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Logo NORMOSPOR VAGINAL CREAM

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

NORMOSPOR VAGINAL CREAM

COMPOSITION:
Each 1 g of cream contains:
Clotrimazole         10 mg
Preservative: 
Nipastat 0,275% m/m
Imidurea 0,300% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
Normospor vaginal cream
is broad spectrum antimycotic with fungicidal properties.

INDICATIONS:
Vaginitis or vulvo-vaginitis due to fungi, mainly candida.

CONTRA-INDICATIONS:
Possible sensitivity to Clotrimazole
The possibility of absorption of clotrimazole when administered vaginally cannot be excluded. The safety in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Fill enclosed vaginal applicator to the top (i.e. 5 g Normospor vaginal cream). Insert deeply into the vagina every night on retiring for six consecutive days. This is best achieved when lying on the back with the legs pulled in a little towards the body. If individual cases should require it, two applications of 5 g VAGINAL CREAM can be used daily, i.e. one in the morning and one in the evening, for 6-12 days. The treatment should not be carried out during menstruation but should be completed before this begins. For candida vulvitis or vulvo-vaginitis the vaginal cream should be applied thinly to the external genitalia 2 or 3 times a day for 1-2 weeks.
For the prevention of re-infection the partner should be treated locally with Normospor vaginal cream at the same time. This preparation does not stain the underwear.

DIRECTIONS FOR USING THE APPLICATOR:
Preparation of the applicator:
1. Wash your hands thoroughly.
2. Screw the open end of one the applicators over the opening of the tube of cream.
  The plunger of the applicator should be pushed right in at this stage.
3. Gently squeeze the bottom of the tube so that the cream fills the applicator to the top, pushing the plunger out to almost its full extent.
4. Unscrew the tube of cream and replace its cap.
Inserting the applicator:
5. Carefully insert the end of the applicator as deeply as possible into the vagina. (Making sure plunger does not fall out). This is best achieved when lying on the back with the legs pulled in a little towards the body.
6. Slowly push the plunger with the forefinger until it stops.
7. Remove the applicator from the vagina and discard it.
Each applicator is for use once only.
The surplus cream may be used to treat any inflammation of the vulva (outer vaginal area) and nearby areas. The cream should be applied thinly and rubbed in gently 2 - 3 times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. In case of systematic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special precautions". In case of accidental ingestion, gastro-intestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.

IDENTIFICATION:
Soft, white cream.

PRESENTATION:
Tube of 50 g with 6 vaginal applicators.

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

REGISTRATION NUMBER:
27/20.2.2/0173

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LTd
Adcock Ingram Park
17 Harrison avenue, Bryanston Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 October 1992

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

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