This information is intended for use by health professionals

1. Name of the medicinal product

DE-NOLTAB

2. Qualitative and quantitative composition

Tri-potassium di-citrato bismuthate equivalent to 120mg Bi2O3

3. Pharmaceutical form

Film-coated tablet

4. Clinical particulars
4.1 Therapeutic indications

For the treatment of gastric and duodenal ulcers.

4.2 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; De-Noltab should not be used for maintenance therapy.

For children:

Not recommended.

4.3 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.

4.4 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.

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6 Pregnancy and lactation

On theoretical grounds De-Noltab is contraindicated in pregnancy. No information is available on excretion in breast milk.

4.7 Effects on ability to drive and use machines

None reported.

4.8 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

4.9 Overdose

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

5. Pharmacological properties
5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

The action is local in the gastro-intestinal tract.

5.3 Preclinical safety data

No relevant pre-clinical safety data has been generated.

6. Pharmaceutical particulars
6.1 List of excipients

Povidone K 30

Polacrillin potassium

Macrogol 6000

Magnesium stearate

Maize starch

Hypromellose

6.2 Incompatibilities

None

6.3 Shelf life

Four years

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

Amber glass bottles and/or aluminium foil strips, containing 112 tablets

6.6 Special precautions for disposal and other handling

None

7. Marketing authorisation holder

Astellas Pharma Ltd.

2000 Hillswood Drive

Chertsey

Surrey

KT16 0RS

United Kingdom

8. Marketing authorisation number(s)

PL0166/0124

9. Date of first authorisation/renewal of the authorisation

1 December 1986;11th January 2007.

10. Date of revision of the text

17 September 2012

11. Legal category

P