Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
mirtazapine
Merck Sharp & Dohme (Australia) Pty Ltd
Registered
MIRTAZON ® _Mirtazapine 30mg and 45mg Tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Mirtazon. 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 Mirtazon 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 MIRTAZON IS USED FOR Mirtazon is used in the treatment of depression including relapse prevention. Depression is longer lasting or more severe than "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. This medicine corrects this chemical imbalance and may help relieve the symptoms of depression. Your doctor, however, may prescribe it for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. Mirtazon is not addictive. BEFORE YOU TAKE MIRTAZON _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE MIRTAZON: • IF YOU ARE ALLERGIC TO MEDICINES CONTAINING MIRTAZAPINE • IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips, mouth, throat or other parts of the body, shortness of breath, wheezing or trouble breathing. DO NOT TAKE MIRTAZON IF YOU ARE TAKING ANOTHER MEDICINE FOR DEPRESSION CALLED A MONOAMINE OXIDASE INHIBITO Izlasiet visu dokumentu
S-CCDS-MK8246-ALL-122018 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION MIRTAZON ® (MIRTAZAPINE) 1 NAME OF THE MEDICINE Mirtazapine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The 30 mg tablets contain 30 mg mirtazapine and the 45 mg strength contains 45 mg of mirtazapine. List of excipients with known effect: lactose monohydrate For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Mirtazon 30 mg tablets are oval, biconvex, red-brown, scored and marked with ‘Organon’ or ‘MSD’ on one side, and on the other side with the (code ) on both sides of the score. The tablet can be divided into equal halves. Mirtazon 45 mg tablets are white tablets (code ). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depression including relapse prevention. 4.2 DOSE AND METHOD OF ADMINISTRATION The tablets should be taken orally, if necessary with fluid, and swallowed without chewing. 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 Mirtazon to this category of patients (refer to Section 5.2 Pharmacokinetic Properties). Mirtazapine has a half-life of 20-40 hours and therefore Mirtazon is suitable for once-a-day administration. It should be taken preferably as a single night-time dose before going to bed. Mirtazon may also be given in sub-doses equally divided over the day (once in the morning and once at night-time). Treatment should preferably be continued until the patient has been completely symptom-free for 4-6 months. After this, treatment can be gradu Izlasiet visu dokumentu