Senokot Syrup

1. Name Of The Medicinal Product

Senokot Syrup Pharmacy.

2. Qualitative And Quantitative Composition

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.

3. Pharmaceutical Form

Syrup.

4. Clinical Particulars

4.1 Therapeutic Indications

In the management of constipation.

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Potassium sorbate

Methyl parahydroxybenzoate

Propyl parahydroxybenzoate

Maltitol syrup

Xanthan gum

Anti-foam emulsion

Prune flavour

Citric acid

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

18 months.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0129

9. Date Of First Authorisation/Renewal Of The Authorisation

13/10/2009

10. Date Of Revision Of The Text

13/10/2009