LOMEXIN 200 mg SOFT VAGINAL CAPSULES

Introduction

Package Leaflet: Information for the User

Lomexin 200 mg Soft Vaginal Capsules

Fenticonazole Nitrate

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Lomexin 200 mg Soft Vaginal Capsules is and what it is used for
2. What you need to know before you use Lomexin 200 mg Soft Vaginal Capsules
3. How to use Lomexin 200 mg Soft Vaginal Capsules
4. Possible side effects
5. Storage of Lomexin 200 mg Soft Vaginal Capsules
6. Contents of the pack and other information

1. What Lomexin 200 mg Soft Vaginal Capsules is and what it is used for

Lomexin 200 mg Soft Vaginal Capsules belongs to a group of medicines called gynecological anti-infectives and antiseptics.

Lomexin 200 mg Soft Vaginal Capsules is indicated for the treatment of vulvovaginal candidiasis.

2. What you need to know before you use Lomexin 200 mg Soft Vaginal Capsules

Do not use Lomexin 200 mg Soft Vaginal Capsules:

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

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before using Lomexin 200 mg Soft Vaginal Capsules:

• if you are pregnant or breastfeeding (see section "Pregnancy, Breastfeeding, and Fertility").
• if you are using a barrier contraceptive method made of latex (see section "Other Medicines and Lomexin"). Consequently, you should take additional measures while using this medicine.
• if you are using spermicides, vaginal douches, or other vaginal products (see section "Other Medicines and Lomexin").
• if you experience irritation or sensitivity to the medicine.
• If there is no improvement in symptoms after one 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 antifungal vaginal medicines.
• if you are over 60 years old.
• if you have any of the following symptoms:

• abnormal 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 Medicines and Lomexin 200 mg Soft Vaginal Capsules

The oils and fatty excipients that are part of the composition of the vaginal capsules can damage latex-based contraceptive methods, such as condoms and diaphragms (see section "Warnings and Precautions").

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

The use of Lomexin should be under medical supervision during pregnancy and breastfeeding.

Driving and Using Machines

Lomexin 200 mg Soft Vaginal Capsules has no or negligible influence on the ability to drive and use machines.

Lomexin 200 mg Soft Vaginal Capsules contains Ethyl 4-Hydroxybenzoate, Sodium Salt (E 215) and Propyl 4-Hydroxybenzoate, Sodium Salt (E 217)

May cause allergic reactions (possibly delayed) because it contains Ethyl 4-Hydroxybenzoate, Sodium Salt (E 215) and Propyl 4-Hydroxybenzoate, Sodium Salt (E 217).

3. How to use Lomexin 200 mg Soft Vaginal Capsules

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

The recommended dose is:

• One 200 mg vaginal capsule for three consecutive days.

Use in Children and Adolescents

The recommended dose for children from 16 years onwards is the same as for adults.

If you use more Lomexin 200 mg Soft Vaginal Capsules than you should

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

If you forget to use Lomexin 200 mg Soft Vaginal Capsules

Do not use a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

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

You may experience a mild burning sensation when the medicine is inserted into the vagina, which disappears quickly. When used as recommended, the absorption of Lomexin is insignificant, and no systemic side effects have been reported.

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

The following side effects have been reported with Lomexin:

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

• vulvovaginal burning sensation
• erythema, pruritus, and rash

Frequency Not Known:

Hypersensitivity in the application area.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lomexin 200 mg Soft Vaginal Capsules

No special storage conditions are required.

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

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the packaging and any unused medicine, ask your pharmacist. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Lomexin 200 mg Soft Vaginal Capsules

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

• The other ingredients are:

Core excipients: medium-chain triglycerides, colloidal silica.

Capsule excipients: gelatin, glycerol (E 422), titanium dioxide (E 171), ethyl 4-hydroxybenzoate, sodium salt (E 215), propyl 4-hydroxybenzoate, sodium salt (E 217).

Appearance and Packaging

Lomexin 200 mg is presented as white-ivory soft vaginal capsules, in PVC/Aluminum blisters, in packs containing 3 soft vaginal capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Casen Recordati, S.L.,

Autovía de Logroño, km 13.300

50180 UTEBO. Zaragoza (Spain)

Manufacturer

CATALENT ITALY, S.P.A.

Via Nettunense, Km 20,100

Aprilia (LT) 04011

Italy

Date of Last Revision of this Leaflet: September 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.