Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
mirtazapine
Merck Sharp & Dohme (Australia) Pty Ltd
Registered
REMERON SOLTAB ® _Mirtazapine 15mg, 30mg and 45mg Orally Disintegrating Tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Remeron SolTab. 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 Remeron SolTab 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 REMERON SOLTAB IS USED FOR Remeron SolTab is used in the treatment of depression 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. Remeron SolTab is not addictive. BEFORE YOU TAKE REMERON SOLTAB _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE REMERON SOLTAB: • 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 REMERON SOLTAB IF YOU ARE TAKING ANOTHER MEDICIN Lesen Sie das vollständige Dokument
S-CCDS-MK8246-ALL-122018 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION REMERON SOLTAB ® (MIRTAZAPINE) 1 NAME OF THE MEDICINE Mirtazapine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg, 30 mg or 45 mg of mirtazapine. Excipients with known effect: Sugar Spheres NF (25/30 Mesh) PI (4780), aspartame. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Remeron SolTab tablets are round, white, flat faced bevelled-edge tablets marked with a code on one side, with a characteristic orange odour. The codes are: 15 mg (code ) 30 mg (code ) 45 mg (code ) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depression 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 Remeron SolTab to this category of patients (refer to Section 5.2 Pharmacokinetic Properties). Mirtazapine has a half-life of 20-40 hours and therefore Remeron SolTab is suitable for once- a-day administration. It should be taken preferably as a single night-time dose before going to bed. Remeron SolTab 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 gradually discontinued to avoid withdrawal TZ 1 TZ 2 TZ 4 S-CCDS-MK8246-ALL-122018 Page 2 of 16 symptoms Lesen Sie das vollständige Dokument