SENOKOT MAX STRENGTH
Active substance: SENNA PODS POWDERED
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Senokot Max Strength.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The tablets contain standardised senna pods equivalent to a total sennoside content (calculated as sennoside B) of 15mg. For excipients see 6.1.
3
PHARMACEUTICAL FORM
Tablets.
4. 4.1.
CLINICAL PARTICULARS Therapeutic Indications For the relief of occasional or non-persistent constipation.
4.2.
Posology and Method of Administration Route of administration Oral. Dosage Adults, including elderly and children over 12: 1 tablet taken at night. Children 12 and under: Consult your doctor.
4.3.
Contra-Indications Senokot Max Strength tablets should not be given when any undiagnosed acute or persistent abdominal symptoms are present.
4.4.
Special Warnings and Special 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.
4.5. Interactions with other Medicinal Products and other Forms of Interaction None stated.
4.6.
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, the product may be used. Clinical studies have shown that breast-fed infants of mothers taking Senokot did not show any side-effects to the drug.
4.7.
Effects on Ability to Drive and Use Machines None stated.
4.8.
Undesirable Effects Temporary mild griping 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. Senna acts 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 Calcium phosphate Maize starch Lactose monohydrate (DC) Magnesium stearate
6.2.
Incompatibilities None known.
6.3.
Shelf life Two years.
6.4.
Special precautions for storage Do not store above 30C. Store in the original package.
6.5.
Nature and contents of container 12, 24 or 48 tablets packed in UPVC/PVDC/Foil blisters, contained in a carton.
6.6.
Instruction for use and handling Not applicable
7.
MARKETING AUTHORISATION HOLDER Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS United Kingdom
8.
MARKETING AUTHORISATION NUMBER PL 00063/0118
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/06/2007
10
DATE OF REVISION OF THE TEXT
19/06/2007
1
NAME OF THE MEDICINAL PRODUCT
Senokot Max Strength.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The tablets contain standardised senna pods equivalent to a total sennoside content (calculated as sennoside B) of 15mg. For excipients see 6.1.
3
PHARMACEUTICAL FORM
Tablets.
4. 4.1.
CLINICAL PARTICULARS Therapeutic Indications For the relief of occasional or non-persistent constipation.
4.2.
Posology and Method of Administration Route of administration Oral. Dosage Adults, including elderly and children over 12: 1 tablet taken at night. Children 12 and under: Consult your doctor.
4.3.
Contra-Indications Senokot Max Strength tablets should not be given when any undiagnosed acute or persistent abdominal symptoms are present.
4.4.
Special Warnings and Special 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.
4.5. Interactions with other Medicinal Products and other Forms of Interaction None stated.
4.6.
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, the product may be used. Clinical studies have shown that breast-fed infants of mothers taking Senokot did not show any side-effects to the drug.
4.7.
Effects on Ability to Drive and Use Machines None stated.
4.8.
Undesirable Effects Temporary mild griping 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. Senna acts 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 Calcium phosphate Maize starch Lactose monohydrate (DC) Magnesium stearate
6.2.
Incompatibilities None known.
6.3.
Shelf life Two years.
6.4.
Special precautions for storage Do not store above 30C. Store in the original package.
6.5.
Nature and contents of container 12, 24 or 48 tablets packed in UPVC/PVDC/Foil blisters, contained in a carton.
6.6.
Instruction for use and handling Not applicable
7.
MARKETING AUTHORISATION HOLDER Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS United Kingdom
8.
MARKETING AUTHORISATION NUMBER PL 00063/0118
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/06/2007
10
DATE OF REVISION OF THE TEXT
19/06/2007
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.
