Diocalm

1. Name Of The Medicinal Product

Diocalm Tablets

2. Qualitative And Quantitative Composition

Morphine Hydrochloride 0.395mg

Activated Attapulgite 312.5mg

Attapulgite 187.5mg

For excipients, see 6.1.

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of occasional diarrhoea and its associated pain and discomfort.

4.2 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: 2 tablets.

Children aged 6 to under 12 years: 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.

4.3 Contraindications

Patients with impaired renal function.

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Labelling:

Warning: Do not exceed the stated dose.

Keep out of reach of children.

If symptoms persist for more than 24 hours, consult your doctor.

As well as taking Diocalm, it is important to replace body fluids lost during diarrhoea.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None.

4.6 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.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None.

4.9 Overdose

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 15.8mg of morphine hydrochloride, 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.

5. Pharmacological Properties

5.1 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 gastrointestinal adsorbents.

5.2 Pharmacokinetic Properties

Morphine salts are absorbed from the gastrointestinal 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 attapulgite have a local action in the gastrointestinal tract. They are insoluble and remain unabsorbed.

5.3 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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Icing Sugar

Paregoric Essence

Magnesium Stearate.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

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.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

SSL International PLC. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 17905/0048

9. Date Of First Authorisation/Renewal Of The Authorisation

31/01/06

10. Date Of Revision Of The Text

23/01/07