Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
mirtazapine
Apotex Pty Ltd
Mirtazapine
Registered
TERRY WHITE CHEMISTS MIRTAZAPINE 1 TERRY WHITE CHEMISTS MIRTAZAPINE _Contains the active ingredient mirtazapine _ 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 this medicine. 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 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 need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Terry White Chemists Mirtazapine. It contains the active ingredient mirtazapine. It is used to treat and prevent the reoccurrence of depression. Depression is longer lasting or more severe than the "low moods" everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This affects your whole body and can cause emotional and physical symptoms, such as feeling low in spirit, loss of interest in activities, unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing. Mirtazapine corrects this chemical imbalance and may help relieve the symptoms of depression. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. _USE IN CHILDREN _ This medicine must not be used in children or adolescents under 18 years of age. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing mirtazapine Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION TERRY WHITE CHEMISTS MIRTAZAPINE (MIRTAZAPINE) TABLETS NAME OF THE MEDICINE Mirtazapine QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15, 30 or 45 mg mirtazapine (as mirtazapine hemihydrate). EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. PHARMACEUTICAL FORM TERRY WHITE CHEMISTS MIRTAZAPINE 30 MG TABLETS Light pink, oval shaped, scored, film coated tablets, imprinted “APO” on one side and “MI” bisect “30” on the other side. TERRY WHITE CHEMISTS MIRTAZAPINE 45 MG TABLETS White to off-white, oval shaped, unscored, film coated tablets, imprinted “APO” on one side and “MI-45” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depression including relapse prevention. 4.2 DOSE AND METHOD OF ADMINISTRATION Terry White Chemists Mirtazapine Tablets are intended for oral administration. Mirtazapine should be taken orally, if necessary with fluid, and swallowed without chewing. DOSAGE ADULTS – Treatment should begin with 15 mg daily. The dosage generally needs to be increased to obtain an optimal clinical response. The effective daily dose is usually between 30 and 45 mg but responses have been observed at 60 mg per day. ELDERLY – The recommended dose is the same as that for adults. In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response. The clearance of mirtazapine may be decreased in patients with renal or hepatic insufficiency. This should be taken into account when prescribing mirtazapine to this category of patients (see section 5.2 PHARMACOKINETIC PROPERTIES). Mirtazapine has a half-life of 20–40 hours and therefore mirtazapine is suitable for once-a-day administration. It should be taken preferably as a single night-time dose before going to bed. 2 Mirtazapine may also be given in sub-doses equally divided over the day (once in the morning and once at night-time). Treat Read the complete document