Therapeutic Indications

Adjunct therapy for the dispersal [by dissolution and/or expulsion] of stones in the common bile duct. To be used in combination with chenodeoxycholic acid.

It has been demonstrated that if Rowachol® is combined with either low or medium dose chenodeoxy cholic acid, the gallstone dissolution rate is greater than if the same dose of chenodeoxycholic acid is used alone.

Combined therapy enables a reduced dose of chenodeoxycholic acid to be used and there is therefore a lower incidence of side effects.

Rowachol® increases biliary secretion, relieves spasm of the bile ducts, enhances metabolic liver function, reducing biliary stasis. By inhibiting HMGCOA reductase endogenous cholesterol production is reduced, maintaining the bile above saturation level, assisting dissolution of gallstones and preventing precipitation of further stones.

Posology and Method of Administration

For oral administration only.

Adult Dose: 1-2 capsules three times daily, taken before meals. A dose of one capsule three times daily is recommended at the start of treatment.

Children: There is no recommended dose for children.

Contra-Indications

None known.

Special Warnings and Special Precautions for Use

Conservative medical treatment for stones in the common bile duct should be initiated with the awareness that duct stones can give rise to clinical complications such as obstructive jaundice, ascending cholangitis, pancreatitis, etc. and the physician should be aware of the necessity of being properly informed [particularly in the case of elderly patients] so that appropriate measures can be taken. Keep out of the reach of children.

Interaction with other medicinal products and other forms of interaction

Caution should be used in patients receiving oral anticoagulants or other agents metabolised by the liver where the dose is critical.

Reduced cholesterol intake in diet is advisable.

Pregnancy and lactation

Although no teratogenic effects have been reported, Rowachol® should not be given in the first trimester of pregnancy. Although no evidence is available, Rowachol® should not be given to lactating females.

Effects on ability to drive and use machines

None.

Undesirable effects

Side effects are uncommon and minor. A small number of patients have noted eructation and a peppermint taste after meals. This can be reduced or avoided by administration of drug on an empty stomach thirty minutes before meals. An insignificant number of patients noted soreness of mouth and buccal ulceration – an effect which can be rapidly reverted by discontinuation of the drug.

Overdose

If medication has been recently ingested, the stomach should be emptied by gastric lavage. Observation should be carried out with symptomatic treatment if necessary.

Monitoring of cardiac, respiratory, renal and hepatic functions are advised. Toxicology experiments in animals suggest that massive doses of essential oils may result in CNS depression leading to stupor and respiratory failure or stimulation leading to excitement and convulsions.

Gastric irritation may occur leading to nausea, vomiting and diarrhoea.