Tripotassium dicitratobismuthate

Overdose

Extremely few cases of overdosage have been reported; contact the company for further information.

Contraindications

In cases of severe renal insufficiency.

Harmful to people on a low potassium diet.

Hypersensitivity to the active substance(s) or to any of the excipients.

Incompatibilities

None

Undesirable effects

System Organ Class

Common

>1/100, <1/10

Uncommon

>1/1000, <1/100

Very rare

<1/10,000, Not known (cannot be estimated from the available data)

Immune system disorders

anaphylactic reaction

Gastrointestinal disorders

blackening of the stool

nausea, vomiting, constipation, diarrhoea

Skin and subcutaneous tissue disorders

rash, pruritus

Preclinical safety data

No relevant pre-clinical safety data has been generated.

Therapeutic indications

For the treatment of gastric and duodenal ulcers.

Pharmacodynamic properties

The active constituent exerts a local healing effect at the ulcer site, and by eradication or reduction of Helicobacter pylori defers relapse.

Pharmacokinetic properties

The action is local in the gastro-intestinal tract.

Name of the medicinal product

Tripotassium Dicitratobismuthate

Qualitative and quantitative composition

Bismuthate Tripotassium Dicitrate

Special warnings and precautions for use

Prolonged use of high doses of bismuth compounds is not recommended because this has occasionally led to reversible encephalopathy. It is, not advisable to take other bismuth-containing drugs concomitantly.

Contains approximately 2 mmol (approximately 40 mg) potassium per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Effects on ability to drive and use machines

None reported.

Dosage (Posology) and method of administration

For Adults, and the Elderly:

One tablet to be taken four times a day, half an hour before each of the three main meals and two hours after the last meal of the day, or

Two tablets to be taken twice daily, half an hour before breakfast and half an hour before the evening meal, or

As directed by the physician

The maximum duration for one course of treatment is two months; Tripotassium Dicitratobismuthatetab should not be used for maintenance therapy.

For children:

Not recommended.

Special precautions for disposal and other handling

None