Package leaflet
SERTADIE 300 mg vaginal ovule
sertaconazole nitrate

Pharmacotherapeutic category
Gynaecological antimicrobials and antiseptics – Imidazole derivatives.

Therapeutic indications
Local treatment of clinically diagnosed vaginal candidiasis.

Contraindications
Hypersensitivity to the active substance, to other closely related compounds from a chemical standpoint, or to other imidazole antifungal agents.
Generally contraindicated during pregnancy and lactation (see Special warnings).

Precautions for use
In cases of candidiasis also involving the vulvar and/or perianal areas, it is advisable to combine treatment with sertaconazole vaginal ovules with local application of another antifungal agent.
To prevent recurrent "ping-pong" infections, antifungal treatment of the sexual partner is also essential.
For local hygiene, the use of neutral or alkaline pH soaps is recommended, as acidic pH soaps may promote Candida proliferation.
The product may be used during menstruation.

Interactions
Concomitant use with spermicides is not recommended, as the product may interfere with contraceptive effectiveness.
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those without a prescription.

Special warnings
In case of local intolerance or allergic reaction, treatment should be discontinued and any residual product removed by vaginal irrigation.
Use of this product may affect latex-based contraceptive devices (condoms and diaphragms), as it may cause their rupture.

Pregnancy and lactation
There are no adequate and well-controlled studies on the use of this medicinal product during pregnancy or lactation. Therefore, the product should only be used when clearly necessary, under direct medical supervision, after carefully weighing the expected benefit to the mother against the potential risk to the fetus or infant.

Dosage and method of administration
Insert the ovule deeply into the vagina, preferably while lying down in a supine position, at bedtime. Treatment consists of a single administration.
If symptoms persist, a second ovule may be inserted 7 days later.

Overdose
Overdose-related effects are not expected.
FOR ANY DOUBT REGARDING THE USE OF SERTADIE, CONSULT YOUR DOCTOR OR PHARMACIST

Undesirable effects
Like all medicinal products, Sertadie can cause adverse effects, although not everybody experiences them.
Local intolerance reactions such as burning or itching sensations have been reported rarely and usually resolve spontaneously.
Allergic reactions are possible.
Rarely, an increase in liver enzymes has been reported.
Following the instructions provided in this leaflet reduces the risk of adverse effects. If any of the listed side effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Expiry date and storage
Check the expiry date stated on the packaging.
The stated expiry date refers to the product stored in its original, unopened packaging under recommended conditions.
Do not use the medicinal product after this date.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Keep the medicine out of the reach and sight of children.

Composition
Each ovule contains:
Active ingredient: sertaconazole nitrate 300 mg
Excipients: solid semisynthetic glycerides (WITEPSOL H19), solid semisynthetic glycerides (SUPPOCIRE NAI-50), anhydrous colloidal silica.

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

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