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

Logo AGOFELL® Syrup

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

AGOFELL® Syrup

COMPOSITION:
Diisopromine hydrochloride 2 mg and sorbitol solution 4,1 g per 5 mL.
Preservative: Ethyl Alcohol 4,8% v/v.

PHARMACOLOGICAL CLASSIFICATION:
A.11.7 Drugs acting on gastro-intestinal tract. Cholagogues.

PHARMACOLOGICAL ACTION:
Diisopromine hydrochloride is a synthetic spasmolytic which neutralizes spastic conditions of the biliary tract and of the sphincter of Oddi.

INDICATIONS:
Functional and organic hepatobiliary disorders accompanied by biliary insufficiency.
Biliary stasis and biliary insufficiency, hypotonia of the gall bladder, spasm of the biliary duct and of the sphincter of Oddi.
Cholecystitis, angiocholitis, cholelithiasis, post cholecystotomy syndrome.
The symptoms of biliary insufficiency, such as pain and sensation of heaviness in the right hypochondrium, abdominal meteorism, dyspeptic complaints and anorexia, sensation of malaise with nausea and vomiting, disappear quickly during treatment with Agofell.

CONTRA-INDICATIONS:
Not suitable for use in children under 6 years of age.

WARNINGS:
Nil.

DOSAGE AND DIRECTIONS FOR USE:
One 5 mL measure of syrup, to be taken 15 minutes before the principal meals.
This dose may be doubled if a pronounced laxative effect is required.
To restore normal physiologic function of the digestive system, treatment should continue for 2 to 3 weeks after symptoms have disappeared. It is preferable that a diet should be instituted to conform with the patient's response to treatment.

Instructions for use:
The bottle comes with a child-proof cap and should be opened as follows:
1. Push the plastic screw cap down.
2. While pressing down, turn the cap counter clockwise.
{illustrated}

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Agofell is not toxic, is well tolerated and provokes no unpleasant side-effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Accidental overdosage or poisoning has not been reported. Should overdosage or accidental poisoning occur, symptomatic, supportive treatment should be instituted.

IDENTIFICATION:
Clear, slightly amber syrup.

PRESENTATION:
Bottles containing 150 mL of syrup.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of the reach of children.

REFERENCE NUMBER:
E594 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN-CILAG
Janssen Pharmaceutica (Pty) Ltd.
(Reg. No. 80/11122/07)
15th Road, Halfway House, 1685.
© JANSSEN PHARMACEUTICA (PTY) LTD.
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28 July 1972.

       
        Code No.: 023447
                98A
                Britepak
® = TRADEMARK

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2000