Boots Dual Action Diarrhoea Relief

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1. Name Of The Medicinal Product

Superdrug Dual Action Diarrhoea Relief

Galpharm Dual Action Diarrhoea Relief

Diocalm Complete

Numark Diarrhoea and Dehydration Relief

Asda Dual Action Diarrhoea Relief

Tesco Dual Action Diarrhoea Relief

Boots Dual Action Diarrhoea Relief

Asda Rehydration Sachets and Anti-Diarrhoea Capsules

2. Qualitative And Quantitative Composition

The sachets contain: Glucose Monohydrate 3.58g

Sodium Chloride 0.47g

Potassium Chloride 0.30g

Sodium Citrate 0.39g

Citric Acid Anhydrous 0.128g

The capsules contain Loperamide Hydrochloride 2mg.

For excipients, see 6.1.

3. Pharmaceutical Form

Powder for oral solution.

A white free-flowing powder mix.

Capsules, hard.

Capsules with blue cap and grey body containing a white to slightly yellow powder.

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic treatment of acute diarrhoea and replacement of associated fluid and electrolyte loss.

4.2 Posology And Method Of Administration

Adults, the elderly and children over 12 years: After the first loose motion, take two capsules followed by the contents of one or two sachets. Then after each subsequent loose motion take one capsule and a further one or two sachets. Do not take more than 6 capsules in 24 hours. Further doses of sachets can be taken after each loose motion, up to a maximum of 16 sachets in 24 hours if necessary.

Not recommended for children under 12 years of age.

Reconstitution of sachets

Reconstitute only with water and ensure the correct amount is used.

The contents of each sachet should be dissolved in 200ml (7 fluid ounces) of fresh drinking water (adults and children). Freshly boiled and cooled water should be used for infants and when fresh water is not available. The solution should be made up immediately before use and used within one hour. If refrigerated the solution may be kept for up to 24 hours.

4.3 Contraindications

The sachets are contraindicated in patients with phenylketonuria or those with hypersensitivity to any of the ingredients.

The capsules are contraindicated in patients with acute ulcerative colitis or pseudomembranous colitis, in those with abdominal distension and where ileus and constipation are present and in children under 12 years of age.

4.4 Special Warnings And Precautions For Use

Sachets: Medical supervision is necessary in the presence of renal disease, including anuria or prolonged oliguria, severe and persistent diarrhoea and vomiting, or inability to drink or retain oral fluids.

Capsules: Should be used with care in patients with severe hepatic disease.

Use should not exceed 24 hours unless advised by a doctor. A doctor should be consulted if diarrhoea is still present after 24 hours treatment. Further investigation into the cause of diarrhoea should be considered if there is no improvement within 2 days of starting treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

The combination product should not be used during pregnancy since loperamide is best avoided during pregnancy. It should be used with caution in lactating women as a small amount of loperamide is excreted in breast milk.

No safety studies on the teratogenicity of loperamide in human pregnancy have been conducted, although studies in animals have not demonstrated any teratogenic effects

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known to occur with the sachets. The following effects have been reported occasionally with the capsules: abdominal pain, dry mouth, dizziness, tiredness and hypersensitivity reactions including skin rashes.

4.9 Overdose

Sachets

If significant overdosage occurs, serum electrolytes should be evaluated. Corrective measures should be carried out and levels monitored until a return to normal levels is achieved.

Capsules

Overdosage of loperamide may result in constipation, paralytic ileus and central nervous depression. Gastric lavage and activated charcoal may be used in the management and if intoxication is suspected naloxone may be given as an antidote.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Rehydration sachets consist of physiological salts and glucose which are used synergistically in solution to aid rehydration. The pharmacodynamic effect is to counter the drop in the extracellular fluid volume and electrolytes in mild to moderate diarrhoea.

Loperamide is an anti-diarrhoeal agent, it inhibits peristalsis and gastro-intestinal secretions. Clinical trials undertaken in patients with acute diarrhoea have demonstrated that following a single 4 mg dose of loperamide, onset of anti-diarrhoeal action was achieved within 1 hour. Comparisons with other anti-diarrhoeal drugs have confirmed the exceptionally rapid onset of action of loperamide.

5.2 Pharmacokinetic Properties

Following partial absorption in the gastro-intestinal tract, loperamide undergoes considerable first-pass metabolism in the liver and is excreted predominantly in the faeces. The elimination half-life is reported to be about 10 hours.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients Sachets: Colloidal Anhydrous Silica   Aspartame (which contains Phenylalanine)   Blackcurrant flavourings. Capsules: Lactose Monohydrate   Maize Starch   Talc   Magnesium Stearate. Capsule Shell is comprised of: Gelatin   Quinoline Yellow (E104)   Erythrosine (E127)   Patent Blue (E131)   Titanium Dioxide (E171). 6.2 Incompatibilities

None stated.

6.3 Shelf Life

Shelf life of product as packaged for sale:

2 years.

Shelf life after reconstitution according to direction:

The reconstituted solution of sachets should be discarded after 1 hour or 24 hours if stored within a refrigerator.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

Reconstituted solution: Can be stored for up to 1 hour at normal room temperature or for up to 24 hours if stored within a refrigerator.

6.5 Nature And Contents Of Container

Single dose foil laminate sachets and an aluminium/PVC blister strip or aluminium / PVC / PVdC blister strip enclosed in an outer carton.

GSL Packs contain 6 sachets and 6 capsules.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Galpharm Healthcare Limited

Hugh House

Upper Cliffe Road

Dodworth Business Park

Dodworth

Barnsley

South Yorkshire

S75 3SP

8. Marketing Authorisation Number(S)

PL 16028/0042

9. Date Of First Authorisation/Renewal Of The Authorisation

12 September 2002 / 20 February 2009

10. Date Of Revision Of The Text

February 2009 (Change to Section 9)

Boots Dual Action Diarrhoea Relief

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