Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium bicarbonate
Torbet Laboratories Ltd
B05XA02
Sodium bicarbonate
10mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01010102
LEAFLET TEXT FOR BABY GRIPE MIXTURE, PL 48259/0018, NOVEMBER 2017 (ALSO FOR DINNEFORDS GRIPE MIXTURE, DINNEFORDS BABY GRIPE MIXTURE, DINNEFORDS INFANT GRIPE MIXTURE , ATKINSONS & BARKERS INFANT GRIPE MIXTURE, SNUFFLEBABE GRIPE MIXTURE) PATIENT INFORMATION LEAFLET Baby Gripe Mixture (Dinnefords Gripe Mixture, Dinnefords Baby Gripe Mixture, Dinnefords Infant Gripe Mixture, Atkinsons & Barkers Infant Gripe Mixture, Snufflebabe Gripe Mixture) (Sodium Bicarbonate) Please read this leaflet carefully as it contains important information about this medicine. If you have any further questions or queries. Please ask your doctor or pharmacist. Baby Gripe Mixture contains the active ingredient sodium bicarbonate 50.0mg/5ml. Also contains: sorbitol sodium, propylene glycol, dill oil terpeneless, caraway oil terpeneless, purified water and nipsept (methyl, ethyl and propyl hydroxybenzoates) (E218, E214, E216) Baby Gripe Mixture is a water white to pale straw coloured syrup with a spicy odour. It is available in bottles containing either 100ml, 140ml or 150ml of product. MA HOLDER: Northumbria Pharma Limited, Netpark, Thomas Wright Way, Sedgefield, County Durham TS21 3FD, UK. MANUFACTURER: Cupal Ltd., King Street, Blackburn, BB2 2DX, UK USES To relieve griping pains and wind in babies BEFORE GIVING BABY GRIPE MIXTURE PLEASE READ THE FOLLOWING • Do not give to babies with heart or kidney problems, high blood pressure or water retention problems • Do not give to babies if they are sensitive to any of the ingredients listed above • Do not exceed the stated dose. • Seek medical advice if symptoms persist or worsen. INSTRUCTIONS FOR USE Liquid for oral use Babies one to six months One 5ml spoonful to be given every four hours if necessary Babies six months to one year Two 5ml spoonfuls to be given every four hours if necessary This product is not recommended for babies under one month or over one year. In the event of accidental or deliberate overdose, seek medical attention immediately. LEAFLET TEXT FOR BABY GRIPE MIXTURE, Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Baby Gripe Mixture Dinnefords Gripe Mixture Dinnefords Baby Gripe Mixture Dinnefords Infant Gripe Mixture Atkinsons & Barkers Infant Gripe Mixture Snufflebabe Gripe Mixture 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium bicarbonate 50.0mg/5ml 3 PHARMACEUTICAL FORM Liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To relieve griping pains and wind in babies 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral Babies one to six months One 5m1 spoonful to be given every four hours if necessary Babies six months to one year Two 5m1 spoonsful to be given every four hours if necessary This product is not recommended for babies under one month or over one year. 4.3 CONTRAINDICATIONS Should be used with caution in babies with cardiac problems, hypertension, impaired renal function or peripheral or pulmonary oedema. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not exceed the stated dose. Seek medical advice if symptoms persist or worsen. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known 4.6 FERTILITY, PREGNANCY AND LACTATION Not applicable 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable 4.8 UNDESIRABLE EFFECTS Excessive intake could cause hypernatraemia 4.9 OVERDOSE Symptoms of hypernatraemia may include drowsiness and irritability, pyrexia, tachypnoea and hyperpnoea. In more severe instances of acute sodium overload, signs of dehydration and convulsions may occur. Treatment The treatment of hypernatraemia includes repair of any dehydration present and gradual reduction of the plasma sodium. The alkalosis if present will respond to the treatment of hypernatraemia. At all times intensive monitoring of the electrolytes, and patient’s circulatory and central nervous system are necessary. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Antacid 5.2 PHARMACOKINETIC PROPERTIES Not applicable 5.3 PRECLINICAL SAFETY DATA There are no preclinical data of relevance to Прочетете целия документ