COMPOSITION Each vaginal capsule contains 200 mg of the active substance miconazole nitrate.
Preservatives: Sodium ethylparaben 0,08% m/m and sodium propylparaben 0,04% m/m.
PHARMACOLOGICAL CLASSIFICATION A. 18.6 Medicines acting on genito-urinary system. Vaginal preparations.
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 200 mg vaginal capsules are contra-indicated in individuals who have shown hypersensitivity to miconazole nitrate or other ingredients of the vaginal capsules.
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 1 capsule should be inserted (as per diagram), deeply into the vagina each morning and evening for 3½ days. Insertion is best done in the reclining position. Alternatively, one capsule can be inserted into the vagina each evening for 7 days.
A second course may be given if the patient is not cured after the first course.
Continue using even if symptoms disappear or menstruation begins.
General hygienic measures should be observed to control the source of infection and reinfection.
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 200 mg vaginal capsules do not stain the skin or clothes. Special precautions Although intravaginal absorption is limited, GYNO-DAKTARIN 200 mg vaginal capsules 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. Interaction Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and GYNO-DAKTARIN 200 mg vaginal capsules, since the rubber may be damaged by the emollient base. The vaginal cream may be considered for use in this situation.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OR 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 smooth, white, gelatin capsule.
PRESENTATION GYNO-DAKTARIN 200 mg vaginal capsules are supplied in amber glass bottles containing 7 x 200 mg capsules for intravaginal insertion.
STORAGE INSTRUCTIONS Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER L/18.6/368
NAME AND BUSINESS ADDRESS OF THE APPLICANT JANSSEN - CILAG
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 80/11122/07)