SENOKOT COMFORT Tablets

Active Substances

Senna Leaf 105.0 mg

Rhubarb Extract 25.0 mg

Wood Charcoal 180.0 mg

Purified Sulphur 50.0 mg

Tablets for oral administration.

Greyish-black, cylindrical, biconvex tablets

Senokot Comfort is a traditional remedy for the symptomatic relief of occasional constipation

Tablets to be taken orally

Adults and elderly

1-2 tablets at or after meals with some liquid.

Children

Not recommended

Intestinal obstruction

Hypersensitivity to any product ingredient

Senokot Comfort tablets should not be given when any undiagnosed acute or persistent abdominal symptoms are present.

Patients with persistent symptoms and those with abdominal pain or vomiting should consult their doctor.

In the case of suspected stomach or intestinal ulcers, appendicitis and intestinal obstruction any kind of laxative is to be avoided.

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.

None known.

Use of Senokot Comfort Tablets is not recommended during pregnancy and lactation, unless on a physician's advice it is concluded that the benefits outweigh the potential risks.

None known.

Excess dosage may cause diarrhoea and disturbed fluid and electrolyte balance. This could reduce, as an example, the tolerance of digitalis compounds.

Overdosage may lead to diarrhoea and, as such, treatment should consist of supportive and symptomatic measures including correction of any fluid or electrolyte imbalance.

The mode of action and effectiveness of the natural constituents of Senokot Comfort tablets are well known. Senokot Comfort tablets contain only vegetable and mineral ingredients which provide a mild laxative, carminative, and adsorbent action.

The effect of this multi-compound is spread throughout the gastro-intestinal tract, therefore a broad basis for activity is provided.

Sulphur acts in the small intestine and the anthraquinone derivatives of rhubarb and senna act in the large intestine. Apart from the purging effect Senokot Comfort has an adsorbing attribute due to the vegetable charcoal, which is deliberately used instead of activated charcoal since the latter is a very strong adsorbent and would cancel the overall effectiveness of the other ingredients of Senokot Comfort.

Senokot Comfort stimulates the entire digestive system and is recommended for constipation, as a stool softener where haemorrhoids etc. can cause pain on defecation.

Not applicable since the product acts locally in the GI tract.

The active ingredients of Senokot Comfort have been used extensively over many years and are well established. No relevant pre-clinical data are therefore available.

Sucrose

Maize starch

Talc

Bolus alba (Heavy Kaolin)

Gum Arabic

Peppermint oil

Fennel oil

None known.

5 years.

Do not store above 25°C. Store in the original container.

250µ PVC/PVdC-blister packs with 20µ aluminium foil/circular shallow tins.

Blister strips of 20, 30 tablets, tins of 100 tablets.

None stated.

Trenka Chem-Pharm Fambrik GmbH

Trading as F.Trenka

A-1040 Wien

Goldeggasse 5

Vienna

Austria

PL 11002/0001

21 November 2002

06/06/2010