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

Logo GYNO-DAKTARIN® 1 200 mg vaginal capsule

© J-C 2003                ZA - 246284 V

SCHEDULING STATUS:
Schedule 1

PROPRIETARY NAME
(and dosage form):

GYNO-DAKTARIN® 1 200 mg vaginal capsule

COMPOSITION
Each vaginal capsule contains 1 200 mg of the active substance
miconazole nitrate.
Preservatives: Sodium ethylparaben 0,06% m/m and sodium propylparaben 0,03% m/m.

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

PHARMACOLOGICAL ACTION
Pharmacodynamics
Miconazole, in vitro, combines antifungal activity against common dermatophytes and yeasts with some antibacterial activity against certain organisms.
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) as previously diagnosed.

CONTRA-INDICATIONS
Gyno-Daktarin vaginal capsules are contra-indicated in individuals who have shown hypersensitivity to miconazole or to any other ingredient of the vaginal capsule.

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 nursing, 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
The vaginal capsule should be inserted (preferably at night) deeply into the vagina while in the reclining position (see diagram).
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The treatment may be repeated if necessary.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Local irritation, pruritus and burning sensation may occur, especially at the start of treatment. Complaints of pelvic cramping, hives and skin rash have also been reported.
General hygienic measures should be observed to control sources of infection and reinfection. Appropriate therapy is indicated when the sexual partner is also infected.
Gyno-Daktarin vaginal capsules do not stain skin or clothes.
Interactions
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after vaginal application, clinically relevant interactions are unlikely to occur. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.
Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and Gyno-Daktarin since the rubber might 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 used if considered appropriate.

IDENTIFICATION
A white to off-white, egg-shaped soft gelatin capsule.

PRESENTATION
Cartons containing one blister strip with one vaginal capsule.

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

REGISTRATION NUMBER
29/18.6/0349

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN-CILAG logo

JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/011122/07)
15TH ROAD
HALFWAY HOUSE
1685

website: www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
1 September 1995.

® = Trademark

New addition to this site: March 2004
Source: Pharmaceutical Industry

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