LORENIL*3 SOFT VAG CAPS 200MG

Lorenil 200 mg vaginal soft capsules
Lorenil 600 mg vaginal soft capsules
fenticonazole nitrate

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

Lorenil is used for the treatment of 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 (cervicitis);
- increased vaginal discharge due to infections (infectious fluor).

Consult 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 Lorenil:
- if you are allergic to fenticonazole or any of the other ingredients of this medicine (listed in paragraph 6);
- Lorenil 600 mg vaginal soft capsules contain soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

Warnings and precautions
Consult your doctor or pharmacist if:
- You are pregnant or breastfeeding (see "Pregnancy, breastfeeding and fertility" section).
- You are using a latex barrier contraceptive method (see "Other medicines and Lorenil" section). Consequently, you must use alternative precautions while using this product.
- You are using spermicides, intravaginal douches or other vaginal products (see "Other medicines and Lorenil" section).
- You experience any irritation or sensitivity to the medicine.
- Your symptoms do not subside within one 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.
     • Traces 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 the treatment.

Children and adolescents
Lorenil 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, Lorenil is only slightly absorbed and no side effects affecting the entire body (systemic effects) are reported.

The use of topical medicines, especially if prolonged, can cause sensitization (see "Warnings and precautions" section).

The following side effects have been reported with Lorenil:

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 those 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.