This information is intended for use by health professionals

1. Name of the medicinal product

EX-LAX® SENNA

2. Qualitative and quantitative composition

Each tablet contains 15 mg of sennosides

For Excipients, see section 6.1

3. Pharmaceutical form

Chocolate bar of tablet

4. Clinical particulars
4.1 Therapeutic indications

Relief of occasional constipation

4.2 Posology and method of administration

The following doses are normally taken at bedtime

Adults: 1 tablet

Children 6 and over: ½ tablet

Not recommended for children under 6.

There is no indication that the dosage should be modified for the elderly.

Route: Oral route of administration

4.3 Contraindications

Ex-Lax Senna 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 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 should be used with caution shortly after bowel surgery.

During use of Ex-Lax Senna, 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 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.Prolong, excessive use of laxatives without interruption should be avoided because of the risk of electrolyte imbalance 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 the 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 the 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

Confectionery chocolate comprising:

Cocoa liquor

Sucrose

Cocoa butter

Lecithin

Vanilin

6.2 Incompatibilities

None known

6.3 Shelf life

60 months

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

Bars of 6, 9 and 12 tablets wrapped in paper backed aluminium foil, or aluminium foil, and packed into cartons.

Pack sizes: 6, 9, 12, 18, 24, 36 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

United Kingdom

Trading as Novartis Consumer Health

8. Marketing authorisation number(s)

PL 00030/0131

9. Date of first authorisation/renewal of the authorisation

01 July 1997

10. Date of revision of the text

6 March 2013

GSL