Hamol Senna tablets

Actavis Senna tablets

Senna tablets

Each tablet contains 154 mg of Senna fruit, equivalent to 7.5 mg hydroxyanthracene glycosides, calculated as sennoside B

Also contains lactose monohydrate (15.82 mg per tablet)

For full list of excipients, see section 6.1

Tablets.

For the relief of occasional or non-persistent constipation.

These tablets are for oral administration.

Adults, including elderly and children over 12: Two tablets taken at night.

Children over 6: Consult your doctor.

Children under 6: Not recommended.

This product should not be given when any undiagnosed acute or persistent abdominal symptoms are present.

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 15.82 mg lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

None known.

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, this product may be used. Clinical studies have shown that breast-fed infants of mothers taking this product did not show any side-effects to the drug.

None known.

Temporary mild griping may occur during adjustment of the dosage.

Where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit drinks, should be given.

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. The tablets act in 8-12 hours.

The action of the sennosides is colon specific and does not depend upon systemic absorption.

No preclinical findings of relevance to the prescriber have been reported.

Calcium phosphate,

Maize starch,

Lactose monohydrate

Magnesium stearate.

None known.

Tablets packed in a polypropylene container: five years.

Tablets packed in uPVC/PVdC/foil blisters: three years.

For tablets in a polypropylene container: store dry below 30°C. Replace cap firmly after use.

For tablets packed in uPVC/PVdC/foil blisters: store dry below 25°C.

Store in the original package to protect from moisture.

50, 100, 200 tablets in a polypropylene container with a snap-fit lid.

10, 20, 40, 60, 80 or 100 tablets packed in uPVC/PVdC/foil blisters, contained in a carton.

Not applicable.

Hamol Limited

103-105 Bath Road

Slough

Berkshire

SL1 3UH

PL 01839/0004.

12/02/2010

12/02/2010