Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
venlafaxine hydrochloride
Pfizer Australia Pty Ltd
Venlafaxine hydrochloride
Registered
ALTVEN ® _Venlafaxine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Altven. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Altven against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ALTVEN IS USED FOR _WHAT IT DOES_ Altven is used in the treatment and prevention of relapse of depression. It is also used in 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. Depression and anxiety are treatable illnesses. Anxiety or tension associated with the normal stress of everyday life usually does not require treatment with medicines. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. _HOW IT WORKS_ Altven contains the active ingredient called venlafaxine hydrochloride. It belongs to a class of medications for depression and anxiety, called Serotonin-Noradrenaline Reuptake Inhibitors (SNRIs). Serotonin and noradrenaline are chemical messengers that allow certain nerves in the brain to work. Altven capsules increase the level of these tw Perskaitykite visą dokumentą
Version: pfpaltvc11115 Supersedes: pfpaltvc10214 Page 1 of 33 PRODUCT INFORMATION ALTVEN VENLAFAXINE (AS HYDROCHLORIDE) NAME OF THE MEDICINE ALTVEN Venlafaxine (as hydrochloride) 37.5 mg, 75 mg and 150 mg modified release capsules. ALTVEN contains the active ingredient venlafaxine (as hydrochloride). The structural formula is shown below: Chemical name: (R/S)-1-[(2-dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride Molecular formula: C 17 H 27 NO 2 .HCl Molecular weight: 313.87 CAS Registry Number: 99300-78-4 DESCRIPTION ALTVEN capsules are an extended-release formulation, which release the active constituent, venlafaxine hydrochloride, from spheroids within the capsule. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Three strengths of ALTVEN capsules are available containing either 37.5 mg, 75 mg or 150 mg of venlafaxine (as hydrochloride). Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Other ingredients are cellulose-microcrystalline, ethylcellulose and hypromellose. The capsule shells contain gelatin, red iron oxide CI 77491, yellow iron oxide CI 77492, titanium dioxide and talc purified. In addition to these, the 37.5 mg capsule shells also contain black iron oxide CI 77499. The 37.5 mg and 75 mg capsule shells are branded with Opacode S-1- 15094/S-1-15095 red ink. The 150 mg capsule shells are branded with TekPrint SB-0007P white ink. Version: pfpaltvc11115 Supersedes: pfpaltvc10214 Page 2 of 33 PHARMACOLOGY ACTIONS Venlafaxine is a structurally novel antidepressant for oral administration; it is chemically unrelated to tricyclic, tetracyclic, or other available antidepressant agents. PHARMACODYNAMICS The antidepressant action of venlafaxine in humans is believed to be associated with its potentiation of neurotransmitter activity in the central nervous system (CNS). Preclinical studies have shown that venl Perskaitykite visą dokumentą