1. Name Of The Medicinal Product
EX-LAX ® SENNA PILLS
2. Qualitative And Quantitative Composition
Each tablet contains senna glycosides 60% 20 mg
(equivalent to sennosides 12 mg)
For excipients see section 6.1
3. Pharmaceutical Form
Coated tablets
Circular , biconvex, brownish red sugar coated tablets with approx. 6mm diameter
4. Clinical Particulars
4.1 Therapeutic Indications
Relief of constipation
4.2 Posology And Method Of Administration
The following doses are normally taken at bedtime
Adults and children over 12: 1 tablet
A second dose may be taken during the day if required. Do not exceed two doses in any 24 hours.
Not recommended for children under 12.
There is no indication that the dosage should be modified for the elderly.
Route:
Oral route of administration.
4.3 Contraindications
Ex-Lax Senna Pills should not be used when intestinal obstruction, bleeding or persistent abdominal symptoms are present.
Not recommended in cases of ileostomy or colostomy.
4.4 Special Warnings And Precautions For Use
Prolonged use is not recommended. Ex-Lax Senna Pills should not be used for more than 7 days without seeking medical advice.
Label/leaflet precaution:
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If a laxative is needed every day or there is persistent abdominal pain - consult your doctor.
If there is no bowel movement after 3 days consult your doctor.
Ex-Lax Senna Pills should be used with caution shortly after bowel surgery.
During use of Ex-Lax Senna Pills, an adequate level of fluid intake should be maintained.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None stated.
4.6 Pregnancy And Lactation
No known adverse effects during pregnancy.
Clinical studies have shown that the breast fed infants of mothers taking a senna laxative did not show any side effects to the drug.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Temporary mild griping may occur.
4.9 Overdose
Overdosage may result in diarrhoea with excessive loss of water and electrolytes, particularly potassium. Treatment should include an increase in fluid intake to reverse the loss of fluid and electrolytes.
Prolonged, excessive use of laxatives without interruption should be avoided because of the risk of electrolyte imbalances and in extreme cases the possibility of irreversible adverse effects on the bowel.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Senna is an anthraquinone laxative which is used to treat constipation and for bowel evacuation before radiological procedures. The active anthraquinones are liberated into the colon from glycosides by colonic bacteria and an effect usually occurs 6 to 12 hours after administration.
5.2 Pharmacokinetic Properties
There is some absorption of the anthraquinones from senna preparations following hydrolysis by colonic bacteria. Excretion occurs in the urine and faeces and also in other secretions including milk.
(Although anthraquinone derivatives may be excreted in the milk of lactating mothers, following normal dosage the concentration is usually insufficient to affect the nursing infant).
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sucrose, lactose monohydrate, maize starch, talc, acacia, titanium dioxide, glucose, stearic acid, gelatin, silica colloidal anhydrous, red iron oxide, carnauba wax
6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 25°C
6.5 Nature And Contents Of Container
Blister pack composed of PVC/PVdC blisters sealed with aluminium foil.
Pack sizes: 6, 9, 10, 12, 18, 20, 24, 30, 36, 40 or 48 tablets.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Novartis Consumer Health UK Ltd
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
Trading as Novartis Consumer Health
8. Marketing Authorisation Number(S)
PL 00030/0148
9. Date Of First Authorisation/Renewal Of The Authorisation
3 November 2000
10. Date Of Revision Of The Text
8 February 2006
Legal category: GSL
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