LAURIMIC 600 MG SOFT VAGINAL CAPSULE

Introduction

Package Leaflet: Information for the User

Laurimic 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Laurimic 600 mg Soft Vaginal Capsule and what is it used for
2. What you need to know before you use Laurimic 600 mg Soft Vaginal Capsule
3. How to use Laurimic 600 mg Soft Vaginal Capsule
4. Possible side effects
5. Storage of Laurimic 600 mg Soft Vaginal Capsule
6. Contents of the pack and further information

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

Laurimic 600 mg Soft Vaginal Capsule belongs to a group of medicines called gynecological anti-infectives and antiseptics. It is a gynecological antimycotic.

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

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

Do not use Laurimic 600 mg Soft Vaginal Capsule:

• If you are allergic to the active substance, to other imidazole derivatives, or to any of the other ingredients of this medicine (listed in section 6).
• Laurimic 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 or pharmacist before you start using Laurimic 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 "Using Laurimic with other medicines"). Consequently, you should take additional measures while using this medicine.

• if you are using spermicides, vaginal douches, or other vaginal products (see section "Using Laurimic with other medicines")

• if you experience irritation or sensitivity to the medicine.
• if the symptoms do not decrease within a week or in case of severe recurrent symptoms.
• if your partner is also infected.
• if you have had more than 2 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
• blood spots in vaginal secretions
• pain, ulcers, 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

Laurimic is not recommended for girls under 16 years old.

Using Laurimic 600 mg Soft Vaginal Capsules with other medicinesInform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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 (a substance inserted vaginally that destroys sperm and is used as a contraceptive alone or in combination with, for example, diaphragms). It is likely that any local vaginal treatment will inactivate a local spermicidal contraceptive.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. The use of Laurimic should be under medical supervision during pregnancy and breastfeeding.

Driving and Using Machines

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

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

It 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 Laurimic 600 mg Soft Vaginal Capsule

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

The recommended dose is 1 vaginal capsule of 600 mg by vaginal route at bedtime. In case of persistent signs and symptoms of vaginitis, a second dose may be repeated after 3 days of administration.

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

If you use more Laurimic 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 error.

If you forget to use Laurimic 600 mg Soft Vaginal Capsule

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

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

4. Possible Side Effects

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

You may experience a slight sensation when inserting the medicine into the vagina, which will disappear quickly. When used as recommended, the absorption of Laurimic is insignificant, and no systemic side effects have been reported.

The use of topical medicines, especially those used for a long time, can cause sensitization (see section "Warnings and Precautions").

The following side effects have been reported with Laurimic:

Very rare (affects less than 1 in 10,000 patients)

• Vulvovaginal burning sensation
• Cutaneous erythema, pruritus, and rash

Frequency not known:

• Hypersensitivity at the application site

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any 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 Laurimic 600 mg Soft Vaginal Capsule

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

Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Laurimic 600 mg Soft Vaginal Capsule:

• The active substance is fenticonazole nitrate. Each vaginal capsule contains 600 mg of fenticonazole nitrate.
• The other ingredients are: titanium dioxide (E 171), gelatin, glycerol (E 422), soybean lecithin (E 322), liquid paraffin, ethyl parahydroxybenzoate, sodium salt (E 215), propyl parahydroxybenzoate, sodium salt (E 217), and white petrolatum.

Appearance and packaging of the product

Laurimic 600 mg Soft Vaginal Capsule is presented as a white-ivory colored soft vaginal capsule, in a PVCPVDC/Aluminum blister pack, in packs containing 1 vaginal capsule.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Manufacturer

Effik

Bâtiment «Le Newton»

9-11, rue Jeanne Braconnier

92366 Meudon la Forêt

France

Catalent Italy, S.p.A.

Via Nettunense, km 20,100

04011 Aprilia

Italy

Date of last revision of this leaflet:09/2020

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/.