Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
duloxetine hydrochloride, Quantity: 67.3 mg
Alembic Pharmaceuticals Australia Pty Ltd
Duloxetine hydrochloride
Capsule, enteric
Excipient Ingredients: titanium dioxide; Gelatin; hypromellose; purified talc; hypromellose phthalate; triethyl citrate; indigo carmine; sucrose; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide; maize starch
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/opaque green hard gelatin capsule '158' on body and 'A' on cap with white ink; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-06-14
Duloxetine Sandoz ® 1 _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DULOXETINE SANDOZ. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking DULOXETINE 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 your medicine. You may need to read it again. WHAT DULOXETINE SANDOZ IS USED FOR DULOXETINE SANDOZ 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 physical symptoms of depression. DULOXETINE SANDOZ is used to treat: major depressive disorder (depression) generalized Anxiety Disorder (excessive worry) ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DULOXETINE SANDOZ HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed DULOXETINE SANDOZ for another reason. DULOXETINE SANDOZ is available only with a doctor's prescription. DULOXETINE SANDOZ is not recommended for use in children and adolescents under the age of 18 years. BEFORE YOU TAKE DULOXETINE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DULOXETINE SANDOZ IF YOU ARE ALLERGIC TO ANY MEDICINES CONTAINING DULOXETINE HYDROCHLORIDE OR 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 DULOXETINE SANDOZ IF YOU HAVE LIVER DISEASE. This could increase the chance of you having liver problems during treatment with DULOXETINE SANDOZ. DO NOT TAKE THIS M Pročitajte cijeli dokument
210721 Duloxetine Sandoz-pi Page 1 of 26 AUSTRALIAN PRODUCT INFORMATION DULOXETINE SANDOZ ® ENTERIC CAPSULES (DULOXETINE HYDROCHLORIDE) 1. NAME OF THE MEDICINE Duloxetine (present as the hydrochloride). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DULOXETINE SANDOZ enteric capsules come in two strengths and contain enteric-coated pellets of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine. Excipient with known effect: sucrose For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM DULOXETINE SANDOZ 30 mg enteric capsule - Opaque blue/white hard gelatin capsule ‘157’ on body and ‘A’ on cap with green ink. DULOXETINE SANDOZ 60 mg _ _ enteric capsule - Opaque blue/opaque green hard gelatin capsule ‘158’ on body and ‘A’ on cap with white ink. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS DULOXETINE SANDOZ is indicated for the treatment of: • major depressive disorder (MDD) • generalised anxiety disorder (GAD) 4.2. D OSE AND METHOD OF ADMINISTRATION _MAJOR DEPRESSIVE DISORDER _ DULOXETINE SANDOZ 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. 210721 Duloxetine Sandoz-pi Page 2 of 26 _INITIAL TOLERABILITY _ For patients in whom initial tolerability may be a concern, such as treatment-naïve patients or those with a history of adverse events with other medications, use of a lower starting dose such as 30 mg once daily for one week before increasing t Pročitajte cijeli dokument