LOMEXIN 600 mg SOFT VAGINAL CAPSULE

Introduction

Package Leaflet: Information for the User

Lomexin 600 mg Soft Vaginal Capsule

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 is Lomexin 600 mg Soft Vaginal Capsule and what is it used for
2. What you need to know before you use 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 further information

1. What is Lomexin 600 mg Soft Vaginal Capsule and what is it used for

Lomexin 600 mg Soft Vaginal Capsule belongs to a group of medicines called gynecological anti-infectives and antiseptics.

Lomexin 600 mg Soft Vaginal Capsule is indicated for the treatment of vulvovaginal candidiasis.

2. What you need to know before you use Lomexin 600 mg Soft Vaginal Capsule

Do not use Lomexin 600 mg Soft Vaginal Capsule

• if you are allergic to fenticonazole nitrate or any of the other ingredients of this medicine (listed in section 6).
• Lomexin 600 mg Soft Vaginal Capsule contains soybean lecithin. If you are allergic to peanuts or soy, you should not use this medicine.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before using Lomexin 600 mg Soft Vaginal Capsule;

• 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"). You will need to 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 vaginal antifungal 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 secretions
• 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 600 mg Soft Vaginal Capsule

The oils and fatty excipients that are part of the composition of the vaginal capsule may 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 may inactivate the vaginal treatment.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

The influence of Lomexin 600 mg Soft Vaginal Capsule on the ability to drive and use machines is nil or insignificant.

Lomexin 600 mg Soft Vaginal Capsule contains ethyl parahydroxybenzoate, sodium salt (E 215) and propyl parahydroxybenzoate, sodium salt (E 217)

May cause allergic reactions (possibly delayed) because it contains ethyl parahydroxybenzoate, sodium salt (E 215) and propyl parahydroxybenzoate, sodium salt (E 217).

3. How to use Lomexin 600 mg Soft Vaginal Capsule

Follow exactly the administration instructions of this medicine indicated 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 into the vagina when lying down.

The recommended dose is:

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

Use in Children and AdolescentsThe recommended dose for children over 16 years old is the same as for adults.

If you use more Lomexin 600 mg Soft Vaginal Capsule 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 600 mg Soft Vaginal Capsule

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 this medicine topically, especially for prolonged periods, may 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
• cutaneous 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 600 mg Soft Vaginal Capsule

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 stated.

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 are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Lomexin 600 mg Soft Vaginal Capsule

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

• The other ingredients are:

Core excipients: liquid paraffin, soft white petrolatum, soybean lecithin.

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

Appearance and Packaging of the Product

Lomexin 600 mg is presented as a soft vaginal capsule, white-ivory in color, in PVC/Aluminum blisters, in packs containing 1 soft vaginal capsule.

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 the 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/.