Leaflet: information for the user

Lomexin 200 mg vaginal soft capsules

Fenticonazole nitrate

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must 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 200 mg vaginal soft capsules are and what they are used for

2. What you need to know before you start using Lomexin 200 mg vaginal soft capsules

3. How to use Lomexin 200 mg vaginal soft capsules

4. Possible side effects

5. Storage of Lomexin 200 mg vaginal soft capsules

6. Contents of the pack and additional information

Lomexin 200 mg vaginal soft capsules belongs to a group of medicines called gynecological antifungals and antiseptics.

Lomexin 200 mg vaginal soft capsules is indicated for the treatment of vulvovaginal candidiasis.

Do not use Lomexin 200 mg vaginal soft capsules:

• if you are allergic to fenticonazole nitrate or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Lomexin 200 mg vaginal soft capsules:

• 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 experience any of the following symptoms:

• abnormal or irregular vaginal bleeding
• blood-stained 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 200 mg vaginal soft capsules

The oils and fatty excipients in the composition of the vaginal soft capsules 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 intend 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 200 mg vaginal soft capsules on the ability to drive and operate machines is negligible or insignificant.

Lomexin 200 mg vaginal soft capsules contain Parahydroxybenzoate of ethyl, sodium salt (E 215) and Parahydroxybenzoate of propyl, sodium salt (E 217)

It may cause allergic reactions (possibly delayed) because it contains Parahydroxybenzoate of ethyl, sodium salt (E 215) and Parahydroxybenzoate of propyl, 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 while lying down.

The recommended dose is:

• One vaginal capsule of 200 mg for three consecutive days.

Use in children and adolescents

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

If you use moreLomexin 200 mg vaginal soft capsulesthan 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.

If you forgot to useLomexin 200 mg vaginal soft capsules

Do not use a double dose to compensate for the 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 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 topical medications, especially if prolonged, 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

Unknown Frequency:

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 Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on 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 disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at 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 200 mg vaginal soft capsules

• The active ingredient is fenticonazole nitrate. Each vaginal capsule contains 200 mg of fenticonazole nitrate.

• The other components are:

Core excipients: medium-chain triglycerides, colloidal silica.

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

Product appearance and packaging contents

Lomexin 200 mg, is presented in the form of white-beige vaginal soft capsules, in PVC/Aluminum blisters, in containers containing 3 vaginal soft capsules.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Casen Recordati, S.L.,

Autovía de Logroño, km 13.300

50180 UTEBO. Zaragoza (Spain)

Manufacturer responsible

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/.