Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Mirtazapine 30mg
Noumed Pharmaceuticals Limited
30 mg
Film coated tablet
Active: Mirtazapine 30mg Excipient: Colloidal silicon dioxide Hyprolose Hypromellose Iron oxide black Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Purified water Titanium dioxide
Prescription
Episodes of major depression.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC white opaque film and Al foil with VMCH coating in carton (UK pack) - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVDC white opaque film and Al foil with VMCH coating in carton (NZ pack) - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture
2021-01-29
New Zealand Consumer Medicine Information 1 MIRTAZAPINE (NOUMED) _MIRTAZAPINE PH. EUR. _ Mirtazapine (Noumed), film-coated tablets, 30 mg & 45 mg WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Mirtazapine (Noumed). This leaflet answers some common questions about Mirtazapine (Noumed). 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 Mirtazapine (Noumed) against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MIRTAZAPINE (NOUMED) IS USED FOR Mirtazapine (Noumed) 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 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 may help relieve the symptoms of depression. ASK YOUR PRESCRIBER IF YOU HAVE ANY QUESTIONS ABOUT WHY MIRTAZAPINE HAS BEEN PRESCRIBED FOR YOU. Your prescriber may have prescribed it for another reason. This medicine is available only with a prescriber’s prescription. This medicine is not addictive. BEFORE YOU USE MIRTAZAPINE (NOUMED) New Zealand Consumer Medicine Information 2 _WHEN YOU MUST NOT USE IT _ Do not take mirtazapine if you are allergic to: • Mirtazapine • other medicines containing mirtazapine • 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 bod Leggi il documento completo
NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 1 of 11 1 PRODUCT NAME Mirtazapine (Noumed), film-coated tablets 30 mg & 45 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _ Mirtazapine (Noumed) 30 mg - Each tablet contains 30 mg Mirtazapine Mirtazapine (Noumed) 45 mg - Each tablet contains 45 mg Mirtazapine _Excipients: _ For full list of excipients, see section 6.1. Tablets contain lactose. 3 PHARMACEUTICAL FORM Tablet, film-coated. Presentation 30 mg Reddish brown, biconvex capsule shaped film-coated tablets with score line on one side and 30 debossed on the other side. This tablet can be halved to give a 15 mg dose. 45 mg White, biconvex, capsule shaped film-coated tablets. Plain on one side and 45 debossed on other side. This tablet cannot be halved. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Episodes of major depression. 4.2 Dose and method of administration Administration The tablets should be taken orally, if necessary, with fluid, and swallowed without chewing. 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. Mirtazapine has a half-life of 20-40 hours and, therefore, Mirtazapine (Noumed) is suitable for once-a-day administration. It should be taken preferably as a single night-time dose before going to bed. Mirtazapine (Noumed) 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. Mirtazapine begins to NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 2 of 11 exert its effect in general after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response within 2-4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2-4 week Leggi il documento completo