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

Logo GYNOL II® Contraceptive Jelly.

SCHEDULING STATUS:
Schedule 1.

PROPRIETARY NAME
(and dosage form):

GYNOL II® Contraceptive Jelly.

COMPOSITION:
Nonoxynol-9 (0,1 g/5 g) with methylparaben 0,2% m/m as the preservative.

PHARMACOLOGICAL CLASSIFICATION:
A 18.7 Contraceptive preparations.

PHARMACOLOGICAL ACTION:
Nonoxynol-9 has spermicidal action.

GYNOL II* is a clear, unscented, unflavoured, water dispersible spermicidal jelly which contains 2% nonoxynol-9 buffered to normal vaginal pH.

GYNOL II* contraceptive jelly must be used in conjunction with an occlusive vaginal diaphragm.

INDICATIONS:
GYNOL II* is indicated for contraception in conjunction with an occlusive vaginal diaphragm.

CONTRA-INDICATIONS:
Hypersensitivity to the product. Where avoidance of pregnancy is essential, the choice of contraceptive should be made in consultation with a doctor or a family planning clinic.

WARNINGS:
For contraceptive effectiveness, the diaphragm should remain in place for 6 hours after intercourse and should be removed as soon as possible thereafter. Continuous wearing of a contraceptive diaphragm for more than 24 hours is not recommended. Retention of the diaphragm for prolonged periods may encourage the growth of certain bacteria in the vaginal tract.

DOSAGE AND DIRECTIONS FOR USE:
The use of GYNOL II* must be in conjunction with an occlusive vaginal diaphragm. The jelly should be spread over the surface of the diaphragm which will be in contact with the cervix, and on the rim. The diaphragm must be allowed to remain in place for six hours after coitus. A fresh application of GYNOL II* must be made prior to any subsequent act of coitus within this period of time without removing the diaphragm. A vaginal applicator should be used for inserting more jelly. If a douche is desired, it should be deferred for at least six hours after intercourse.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
In rare cases one or other partner may experience a degree of irritation, in which case an alternative contraceptive method or preparation is recommended.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
This has not been encountered. Treatment would be symptomatic.

CONDITIONS OF REGISTRATION:
None.

IDENTIFICATION:
A smooth, unscented, translucent jelly.

PRESENTATION:
Aluminium tube, containing 81 g of jelly, with a polyethylene screw cap.

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

REGISTRATION NUMBER:
T/18.7/106

NAME AND BUSINESS ADDRESS OF APPLICANT:
Johnson & Johnson Professional Products (Pty) Ltd
(Reg. No. 83/13283/07)
New Road
HALFWAY HOUSE, Transvaal

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

Cilag
©Johnson & Johnson
® Trademark Highland Print Code No.: 021706
86E0588

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