Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
duloxetine hydrochloride
Apotex Pty Ltd
Duloxetine hydrochloride
Registered
TERRY WHITE CHEMISTS 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 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 Terry White Chemists 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 s Read the complete document
Product Information - Australia Terry White Chemists Duloxetine Enteric Capsules Page 1 TERRY WHITE CHEMISTS DULOXETINE ENTERIC CAPSULES NAME OF THE MEDICINE Duloxetine hydrochloride Chemical Name: (+)-(_S_)-N-methyl-γ-(1-naphthalenyloxy)-2-thiophenepropylamine 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. Each capsule contains enteric-coated pellets of duloxetine hydrochloride, equivalent to 30 mg or 60 mg duloxetine, that are designed to prevent degradation of the drug in the acidic environment of the stomach. In addition, each capsule contains Sugar Spheres (ARTG ID 2535), hypromellose, purified talc, purified water, sucrose, hypromellose phthalate, triethyl citrate, gelatin, titanium dioxide, brilliant blue FCF, iron oxide yellow (60 mg capsule only), Tekprint SB-4020 Green Ink (ARTG ID 2652; 30 mg capsule only) and TekPrint SW-0012 White Ink (ARTG ID 13175; 60 mg capsule only). PHARMACOLOGY PHARMACOLOGICAL ACTIONS Duloxetine is a selective serotonin and noradrenaline reuptake inhibitor, and weakly inhibits dopamine uptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors. Although the mechanism of the antidepressant action of duloxetine in humans is unknown, it is believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS. Duloxetine dose-dependently increased extracellular levels of serotonin and noradrenaline in selected brain areas of animals, and neurochemical and behavioural studies in animals indicate an enhancement of central serotonin and noradrenaline neurotransmission. Duloxetine undergoes extensive metabolism, but the major circulating metabolites have not been shown to contribute significantly to the pharmacologic activity of duloxetine. Duloxetine displayed analgesic activity in rodent models of persistent, in Read the complete document