INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
GYNO-DAKTARIN® VC vaginal cream

SCHEDULING STATUS
Schedule 2.

PROPRIETARY NAME
(and dosage form)

GYNO-DAKTARIN^® VC vaginal cream

COMPOSITION
Each 5 g contains 100 mg of the active substance, miconazole nitrate and 0,2% m/m of benzoic acid as preservative.

PHARMACOLOGICAL CLASSIFICATION
A.18.6 Medicines acting on the genito-urinary system. Vaginal preparations.

PHARMACOLOGICAL ACTION
Pharmacodynamics
Miconazole combines a potent antifungal activity against common dermatophytes and yeasts with an antibacterial activity against certain gram-positive bacilli and cocci.
Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.
Pharmacokinetics
Systemic absorption after intravaginal administration is limited. Unchanged miconazole could not be traced in blood plasma or urine.

INDICATIONS
For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections. (Vaginal candidiasis).

CONTRA-INDICATIONS
GYNO-DAKTARIN* VC vaginal cream is contraindicated in individuals who have shown hypersensitivity to miconazole nitrate or other ingredients of the cream.

WARNINGS
Use only if you have already had a vaginal yeast infection diagnosed by a medical practitioner and you have the same symptoms now, otherwise consult your doctor. These symptoms include itching and burning of the vagina and sometimes a white discharge.
If there is no improvement in 3 days or if symptoms have not disappeared within seven days, then consult a medical practitioner as not all vaginal infections are caused by yeasts.
Consult a medical practitioner if you have abdominal pain, fever or foul smelling vaginal discharge before or during use of this medication.
If symptoms recur within 2 months, consult a medical practitioner.
If you are pregnant or think you may be pregnant or are breast-feeding, do not use this medication except on the advice of a medical practitioner.
Do not use in girls under 12 years of age, except on the advice of a medical practitioner.
If skin rash or new irritation occurs, discontinue use.

DOSAGE AND DIRECTIONS FOR USE
Once daily before retiring, the contents of 1 applicator (about 5 g of cream) should be inserted deeply into the vagina. Repeat this procedure for 7 days.
Continue using even if symptoms disappear or menstruation begins.
A second course may be given if the patient is not cured after the first course.
General hygienic measures should be observed to control the source of infection and reinfection.

DIRECTIONS FOR USE:

1.	To open the tube, unscrew cap, invert it and screw the cap back onto the tube to pierce the aluminium sealing strip. Replace the cap with the applicator.

{illustrated}

2.	Push on the end of the tube to bring cream into the applicator. If the piston shows resistance pull gently. The applicator should be filled completely unless the prescribing physician prescribes otherwise.
3.	Remove applicator from the tube and replace the cap, immediately.
4.	While lying down with knees bent and spread out, insert the applicator into the vagina as deeply as possible (see diagram). Press the piston completely. Then remove the applicator without touching the piston. The applicator should be kept clean. Wash it carefully with soap and lukewarm water. If the doctor specially recommends sterilisation of the applicator, follow his directions. Do not use water over 50°C or ether to clean the applicator. Store the applicator in a case or other clean packing. The applicator consists of 2 parts which allows it to be easily washed and dried. The applicator can be taken apart by pulling the piston out of the cylinder. To reassemble, introduce the thinnest end of the piston into the lower end of the cylinder and the piston into the cylinder.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
If local or allergic reaction should occur, the treatment should be discontinued.
Most frequently reported were local irritation, pruritus and burning sensation, especially at the start of treatment. Complaints of pelvic cramping, hives, skin rash have been reported.
GYNO-DAKTARIN VC vaginal cream does not stain the skin or clothes.
Although intravaginal absorption is limited, GYNO-DAKTARIN VC vaginal cream should only be used during the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits outweigh the possible risks. It is not known whether miconazole nitrate is excreted in human milk. Care should be exercised during lactation.
Interaction
Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and GYNO-DAKTARIN since the rubber may be damaged

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In the event of accidental ingestion of large quantities of the drug, an appropriate method of gastric emptying may be considered appropriate.

IDENTIFICATION
A white homogenous cream.

PRESENTATION
GYNO-DAKTARIN* VC vaginal cream is supplied in a tube containing 40 g or 78 g of cream together with an applicator for intravaginal administration.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
G/18.6/61

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN - CILAG
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 80/11122/07)
15TH ROAD
HALFWAY HOUSE, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
16 September 1994.
                                Code No.: 023375
                                97D
Britepak
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