Diocalm Ultra Capsules

1. Name Of The Medicinal Product

Diocalm Ultra Capsules.

2. Qualitative And Quantitative Composition

Loperamide Hydrochloride Ph Eur 2.0mg / capsule.

3. Pharmaceutical Form

Capsule.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic treatment of acute diarrhoea.

4.2 Posology And Method Of Administration

Oral. Adults and children aged 12 years and over:

P classification: Two capsules immediately, followed by one capsule after each further bout of diarrhoea up to a maximum of eight capsules in any 24 hours.

GSL classification: Two capsules immediately, followed by one capsule after each further bout of diarrhoea up to a maximum of six capsules in any 24 hours.

Not to be given to children under 12 years.

4.3 Contraindications

Hypersensitivity to the active ingredient. Conditions where inhibition of peristalsis is to be avoided, e.g. diverticular disease and ulcerative colitis.

4.4 Special Warnings And Precautions For Use

This product should be used with caution in cases of impaired liver function.

GSL Classification: Patients suffering Irritable Bowel Syndrome should not use this product. The first line of treatment in acute diarrhoea is the prevention or treatment of fluid and electrolyte depletion; this is of particular importance to frail and elderly patients.

The following will appear on the product labeling (P or GSL): Warning: do not exceed the stated dose. Keep out of reach of children. If symptoms persist for more than 24 hours consult your doctor. If you are pregnant, consult your doctor before use. This medicine is for the relief of the symptoms of diarrhoea and is not a substitute for oral rehydration therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

No teratogenic effects have been shown in animals. However safety in humans has not been established and the product should only be taken under medical supervision. Caution is advised during lactation.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Rarely, skin rashes, including urticaria, have been reported.

4.9 Overdose

The following effects may be observed in cases of overdose: constipation, ileus and neurological symptoms. Treatment would be symptomatic. In severe overdose, naloxone can be given as an antidote if required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

By binding to opiate receptors in the gut wall, loperamide hydrochloride reduces propulsive peristalsis, increases intestinal transit time and enhances resorption of water and electrolytes.

5.2 Pharmacokinetic Properties

Following partial absorption in the gastrointestinal tract, loperamide undergoes first-pass metabolism in the liver and is excreted predominantly in the faeces. The elimination half-life is reported as about ten hours.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose (DMV), Maize Starch (Dried), Microcrystalline Cellulose (Avicel PH101), Pregelatinised Starch (Dried), Croscarmellose Sodium, Dimeticone. Shell cap: Yellow Iron Oxide (E172), Black Iron Oxide (E172), Indigo Carmine (E132), Titanium Dioxide (E171), Gelatin. Shell body: Titanium Dioxide (E171), Gelatin.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Clear blisters of hard polyvinylchloride 250µm thick backed with aluminium foil 0.02 hard silver, smooth shiny-sided hot sealable against PVC and PVdC dull sided unprinted. 6 or 12 capsules per strip are packed in a cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

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

8. Marketing Authorisation Number(S)

PL 17905/0049

9. Date Of First Authorisation/Renewal Of The Authorisation

23/03/06

10. Date Of Revision Of The Text

23/03/06