Laurimic 600 mg soft vaginal capsule

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Laurimic 600 mg soft vaginal capsule

Fenticonazole nitrate

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Laurimic 600 mg soft vaginal capsule is and what it is used for
2. What you need to know before using Laurimic 600 mg soft vaginal capsule
3. How to use Laurimic 600 mg soft vaginal capsule
4. Possible adverse effects
5. How to store Laurimic 600 mg soft vaginal capsule
6. Contents of the pack and other information

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

Laurimic 600 mg vaginal soft capsule belongs to a group of medicines called gynecological anti-infectives and antiseptics. It is a gynecological antifungal agent.

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

2. What you need to know before using 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 soy lecithin. If you are allergic to peanuts or soy, you should not use this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Laurimic 600 mg soft vaginal capsule.

• If you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

• If you are using a latex barrier contraceptive method (see section “Use of Laurimic with other medicines”). Therefore, you should take additional contraceptive measures while using this medicine.

• If you are using spermicides, vaginal douches, or other vaginal products (see section “Use of Laurimic with other medicines”).

• If you experience irritation or sensitivity to the medicine.

• If symptoms do not improve within one week or in case of recurrent severe 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 infection.

• If you have had hypersensitivity to imidazoles or other vaginal antifungal medicines.

• If you are over 60 years of age.

• If you have any of the following symptoms:

• Abnormal or irregular vaginal bleeding

• Blood spots in vaginal discharge

• Vulvar or vaginal pain, ulcers, or blisters

• 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 of age.

Use of Laurimic 600 mg soft vaginal capsules with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The oils and fatty excipients contained in the soft vaginal capsules may damage latex-based contraceptive methods, such as condoms and diaphragms (see section “Warnings and precautions”).

The use of spermicides (a substance inserted vaginally that destroys sperm and is used as a contraceptive alone or in combination, for example, with diaphragms) is not recommended. Any local vaginal treatment may inactivate a local spermicidal contraceptive.

Pregnancy, breastfeeding and fertility

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

Driving and use of machines

The influence of Laurimic 600 mg soft vaginal capsule on the ability to drive and use machines is none or negligible.

Laurimic 600 mg soft vaginal capsule contains ethyl p-hydroxybenzoate, sodium salt (E 215) and propyl p-hydroxybenzoate, sodium salt (E 217)

May cause allergic reactions (possibly delayed) as it contains ethyl p-hydroxybenzoate, sodium salt (E 215) and propyl p-hydroxybenzoate, sodium salt (E 217).

3. How to use Lurimic 600 mg soft vaginal capsule

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 soft vaginal capsule of 600 mg administered vaginally at bedtime. If signs and symptoms of vaginitis persist, a second dose may be repeated three days after the first 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used or accidentally ingested.

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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

A slight sensation may occur when the medicine is inserted into the vagina, which will quickly disappear. When used as recommended, systemic absorption of Laurimic is negligible, and no adverse effects throughout the rest of the body (systemic effects) have been reported.

The use of topical medication, especially when used for prolonged periods, may lead to sensitization (see section “Warnings and precautions”).

The following adverse effects have been reported with Laurimic:

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

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

Frequency not known:

• Hypersensitivity at the application site

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Laurimic 600 mg soft vaginal capsule:

• The active substance is fenticonazole nitrate. Each soft vaginal capsule contains 600 mg of fenticonazole nitrate.
• The other components 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 soft paraffin.

Appearance of the product and contents of the pack

Laurimic 600 mg soft vaginal capsule is presented as a soft vaginal capsule of white-ivory color, in PVCPVDC/Aluminum blisters, in packages containing 1 soft 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 the most recent revision of this package leaflet: 09/2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.