GYNO-DAKTARIN Pessary 100 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
MICONAZOLE NITRATE
Available from:
Janssen-Cilag Ltd
Dosage:
100 Milligram
Pharmaceutical form:
Pessary
Authorization date:
1996-06-10
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gyno-Daktarin 100 mg Pessaries.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains 100 mg miconazole nitrate.
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Pessary.
The pessaries are white to beige coloured and egg-shaped.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the local treatment of vulvo vaginal candidosis infections and superinfections due to gram-positive
microorganisms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gyno-Daktarin pessaries are for vaginal administration.
Adult females:
One pessary inserted deeply into the vagina. This is best done in the reclining position. Repeat this procedure before
retiring once nightly for 14 days or two pessaries inserted nightly for 7 days. Continue the course of treatment, even
after pruritus and leukorrhoea have disappeared or menstruation begins.
4.3 CONTRAINDICATIONS
Gyno-Daktarin pessaries are contraindicated in individuals with a known hypersensitivity to miconazole or another
ingredient of the pessaries.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Should local sensitisation or an allergic reaction occur, treatment should be discontinued.
Appropriate therapy is indicated when the sexual partner is also infected.
The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the
effectiveness of latex contraceptive agents. Therefore Gyno-Daktarin pessaries should not be used concurrently with a
latex condom or latex diaphragm.
Gyno-Daktarin pessaries do not stain skin or clothes.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/03/2011_
_CRN 2076765_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL
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