SENOKOT SYRUP PHARMACY
Active substance: SENNOSIDES
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SUMMARY OF PRODUCT CHARACTERISTICS
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
4.1
CLINICAL PARTICULARS
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: spoonfuls at night. Two to four 5 ml
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 illconsequence. 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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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
13 months.
6.4
Special precautions for storage Do not store above 25C. 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 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
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
4.1
CLINICAL PARTICULARS
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: spoonfuls at night. Two to four 5 ml
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 illconsequence. 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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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
13 months.
6.4
Special precautions for storage Do not store above 25C. 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 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
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
