País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
duloxetine hydrochloride
Lupin Australia Pty Limited
Duloxetine hydrochloride
Registered
Duloxetine GH CMI v2 Sep2017 Page 1 of 6 CONSUMER MEDICINE INFORMATION DULOXETINE GH duloxetine hydrochloride What is in this leaflet This leaflet answers some common questions about Duloxetine GH. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. Always follow the instructions that your doctor and pharmacist give you about the medicine. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. The updated leaflet may contain important information about Duloxetine GH and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Duloxetine GH against the benefits they expect it will have for you. Always follow the instructions that your doctor and pharmacist give you about Duloxetine GH. If you have any concerns, or are unsure about taking this medicine, ask your doctor or pharmacist for more advice. Keep this leaflet with the medicine. Do not throw this leaflet away. You may need to read it again. What Duloxetine GH is used for Duloxetine GH is used to treat major depressive disorder (depression) and Generalised Anxiety Disorder (excessive worry). Duloxetine GH 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. Ask your doctor if you have any questions about why this medicine has been prescribed for you. This medicine is available only with a doctor's prescription. Duloxetine GH is not recommended for use in children and adolescents under the age of 18 years. Before you take Duloxetine GH When not to take it Do no Leia o documento completo
PRODUCT INFORMATION Duloxetine GH NAME OF THE MEDICINE Duloxetine (as hydrochloride) Duloxetine Hydrochloride is a selective serotonin and noradrenaline reuptake inhibitor (SNRI) for oral administration. It is chemically unrelated to tricyclics, alpha adrenergic receptor agonists or antimuscarinics. Its chemical designation is (+)-(_S_)-_N_-methyl-γ-(1-naphthalenyloxy)-2- thiophenepropanamine hydrochloride. Chemical Formula: C 18 H 19 NOS HCl Molecular Weight: 333.9 CAS No: 136434-34-9 Chemical Structure: DESCRIPTION _DULOXETINE HYDROCHLORIDE _ It is a white to cream coloured powder, which is sparingly soluble in water, freely soluble in methanol and practically insoluble in hexane. Duloxetine GH is a delayed release capsule for oral administration. Each capsule contains enteric- coated mini tablets of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine that are designed to prevent degradation of the drug in the acidic environment of the stomach. _ _ _ _ _ _ 2 DULOXETINE GH _Version 1, 4 June 2013_ _EXCIPIENTS _ Inactive ingredients include Lactose, Croscarmellose sodium, Pregelatinised maize starch, Polysorbate 80, Magnesium stearate, Hypromellose, Hypromellose phthalate, Purified talc, Triethyl citrate. The 30 mg capsule is a Size 3 hard gelatin capsule (ARTG No. 108081) with a dark blue cap and a white body and contains Indigo carmine CI73015, Gelatin, Titanium dioxide and Sodium lauryl sulfate. The 60 mg capsule is a Size 1 hard gelatin capsule (ARTG No. 108080) with a dark blue cap and a green body and contains Indigo carmine CI73015, Gelatin, Titanium dioxide, Iron oxide yellow CI77492 and Sodium lauryl sulfate. Both capsule shells are imprinted with TekPrint SW-9008 Black Ink, (ARTG No. 2328) and TekPrint SW-0012 White Ink (ARTG No. 13175). PHARMACOLOGY _PHARMACODYNAMIC PROPERTIES AND MECHANISM OF ACTION _ Duloxetine is a selective serotonin and noradrenaline reuptake inhibitor, and weakly inhibits dopamine uptake with no significant affinity for histaminergic, dopaminergic, cholinergi Leia o documento completo