Senokot 7.5 mg / 5 ml Syrup

1. Name Of The Medicinal Product

Senokot 7.5 mg/5 ml Syrup.

2. Qualitative And Quantitative Composition

Each 5 ml of Senokot Syrup contains calcium sennosides equivalent to 7.5 mg per 5 ml total sennosides (calculated as sennoside B).

3. Pharmaceutical Form

Syrup.

Amber, slightly viscous liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

As a laxative for the relief of occasional or non-persistent constipation.

4.2 Posology And Method Of Administration

Senokot 7.5 mg/5 ml Syrup is for oral administration.

Adults, including the elderly and children over 12: Two 5 ml spoonfuls.

Not to be given to children under 12 years except on medical advice. Where administration to children is necessary, the recommended dose is as follows.

Children over 6 years: One 5 ml spoonful.

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

Senokot should be taken as a single dose at bedtime by adults and in the morning by children.

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

4.3 Contraindications

Senokot 7.5 mg/5 ml Syrup should not be given when any undiagnosed acute or persistent abdominal symptoms are present.

4.4 Special Warnings And Precautions For Use

Not to be given to children except on medical advice.

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.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

The Physician should be satisfied that there is no underlying gastro intestinal pathology masking as constipation before recommending this product. Enquiry should be made about bowel habit, (particularly recent changes in bowel habit such as persistent diarrhoea or constipation), evacuation and bleeding per rectum.

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 illconsequence. If laxative treatment is required during pregnancy Senokot 7.5 mg/5 ml Syrup may be used.

Anthraquinones are excreted into breast milk, but 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 E202

Methyl parahydroxybenzoate E218

Propyl parahydroxybenzoate E216

Maltitol liquid E965

Xanthan gum

Anti-foam (Medical C) emulsion

Prune flavour

Citric acid anhydrous

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Eighteen 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 100, 150 or 200 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 00063/0123.

9. Date Of First Authorisation/Renewal Of The Authorisation

8^th April 2005

10. Date Of Revision Of The Text

11/04/2007