Label: information for the patient

Clotrimazol Gine-Canesmed 20 mg/g vaginal cream EFG

clotrimazol

Read this label carefully before starting to use this medication, as it contains important information for you.

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

Contents of the package and additional information

Clotrimazol is an antifungal (a medication used to treat infections caused by fungi).

This medication is indicated, in adults and adolescents over 12 years old, 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,
• Non-complicated vulvovaginal candidiasis (fungal infections occurring sporadically or less than 4 infections in the last year or infections with mild to moderate symptoms).

Do not use Clotrimazol Gine-Canesmed

If you are allergic to clotrimazol, imidazoles in general or to 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 Clotrimazol Gine-Canesmed.

Inform your doctor before using this medication if you have problems with your immune system, for example if you are being treated with oral corticosteroids or have an HIV, AIDS or diabetes infection.

In case of fever (38°C or higher), abdominal or back pain, lower back pain, abundant watery vaginal secretions and/or nausea, you must consult your doctor to rule out another type of disease.

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 appears during treatment.

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

In case of an allergic reaction during its use, treatment should be suspended and you should immediately consult your doctor. Signs of a severe allergic reaction include swollen and itchy rash, swelling, sometimes on the face or in the mouth that causes difficulty breathing.

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

Children and adolescents

This medication is indicated for children over 12 years old, see How to use Clotrimazol Gine-Canesmedfor administration instructions.

Use of Clotrimazol Gine-Canesmed with other medications

Inform your doctor or pharmacist that you are taking, have taken recently 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 provide the necessary follow-up.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

Clotrimazol may be used during breastfeeding.

Driving and operating machinery

The influence of Clotrimazol Gine-Canesmed on the ability to drive and operate machinery is negligible or insignificant.

Clotrimazol Gine-Canesmed contains cetoestearic alcohol and benzyl alcohol

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

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

Administration via the vagina. Do not ingest.

The recommended dose is:

Adults and adolescents over 12 years old

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 a vaginal applicator load (approximately 5 g)once a day, preferably at night, for 7-14 consecutive days.

Uncomplicated vulvovaginal candidiasis(fungal infections occurring sporadically or less than 4 infections in the last year or infections with mild to moderate symptoms):Apply a vaginal applicator load (approximately 5 g), once a daypreferably at night, for 3 consecutive days.

The cream should be inserted deeply into the vagina (seeINSTRUCTIONS FOR USE OF THE APPLICATOR), with the patient lying on her back and 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, the use of the applicator is not recommended. Instead, use vaginal tablets, 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 infection, AIDS, or diabetes, consult your doctor.

Avoid contact with the eyes, as it may cause irritation. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.

If you use more Clotrimazol Gine-Canesmed than you should

An 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 Toxicological Information Service. Phone (91) 562 04 20 indicating the medication and the amount ingested.

If you forget to use Clotrimazol Gine-Canesmed

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

If you interrupt treatment with Clotrimazol Gine-Canesmed

Continue using Clotrimazol Gine-Canesmed until you complete the treatment, even if you feel better. You need to complete the treatment to cure the infection. If you interrupt treatment, the fungi may not have disappeared.

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

Like all medications, Clotrimazol Gine-Canesmed may produce adverse effects, although not everyone will experience them.

Adverse reactions withunknown 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 peeling, 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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication

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 Clotrimazol Gine-Canesmed after the expiration date that appears on the packaging, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the Sigre collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Clotrimazol Gine-Canesmed

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

Appearance of the product and content of the packaging

White cream.

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

Holder of the authorization and responsible for manufacturing

Holder of the marketing authorization

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

GP Grenzach Produktions GmbH

Emil-Barell-Str. 7

79639 Grenzach-Wyhlen

Germany

Last review date of this leaflet: October 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/