Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
Venlafaxine hydrochloride
Sun Pharma ANZ Pty Ltd
Venlafaxine hydrochloride
VENLA RBX CMI V5 Aug 2013 Page 1 of 13 VENLA RBX VENLAFAXINE MODIFIED RELEASE CAPSULES CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VENLA RBX (venlafaxine hydrochloride) modified release capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking VENLA RBX against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT VENLA RBX IS USED FOR VENLA RBX contains the active ingredient venlafaxine (as hydrochloride). VENLA RBX is used for the treatment and prevention of relapse of depression, and for the treatment of panic attacks and anxiety, including avoidance or fear of social situations. Depression can affect your whole body and may cause emotional and physical symptoms such as feeling low in spirit, being unable to enjoy life, poor appetite or overeating, disturbed sleep, loss of sex drive, lack of energy and feeling guilty over nothing. Excessive anxiety is a condition in which you feel constantly and uncontrollably worried and distressed. It may also make you feel irritable, and cause difficulty in thinking and sleeping. Other common symptoms associated with anxiety may include a dry mouth, a lump in the throat, cold clammy hands, diarrhoea and nausea. VENLA RBX CMI V5 Aug 2013 Page 2 of 13 Depression and anxiety are treatable illnesses. Anxiety or tension associated with the normal stress of everyday life usually does not require treatment with medicines. V Läs hela dokumentet
VENLA RBX PI V6 Page 1 of 28 VENLA RBX VENLAFAXINE MODIFIED RELEASE CAPSULES NAME OF THE MEDICINE Venlafaxine hydrochloride Structural formula: Molecular formula: C 17 H 27 NO 2 HCl_ _ Molecular weight: 313.87 Chemical structure: (_R/S_)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride CAS Number: 93413 – 69 -5 (venlafaxine) 99300-78-4 (venlafaxine hydrochloride) DESCRIPTION VENLA RBX modified release capsules are a structurally novel antidepressant for oral administration. Each capsule of VENLA RBX contains 37.5 mg, 75 mg or 150 mg of venlafaxine (as hydrochloride). VENLA RBX modified release capsules contain the following inactive ingredients: microcrystalline cellulose, povidone, purified talc, colloidal anhydrous silica, magnesium stearate, ethylcellulose, copovidone, gelatin and titanium dioxide. In addition to these, the 37.5 mg capsules also contain iron oxide black, iron oxide red, iron oxide yellow and TekPrint SB-1033 Red Ink (proprietary ingredient # 106948), the 75 mg capsules also contain iron oxide black, iron oxide red and TekPrint SB-1033 Red Ink (proprietary ingredient # 106948), and the 150 mg capsules also contain Brilliant Blue FCF, Allura Red AC, Sunset Yellow FCF and TekPrint SB-0007P White Ink (proprietary ingredient # 2216). PHARMACOLOGY VENLA RBX PI V6 Page 2 of 28 PHARMACODYNAMIC PROPERTIES Venlafaxine is a structurally novel antidepressant for oral administration; it is chemically unrelated to tricyclic, tetracyclic, or other available antidepressant agents. The antidepressant action of venlafaxine in humans is believed to be associated with its potentiation of neurotransmitter activity in the central nervous system. Preclinical studies have shown that venlafaxine and its major metabolite, _ O_-desmethylvenlafaxine (ODV), are potent inhibitors of serotonin and noradrenaline reuptake, and also weakly inhibit dopamine reuptake. Venlafaxine is a racemate. The _R_-enantiomer is rela Läs hela dokumentet