Senokot Comfort Tablets

1. Name Of The Medicinal Product

SENOKOT COMFORT Tablets

2. Qualitative And Quantitative Composition

Active Substances

Senna Leaf 105.0 mg

Rhubarb Extract 25.0 mg

Wood Charcoal 180.0 mg

Purified Sulphur 50.0 mg

3. Pharmaceutical Form

Tablets for oral administration.

Greyish-black, cylindrical, biconvex tablets

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

Tablets to be taken orally

Adults and elderly

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

Children

Not recommended

4.3 Contraindications

Intestinal obstruction

Hypersensitivity to any product ingredient

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

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose

Maize starch

Talc

Bolus alba (Heavy Kaolin)

Gum Arabic

Peppermint oil

Fennel oil

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

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

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

6.6 Special Precautions For Disposal And Other Handling

None stated.

Administrative Data

7. Marketing Authorisation Holder

Trenka Chem-Pharm Fambrik GmbH

Trading as F.Trenka

A-1040 Wien

Goldeggasse 5

Vienna

Austria

8. Marketing Authorisation Number(S)

PL 11002/0001

9. Date Of First Authorisation/Renewal Of The Authorisation

21 November 2002

10. Date Of Revision Of The Text

06/06/2010