FALVIN "1.000 MG SOFT VAGINAL CAPSULES"2 CAPSULES"

Name
Falvin 1000 mg vaginal soft capsules
Fenticonazole nitrate


What is it and what is it used for?
Falvin contains the active substance fenticonazole nitrate.
It belongs to a group of medicines called “gynecological antimicrobials and antiseptics”.

Falvin is used to treat the following conditions:
• vaginal infections caused by a microorganism called Trichomonas vaginalis (vaginal trichomoniasis)
• vaginal infections caused in mixed form by two microorganisms called Trichomonas vaginalis and Candida albicans
• infections of the mucous membranes of the genital organs caused by a fungus called Candida such as:
- inflammation of the vulva and vagina (vulvovaginitis)
- inflammation of the cervix (affected)
- increased vaginal discharge due to the presence of infections (infectious fluoride).

Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.


What you need to know before taking the medicine
Do not use Falvin
- if you are allergic to fenticonazole or any of the other ingredients of this medicine (listed in section 6).
- Falvin 1000 mg vaginal soft capsules contain soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.


Warnings and precautions
Talk to your doctor or pharmacist if:
- You are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
- You are using a latex barrier method of contraception (see the section “Other medicines and Falvin”). Therefore, you must use alternative precautions while using this product.
- You are using spermicides, vaginal douches or other vaginal products (see section “Other medicines and Falvin”).
- Exhibits any irritation or sensitivity to the medicine.
- Your symptoms do not improve within a week or if your symptoms are severe or recurrent.
- His partner is also infected.
- Have had more than two previous infections in the last 6 months.
- Have you or your partner ever had a sexually transmitted disease?
- Have you ever had hypersensitivity to imidazoles or other vaginal antifungal products?
- He is over 60 years old.
- Have any of the following symptoms:
• Abnormal or irregular vaginal bleeding.
• Trace of blood from a vaginal discharge.
• Sores, ulcers, or blisters on the vulva or vagina.
• Lower abdominal pain or difficulty urinating (dysuria).
• Adverse effects such as redness, itching or rash associated with treatment.

Children and adolescents
Falvin is not recommended for children under 16 years of age.


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

When the medicine is inserted into the vagina, a slight burning sensation may occur, which will disappear quickly. When used as recommended, Falvin is only slightly absorbed, and no side effects involving the entire body (systemic effects) have been reported.

The use of topical medicines, especially if prolonged, can cause sensitization (see the paragraph “Warnings and precautions”).

The following side effects have been reported with Falvin:

Very rare (may affect up to 1 in 10,000 people):
• vulvovaginal burning sensation
• redness of the skin (erythema), itching and skin rash.

Frequency not known:
• hypersensitivity at the application site.

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.