Label: information for the user

Gine-Canestén 500 mg soft vaginal capsule

clotrimazol

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

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4,

You should consult a doctor if your condition worsens or does not improve after 3 days.

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

This medication is indicated for thetreatment of uncomplicated vulvovaginal candidiasis (vaginal infection caused by a fungus calledCandida) (See Warning and Precautions section).

The main symptoms are itching accompanied by an increase in vaginal discharge, pain, and redness of the vaginal and vulvar areas, burning, and a sensation of scorching while urinating. These symptoms are not specific to vulvovaginal candidiasis. If in doubt, consult your doctor.

No use Gine-Canestén

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Gine-Canestén.

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.

You should consult a doctor if symptoms worsen during treatment or persist after 3 days or if you observe an increase in vaginal discharge or changes in its appearance or odor, or if you experience vaginal bleeding.

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

In case of an allergic reaction during its use, the treatment should be suspended and you should immediately go to 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.

Do not use tampons, vaginal douches, spermicides or other vaginal products while using this medication, for more information see the section“Use of Gine-Canestén with other medications”.

It is not recommended to start treatment during menstruation.The 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 the partner from becoming infected...

Children

Do not use in children under 12 years.

Use of Gine-Canestén 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).

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

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

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In the case of treatment with this medication in the last 4-6 weeks of pregnancy, it is recommended to dispense with the use of the applicator by inserting the vaginal capsule directly with the finger, after careful washing of the hands.

Breastfeeding

Clotrimazole can be used during breastfeeding.

Driving and operating machines

The influence of Gine-Canestén on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

This medication is administered via the vagina. Do not ingest.

The recommended dose is:

Adults and adolescents over 12 years old

Generally, one vaginal capsule administered preferably at night before going to bed is sufficient. The vaginal capsule must be inserted deeply into the vagina (see applicator usage instructions), with the patient lying on her back and her legs slightly bent.

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, you must consult your doctor.

Pregnant women

In case of treatment in the last 4-6 weeks of pregnancy, it is recommended not to use the applicator and insert the vaginal capsule directly with your finger, after careful washing of your hands.

USAGE INSTRUCTIONS

If you use more Gine-Canestén than you should

An accidental ingestion may cause gastrointestinal discomfort and/or vomiting. An accidental administration in the eyes may cause burning and eye irritation without severity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone (91) 562 04 20 indicating the medication and the amount ingested.

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

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

Immune System Disorders:

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

Vascular Disorders:

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

Respiratory, Thoracic, and Mediastinal Disorders:

Difficulty breathing.

Gastrointestinal Disorders:

Abdominal pain, nausea.

Skin and Subcutaneous Tissue Disorders:

Rash,, urticaria (raised, red, itchy hives).

Reproductive and Mammary System Disorders:

Vaginal desquamation, vaginal discharge, vulvovaginal pruritus, vulvovaginal erythema, sensation of burning in the genital area, vulvovaginal discomfort, vulvovaginal pain, and vaginal bleeding.

General and Local Systemic Disorders:

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

Store in the original packaging to protect it from moisture

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

Do not use Gine-Canestén 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 thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Gine-Canestén

- The active ingredient is clotrimazol. Each vaginal capsule contains 500 mg of clotrimazol.

-The other components (excipients) are: White soft paraffin, liquid paraffin, gelatine, glycerol (E-422), purified water, titanium dioxide (E-171), yellow quinoline (E-104), yellow-orange S (E-110), lecithin, medium-chain triglycerides

Appearance of the product and contents of the packaging:

This medication is a yellow-colored vaginal capsule in the shape of a drop.It is presented in packaging that contains 1 vaginal capsule and a vaginal applicator.

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-Barrel-Strasse 7

79639 Grenzach-Whylen

Germany

Dateofthelastreviewofthisleaflet:March 2022

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/