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

Logo URISPAS 200
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

URISPAS 200
Flavoxate hydrochloride Tablets

COMPOSITION:
Each tablet contains flavoxate hydrochloride 200 mg.
Contains sodium benzoate.

PHARMACOLOGICAL CLASSIFICATION:
A 18 Medicines acting on Genito-urinary system.

PHARMACOLOGICAL ACTION:
Flavoxate hydrochloride is a non-specific, direct-acting, smooth muscle relaxant.

INDICATIONS:
URISPAS 200 is indicated for its anti-spasmodic action in urological disorders.

CONTRA-INDICATIONS:
Hypersensitivity to flavoxate hydrochloride. Pyloric or duodenal obstruction, obstructive intestinal lesions, or ileus, achalasia, gastro-intestinal haemorrhage and obstructive uropathies of the lower urinary tract. Safety in pregnancy and lactation has not been established. URISPAS 200 tablets are not recommended for use in children under 12 years of age.

WARNINGS:
In the event of drowsiness or blurred vision, patients should not drive or operate machinery.

DOSAGE AND DIRECTIONS FOR USE:
Adults - One tablet three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
URISPAS 200 tablets should be used with caution in patients with suspected glaucoma. Adverse reactions noted include:
Gastro-intestinal        : nausea, vomiting, dry mouth, diarrhoea.
Central nervous system : vertigo, headache, mental confusion, especially in the elderly, drowsiness, fatigue, and nervousness.
Haematologic : reversible leukopenia.
Cardiovascular : tachycardia and palpitations
Allergic : urticaria and other dermatoses, eosinophilia and hyperpyrexia.
Ophthalmic : increased ocular tension, blurred vision, disturbance in eye accommodation.
Renal : dysuria.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The most likely symptoms of overdose are blurred vision, dry mouth, drowsiness and diarrhoea or constipation. Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
White, sugar-coated tablets overprinted with the name “Urispas 200”in red ink.

PRESENTATION:
Securitainers of 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from moisture. Keep out of reach of children.

REGISTRATION NUMBER:
29/18/0428

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 August 1995.

Updated on this site: February 2005
Source: Pharmaceutical Industry

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