Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
venlafaxine hydrochloride, Quantity: 84.85 mg (Equivalent: venlafaxine, Qty 75 mg)
Viatris Pty Ltd
Capsule, modified release
Excipient Ingredients: purified talc; Gelatin; titanium dioxide; iron oxide yellow; microcrystalline cellulose; ethylcellulose; iron oxide red; hypromellose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid
Oral
7 capsules, 28 capsules, 14 capsules
(S4) Prescription Only Medicine
EFEXOR-XR is indicated for the treatment of: Major depression, including prevention of relapse and recurrence where appropriate; Generalised anxiety disorder; Social Anxiety Disorder; and Panic Disorder, including prevention of relapse.
Visual Identification: hard gelatin capsule with peach cap and body containing white to off white spheroids of about 1mm in diameter. Red printing of "W" and 75; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1998-05-11
EFEXOR ® -XR _Venlafaxine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Efexor-XR. 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 Efexor-XR 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 EFEXOR-XR IS USED FOR _WHAT IT DOES_ Efexor-XR 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_ Efexor-XR 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. Efexor-XR capsules increas Pročitajte cijeli dokument
Version: ujpefexc21021 Supersedes: ujpefexc11021 Page 1 of 34 AUSTRALIAN PRODUCT INFORMATION – EFEXOR -XR (VENLAFAXINE HYDROCHLORIDE) 1. NAME OF THE MEDICINE Venlafaxine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EFEXOR-XR modified release capsules contain venlafaxine (as hydrochloride) 37.5 mg, 75 mg and 150 mg. For the full list of excipients, See section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Modified release capsules. Venlafaxine hydrochloride is released from spheroids within the capsule. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. EFEXOR-XR modified release capsules are available for oral use as: 37.5 mg, grey cap/peach body with ‘W’ on the cap and “37.5” on the body. 75 mg, peach cap and body with ‘W’ on the cap and “75” on the body. 150 mg, dark orange cap and body with ‘W’ on the cap and “150” on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EFEXOR-XR is indicated for the treatment of: • Major Depression, including prevention of relapse and recurrence where appropriate • Generalised Anxiety Disorder • Social Anxiety Disorder • Panic Disorder, including prevention of relapse. Version: ujpefexc21021 Supersedes: ujpefexc11021 Page 2 of 34 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE _MAJOR DEPRESSION, GENERALISED ANXIETY DISORDER AND SOCIAL ANXIETY DISORDER_ The usual recommended dose for the treatment of major depression, generalised anxiety disorder or social anxiety disorder is 75 mg per day given once daily. After two weeks, the dose may be increased to 150 mg per day given once daily if further clinical improvement is required. If needed, this can be increased up to 225 mg given once daily. Dose increments should be made at intervals of approximately 2 weeks or more, but not less than 4 days. The recommended dose is based on results of clinical trials in which EFEXOR-XR was mostly given once daily in doses from 75 to 225 mg. Antidepressant activity with the 75 Pročitajte cijeli dokument