Senokot 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.
6.1. 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
13 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. Instructions for use and handling (, and disposal)
No special instructions.
6.6. Special precaution for disposal
No special requirements.
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
8th April 2005
10 DATE OF REVISION OF THE TEXT
05/11/2012