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

Logo MEDASPOR VAGINAL CREAM

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MEDASPOR VAGINAL CREAM

COMPOSITION:
Each 1 g contains:
Clotrimazole BP                 10 mg
Preservatives: Nipastat        0.275% m/m
  Imidurea        0.30% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
MEDASPOR VAGINAL CREAM is a broad spectrum antimycotic with fungicidal properties.

INDICATIONS:
Vaginitis or vulvo-vaginitis due to fungi, mainly Candida.
For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (Vaginal candidiasis).

CONTRA-INDICATIONS:
Possible sensitivity to clotrimazole. The possibility of absorption of clotrimazole when administered vaginally can not 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 MEDASPOR VAGINAL CREAM). Insert deeply into the vagina every night on retiring for six (or seven) consecutive nights even during menstruation and even if symptoms disappear. This is best achieved when lying on the back with the legs pulled in a little towards the body. If individual cases require it, two applications of vaginal cream can be used daily, i.e. one in the morning and one in the evening, for 6-12 consecutive days. 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 MEDASPOR VAGINAL CREAM at the same lime. This preparation does not stain the underwear.

WARNINGS:
(i) 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.
(ii) 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.
(iii) Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge before or during use of this medication.
(iv) If symptoms recur within 2 months, consult a medical practitioner.
(v) If you are pregnant or think you may be pregnant or are nursing, do not use this medication except on the advice of a medical practitioner.
(vi) Do not use in girls under 12 years of age, except on the advice of a medical practitioner.
(vii) If skin rash or new irritation occurs, discontinue use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. In the case of systemic 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 the 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 8 vaginal applicators.

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

REGISTRATION NUMBER:
27/20.2.2/0285

NAME AND BUSINESS ADDRESS OF APPLICANT:
MEDPRO PHARMACEUTICA (PTY) LTD.
ROSEN HEIGHTS, ROSEN PARK, BELLVILLE 7530 RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1999

Patient Information

DIRECTIONS FOR USING THE APPLICATOR

PREPARATION OF THE APPLICATOR
{Illustrated}
1. Wash your hands thoroughly.
2. Screw the open end of one of the applicators over the opening of the tube of the 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 the 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 the 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.
Follow your doctor's instructions.

Medpro
logo

6455C

Updated on this site: January 2003
Current: January 2017
Source: SOURCE http://www.cipla.co.za/wp-content/uploads/2013/10/otc_medaspor-50g-vaginal.pdf

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2016