Kaolin and Morphine mixture

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium bicarbonate; Chloroform; Morphine hydrochloride; Kaolin light

Available from:

A A H Pharmaceuticals Ltd

ATC code:

A07DA52

INN (International Name):

Sodium bicarbonate; Chloroform; Morphine hydrochloride; Kaolin light

Dosage:

50gram/1litre ; 5ml/1litre ; 91.6mg/1litre ; 200gram/1litre

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01040200

Patient Information leaflet

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

Summary of Product characteristics

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