De-Noltab
SUMMARY OF PRODUCT CHARACTERISTICS
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.
5.1 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
Aluminium foil strips, containing 112 tablets
6.6 Special precautions for disposal
None
MARKETING AUTHORISATION HOLDER
7
Astellas Pharma Ltd.
2000 Hillswood Drive
Chertsey
Surrey
KT16 0RS
UK
8 MARKETING AUTHORISATION NUMBER
PL 00166/0124
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/01/2007
10 DATE OF REVISION OF THE TEXT
11/12/2012