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

Logo ANUGESIC Suppositories
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

ANUGESIC Suppositories

COMPOSITION:
Each suppository contains:
  Pramoxine Hydrochloride         25,1 mg
  Bismuth Subgallate         64,58 mg
  Bismuth Oxide         25,11 mg
  Bismuth Subiodide         0,52 mg
  Resorcinol         25,11 mg
  Balsam Peru         51,65 mg
  Benzyl Benzoate         34,43 mg
  Zinc Oxide         316,1 mg
  Boric Acid         143,5 mg

PHARMACOLOGICAL CLASSIFICATION:
A: 11.8 Suppositories and anal ointments

PHARMACOLOGICAL ACTION:
Anugesic Suppositories have surface anaesthetic action, to relieve anal pain and pruritis (itching), while also lubricating, soothing and reducing oedema.

INDICATIONS:
The suppositories relieve pain and pruritis (itching) due to haemorrhoids (piles) and other related ano-rectal conditions (proctitis, cryptitis, fissures, pruritis ani and incomplete fistulas).

CONTRA-INDICATIONS:
Serious rectal pathology.
Known hypersensitivity to any of the ingredients. Pregnancy. Haemorrhoids and other inflammatory conditions of the rectum are sometimes of a serious nature. In cases of rectal bleeding, or persistence of the condition, consult your doctor.

WARNING:
As with all bismuth-containing preparations, neurotoxicity may occur with prolonged or excessive use.

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:
Remove plastic cover and insert one suppository every three or four hours or as directed by the physician.
1. Tear along the perforation to remove one suppository from the strip (see figure 1 below).
2. Grasp the two halves of the plastic cover firmly, holding between the thumb and forefinger of each hand (as indicated in figure 2 below). Gently pull apart to fully expose the suppository.
3. Remove the suppository, and insert as deeply into the anus as possible.
The suppositories are specially shaped for easy insertion into the anus. You may find insertion of the suppositories easier if you place one foot on a chair or lie on your side with one leg drawn up as high as possible under the chin.
{illustrated}
Children:        Not recommended.
Not to be taken orally.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity reactions may occur. Stinging or burning may occur. Use should be discontinued if redness, irritation, swelling or pain persists or increases.
Absorption of large amounts of pramoxine hydrochloride through the mucous membranes or damaged skin may result in systemic toxic effects.
Resorcinol may be absorbed through the skin or from ulcerated surfaces and prolonged use may lead to myxoedema.
Boric acid should be used with caution on abraded or damaged skin.

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

IDENTIFICATION:
A smooth bluish suppository.

PRESENTATION:
Box of 10 suppositories.

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

REFERENCE NUMBER:
E512 (Act 101/1965)

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:
19 April 1972.

Revised:09/10/91

Updated on this site: February 2005
Source: Pharmaceutical Industry

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