Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Magnesium carbonate; Simeticone; Calcium carbonate
Bayer Plc
A02AF02
Magnesium carbonate; Simeticone; Calcium carbonate
80mg ; 25mg ; 680mg
Chewable tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01010201; GTIN: 5010605296024 5010605296055
Bayer Ref No: t Reference No: Brand: Range: Product: Pack Type: Pack Size: Action: Date: Country: Finished Goods Code: Synaps Request Code: Component Code: CAD Ref No: Printer: Packaging Site: Substrate: Barcode 1 Type: Barcode 1 Mag: Barcode 2 Type: Barcode 2 Mag: Pharmacode No/NE: PIL 135 x 197 Rennie Deflatine Tablets Leaflet UK 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. UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM STUDIO USE ONLY v1.0 Sm•Art check results: Cutter Guides Technical & Non Printing Items BAYER ARTWORK PANEL 18/36 Pack Packaging Site Approval: ARTWORK APPROVAL PANEL Name: Date: Action: Country Approval: Name: Date: Action: BAY371331 Main Text (body copy): Height (based on lower case x): 10 pt 1.8 mm FONT SIZE PANEL 1 LTH Process Black Colours 00000000 CALCIUM CARBONATE, MAGNESIUM CARBONATE, SIMETICONE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ALWAYS TAKE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS YOUR DOCTOR OR PHARMACIST HAS TOLD YOU. - KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. - ASK YOUR PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE. - 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._ - YOU MUST CONTACT A DOCTOR IF YOU DO NOT FEEL BETTER OR IF YOU FEEL WORSE AFTER 14 DAYS. WHAT IS IN THIS LEAFLET 1. WHAT RENNIE DEFLATINE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE DEFLATINE 3. HOW TO TAKE RENNIE DEFLATINE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE RENNIE DEFLATINE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT RENNIE® DEFLATINE IS AND WHAT IT IS USED FOR RENNIE DEFLATINE RELIEVES THE PAIN AND DISCOMFORT OF BLOATING, BILIOUSNESS, FLATULENCE, AND TRAPPED WIND. EACH TABLET IS FORMULATED WITH SIMETICONE, A H Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rennie Deflatine Rennie Heartburn, Indigestion and Wind Relief 680mg/80mg/25mg Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calcium Carbonate 680.0 mg Magnesium Carbonate, heavy 80.0 mg Simethicone 25.0 mg Also contains Sorbitol (E420) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Chewable Tablet Cream white flat round tablet, scored on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the effective relief of acid indigestion, nervous indigestion, heartburn, upset stomach, uncomfortable bloating, biliousness, flatulence, painful trapped wind, and indigestion and heartburn during pregnancy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Tablets to be taken orally, sucked or chewed. Adults and children over 12 years One or two tablets to be sucked or chewed as required. A maximum daily dose of 8g calcium carbonate, corresponding to 11 tablets a day, must not be exceeded. Children Not recommended for children under 12 years. As with all antacids, if symptoms persist despite 14 days of continuous therapy, diagnostic measures are strongly recommended in order to rule out a more serious disease. 4.3 CONTRAINDICATIONS Rennie should not be administered to patients with: • Hypersensitivity to any of the ingredients of the product • Hypercalcaemia and/or conditions resulting in hypercalcaemia • Nephrolithiasis due to calculi containing calcium deposits • Severe renal insufficiency • Hypophosphataemia 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE • Prolonged use should be avoided. • The stated dose should not be exceeded. If, after 14 days of treatment, symptoms persist or only partly disappear the patient should consult a doctor. • Caution should be exercised in patients with mild to moderate impairment of renal function (see section 4.3 – contraindication in severe renal insufficiency). If Rennie is used in such patients, plasma calcium, phosphate and magnesium levels should be regu Прочитать полный документ