DAKTARIN "20 MG/G VAGINAL CREAM" 1 78 G TUBE WITH 16 DISPOSABLE APPLICATORS"

Name
DAKTARIN 20 mg/g vaginal cream
Miconazole nitrate


What is it and what is it used for?
Daktarin contains miconazole nitrate which belongs to a group of medicines called anti-infectives and antiseptics, used to treat infections.

Daktarin is a gynecological medicine indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida fungi) and superinfections (new infections that overlap with an existing infection) due to Gram-positive bacteria.

Talk to your doctor if you do not feel better or if you feel worse.


What you need to know before taking the medicine
Do NOT use Daktarin
• if you are allergic to miconazole or other similar antifungal medicines or to any of the other ingredients of this medicine (listed in section 6).


Warnings and precautions
Talk to your doctor or pharmacist before using Daktarin.
It is advisable to apply the following hygienic measures to avoid sources of infection or reinfection (new infections by the same fungus):
- keep towels and underwear for personal use to avoid infecting other people;
- change your underwear regularly to avoid reinfection.

Your sexual partner may also need treatment if he or she has been infected. If you have any concerns, consult your doctor.

Daktarin does not stain skin or clothing.

Daktarin vaginal cream should not be used simultaneously with latex condoms or diaphragms. Daktarin vaginal cream may damage latex products and prevent them from working properly.

If sensitization or an allergic reaction occurs, treatment should be discontinued.

Daktarin should not be used at the same time as latex condoms or diaphragms.

Avoid contact of Daktarin with rubber (latex)-based contraceptives such as condoms or diaphragms, as the components of Daktarin can damage the latex, compromising its contraceptive efficacy and protection against sexually transmitted diseases.

Children and adolescents:
The safety and efficacy of Daktarin have not been established in children and adolescents (under 18 years of age).


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Below is a list of side effects that have occurred with Daktarin vaginal cream:

Very rare (may affect up to 1 in 10,000 people):
• Allergy, including severe allergic reaction that occurs rapidly (anaphylactic and anaphylactoid reaction)
• Swelling of the face, mouth, lips and/or tongue (angioedema)
Stop taking Daktarin and seek emergency medical attention immediately if you notice or suspect any of these very rare side effects:
• Itching
• Vaginal irritation
• Application site reaction

Not known (frequency cannot be estimated from the available data)
• Itching of the female genitals
• Vaginal burning sensation
• Vulvovaginal discomfort
• Heachache
• Pain during menstruation (dysmenorrhea)
• Abdominal pain
• Pain in the upper abdomen
• Nausea
• Vaginal discharge
• Vaginal bleeding
• Vaginal pain
• Urinary tract infection
• Difficult or painful urination (dysuria)
• Itchy skin rash (pruritic rash)

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.