CLOTRIMAZOL GINE-CANESMED 500 mg VAGINAL TABLET

Introduction

Patient Information Leaflet

Clotrimazole Gine-Canesmed 500 mg vaginal tablet EFG

clotrimazole

Read this leaflet carefully before starting to use this medicine, as 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, pharmacist, or nurse.
• This medicine 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, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Clotrimazole Gine-Canesmed is and what it is used for
2. What you need to know before using Clotrimazole Gine-Canesmed
3. How to use Clotrimazole Gine-Canesmed
4. Possible side effects
5. Storage of Clotrimazole Gine-Canesmed
6. Package contents and additional information

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

Clotrimazole is an antifungal (a medicine used to treat fungal infections).

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

• Complicated vulvovaginal candidiasis (4 or more fungal infections in the last year or infections with severe symptoms or patients with weakened immune systems) and,
• Uncomplicated vulvovaginal candidiasis (sporadic fungal infections or less than 4 infections in the last year or infections with mild to moderate symptoms).

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

Do not use Clotrimazole Gine-Canesmed

If you are allergic to clotrimazole, imidazoles in general, or 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 Clotrimazole Gine-Canesmed.

Before using this medicine, inform your doctor if you have problems with your immune system, such as if you are taking oral corticosteroids or have HIV, AIDS, or diabetes.

In case of fever (38°C or higher), abdominal or back pain, lumbar pain, abundant watery vaginal discharge, and/or nausea, you should consult your doctor to rule out other types of illness.

You should not use tampons, vaginal 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 start of menstruation.

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

It is recommended to avoid sexual intercourse in case of vaginal infection and while using this medicine to prevent the partner from becoming infected.

In case of an allergic reaction during use, treatment should be discontinued and your doctor should be consulted immediately. The signs of a severe allergic reaction include a swollen and itchy rash, swelling, sometimes on the face or in the mouth, which can cause difficulty breathing.

You should consult a doctor if symptoms worsen during treatment or persist after completion of the treatment, or if there is 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 in children over 12 years, see below How to use Clotrimazole Gine-Canesmedfor administration instructions.

Using Clotrimazole Gine-Canesmed with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines, especially if you are taking tacrolimus or sirolimus (medicines used in transplant patients), so that your doctor can monitor you properly.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

Clotrimazole can be used during breastfeeding.

Driving and using machines

The influence of Clotrimazole Gine-Canesmed on the ability to drive and use machines is negligible or non-existent.

3. How to use Clotrimazole Gine-Canesmed

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

Vaginal administration. Do not swallow.

The recommended dose is:

Adults and adolescents over 12 years

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

Uncomplicated vulvovaginal candidiasis (sporadic fungal infections or less than 4 infections in the last year or infections with mild to moderate symptoms): Apply a single vaginal tablet preferably at night.

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

The vaginal tablets require adequate moisture conditions in the vagina for optimal dissolution of the medicine. If these conditions are not met, part of the medicine may not dissolve completely and may come out of the vagina. To prevent this, it is essential 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 assess the use of alternative treatments.

If symptoms persist after completing the treatment or recur within two months, or if you have problems with your immune system, HIV, AIDS, or diabetes, you should consult your doctor.

Eye contact should be avoided, as it may cause irritation. If accidental eye contact occurs, rinse with plenty of water and consult an ophthalmologist if necessary.

If you use more Clotrimazole 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. Phone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Clotrimazole Gine-Canesmed

In case of a missed dose, wait for the next one. Do not apply a double dose to make up for the missed dose.

If you interrupt treatment with Clotrimazole Gine-Canesmed

Continue using Clotrimazole Gine-Canesmed until the treatment is completed, even if you feel better. You need to complete the full treatment to cure the infection. If you interrupt the treatment, the fungus may not have disappeared.

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

4. Possible side effects

Like all medicines, Clotrimazole Gine-Canesmed can cause side effects, although not everyone gets them.

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

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

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

Breathing difficulties.

Abdominal pain, nausea.

Rash, urticaria (raised red itchy patches).

Vaginal scaling, vaginal discharge, vulvovaginal itching, vulvovaginal erythema, burning sensation in the genital area, vulvovaginal discomfort, vulvovaginal pain, and vaginal bleeding.

Irritation at the application site, edema, pain.

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

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: http://www.notificaram.es. By reporting side 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 packaging, after the abbreviation CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Clotrimazole Gine-Canesmed

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

Appearance of the product and package contents

White, oblong vaginal tablets.

They are presented in a cardboard box containing a blister pack (polyamide/aluminum foil/polyvinyl chloride heat-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 last revision of this leaflet: February 2022

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