SENOKOT TABLETS
Active substance: SENNA PODS POWDERED
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Senokot Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 154mg of senna fruit, equivalent to 7.5mg hydroxyanthracene glycosides, calculated as sennoside B. Also contains lactose monohydrate (15.82mg per tablet) For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
4
4.1
CLINICAL PARTICULARS
Therapeutic indications 500 or 1000 Tablet (Dispensing) Pack For the management of constipation All Other Packs For the relief of occasional or non-persistent constipation
4.2
Posology and method of administration Senokot Tablets are for oral administration 500 or 1000 Tablets (Dispensing) Pack For the management of constipation Adults, including elderly and children over 12: Two to four tablets Children over 6: One to two tablets Children 6 and under: Not recommended 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 dosage should be reduced and can usually be stopped. All Other Packs For the relief of occasional and non-persistent constipation Adults, including elderly and children over 12: Two tablets taken at night
4.3
Children over 6: Consult your doctor Children under 6: Not recommended Contraindications Senokot Tablets should not be given when any undiagnosed acute or persistent abdominal symptoms are present. Special warnings and precautions for use If there is no bowel movement after three days, consult your doctor. If laxatives are needed every day, or abdominal pain persists, consult your doctor. The product contains lactose. One tablet contains 15.82mg lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.4
4.5
Interaction with other medicinal products and other forms of interaction None known Pregnancy and lactation There is some evidence for the safety of senna in human pregnancy and it has been in use for many years without apparent ill-consequence. If laxative treatment is required during pregnancy, Senokot Tablets may be used. Clinical studies have shown that breast-fed infants of mothers taking Senokot did not show any side-effects to the drug. Effects on ability to drive and use machines None known Undesirable effects Temporary mild griping may occur during adjustment of the dosage. Overdose Where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit drinks, should be given.
4.6
4.7
4.8
4.9
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. Senna acts in 8-12 hours. Pharmacokinetic properties The action of the sennosides is colon specific and does not depend upon systemic absorption.
5.2
5.3
Preclinical safety data No preclinical findings of relevance to the prescriber have been reported.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Calcium phosphate, maize starch, DC lactose and magnesium stearate Incompatibilities None known Shelf life Tablets in a polypropylene container: five years Tablets packed in uPVC/PVdC/foil blisters: three years Special precautions for storage For tablets in a polypropylene container: store below 30oC For tablets packed in uPVC/PVdC/foil blisters: store below 25oC Store in the original package Also for polypropylene container: replace cap firmly after use Nature and contents of container 50, 100, 200, 500 or 1000 tablets in a polypropylene container with a snap-fit lid 6, 8, 10, 12, 20, 40, 60, 80 or 100 tablets packed in uPVC/PVdC/foil blisters, contained in a carton.
6.2
6.3
6.4
6.5
6.6
Special precautions for disposal Not applicable
7
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS
8
MARKETING AUTHORISATION NUMBER
PL 00063/5000R
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/03/1987 / 15/07/2005
10
DATE OF REVISION OF THE TEXT
02/07/2009
1
NAME OF THE MEDICINAL PRODUCT
Senokot Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 154mg of senna fruit, equivalent to 7.5mg hydroxyanthracene glycosides, calculated as sennoside B. Also contains lactose monohydrate (15.82mg per tablet) For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
4
4.1
CLINICAL PARTICULARS
Therapeutic indications 500 or 1000 Tablet (Dispensing) Pack For the management of constipation All Other Packs For the relief of occasional or non-persistent constipation
4.2
Posology and method of administration Senokot Tablets are for oral administration 500 or 1000 Tablets (Dispensing) Pack For the management of constipation Adults, including elderly and children over 12: Two to four tablets Children over 6: One to two tablets Children 6 and under: Not recommended 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 dosage should be reduced and can usually be stopped. All Other Packs For the relief of occasional and non-persistent constipation Adults, including elderly and children over 12: Two tablets taken at night
4.3
Children over 6: Consult your doctor Children under 6: Not recommended Contraindications Senokot Tablets should not be given when any undiagnosed acute or persistent abdominal symptoms are present. Special warnings and precautions for use If there is no bowel movement after three days, consult your doctor. If laxatives are needed every day, or abdominal pain persists, consult your doctor. The product contains lactose. One tablet contains 15.82mg lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.4
4.5
Interaction with other medicinal products and other forms of interaction None known Pregnancy and lactation There is some evidence for the safety of senna in human pregnancy and it has been in use for many years without apparent ill-consequence. If laxative treatment is required during pregnancy, Senokot Tablets may be used. Clinical studies have shown that breast-fed infants of mothers taking Senokot did not show any side-effects to the drug. Effects on ability to drive and use machines None known Undesirable effects Temporary mild griping may occur during adjustment of the dosage. Overdose Where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit drinks, should be given.
4.6
4.7
4.8
4.9
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. Senna acts in 8-12 hours. Pharmacokinetic properties The action of the sennosides is colon specific and does not depend upon systemic absorption.
5.2
5.3
Preclinical safety data No preclinical findings of relevance to the prescriber have been reported.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Calcium phosphate, maize starch, DC lactose and magnesium stearate Incompatibilities None known Shelf life Tablets in a polypropylene container: five years Tablets packed in uPVC/PVdC/foil blisters: three years Special precautions for storage For tablets in a polypropylene container: store below 30oC For tablets packed in uPVC/PVdC/foil blisters: store below 25oC Store in the original package Also for polypropylene container: replace cap firmly after use Nature and contents of container 50, 100, 200, 500 or 1000 tablets in a polypropylene container with a snap-fit lid 6, 8, 10, 12, 20, 40, 60, 80 or 100 tablets packed in uPVC/PVdC/foil blisters, contained in a carton.
6.2
6.3
6.4
6.5
6.6
Special precautions for disposal Not applicable
7
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS
8
MARKETING AUTHORISATION NUMBER
PL 00063/5000R
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/03/1987 / 15/07/2005
10
DATE OF REVISION OF THE TEXT
02/07/2009
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.
