CLOTRIMAZOL GINE-CANESMED 20 mg/g VAGINAL CREAM

Introduction

Package Leaflet: Information for the Patient

Clotrimazole Gine-Canesmed 20 mg/g Vaginal Cream EFG

clotrimazole

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, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

Contents of the packaging and additional information

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

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

This medication 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 a weakened immune system) 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 medication (listed in section 6).

Warnings and precautions

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

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

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

You should not use tampons, vaginal douches, spermicides, or other vaginal products while using this medication.

It is not recommended to start treatment during menstruation. Treatment should have ended before the start of menstruation.

This medication 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 medication to prevent the partner from becoming infected.

In case of an allergic reaction during use, treatment should be discontinued and you should immediately consult your doctor. 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 completing it, or if you experience increased vaginal discharge or changes in its appearance or odor, or if you experience vaginal bleeding.

Children and adolescents

This medication is indicated in children over 12 years, see How to use Clotrimazole Gine-Canesmedfor administration instructions.

Using Clotrimazole Gine-Canesmed with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication, especially if you are taking tacrolimus or sirolimus (medications 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 medication.

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 nil or insignificant.

Clotrimazole Gine-Canesmed contains cetyl stearyl alcohol and benzyl alcohol

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl stearyl alcohol.

This medication contains 20 mg of benzyl alcohol per gram of cream.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

3. How to use Clotrimazole Gine-Canesmed

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

Vaginal administration. Do not ingest.

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 a weakened immune system): Apply one applicatorful (approximately 5 g) once a day, preferably at night, for 7-14 consecutive days.

Uncomplicated vulvovaginal candidiasis (sporadic fungal infections or less than 4 infections in the last year or infections with mild to moderate symptoms): Apply one applicatorful (approximately 5 g) once a day, preferably at night, for 3 consecutive days.

The cream should be inserted deeply into the vagina (see INSTRUCTIONS FOR USE OF THE APPLICATOR), with the patient lying on her back and with her legs slightly bent, preferably at night before going to bed.

Pregnant women

In case of treatment during the last 4 or 6 weeks of pregnancy, it is not recommended to use the applicator. Therefore, it is recommended to use vaginal tablets instead of the vaginal cream, as they can be inserted directly with the finger, after careful hand washing.

If symptoms persist after completing 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 upset 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 medication 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 you complete the treatment, even if you feel better. You need to complete the full treatment to cure the infection. If you interrupt treatment, the fungus may not have disappeared.

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

4. Possible side effects

Like all medications, 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.

Syncope (sudden loss of consciousness, fainting), hypotension (low blood pressure).

Difficulty breathing.

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 require 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 package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Clotrimazole Gine-Canesmed

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

No special storage conditions are required. Store in the original packaging.

Do not use Clotrimazole Gine-Canesmed after the expiration date stated on the packaging, after the abbreviation CAD. The expiration date is the last day of the month indicated.

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

6. Contents of the packaging and additional information

Composition of Clotrimazole Gine-Canesmed

• The active ingredient is clotrimazole. Each gram of cream contains 20 mg of clotrimazole.
• The other components (excipients) are: sorbitan stearate type I, polysorbate 60, cetyl palmitate, cetyl stearyl alcohol, octyldodecanol, benzyl alcohol, and purified water.

Appearance of the product and contents of the packaging

White cream.

It is presented in a cardboard box containing an aluminum tube with a PE cap and 20 g of cream, and 3 disposable vaginal applicators made of PE/PP.

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-Str. 7

79639 Grenzach-Wyhlen

Germany

Date of the last revision of this package leaflet:October 2021

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