Gyno-Daktarin Vaginal Cream

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:

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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.