INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
GYNO-DAKTARIN® Combipak

SCHEDULING STATUS:
Schedule 1

PROPRIETARY NAME
(and dosage form):

GYNO-DAKTARIN^® Combipak

COMPOSITION

a)	Each vaginal capsule contains 400 mg of the active substance miconazole nitrate with sodium ethylparaben 0,073% m/m and sodium propylparaben 0,036% m/m as preservatives.
b)	Each 5 g of cream 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 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
After the capsule has been inserted into the vagina, the outer covering rapidly disintegrates and the active suspension is almost instantaneously released. 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
Contra-indicated in individuals who have shown hypersensitivity to miconazole nitrate or any other ingredient.

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 breastfeeding 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
One capsule should be inserted (as per diagram) into the vagina each evening, for three consecutive days.
Continue using even if symptoms disappear or menstruation begins.
The cream should be applied, morning and evening, to the area around the entrance to the vagina.
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.
{illustrated here}

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 the treatment. Complaints of pelvic cramping, hives, skin rash have also been reported.
Neither the vaginal capsules nor the cream will stain the skin or clothes.
Special precautions
Although intravaginal absorption is limited, GYNO-DAKTARIN Combipak 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. Caution should be exercised during lactation.
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 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)	A smooth, white to off-white, egg-shaped, soft gelatin capsule.
b)	A smooth, white cream with a faint odour, miscible with water.

PRESENTATION

a)	3 x 400 mg capsules in blister packs for intra-vaginal insertion and tube containing 20 g cream.
b)	Amber glass bottles containing 3 x 400 mg capsules for intravaginal insertion and tube containing 20 g cream.

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

REGISTRATION NUMBER
U/18.6/103

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
16 September 1994

                Code No.: 024426
        2003K
        Britepak

Updated on this site: March 2004
Source: Pharmaceutical Industry
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