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

Logo ULSANIC 1 g TABLETS
ULSANIC EFFERVESCENT TABLETS
ULSANIC SUSPENSION

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

ULSANIC 1 g TABLETS
ULSANIC EFFERVESCENT TABLETS
ULSANIC SUSPENSION

COMPOSITION:
Each tablet contains:        1 g
Sucralfate
Each effervescent tablet contains:        1 g Sucralfate
Each 5 mL suspension contains:        1 g Sucralfate
Preservatives:
Sodium propylparaben         0,04% m/v
Sodium methylparaben         0,075% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.3 Medicines acting on the gastro-intestinal tract: Other.

PHARMACOLOGICAL ACTION:
Ulsanic is therapeutically anti-ulcerogenic and capable of inhibiting the proteolytic action of pepsin.
Ulsanic forms a protective film over the mucosa in ulcerated or inflamed areas of the stomach and protects the gastric mucosa, and has the ability to absorb pepsin, trypsin and bile acids.

INDICATIONS:
Gastric ulcer, duodenal ulcer, chronic gastritis and reflux oesophagitis.
Ulsanic produces relief of subjective symptoms of peptic ulceration e.g. epigastric pain, hyperchlorhydria, vomiting, etc.
Maintenance treatment after successful endoscopically proven, recently healed duodenal ulcer.

CONTRA-INDICATIONS:
Hypersensitivity to sucralfate..

DOSAGE AND DIRECTIONS FOR USE:
The usual adult dosage is one tablet or one effervescent tablet or 5 mL (one medicine measure) of suspension three or four times a day between meals and at bedtime. The effervescent tablet should be dissolved in a glass of water.
A dosage regimen of 2 g twice daily (i.e. 2 tablets, or 2 effervescent tablets or 10 mL suspension, mornings and evenings) has also been shown to be effective for the treatment of duodenal ulcer.
Reflux Oesophagitis
One tablet mixed with water or one effervescent tablet dissolved in water or 5 mL (one medicine measure) of suspension four times a day between meals and at bedtime.
Maintenance treatment after successful healing of duodenal ulcer
One Ulsanic 1 g tablet or one effervescent tablet twice daily i.e. one tablet half an hour before breakfast and one tablet half an hour before supper on an empty stomach. Treatment should be continued for 12 months.
Relief is usually experienced by peptic ulcer patients following the administration of Ulsanic alone, although a short-term regime with additional analgesic and spasmolytic agents may be of greater benefit in some patients with incipient clinical manifestations, especially severe pain in the epigastrium.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Constipation is the most frequently reported adverse effect of sucralfate although other gastro-intestinal effects such as diarrhoea, nausea, or gastric discomfort may occur. Other adverse effects reported have included dry mouth, dizziness, drowsiness, vertigo, skin rashes, pruritus and back pain. In patients with renal failure, absorption of aluminium may cause adverse effects.
The safety and efficacy of the maintenance treatment exceeding a period of 12 months have not been established.
Sucralfate should be administered with caution in patients with renal impairment because of the risk of accumulation of the small amount of aluminium absorbed from the medicine. Sucralfate may interfere with the absorption of other medicines and it has been suggested that there should be an interval of 2 hours between the administration of sucralfate and other concurrent non-antacid medication. Some of the medicines reported to be affected by sucralfate include cimetidine, ranitidine, digoxin, ketoconazole, phenytoin, fluoroquinolone antibacterials, tetracycline, thyroxine, and possibly warfarin. The recommended interval between sucralfate and other antacids is 30 minutes.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment should be symptomatic and supportive.

IDENTIFICATION:
Tablets        White capsule-shaped tablets marked ULSANIC on one side and scored on the reverse.
Effervescent tablets Flat, round,, faintly peach-coloured tablets with orange speckles and bevelled edges, producing an orange-coloured opaque dispersion with an orange odour and bitter after taste.
Suspension Off-white, orange flavoured, viscous suspension.

PRESENTATION:
Tablets Containers of 20 and 120 tablets
Effervescent tablets Containers of 10 and 20 tablets
Suspension Plastic bottles of 100 mL, 300 mL and 600 mL

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Ulsanic tablets
        Q/11.4.3/147.
Ulsanic effervescent tablets        31/11.4.3/0119.
Ulsanic Suspension        V/11.4.3/315.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18 October 1996

Lennon logo
                G313
                KOHLER C&P P.E.

Updated on this site: October 2001

Current: April 2005

Source: Hospital Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005