Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
venlafaxine hydrochloride
Apotex Pty Ltd
Venlafaxine hydrochloride
Registered
APO-VENLAFAXINE XR CAPSULES _Venlafaxine hydrochloride_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about venlafaxine. 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 using this medicine against the benefits they expect it will 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Venlafaxine is used to treat major depression, and to prevent it coming back. It is also used to treat panic attacks and anxiety. Venlafaxine belongs to a group of medicines called serotonin- noradrenaline reuptake inhibitors (SNRIs). Depression may cause emotional and physical symptoms such as feeling low, poor appetite or lack of energy. Excessive anxiety may cause you to feel constantly and uncontrollably worried and distressed. It may also make you feel irritable, and cause difficulty in thinking and sleeping. _HOW IT WORKS_ Venlafaxine increases the level of serotonin and noradrenaline in the brain, helping to restore your feeling of wellness. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Venlafaxine XR for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine for children under the age of 18 years. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • venlafaxine • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, t Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION APO-VENLAFAXINE XR (VENLAFAXINE HYDROCHLORIDE) CAPSULES 1 NAME OF THE MEDICINE Venlafaxine hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release capsule contains venlafaxine 75 mg (as 84.90 mg venlafaxine hydrochloride) or venlafaxine 150 mg (as 169.80 mg venlafaxine hydrochloride) as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Gelatin (also contains sulfites and phenylalanine). For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM VENLAFAXINE XR 75 MG MODIFIED RELEASE CAPSULES Peach opaque / peach opaque size 1 hard capsule with thick and thin radial circular band on the body and cap in red ink. The capsule is filled with white to off white, round, biconvex, film coated mini tablets. VENLAFAXINE XR 150 MG MODIFIED RELEASE CAPSULES Dark orange / dark orange size 0 hard capsule with thick and thin radial circular band on the body and cap in white ink. The capsule is filled with white to off white, round, biconvex, film coated mini tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of major depression, including prevention of relapse and recurrence where appropriate. • Generalised Anxiety Disorder. • Social Anxiety Disorder. • Panic Disorder, including prevention of relapse. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Venlafaxine XR 75 mg and 150 mg Modified Release Capsules are intended for oral administration. 2 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/day given once daily. After two weeks the dose may be increased to 150 mg/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 two weeks or more, but not less than four days. The recommended dose is based on results of clinical trial Прочитать полный документ