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NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Morphine Hydrochloride 0.395mg Activated Attapulgite 312.5mg Attapulgite 187.5mg
For excipients, see 6.1.
For the relief of occasional diarrhoea and its associated pain and discomfort.
Posology and Method of Administration Directions for Use The tablets should be chewed and then followed by a drink of water. As well as using Diocalm, it is important to replace body fluids lost during diarrhoea. Recommended dose Adults and children aged 12 years and over: Children aged 6 - 12 years: 2 tablets 1 tablet
The recommended dose should be taken every two to four hours as required according to the severity of the symptoms. Do not take more than six doses in 24 hours.
Not to be given to children under 6 years. Elderly: As the adult dose.
Contra-indications Patients with impaired renal function. Hypersensitivity to any of the ingredients.
Special Warnings and Precautions for Use Labelling Warning. Do not exceed the stated dose. Keep out of the reach of children. If symptoms persist for more than 24 hours, consult your doctor. As well as using Diocalm, it is important to replace body fluids lost during diarrhoea.
Interactions with other Medicaments and other forms of Interaction None.
Pregnancy and Lactation There are no known contraindications to the use of the product during pregnancy and lactation, but as with all medicines caution should be exercised.
Effects on Ability to Drive and Use Machines None
Undesirable Effects None
Overdosage is considered a theoretical possibility but in practice, not a significant hazard with the small level of morphine in the product (40 tablets contain 15.8 mg of morphine HCl, an analgesic dose). Larger doses would cause nausea, vomiting, constipation, drowsiness and confusion. Convulsions may occur in infants and children, Morphine dependence is not considered to be a likely problem with the low doses of morphine present in the product.
Pharmacodynamic properties Pharmacotherapeutic group: Morphine, combinations, ATC code: A07DA52. Morphine acts by antimotility and antisecretory mechanisms on the gastrointestinal tract and is used in the symptomatic treatment of diarrhoea. Attapulgite and activated attapulgite are effective gastro-intestinal adsorbents.
Pharmacokinetic Properties Morphine salts are absorbed from the gastro-intestinal tract. Conjugation to morphine 3- and 6-glucoronides occurs in the liver. About 10% of a dose of morphine is excreted through the bile into the faeces and the remainder is excreted in the urine, mainly as conjugates. Attapulgite and activated attapuigite have a local action in the gastro-intestinal tract. They are insoluble and remain unabsorbed.
Preclinical Safety Data Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product.
List of excipients Icing sugar Paregoric essence Magnesium stearate
Incompatibilities None known.
Shelf Life 3 years.
Special Precautions for Storage None.
Nature and Contents of Container a) b) Polypropylene securitainer with a polyethylene moulded cap and containing a polyether wad. Content: 20 or 40 tablets. Blister strips made of PVC/PVDC coated plastic with aluminium foil backing. Each strip contains 10 tablets. Two or four strips are contained in a boxboard carton.
Instruction for Use/Handling Not applicable.
MARKETING AUTHORISATION HOLDER
SSL International plc Venus, 1 Old Park Lane
Trafford Park, Manchester M41 7HA UK
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATE OF REVISION OF THE TEXT