País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Magnesium trisilicate; Sodium alginate; Sodium bicarbonate; Aluminium hydroxide gel dried
Actavis UK Ltd
n/a
Magnesium trisilicate; Sodium alginate; Sodium bicarbonate; Aluminium hydroxide gel dried
8mg/1ml ; 44mg/1ml ; 14mg/1ml ; 16mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01010201; GTIN: 5011309892017
6. FURTHER INFORMATION WHAT IS IN THIS MEDICINE THE ACTIVE INGREDIENTS PER 5ML ARE: sodium alginate 220mg, dried aluminium hydroxide gel 80mg, magnesium trisilicate 40mg, sodium hydrogen carbonate 70mg. THE OTHER INGREDIENTS ARE: aluminium magnesium silicate, sunset yellow (E110), butterscotch flavour, peppermint liquid, saccharin sodium, sodium methyl hydroxybenzoate (E219), sodium propyl hydroxybenzoate and purified water. WHAT THE MEDICINE LOOKS LIKE Gastrocote Liquid is a peach coloured suspension which smells of butterscotch and mint. It is supplied in 500ml bottles. MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf, Reykjavikurvegi 76-78 220 Hafnarfjordur, Iceland. MANUFACTURER Thornton and Ross Ltd, Huddersfield, HD7 5QH, UK. Gastrocote is a trade mark of Actavis Group PTC ehf THIS LABEL WAS REVISED IN APRIL 2012 PL 30306/0076 AAAD6166 1. WHAT THE MEDICINE IS FOR Gastrocote Liquid is used for heartburn, including • Heartburn in pregnancy. • Reflux oesophagitis. • Gastric reflux. • Acid indigestion. 2. BEFORE YOU USE THIS MEDICINE DO NOT USE THE MEDICINE IF YOU OR YOUR CHILD HAVE • An ALLERGY to any of the ingredients listed in section 6. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU OR YOUR CHILD HAVE • Kidney problems. • Or are on a controlled salt or phosphate diet. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING • Antibiotics such as ciprofloxacin or tetracycline. Do not take Gastrocote Liquid within two hours of any other medicine. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS • This product contains 2.13 mmol (49mg) of sodium per 5ml dose. This should be taken into account by people on a controlled sodium diet. • It contains sunset yellow and hydroxybenzoates which may cause allergic reactions (possibly delayed). 3. HOW TO USE THIS MEDICINE • Take this medicine by mouth. • Shake the bottle well before use. • Take after main meals and at bedtime. ADULTS AND THE ELDERLY • Take one to three 5ml spoonfuls four times a day. CHILDREN 6 TO 12 YEARS OLD • Take one to two Leia o documento completo
GASTROCOTE LIQUID Summary of Product Characteristics Updated 19-Dec-2012 | Actavis UK Ltd 1. Name of the medicinal product Gastrocote Liquid 2. Qualitative and quantitative composition Sodium Alginate 220mg Dried aluminium hydroxide gel 80mg Magnesium trisilicate 40mg Sodium hydrogen carbonate 70mg ALSO CONTAINS: Sodium Methylhydroxybenzoate (E219) Sodium Propylhydroxybenzoate (E217) 3. Pharmaceutical form Oral suspension 4. Clinical particulars 4.1 Therapeutic indications Gastrocote Liquid is indicated in heartburn, including heartburn of pregnancy, reflux oesophagitis, particularly where associated with hiatus hernia and in all cases of epigastric distress with gastric reflux or regurgitations. It is also indicated in acid indigestion. 4.2 Posology and method of administration Oral Adults and children over 12: One - three 5ml spoonfuls to be taken four times daily, that is, after main meals and at bedtime. Children 6 to 12 years: One two 5ml spoonfuls to be taken four times daily, that is, after main meals and at bedtime. Not recommended for children under 6 years of age. 4.3 Contraindications Hypersensitivity to any of the ingredients. 4.4 Special warnings and precautions for use Should be used with caution in patients with renal dysfunction due to increased risk of aluminium toxicity (e.g. aluminium induced encephalopathy). Caution should also be taken in patients on a low phosphate diet. The content of sodium should also be taken into account by patients on a sodium controlled diet. This medicinal product contains 2.13mmol (or 49mg) sodium per 5ml dose. If symptoms persist consult your doctor. Gastrocote liquid contains sunset yellow (E110) and hydroxybenzoates which may cause allergic reactions (possibly delayed). 4.5 Interaction with other medicinal products and other forms of interaction The absorption of the following substances may be decreased by simultaneous use of antacids: - Quinolones (e.g. ciprofloxacin, norfloxacin and ofloxacin) - Tetracycline derivatives (e.g. tetracycline and doxycycline) A Leia o documento completo