Therapeutic indications
For the symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for up to 5 days in adults and children over 9 years.  For the symptomatic treatment of chronic diarrhoea in adults.  (POM)

For the symptomatic treatment of acute diarrhoea in adults and children over 12 years.  (P and GSL)

For the symptomatic treatment of acute diarrhoea associated with irritable bowel syndrome in adults, previously medically diagnosed.  (P only)

method of administration
For oral administration.

a) Acute diarrhoea

i.  P and POM


Adults, including the elderly and children over 12 years

Two capsules initially followed by 1 capsule after each loose motion, up to a maximum of eight capsules in 24 hours.  The usual dose is 3 to 4 capsules daily.

ii.  POM

1.  Children 9-12 years

One capsule four times daily until diarrhoea is controlled (up to 5 days).

2.  Children under 9 years

Not recommended.

iii.  GSL


Adults, including the elderly and children over 12 years:

Two capsules initially followed by 1 capsule after every loose motion, up to a maximum of six capsules in 24 hours.

b) Chronic diarrhoea in adults and the elderly (POM)

Initially two to four capsules to be taken daily in divided doses depending on severity.  The dose can subsequently be adjusted as necessary up to a maximum of 8 capsules daily.

c) Symptomatic treatment of diarrhoea associated with irritable bowel syndrome in adults and the elderly (P)

Two capsules to be taken initially.  The usual dose is between two and four capsules daily in divided doses, depending on severity.  If necessary, the dose may be increased up to a maximum daily dosage of 8 capsules.



Contraindications
This medicine should not be used in patients hypersensitive to any of the ingredients or in children under 9 years of age.  Loperamide should not be used when inhibition of peristalsis is to be avoided, in particular where ileus or constipation occur and should be avoided in patients with abdominal distension.  Toxic megacolon has occurred in patients with inflammatory bowel disease or pseudomembranous colitis given antidiarrhoeal therapy.  Loperamide should not be used alone in patients with dysentery.

Loperamide should not be used when inflammatory bowel disease is present (GSL).

Special warnings and precautions for use
P and GSL

This medicine should be given with caution to patients with impaired liver function.  Loperamide is for the symptomatic relief of acute diarrhoea and is not a suitable substitute for rehydration therapy.  This product should not be used for prolonged periods.

Keep all medicines out of the reach of children.

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

Ponceau 4R (E124) can cause allergic-type reactions including asthma.  Allergy is more common in those people who are allergic to aspirin.


Also for P use only

If you are an adult taking this medicine to control episodes of diarrhoea associated with irritable bowel syndrome, diagnosed by your doctor, you should seek medical advice if your symptoms continue for more than two weeks or if you need to take this product for more than two weeks.

Diarrhoea is a common presentation of a number of serious gastrointestinal conditions and this medicine should not be used for prolonged periods until the underlying cause for persistent diarrhoea has been investigated

Pregnancy and lactation
The safety of loperamide during pregnancy has not been established and therefore the product should be avoided during this period.

Whilst the fraction of loperamide secreted into breast milk is extremely low, caution is advised if the drug is to be given during lactation.

Undesirable effects
Abdominal pain, nausea, vomiting, constipation, dry mouth, dizziness, fatigue and hypersensitivity reactions, such as skin rashes including urticaria.  Occasionally associated with the development of paralytic ileus and bloating