Package Insert: Information for the User

Laurimic 200 mg Vaginal Soft Capsules

Fenticonazole Nitrate

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others who may 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 package insert. See section 4.

Laurimic 200 mg vaginal soft capsules belongs to a group of medicines called gynecological anti-infectives and antiseptics. It is a gynecological antimycotic.

Laurimic 200 mg vaginal soft capsules is indicated for the treatment of vulvovaginal candidiasis.

Do not use Laurimic 200 mg vaginal soft capsules:

• If you are allergic to the active ingredient, to other imidazolic derivatives, or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Laurimic 200 mg vaginal soft capsules.

• 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.
• 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 other vaginal antifungal medications.
• 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
• 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 old.

Use of Laurimic 200 mg vaginal soft capsules with other medicationsInform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The oils and fatty excipients in the composition of the vaginal soft 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 if you 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 machinery

The influence of Laurimic 200 mg vaginal soft capsules on the ability to drive and operate machinery is negligible or insignificant.

Laurimic 200 mg vaginal soft capsules contain phenoxyethanol, sodium salt (E 215) and phenoxypropyl, sodium salt (E 217)

It may cause allergic reactions (possibly delayed) because it contains phenoxyethanol, sodium salt (E 215) and phenoxypropyl, 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.

Laurimic vaginal soft capsules are used only by vaginal route. Do not ingest.

The capsule vaginal soft should be inserted deeply into the vagina while lying down.

The recommended dose is one vaginal soft capsule, before lying down, for 3 consecutive days.

If you use more Laurimic 200 mg vaginal soft capsules 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 Laurimic 200 mg vaginal soft capsules

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 all people 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 rash

Unknown Frequency:

• 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 Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on 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 200 mg vaginal soft capsules

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

• The other components are: titanium dioxide (E 171), gelatin, glycerol (E 422), ethyl parahydroxybenzoate, sodium chloride (E 215), propyl parahydroxybenzoate, sodium chloride (E 217), anhydrous colloidal silica, and medium-chain triglycerides.

Appearance of the product and content of the packaging

Laurimic 200 mg vaginal soft capsules are presented in the form of a white-beige-colored vaginal soft capsule, in a PVC-PVDC/Aluminum blister, in containers containing 3 vaginal soft capsules.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Laboratorios Effik, S.A

C/ San Rafael, 3

28108 Alcobendas-Madrid

Spain

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