Laurimic 200 mg soft vaginal capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Laurimic 200 mg soft vaginal capsules

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 200 mg soft vaginal capsules is and what it is used for
2. What you need to know before using Laurimic 200 mg soft vaginal capsules
3. How to use Laurimic 200 mg soft vaginal capsules
4. Possible adverse effects
5. How to store Laurimic 200 mg soft vaginal capsules
6. Contents of the pack and other 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 medicines called gynecological anti-infectives and antiseptics. It is a gynecological antifungal agent.

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

2. What you need to know before using Laurimic 200 mg soft vaginal capsules

Do not use Laurimic 200 mg soft vaginal capsules:

• 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).

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 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.

• 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 within the last 6 months.

• If you or your partner have had a sexually transmitted infection.

• If you have had hypersensitivity to imidazoles or to 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
  • 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 of age.

Use of Laurimic 200 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 formulation of 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 with, for example, diaphragms) is not recommended. Any local vaginal treatment may inactivate a locally acting spermicidal contraceptive.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might 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 using machines

The influence of Laurimic 200 mg soft vaginal capsules on the ability to drive and operate machinery is none or negligible.

Laurimic 200 mg soft vaginal capsules contains ethylparahydroxybenzoate, sodium salt (E 215) and propylparahydroxybenzoate, sodium salt (E 217)

May cause allergic reactions (possibly delayed) as it contains ethylparahydroxybenzoate, sodium salt (E 215) and propylparahydroxybenzoate, sodium salt (E 217).

3. How to use Laurimic 200 mg soft vaginal capsules

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

Laurimic soft vaginal capsules are for vaginal use only. Do not swallow.

The soft vaginal capsule should be inserted deeply into the vagina at bedtime.

The recommended dose is one soft vaginal capsule, administered 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 at telephone number 91 562 04 20, indicating the medicine and the amount used or accidentally ingested.

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 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, absorption of Laurimic is negligible and no adverse effects in the rest of the body (systemic effects) have been reported.

The use of topical medication, especially when prolonged, may lead to 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
• 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 200 mg Soft Vaginal Capsules

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. Instead, dispose of unused medicines and their packaging at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the package and other information

Composition of Laurimic 200 mg vaginal soft capsules

• The active substance 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 salt (E 215), propyl parahydroxybenzoate sodium salt (E 217), colloidal anhydrous silica, and medium-chain triglycerides.

Appearance of the product and contents of the package

Laurimic 200 mg vaginal soft capsules are presented as white-ivory coloured vaginal soft capsules, packed in PVC-PVDC/aluminum blisters, in packages containing 3 vaginal soft 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 most recent revision of this 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/.