Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
Duloxetine hydrochloride
Apotex Pty Ltd
Medicine Registered
CHEMMART DULOXETINE _Contains the active ingredient duloxetine (as duloxetine hydrochloride)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about duloxetine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Chemmart Duloxetine. It contains the active ingredient duloxetine hydrochloride. It is used to treat: • major depressive disorder (MDD) • generalised anxiety disorder (GAD) - excessive worry. 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. _HOW IT WORKS_ 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. _USE IN CHILDREN_ This medicine should not be used in children and adolescents under the age of 1 Lestu allt skjalið
Product Information – Australia Chemmart Duloxetine Enteric Capsules Page 1 CHEMMART DULOXETINE ENTERIC CAPSULES NAME OF THE MEDICINE Duloxetine hydrochloride Chemical Name: (+)-(S)-N-methyl- γ-(1-naphthalenyloxy)-2thiophenepropylamine hydrochloride Structural Formula: Molecular Formula: C 18 H 19 NOS•HCl Molecular Weight: 333.88 CAS Registry Number: 136434-34-9 DESCRIPTION Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Duloxetine is available as capsules for oral administration. Each capsule contains enteric-coated pellets of duloxetine hydrochloride equivalent to 30mg or 60mg of duloxetine that are designed to prevent degradation of the drug in the acidic environment of the stomach. In addition each capsule fill contains the following inactive ingredients: methylcellulose, poloxamer, hypromellose, purified talc, polyvinyl acetate phthalate and dibutyl sebacate. In addition, each capsule shell contains the following inactive ingredients: gelatin, purified water, titanium dioxide, indigo carmine, iron oxide yellow (60mg capsules only) and proprietary ink ((TekPrint SB- 4028 Green Ink (ARTG#107268) for 30mg capsules), (TekPrint SB-0007P White Ink (ARTG#2216) for 60mg capsules)). 30MG Hard gelatin capsules with a white opaque body and blue opaque cap. Imprinted “APO D30” in green ink. Filled with white to off-white granules. 60MG Hard gelatin capsules with a green opaque body and blue opaque cap. Imprinted “APO D60” in white ink. Filled with white to off-white granules. PHARMACOLOGY PHARMACOLOGICAL ACTIONS Duloxetine is a selective se Lestu allt skjalið