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

Logo ANUGESIC OINTMENT
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

ANUGESIC OINTMENT

COMPOSITION:
Each gram of ointment contains:
Pramoxine Hydrochloride         10,0 mg
Preservatives:
Methylparaben         0,02% m/m
Propylparaben         0,02% m/m

PHARMACOLOGICAL CLASSIFICATION:
A: 11.8 Suppositories and Anal Ointments.

PHARMACOLOGICAL ACTION:
Anugesic Ointment is a surface anaesthetic.

INDICATIONS:
The ointment relieves anal pain and pruritis (itching).

CONTRA-INDICATIONS:
Serious rectal pathology. Known hypersensitivity to pramoxine hydrochloride. Pregnancy. In cases of rectal bleeding or inflammatory conditions of the rectum, consult your doctor.

DOSAGE AND DIRECTIONS FOR USE:
The area around the anal opening should be cleansed with soap and warm water, then dried carefully by patting (not rubbing) with soft toilet tissue or cottonwool before medication is used.
Adults:
Anugesic Ointment may be applied as often as necessary, but duration of use should be limited to a few days.
1. To apply internally, screw off the cap and attach the cleansed applicator nozzle (enclosed).
2. Insert the applicator into the anus and release the desired quantity of ointment.
3. Then apply a thin film of ointment over the external area. The product is nonstaining, however if excess product is applied remove gently with gauze or soft tissue.
4. After each application the applicator nozzle must be removed and carefully washed in hot water with detergent and then thoroughly rinsed in clear water.
Children: Not recommended.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Stinging or burning may occur. Possibility of allergic reaction exists. Use should be discontinued if redness, irritation, swelling or pain persists or increases. Absorption of large amounts through the mucous membranes or damaged skin may result in systemic toxic effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Systemic toxic effects may include yawning, restlessness, excitement, nervousness, dizziness, blurred vision, nausea, vomiting, muscle twitching and convulsions.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A smooth, white ointment with a characteristic odour.

PRESENTATION:
Tube containing 25 g Anugesic Ointment with an applicator.

STORAGE INSTRUCTIONS:
Store in a cool, (below 25°C), dry place out of reach of children.

REGISTRATION NUMBER:
T/11.8/65

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18 November 1985

Revised: 27/12/88

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