FALVIN*2VPS SOFT VAG 1000MG

Falvin 1000 mg vaginal soft capsules
Fenticonazole nitrate

What it is and what it is used for
Falvin contains the active ingredient fenticonazole nitrate.
It belongs to a group of medicines called "gynaecological antimicrobials and antiseptics".

Falvin is used for the treatment of the following conditions:
• vaginal infections caused by a microorganism called Trichomonas vaginalis (vaginal trichomoniasis)
• vaginal infections caused by a mixed form of 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:
   - inflammations of the vulva and vagina (vulvovaginitis)
   - inflammations of the cervix (cervicitis)
   - increased vaginal discharge due to the presence of infections (infectious fluor).

Contact your doctor if you do not feel better or if you feel worse after a short period 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 contraceptive method (see section "Other medicines and Falvin"). Consequently, you should use alternative precautions while using this product.
- You are using spermicides, intravaginal douches or other vaginal products (see section "Other medicines and Falvin").
- You experience any irritation or sensitivity to the medicine.
- Your symptoms do not improve within a week or in case of severe or recurrent symptoms.
- Your partner is also infected.
- You have had more than two previous infections in the last 6 months.
- You or your partner have ever had a sexually transmitted disease.
- You have ever had hypersensitivity to imidazoles or other vaginal antifungal products.
- You are over 60 years old.
- You have any of the following symptoms:
   • Abnormal or irregular vaginal bleeding.
   • Trace of blood in 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 quickly disappear. When used as recommended, Falvin is only slightly absorbed and no side effects affecting the whole body (systemic effects) have been reported.

The use of topical medicines, especially if prolonged, can cause sensitisation (see section "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
   • skin redness (erythema), itching and skin rash.

Frequency not known:
   • hypersensitivity at the application site.

Reporting of side effects
If you get 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.