Leaflet: information for the user

Lomexin 600 mg soft vaginal capsule

Fenticonazole nitrate

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Lomexin 600 mg soft vaginal capsule is and what it is used for

2. What you need to know before you start using Lomexin 600 mg soft vaginal capsule

3. How to use Lomexin 600 mg soft vaginal capsule

4. Possible side effects

5. Storage of Lomexin 600 mg soft vaginal capsule

6. Contents of the pack and additional information

Lomexin 600 mg soft vaginal capsule belongs to a group of medicines called gynecological antifungals and antiseptics.

Lomexin 600 mg soft vaginal capsule is indicated for the treatment of vulvovaginal candidiasis.

Do not use Lomexin 600 mg soft vaginal capsule

• if you are allergic to fenticonazole nitrate or any of the other components of this medication (listed in section 6).
• Lomexin 600 mg soft vaginal capsule contains soy lecithin. If you are allergic to peanuts or soy, you should not use this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Lomexin 600 mg soft vaginal capsule;

• if you are pregnant or breastfeeding (see section “Pregnancy, lactation, and fertility”).
• if you are using a barrier contraceptive made of latex (see section “Other medications and Lomexin”). Consequently, you should take additional measures while using this medication.
• if you are using spermicides, vaginal douches, or other vaginal products (see section “Other medications and Lomexin).
• if you experience irritation or sensitivity to the medication.
• if no improvement of symptoms occurs after a week or in case of severe recurrent symptoms.
• if your partner is also affected.
• if you have had more than two previous infections in the last 6 months.
• if you or your partner have had a sexually transmitted disease.
• if you have had hypersensitivity to imidazoles or other vaginal antifungal medications.
• if you are over 60 years old.
• if you present any of the following symptoms:

• sudden or irregular vaginal bleeding
• spotting of blood in vaginal discharge
• ulcers, sores, or blisters on the vulva or vagina
• lower abdominal pain or dysuria
• adverse effects such as redness, itching, or rash associated with treatment

Children and adolescents

Lomexin is not recommended for girls under 16 years old.

Other medications and Lomexin 600 mg soft vaginal capsule

The oils and fatty excipients in the composition of the soft vaginal capsule may damage barrier contraceptives made of latex, such as condoms and diaphragms (see section “Warnings and precautions”).

It is not recommended to use spermicides (substances inserted vaginally, which destroy sperm and are used as a contraceptive method alone or in combination with, for example, diaphragms). These may inactivate the vaginal treatment.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, or if you plan to become pregnant, consult your doctor before using this medication. The use of Lomexin should be under medical supervision during pregnancy and lactation.

Driving and operating machines

The influence of Lomexin 600 mg soft vaginal capsule on the ability to drive and operate machines is negligible or insignificant.

Lomexin 600 mg soft vaginal capsule contains parahydroxybenzoic acid ethyl ester, sodium salt (E 215) and parahydroxybenzoic acid propyl ester, sodium salt (E 217)

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid ethyl ester, sodium salt (E 215) and parahydroxybenzoic acid propyl ester, sodium salt (E 217).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Lomexin vaginal capsules are for vaginal use only. Do not ingest.

The vaginal capsule should be inserted as deeply as possible into the vagina while lying down.

The recommended dose is:

• One vaginal capsule (single dose). If symptoms persist, a second dose may be administered three days later.

Use in children and adolescentsThe recommended dose for children 16 years of age and older is the same as for adults.

Using moreLomexin 600 mg soft vaginal capsulethan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount used or ingested by mistake.

Missing a doseLomexin 600 mg soft vaginal capsule

Do not use a double dose to compensate for missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

You may experience a mild sensation of burning when the medication is introduced into the vagina, which disappears quickly. When used as recommended, the absorption of Lomexin is insignificant and no adverse effects have been reported in the rest of the body (systemic effects).

The use of this medication topically, especially prolonged use, may cause sensitization (see section “Warnings and Precautions”).

The following adverse effects have been reported with Lomexin:

Very Rare (affects less than 1 patient in 10,000)

• vulvovaginal burning sensation
• Cutaneous erythema, pruritus, and eruption

Frequency Not Known:

• Hypersensitivity at the application site.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No requires special conditions for conservation

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofLomexin 600 mg soft vaginal capsule

• The active ingredient is fenticonazole nitrate. Each vaginal capsule contains 600 mg of fenticonazole nitrate.

• The other components are:

Core excipients: liquid paraffin, white soft vaseline, soy lecithin.

Capsule excipients: gelatin, glycerol (E 422), titanium dioxide (E 171), ethyl parahydroxybenzoate, sodium salt (E 215), propyl parahydroxybenzoate, sodium salt (E 217).

Appearance of the product and contents of the packaging

Lomexin 600 mg is presented in the form of a white-beige soft vaginal capsule, in a PVC/Aluminum blister, in packaging containing 1 soft vaginal capsule.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Casen Recordati, S.L.,

Autovía de Logroño, km 13.300

50180 UTEBO. Zaragoza (Spain)

Responsible manufacturer

CATALENT ITALY, S.P.A.

Via Nettunense, Km 20,100

04011 Aprilia (LT)

Italy

Last review date of this leaflet: September 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.