Senokot Syrup Pharmacy.

The syrup contains sennosides USP equivalent to a total sennoside content (calculated as sennoside B) of 7.5 mg per 5 ml.

For excipients, see Section 6.1.

Syrup.

In the management of constipation.

Senokot Syrup Pharmacy is for oral administration.

Adults, including the elderly and children over 12: Two to four 5 ml spoonfuls at night.

Children over 6 years: One to two 5 ml spoonfuls in 24 hours.

Children aged 2 to 6 years: Half to one 5 ml spoonful in 24 hours.

New users should start the lowest dose and increase, if necessary, by one half of the initial dose each day. Once regularity has been regained the dosage should be reduced and can usually be stopped.

If no bowel action has occurred after three days of progressively increased dosage, a medical examination should be considered.

Senokot Syrup Pharmacy should not be given when any undiagnosed acute or persistent abdominal symptoms are present.

If there is no bowel movement after three days consult a doctor.

If laxatives are needed every day or abdominal pain persists consult a doctor.

Each 5 ml of syrup can provide up to 3.2 kcal and this should be taken into account when treating diabetics.

None known.

There is some evidence for the safety of senna derived products in human pregnancy which have been in use for many years without apparent ill-consequence. If laxative treatment is required during pregnancy Senokot Syrup Pharmacy may be used. Clinical studies have shown that breast-fed infants of mothers taking senna derived products did not show any significant side-effects.

None known.

Temporary mild griping may occur during adjustment of the dosage. Hypersensitivity reactions associated with the esters of hydroxybenzoates (parabens) may occur.

Where diarrhoea is severe conservative measures are usually sufficient; generous amounts of fluid, especially fruit drinks, should be given.

The sugar moiety of the sennosides is removed by bacteria in the large intestine releasing the active anthrone fraction. This stimulates peristalsis via the submucosal and myenteric nerve plexuses. Sennosides act in 8 – 12 hours.

The action of the sennosides is colon specific and does not depend upon systemic absorption.

No preclinical findings of relevance to the prescriber have been reported.

Potassium sorbate

Methyl parahydroxybenzoate

Propyl parahydroxybenzoate

Maltitol syrup

Xanthan gum

Anti-foam emulsion

Prune flavour

Citric acid

Purified water

None known.

18 months.

Do not store above 25°C. Do not freeze.

Glass bottle with a polypropylene cap with a polyethylene tamper-evident band with an expanded polyethylene wad containing 500 ml syrup.

No special instructions.

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.

United Kingdom

PL 00063/0129

13/10/2009

13/10/2009