Hamol Senna Tablets

1. Name Of The Medicinal Product

Hamol Senna tablets

Actavis Senna tablets

Senna tablets

2. Qualitative And Quantitative Composition

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

3. Pharmaceutical Form

Tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of occasional or non-persistent constipation.

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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

4.4 Special Warnings And 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.

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

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, 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.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Temporary mild griping may occur during adjustment of the dosage.

4.9 Overdose

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

5. Pharmacological Properties

5.1 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. The tablets act 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. Pharmaceutical Particulars

6.1 List Of Excipients

Calcium phosphate,

Maize starch,

Lactose monohydrate

Magnesium stearate.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Tablets packed in a polypropylene container: five years.

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

6.4 Special Precautions For Storage

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.

6.5 Nature And Contents Of Container

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.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Hamol Limited

103-105 Bath Road

Slough

Berkshire

SL1 3UH

8. Marketing Authorisation Number(S)

PL 01839/0004.

9. Date Of First Authorisation/Renewal Of The Authorisation

12/02/2010

10. Date Of Revision Of The Text

12/02/2010