Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Morphine hydrochloride; Chloroform; Kaolin light; Sodium bicarbonate
Alliance Healthcare (Distribution) Ltd
A07DA52
Morphine hydrochloride; Chloroform; Kaolin light; Sodium bicarbonate
91.6mg/1litre ; 5ml/1litre ; 200gram/1litre ; 50gram/1litre
Oral suspension
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 01040200
FRONT FACE: PRINT LAYOUT DI 65MM X 170MM AGRAM MULTIPEEL WITH 50MM HINGE LEFT FRONT FACE REVERSE: CARRIER: MHRA HEADER BOX PRODUCT TITLE COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE COLOURS USED FONTS USED POINT SIZES USED MIN MAX Process Cyan Process Magenta Process Yellow Process Black Text free area (non-printing) Braille Keyline (non-printing) Landscape peelable label 200ml 92774771902 65 x 170mm 6 22.05.2019 Kaolin & Morphine Mixture Helvetica 7pt 8pt PEEL HERE P 200ML IMPORTANT: PEEL THIS LABEL AT CORNER AND READ BEFORE USE. DO NOT TEAR OFF, RE-FIX FOR FUTURE USE. For symptomatic relief of diarrhoea and upset stomachs. SHAKE THE BOTTLE. Take the suspension by mouth. ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS: Take 2 x 5ml spoonfuls. Repeat up to three times a day if required. DO NOT GIVE TO CHILDREN UNDER 12 YEARS OLD. DO NOT EXCEED THE STATED DOSE. Do not take with alcoholic or hot drinks. PEEL WHERE SHOWN FOR FURTHER PRECAUTIONS. ACTIVE INGREDIENTS PER 10ML: kaolin light 2g, sodium hydrogen carbonate 500mg, morphine hydrochloride 0.916mg. ALSO CONTAINS amongst other ingredients: ethanol (0.46 vol%), sucrose, parahydroxybenzoates (E219, E217), sodium (148mg/10ml), benzyl alcohol (0.05µg/10ml). PEEL WHERE SHOWN FOR FULL LIST OF INGREDIENTS. Do not store above 25°C. Keep tightly closed. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Manufactured by the licence holder L.C.M. Ltd., Huddersfield, HD7 5QH, UK for Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK. PL 12965/0021 92774771902 5 011309 034219 This medicine contains kaolin to help remove toxic substances from the digestive system and increase the bulk of solid waste. It also contains sodium hydrogen carbonate which neutralizes excess stomach acid and morphine which calms the gut. 1. 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 3. • A BLOCKED INTESTINE OR BOWEL PROBLEMS. • LIVER DISEASE. • SHALLOW BREATH, BREATHING DIFFICULTIES OR DURING Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kaolin and Morphine Mixture 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kaolin Light (Grade A1) 1g Sodium Hydrogen Carbonate Powder 250mg Morphine Hydrochloride 0.458mg per 5ml dose. Each 5ml dose contains 0.46%vol ethanol (alcohol) Each 5ml dose contains 3.2mmol (74mg) sodium Each 5ml dose contains 0.08g sucrose Each 5ml dose contains 0.000025mg benzyl alcohol Each 5ml dose contains 32.5mg sodium methyl hydroxybenzoate Each 5ml dose contains 3.4mg sodium propyl hydroxybenzoate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension. A buff coloured suspension which separates on standing to give a buff coloured sediment and a brown supematant liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For relief of the symptoms of diarrhoea and upset stomachs in adults and children over 12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral. Recommended doses: Adults and children over 12 years: Two 5ml spoonfuls. Children under 12 years: Not recommended for children under 12 years. Directions for use: Shake the bottle. Dosage schedule: The dose may be repeated 3 times daily or as directed. 4.3 CONTRA-INDICATIONS Kaolin is contraindicated in intestinal obstruction. Whilst this product only contains a small amount of morphine, theoretically it should be contraindicated in the same conditions as other morphine-containing preparations. These conditions include respiratory depression, obstructive airways disease, known morphine sensitivity, acute hepatic disease, acute alcoholism, head injuries, coma, convulsive disorders, where intracranial pressure is raised, and in concurrent administration with monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Hypersensitivity to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As this product contains sodium hydrogen carbonate, it should not be administered to patients with metabolic or respiratory alkalosis, h Lue koko asiakirja