Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Indoramin hydrochloride
Alliance Healthcare (Distribution) Ltd
C02CA02
Indoramin hydrochloride
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040100
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs v3/July 2017 Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info 3D Render ID 07 Aug 2019 20:20 Indoramin 20 mg 60 Label Leaflet 1925285 1473329 1925285 PL 04569/0473 NA LL0437AG 259 NA 384695 1 United Kingdom NA 5016695000251 NA 4 Myriad Pro 52 x 101 mm 9 pt 6 pt Keyline Varnish Free Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs v3/July 2017 Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info 3D Render ID 07 Aug 2019 20:20 Indoramin 20 mg 60 Label Leaflet 1925285 1473329 1925285 PL 04569/0473 NA LL0437AG 259 NA 384695 1 United Kingdom NA 5016695000251 NA 4 Myriad Pro 52 x 101 mm 9 pt 6 pt Braille Keyline Varnish Free INDORA- MIN #20 mg Tablets INDORA- MIN #20 mg Tablets Location is fixed here for Variable Data Coding (maximum five lines) along with 2D Data Matrix code. Prompt words ( (1) according to previously agreed translation), variable batch data and 2D Data Matrix code will be online printed in the following order (or matrix first then test)and layout: Standard font size is 2.0mm for online printed batch data. Keep this section as part of the artwork in keyline colour. Keep this flap blank and varnish free for online printing. Information box: *PC: 00000000000000 *SN: 00000000000000 Lot: 0000000000 EXP: MM/YYYY Variable Data Information box for online printing - United Kingdom * Will be printed only after serialisation go live Keep this section as part of the Artwork in Keyline colour. Variable Dat Lees het volledige document
1. NAME OF THE MEDICINAL PRODUCT Indoramin 20 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg indoramin (as hydrochloride). Excipient of known effect: Each film-coated tablet contains 186.53 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 9mm x 9mm shield shaped, normal convex, white film coated tablet debossed ‘G’ on one side and ‘IR’ on the other. 20 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Conditions for which alpha blockade is indicated. Management of urinary outflow obstruction due to benign prostatic hyperplasia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Hyperplasia _ _ _Adults: _ 20 mg twice daily Dosage may be increased in 20 mg increments at two-weekly intervals up to max. 100 mg per day if required. _Older People: _ 20 mg at night may be adequate. _Children: _ Not recommended. Method of administration Oral. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with established heart failure. Patients already under treatment with a monoamine oxidase inhibitor. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Incipient cardiac failure should be controlled before treatment with Indoramin 20 mg tablets. Caution should be observed in prescribing Indoramin 20 mg tablets for patients with hepatic or renal insufficiency. A few cases of extrapyramidal disorders have been reported in patients treated with Indoramin 20 mg tablets. Caution should be observed in prescribing Indoramin 20 mg tablets in patients with Parkinson's disease. In animals and in the one reported case of overdose in humans, convulsions have occurred. Due consideration should be given and great caution exercised in the use of Indoramin 20 mg tablets in patients with epilepsy. The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or Lees het volledige document