LAURIMIC 200 mg SOFT VAGINAL CAPSULES

Introduction

Package Leaflet: Information for the User

Laurimic 200 mg Soft Vaginal Capsules

Fenticonazole Nitrate

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Laurimic 200 mg Soft Vaginal Capsules are and what they are used for
2. What you need to know before starting to use Laurimic 200 mg Soft Vaginal Capsules
3. How to use Laurimic 200 mg Soft Vaginal Capsules
4. Possible side effects
5. Storage of Laurimic 200 mg Soft Vaginal Capsules
6. Package Contents and Additional Information

1. What Laurimic 200 mg Soft Vaginal Capsules are and what they are used for

Laurimic 200 mg Soft Vaginal Capsules belong to a group of medications called gynecological anti-infectives and antiseptics. It is a gynecological antimycotic.

Laurimic 200 mg Soft Vaginal Capsules are indicated for the treatment of vulvovaginal candidiasis.

2. What you need to know before starting to use Laurimic 200 mg Soft Vaginal Capsules

Do not use Laurimic 200 mg Soft Vaginal Capsules:

• If you are allergic to the active ingredient, other imidazole derivatives, or 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 Soft Vaginal Capsules.

• 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 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
• 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 200 mg Soft Vaginal Capsules with Other MedicationsInform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The oils and fatty excipients that are part of the composition of the vaginal capsules may 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). Any local vaginal treatment is likely to inactivate a local spermicidal contraceptive.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

The influence of Laurimic 200 mg Soft Vaginal Capsules on the ability to drive and use machines is negligible.

Laurimic 200 mg Soft Vaginal Capsules contain Ethyl 4-Hydroxybenzoate, Sodium Salt (E 215) and Propyl 4-Hydroxybenzoate, Sodium Salt (E 217)

They may cause allergic reactions (possibly delayed) because they contain Ethyl 4-Hydroxybenzoate, Sodium Salt (E 215) and Propyl 4-Hydroxybenzoate, Sodium Salt (E 217).

3. How to Use Laurimic 200 mg Soft Vaginal Capsules

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Laurimic Soft Vaginal Capsules are for vaginal use only. Do not ingest.

The capsule should be inserted deep into the vagina when going to bed.

The recommended dose is one soft vaginal capsule, before going to bed, for 3 consecutive days.

If you use more Laurimic 200 mg Soft Vaginal Capsules 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 medication and the amount used or ingested by error.

If you forget to use Laurimic 200 mg Soft Vaginal Capsules

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

A mild sensation may be experienced when the medication is inserted into the vagina, which will disappear quickly. When used as recommended, the absorption of Laurimic is negligible, and no systemic side effects have been reported.

The use of topical medications, especially those used for prolonged periods, may 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
• Skin erythema, pruritus, and rash

Frequency Not Known:

• Hypersensitivity at the application site

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Laurimic 200 mg Soft Vaginal Capsules

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

Do not store above 30°C.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Laurimic 200 mg Soft Vaginal Capsules

• The active ingredient is Fenticonazole Nitrate. Each soft vaginal capsule contains 200 mg of Fenticonazole Nitrate.

• The other components are: Titanium Dioxide (E 171), Gelatin, Glycerol (E 422), Ethyl 4-Hydroxybenzoate, Sodium Salt (E 215), Propyl 4-Hydroxybenzoate, Sodium Salt (E 217), Colloidal Anhydrous Silica, and Medium-Chain Triglycerides.

Appearance of the Product and Package Contents

Laurimic 200 mg Soft Vaginal Capsules are presented in the form of a white-ivory colored soft vaginal capsule, in PVC-PVDC/Aluminum blisters, in packages containing 3 soft vaginal capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas-Madrid

Spain

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 Last Revision of this Package Leaflet:09/2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.