20
APO- DULOXETINE 1 APO- DULOXETINE _Contains the active ingredient duloxetine (as duloxetine hydrochloride) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine 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 THIS MEDICINE IS USED FOR Duloxetine is used to treat: • major depressive disorder (MDD) • generalised anxiety disorder (GAD) - excessive worry Duloxetine belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). SNRIs are believed to work by their action on serotonin and noradrenaline in the brain. Serotonin and noradrenaline are the chemical messengers responsible for controlling the psychological and painful symptoms of depression. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine should not be used in children and adolescents under the age of 18 years. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing duloxetine • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD LIVER DISEASE. DO NOT TAKE THIS MEDICINE IF YOU ARE TA Pročitajte cijeli dokument
1 AUSTRALIAN PRODUCT INFORMATION APO- DULOXETINE (DULOXETINE HYDROCHLORIDE) ENTERIC CAPSULES 1 NAME OF THE MEDICINE Duloxetine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg or 60 mg duloxetine (as hydrochloride) as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Sucrose. APO- Duloxetine capsules also contain traces of sulphites and phenylalanine. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Each capsule contains enteric-coated pellets of duloxetine hydrochloride that are designed to prevent degradation of the drug in the acidic environment of the stomach. 30 MG CAPSULES – Hard gelatin capsules with a white opaque body and blue opaque cap. Imprinted “157” on the body and “A” on the cap in green ink. Filled with white to off-white granules. 60 MG CAPSULES – Hard gelatin capsules with a green opaque body and blue opaque cap. Imprinted “158” on the body and “A” on the cap in white ink. Filled with white to off-white granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of major depressive disorder (MDD). • Treatment of generalised anxiety disorder (GAD). 4.2 DOSE AND METHOD OF ADMINISTRATION APO- Duloxetine capsules are intended for oral administration. DOSAGE MAJOR DEPRESSIVE DISORDER Duloxetine should be administered for the treatment of major depressive disorder at a dose of 60 mg once daily, with or without food. There is no adequate evidence suggesting that patients not responding to 60 mg once daily will benefit from having their dose increased. GENERALISED ANXIETY DISORDER The recommended starting dose of duloxetine in patients with generalized anxiety disorder is 30 mg once daily with or without food. The daily dose should be increased in 30 mg increments until the minimum effective dose is achieved. The maximum dose is 120 mg per day, given as 120 mg once daily. Doses above 120 mg have not been systematically evaluated. 2 INITIAL TOLERABILITY For patients in whom initial tolerabi Pročitajte cijeli dokument