EX-LAX ^® SENNA PILLS

Each tablet contains senna glycosides 60% 20 mg

(equivalent to sennosides 12 mg)

For excipients see section 6.1

Coated tablets

Circular , biconvex, brownish red sugar coated tablets with approx. 6mm diameter

Relief of constipation

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.

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.

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:

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.

None stated.

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.

None known.

Temporary mild griping may occur.

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.

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.

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).

Not applicable.

Sucrose, lactose monohydrate, maize starch, talc, acacia, titanium dioxide, glucose, stearic acid, gelatin, silica colloidal anhydrous, red iron oxide, carnauba wax

None known.

36 months

Do not store above 25°C

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.

Not applicable.

Novartis Consumer Health UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as Novartis Consumer Health

PL 00030/0148

3 November 2000

8 February 2006

Legal category: GSL