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

Logo NIZOVULES®

SCHEDULING STATUS:
Schedule 4.

PROPRIETARY NAME
(and dosage form):

NIZOVULES®

COMPOSITION:
Each ovule contains 400 mg of the active ingredient,
ketoconazole

PHARMACOLOGICAL CLASSIFICATION:
A.18.6 Vaginal preparations.

PHARMACOLOGICAL ACTION:
NIZOVULES, a synthetic imidazole dioxolane derivative, has antimycotic activity against dermatophytes, yeasts, and other pathogenic fungi.

INDICATIONS:
NIZOVULES are indicated for the local treatment of acute and chronic vaginal candidiasis.

CONTRA-INDICATIONS:
NIZOVULES are contra-indicated in patients who have shown hypersensitivity to ketoconazole (or other imidazole preparations), or to any of their ingredients.

DOSAGE AND DIRECTIONS FOR USE:
Acute vulvovaginal candidiasis: (i.e. fewer than 3 episodes during the previous year).
Insert one ovule 400 mg into the vagina daily for 3 to 5 consecutive days, depending on the severity of the clinical symptoms.
Chronic recurrent vulvovaginal candidiasis: (i.e. 3 or more episodes during the previous year).
Insert one ovule 400 mg into the vagina daily for 5 consecutive days, immediately after the cessation of menstruation, to be repeated if needed after successive menstrual cycles.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Patients may experience a burning sensation, irritation or pruritus of the vagina and vulva.
Precautions: If local irritation or an allergic reaction occurs, treatment should be stopped. General hygenic measures should be observed to control sources of infection and reinfection.
Appropriate therapy is indicated when the sexual partner has also been infected. NIZOVULES do not stain skin or clothes.
Interactions:
Contact should be avoided between latex products such as contraceptive diaphragms or condoms and certain vaginal products since the rubber might be damaged.. This may also apply to NIZOVULES.
Pregnancy and lactation: Safety in pregnancy has not been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage have not yet been reported. If poisoning or excessive overdosage is suspected, treatment is supportive and symptomatic, including gastric lavage with accidental ingestion..

IDENTIFICATION:
A white ovule (ovoid capsule).

PRESENTATION:
NIZOVULES are supplied in polyethylene-polyvinylchloride strips of 3 ovules.

STORAGE INSTRUCTIONS:
Store below 25°C
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
S/18.6/56

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:
26 June 1985

                        Code No.: 023230
                        96J
® TRADEMARK

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