This information is intended for use by health professionals
Tri-potassium di-citrato bismuthate equivalent to 120mg Bi2
For the treatment of gastric and duodenal ulcers.
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; De-Noltab should not be used for maintenance therapy.
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.
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.
No other medicines, food or drink, in particular antacids, milk, fruit or fruit juices, should be consumed within half an hour before or after a dose of De-Nol as they may influence its effect. The efficacy of oral tetracyclines may be inhibited.
On theoretical grounds De-Noltab is contraindicated in pregnancy. No information is available on excretion in breast milk.
| System Organ Class
|| 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
Extremely few cases of overdosage have been reported; contact the company for further information.
The active constituent exerts a local healing effect at the ulcer site, and by eradication or reduction of Helicobacter pylori
The action is local in the gastro-intestinal tract.
No relevant pre-clinical safety data has been generated.
Povidone K 30
Amber glass bottles and/or aluminium foil strips, containing 112 tablets
Astellas Pharma Ltd.
2000 Hillswood Drive
1 December 1986;11th