ULCERONE® SOLUTION

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

ULCERONE® SOLUTION

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ULCERONE^® SOLUTION

COMPOSITION:
Each 5 mL contains Tri-potassium di-citrato Bismuthate-III equivalent to 120 mg Bi203 with buffers, stabilisers, flavours, colouring and excipient.
Preserved with 0,1% m/v Nipacombin A.

PHARMACOLOGICAL CLASSIFICATION:
A11.10 Medicines acting on Gastro-Intestinal Tract (Special Combinations)

PHARMACOLOGICAL ACTION:
The active ingredient of Ulcerone is a colloidal bismuth hydrosol which has the ability to combine with the necrotic protein material oozing from the ulcer bed and form a Bismuth-protein chelate over the ulcer base (surface). Due to the affinity of the Bismuth ion for granulating tissue this Bismuth-protein chelate complex is held in position until the ulcer has healed at which stage it will break up and slough away. Recent studies also indicate that Ulcerone exerts, in addition, a strong mucous-stimulating effect on the duodenal mucosa. Note: Due to its strong intra-molecular bonding, the Bismuth-protein chelate is insoluble in gastric and duodenal secretions and impervious to the passage of food chyme over it. The patient is, therefore, able to relax all dietary restrictions from the 4th day of treatment onwards avoiding only strong condiments and those foods known from experience to be particularly irritating in each case.

INDICATIONS:
Peptic ulcers including gastric and duodenal ulcers. Post-operative ulcers. Peptic ulcers associated with hiatus hernia.

CONTRA-INDICATIONS:

(i)	Severe renal insufficiency.
(ii)	Insufficient data is available to judge the possible teratogenic effect of colloidal bismuth compounds. Ulcerone should therefore not be administered during pregnancy.

WARNING:
There exists the possibility of neurotoxicity with prolonged or excessive use of medicines containing Bismuth.
Keep out of the reach of children.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
One to two 5 mL medicine measures in 15 mL water, three times a day on an empty stomach half-an-hour before meals and a 4th dose at night, 2 hours after the evening meal. No liquids or food to be taken for at least half-an-hour before or after each dose.

Children (under 12 years):
Half a 5 mL medicine measure in 15 mL of water three times a day on an empty stomach either half-an-hour before meals or 2 hours after meals. No liquids or foods to be taken for at least half-an-hour before or after each dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The use of Ulcerone during the acute stage of gastritis or duodenitis may cause an increase in pain, nausea and/or vomiting especially during the early stages of treatment.

(a)	In mild cases the dosage should be reduced to half a 5 mL medicine measure of Ulcerone in 15 mL water at the specified times for 3-4 days or until symptoms have been relieved. Then revert to the normal dosage outlined above.
(b)	In severe cases, discontinue treatment with Ulcerone and treat the gastritis with Gastrinol^® or any other suitable regimen such as light diet anti-spasmodic and antacid therapy. Once symptoms have been relieved, recommence treatment using half a 5 mL medicine measure of Ulcerone in 15 mL water at the specified times for 3-4 days before increasing to the normal dose (see dosage).

Note:

(a)	It is normal for Ulcerone to blacken the stool during therapy, owing to the formation of variable amounts of Bismuth Sulphide in the bowel. Patients should be advised thereof to avoid misapprehension of melaena. Discolouration of the stools may easily be distinguished from melaena with the usual tests.
(b)	Darkening of the tongue and gum-line has been reported. This is only transient and disappears after treatment has been completed.
(c)	Ulcerone may harden the stool and cause constipation in some cases. This may be corrected by prescribing a mild contact laxative last thing at night until relieved.
(d)	Reduced absorption and lowered blood levels of tetracyclines may be experienced if administered concomitantly with Ulcerone therapy.
(e)	Electrolyte imbalance does not occur.
(f)	The use of other bismuth-containing preparations is contra-indicated during, and for at least two months after therapy with Ulcerone.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No LD50 has been established in acute toxicity animal studies in rats and mice.

IDENTIFICATION:
A clear, carmine-red solution, more viscous than water, with an odour of blackberry and ammonia.

PRESENTATION:
600 mL (30-day) treatment packs and 250 mL supplementary packs.

STORAGE INSTRUCTIONS:
Store in carton.
Protect from light and store below 25°C.
Keep the bottle well closed.
Keep out of the reach of children.

APPLICATION NUMBER:
E1157 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
Port Elizabeth
6000

DATE OF PUBLICATION

8/72	P833
	L.LTD. L.18710