Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mirtazapine
A A H Pharmaceuticals Ltd
N06AX11
Mirtazapine
45mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5025903006237
Myriad Pro 9 pt 9 pt Mirtazapine_45mg_15mg_30mg_all Leaflet 1941517 1936886 1941517 N/A Aurobindo Pharma Ltd (Unit-III : Hyderabad - IN) P1521870 21870 N/A 102854961/0020 3 United Kingdom Leaflet KLD 280 x 480 mm (60 x 35 mm) N/A 1 280 x 480 mm BLACK 1 / 2 N/A v3/Jul 2017 Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs Affiliate Item Code 3D Render ID 23:00 18 Sep 19 PACKAGE LEAFLET: INFORMATION FOR THE USER MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Mirtazapine is and what it is used for 2. What you need to know before you take Mirtazapine 3. How to take Mirtazapine 4. Possible side effects 5. How to store Mirtazapine 6. Contents of the pack and other information 1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR Mirtazapine is one of a group of medicines called ANTIDEPRESSANTS. Mirtazapine is used to treat depressive illness in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE DO NOT TAKE MIRTAZAPINE: • if you are ALLERGIC to mirtazapine or any of the other ingredients of this medicine (listed in section 6) if you are taking or have recen Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mirtazapine 45 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg of mirtazapine. Excipient with known effects: 18 mg of Aspartame (E951) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Orodispersible tablet The tablets are white or almost white, 12 mm round, biconvex, uncoated tablets and marked M4. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of depressive illness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablet should be taken out of the blister with dry hands and should be placed on the tongue. The tablet will disintegrate and can be swallowed without water. The tablet should be 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 15 and 45 mg. 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. Children: Since safety and efficacy of Mirtazapine has not been established in children, it is not recommended to treat children with Mirtazapine. Two randomised placebo-controlled trials failed to demonstrate efficacy for Mirtazapine in the treatment of children and adolescents with major depressive disorder. Safety and efficacy of Mirtazapine in paediatric depression can not be extrapolated from adult data. Children and adolescents under the age of 18 years Mirtazapine Tablets should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 4.4, 4.8 and 5.1). 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. Mirt Read the complete document