SERTADIE 300 mg Czopek Dopochwowy

Treść ulotki

1. SERTADIE 300 mg vaginal ovule

Package leaflet

SERTADIE 300 mg vaginal ovule

sertaconazole nitrate

Pharmacotherapeutic category
Gynaecological antimicrobials and antiseptics - Imidazole derivatives.

Therapeutic indications
Local treatment of clinically confirmed vaginal candidiasis.

Contraindications
Hypersensitivity to the components or to other substances closely related from a
chemical point of view. In particular, to antifungal agents of the imidazole group.
Generally contraindicated in pregnancy and breastfeeding (see Special warnings
and precautions for use).

Precautions for use
In the case of candidiasis also involving the vulvar and/or perianal areas, it is advisable to
combine therapy with sertaconazole vaginal ovules with local treatment
with another antifungal agent.
In order to prevent recurrent infections with the so-called ping-pong mechanism, it is
essential to also treat the partner with antifungal agents.
For local hygiene, it is recommended to use soaps with a neutral or alkaline pH, as soaps with a
acidic pH can promote the proliferation of Candida.
The product can also be used during menstruation.

Interactions
Concomitant use of spermicides is not recommended as the product may interfere
with contraceptive activity.
Inform your doctor or pharmacist if you have recently taken any other
medicines, including those available over the counter.

Special warnings and precautions for use
In case of local intolerance or allergic reaction, treatment should be
interrupted and the removal of the residual product can be carried out by vaginal irrigations.
The use of the product may interfere with the effectiveness of latex contraceptives
(condoms and diaphragms) as it may cause them to break.

Pregnancy and breastfeeding
There are no adequate and well-controlled studies on the use of the medicine in pregnancy or
breastfeeding. Therefore, the medicine should only be used if necessary, under
direct medical supervision, after assessing the expected benefit for the mother in
relation to the possible risk to the fetus or infant.

Posology and method of administration
Insert the ovule deeply into the vagina, preferably in a supine position, in the evening
at bedtime. The treatment provides for a single administration.
In case of persistence of symptoms, a second ovule may be inserted
after 7 days.

Overdose
No effects related to an overdose of the drug are predictable
FOR ANY DOUBT ABOUT THE USE OF SERTADIE, CONSULT YOUR DOCTOR
OR PHARMACIST

Undesirable effects
Like all medicines, Sertadie can cause side effects, although not everyone
experiences them.
Rarely, reports of local intolerance have been reported, such as a sensation of
burning or itching, which generally resolve spontaneously.
Allergic reactions are possible.
Rarely, an increase in liver enzymes has been reported.
undesirable. If any of these side effects worsen, or if you notice any not listed in this leaflet, please inform your doctor or pharmacist.

Expiry date and storage
Check the expiry date indicated on the packaging.
The expiry date indicated refers to the product in intact packaging,
correctly stored.
Caution: do not use the medicine after this date.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.
Keep the medicine out of the reach and sight of children.

Composition
One ovule contains:
active ingredient: sertaconazole nitrate 300 mg
excipients: semi-synthetic solid glycerides (WITEPSOL H19), semi-synthetic solid glycerides
(SUPPOCIRE NAI-50), anhydrous colloidal silica.

Pharmaceutical form and packaging
Vaginal ovule.
Single-dose packaging.

Marketing authorisation holder and manufacturer:
Holder:FERRER Int. S.A. – Gran Via Deb Carlos III, 94 – BARCELONA
(SPAIN)
Manufacturer: Trommsdorff GmbH & Co. KG
Trommsdorffstr. 2-6
52475 Alsdorf
GERMANY