Clotrimazole Gine-Canesmed 500 mg vaginal tablet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Clotrimazol Gine-Canesmed 500 mg vaginal tablet EFG

clotrimazole

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

Leaflet contents:

1. What Clotrimazol Gine-Canesmed is and what it is used for
2. What you need to know before using Clotrimazol Gine-Canesmed
3. How to use Clotrimazol Gine-Canesmed
4. Possible side effects
5. How to store Clotrimazol Gine-Canesmed
6. Contents of the pack and other information

1. What Clotrimazole Gine-Canesmed is and what it is used for

Clotrimazole is an antifungal (a medicine used to treat infections caused by fungi).

This medicine is indicated in adults and adolescents over 12 years of age for the treatment of:

• Complicated vulvovaginal candidiasis (4 or more fungal infections in the past year, or infections with severe symptoms, or patients with a weakened immune system), and
• Uncomplicated vulvovaginal candidiasis (fungal infections occurring sporadically or fewer than 4 infections in the past year, or infections with mild to moderate symptoms).

2. What you need to know before using Clotrimazol Gine-Canesmed

Do not use Clotrimazol Gine-Canesmed

If you are allergic to clotrimazole, imidazoles in general, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Clotrimazol Gine-Canesmed.

Before using this medicine, inform your doctor if you have problems with your immune system, for example if you are being treated with oral corticosteroids or have HIV infection, AIDS, or diabetes.

If you develop fever (38°C or higher), abdominal or back pain, flank pain, profuse watery vaginal discharge and/or nausea, you should consult your doctor to rule out other types of illness.

Do not use tampons, intravaginal douches, spermicides, or other vaginal products while using this medicine.

It is not recommended to start treatment during menstruation. Treatment should be completed before the onset of menstruation.

This medicine may reduce the effectiveness and safety of latex products, such as condoms and diaphragms. This effect is temporary and occurs only during treatment.

It is recommended to avoid sexual intercourse in case of vaginal infection and while using this medicine to prevent transmission to your partner.

If an allergic reaction occurs during use, treatment must be stopped and you should immediately contact your doctor. Signs of a severe allergic reaction include raised, itchy rash, swelling, sometimes in the face or mouth, causing difficulty breathing.

You should consult a doctor if symptoms worsen during treatment or persist after completion of treatment, or if you notice an increase in vaginal discharge or changes in its appearance or odor, or if you experience vaginal bleeding.

Children and adolescents

This medicine is indicated for children over 12 years of age. See below How to use Clotrimazol Gine-Canesmed for administration instructions.

Use of Clotrimazol Gine-Canesmed with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking tacrolimus or sirolimus (medicines used in transplant patients), so that your doctor can provide appropriate monitoring.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Clotrimazole may be used during pregnancy, but only under the supervision of a healthcare professional.

Breastfeeding

Clotrimazole may be used during breastfeeding.

Driving and using machines

The influence of Clotrimazol Gine-Canesmed on the ability to drive and use machines is none or negligible.

3. How to use Clotrimazole Gine-Canesmed

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

Administer by vaginal route. Do not ingest.

The recommended dose is:

Adults and adolescents over 12 years of age

Complicated vulvovaginal candidiasis (4 or more fungal infections in the past year, or infections with severe symptoms, or patients with a weakened immune system): Insert one vaginal tablet preferably at night once a week for two consecutive weeks.

Uncomplicated vulvovaginal candidiasis (infections caused by fungi occurring sporadically or less than 4 infections in the past year, or infections with mild to moderate symptoms): Insert a single vaginal tablet preferably at night.

The tablet should be inserted deeply into the vagina with the finger (see below), while the patient is lying on her back with her legs slightly bent.

Vaginal tablets require adequate moisture conditions in the vagina for optimal dissolution of the medication. If these conditions are not met, part of the medication may not dissolve completely and could come out of the vagina. To prevent this, it is important to insert the tablet as deeply as possible into the vagina at bedtime. If the vaginal tablet does not dissolve completely after the first administration, consult your doctor or pharmacist to consider alternative treatments.

If symptoms persist at the end of treatment, recur within two months, or if you have immune system disorders, HIV infection, AIDS, or diabetes, you should consult your doctor.

Contact with the eyes should be avoided, as it may cause stinging. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.

If you use more Clotrimazol Gine-Canesmed than you should

Accidental ingestion may cause gastrointestinal discomfort and/or vomiting.

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 medication and the amount ingested.

If you forget to use Clotrimazol Gine-Canesmed

If you miss a dose, wait until the next scheduled dose. Do not apply a double dose to make up for the missed dose.

If you interrupt treatment with Clotrimazol Gine-Canesmed

Continue using Clotrimazol Gine-Canesmed for the full duration of treatment, even if you feel better. You need to complete the full course of treatment to cure the infection. If you stop treatment prematurely, the fungi may not have been fully eradicated.

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

4. Possible adverse effects

Like all medicines, Clotrimazole Gine-Canesmed may produce adverse effects, although not everyone experiences them.

Adverse reactions with unknown frequency (cannot be estimated from the available data) are:

Angioedema (swelling under the skin), allergic reaction, hypersensitivity.

Allergic reactions: syncope (sudden loss of consciousness, fainting), hypotension (low blood pressure).

Difficulty breathing.

Abdominal pain, nausea.

Rash, urticaria (raised red itchy welts).

Vaginal desquamation, vaginal discharge, vulvovaginal itching, vulvovaginal erythema, genital burning sensation, vulvovaginal discomfort, vulvovaginal pain, and vaginal bleeding.

Irritation at the application site, edema, pain.

These symptoms usually do not require discontinuation of treatment and are more frequent during the first days of treatment.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clotrimazole Gine-Canesmed

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

Do not store above 25°C. Store in the original packaging.

Do not use Clotrimazole Gine-Canesmed after the expiry date stated on the container, following the abbreviation CAD. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the Sigre Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Clotrimazol Gine-Canesmed

• The active substance is clotrimazole. Each vaginal tablet contains 500 mg of clotrimazole.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose (E460i), lactic acid (E270), calcium lactate pentahydrate, corn starch, hypromellose, anhydrous colloidal silica, crospovidone (E1202), and magnesium stearate.

Appearance of the product and contents of the pack

White, oval-shaped vaginal tablets.

Presented in a cardboard box containing one blister (a thermoformed polyamide/soft aluminum/polyvinyl chloride laminate sealed to a hard aluminum foil) with 1 vaginal tablet.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

GP Grenzach Produktions GmbH

Emil-Barell-Strasse 7

79639 Grenzach-Wyhlen

Germany

Date of the most recent revision of this leaflet: February 2022

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/