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HAMOL SENNA TABLETS

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Hamol 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 and 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
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
01/11/2012

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