Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium alginate; Potassium bicarbonate
Forum Health Products Ltd
Sodium alginate; Potassium bicarbonate
100mg/1ml ; 20mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01010201; GTIN: 5000158065635 5000158064515
0.0 mm 100% EAN 13 5000158065109 22.9 mm 30 microns N/A 26.1 mm BARCODE INFO Barcode Type: Barcode Number: Magnification: Truncated By: Full Height: Bar Height (Smallest Bar): BWR: Encoded Data: Trident Reference No: ZEN Ref: Action: Brand: Category: Segment Group: Segment: Pack Size: Market/Country: Date: Component Code (2D if applicable) : Parent Technical Packaging Specification: Finished Goods Code: Supply Point: 3rd Party Code Pharmacode No/NE: Edgemark Position: CAD Cam Ref: Printer: Substrate: N/A N/A RB Hull NA N/A Gaviscon Adult Advance Liquid Peppermint 300ml RB391858 Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only. STUDIO USE ONLY v2.0 Sm•Art check results: Cutter Guides Technical & Non Printing Items Cutter 2 (if applicable) Guides 2 (if applicable) Multi Packaging Solutions (Bourne, UK) G-Lbl-D8340700-70x177.8mm PPTD1736 TR1686077 PP-White SA UK 16/01/20 B Mel Hall RB00000 G=2; O=0; R=1; - MH - 16/01/20 14:35:33 RB Artwork and Print Specification D8340700 Artwork Type: RB Artwork Creation IDM 10 mm 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 1 FLX PANTONE Reflex Blue C 2 FLX PANTONE 320 C 3 FLX PANTONE 7488 C 4 FLX PANTONE 185 C 5 FLX Process Yellow 6 FLX Braille 7 FLX VRN-HighGlossUV+Opt Brightener 8 FLX Release Varnish Colours (Label _Peel Read) RBH Contact: James Hart Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100 UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT. CUSTOMER INFO: Important Please Read: Retouching has not been approved. Data will not be created for this job until all retouching is approved. CUSTOMER INFO: Minimum Point Size = _Leaflet Copy = 9pt_ 7.00pt GAVISCON ADVANCE PEPPERMINT FLAVOUR ORAL SUSPENSION T B R 2 6 7 4 - D 8 3 4 0 7 0 0 – E n g l i s h GAVISCON ADVANCE PEPPERMINT FLAVOUR ORAL SUSPENSION. Sodium alginate and potass Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Advance Peppermint Flavour Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg. 1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20.0 mg. Each 10 ml dose is equivalent to two 5 ml measuring spoons. Excipient(s) with known effect: Methyl parahydroxybenzoate E218 Propyl parahydroxybenzoate E216 Sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. Off-white viscous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children 12 years and over: 5-10 ml after meals and at bedtime (one to two 5 ml measuring spoons). Children under 12 years: Should be given only on medical advice. Elderly: No dose modification is required for this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4). 4.3 CONTRAINDICATIONS The medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms do not improve after 7 d Lestu allt skjalið