Label: information for the user

Laurimic 600 mg soft vaginal capsule

Fenticonazole nitrate

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

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

Do not use Laurimic 600 mg soft vaginal capsule:

• If you are allergic to the active ingredient, to other imidazolic derivatives or to any of the other components of this medication (included 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 medication.

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, lactation and fertility”).
• if you are using a barrier contraceptive made of latex (see section “Use of Laurimic with other medications”). Consequently, you should take additional measures while using this medication.

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

• if you experience irritation or sensitivity to the medication.
• if 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 to other vaginal antifungal medications.
• if you are over 60 years old.
• if you have any of the following symptoms:

• vaginal bleeding that is abnormal or irregular
• blood spots in vaginal secretions
• vulvar or vaginal 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 old.

Use of Laurimic 600 mg soft vaginal capsules with other medicationsInform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

The oils and fatty excipients that form part of the composition of the soft vaginal 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 (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 spermicide.

Pregnancy, lactation and fertility

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

Driving and operating machines

The influence of Laurimic 600 mg soft vaginal capsule on the ability to drive and operate machines is negligible or insignificant.

Laurimic 600 mg soft vaginal capsule contains parahydroxybenzoic acid ethyl ester, sodium salt (E 215) and parahydroxybenzoic acid propyl ester, sodium salt (E 217)

It may produce allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid ethyl ester, sodium salt (E 215) and parahydroxybenzoic acid propyl ester, 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.

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

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

If you use more Lurimic 600 mg soft vaginal capsule than 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 use Lurimic 600 mg soft vaginal capsule

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 or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

You may experience a mild sensation when the medication is inserted into the vagina, which will disappear quickly. When used as recommended, the absorption of Laurimic is insignificant and no adverse effects have been reported in the rest of the body (systemic effects).

The use of topical medication, especially prolonged use, may cause sensitization (see section “Warnings and Precautions”).

The following adverse effects have been reported with Laurimic:

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

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

Frequency not known:

• 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 the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. 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 of Laurimic 600 mg vaginal soft capsule:

• The active ingredient is fenticonazole nitrate. Each vaginal soft capsule contains 600 mg of fenticonazole nitrate.
• The other components are: titanium dioxide (E 171), gelatin, glycerol (E 422), soy lecithin (E 322), liquid paraffin, ethyl parahydroxybenzoate, sodium chloride (E 215), propyl parahydroxybenzoate, sodium chloride (E 217), and white vaseline.

Appearance of the product and contents of the packaging

Laurimic 600 mg vaginal soft capsule is presented in the form of a white-beige colored vaginal soft capsule, in a PVCPVDC/Aluminum blister, in containers containing 1 vaginal soft capsule.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Responsible 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

Last review date of this leaflet:09/2020

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.