Gine-canesten 500 mg comprimido vaginal

Label: information for the user

Gine-Canestén 500 mg vaginal tablet

clotrimazole

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, pharmacist, or nurse

• 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 any adverse effects, consult your doctor, pharmacist, or nurse, 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.

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

This medication is indicated for the treatment of uncomplicated vulvovaginal candidiasis (vaginal infection caused by a fungus called Candida) (See Warnings 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 scalding when 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 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 Gine-Canestén.

Do not ingest.

Inform your doctor 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.

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.

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

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 hives, swelling, sometimes on the face or in the mouth that causes difficulty breathing.

Use in 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

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

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

Breastfeeding

Clotrimazol 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 for this medication contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubts, ask your doctor, pharmacist, or nurse.

The recommended dose is:

Adults and adolescents over 12 years old

This medication is administered via the vagina.

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

Vaginal tablets require suitable humidity conditions in the vagina for optimal dissolution of the medication. In case these conditions are not met, part of the medication might not dissolve completely and be expelled from 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 with your doctor or pharmacist to evaluatethe use of alternative treatments.

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 with your doctor.

Use in children

Do not use in children under 12 years old.

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. Phone (91) 562 04 20 indicating the medication and the amount ingested.

If you forgot to use Gine-Canestén

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 the treatment with Gine-Canestén

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

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

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 patches).

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 Localized Disorders:

Site irritation, 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 on the safety of this medication

Do not store at a temperature above 25°C.

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, afterthe abbreviation CAD. Theexpiration 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, medical devices, and medications that you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging, medical devices, and medications that you no longer need. In this way, you will help protect the environment.

Composition of Gine-Canestén

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

Appearance of the product and contents of the package:

This medicine is white, elongated vaginal tablets. It is presented in packages containing 1 vaginal tablet in a blister composed of (polyamide/aluminum soft/cloruro de polivinyl termosellado to a hard aluminum sheet) and an applicator formed by three elements: applicator body (LDPE), plunger (HDPE) and red lock (HDPE). The blister with the vaginal tablet and the applicator are presented in a cardboard box.

Marketing Authorization Holder

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

GP Grenzach Produktions GmbH

Emil-Barell-Strasse 7

79639 Grenzach-Wyhlen

Germany

Last review date of this leaflet: February 2022

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