Gine-Canesten 500 mg vaginal tablet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gine-Canestén 500 mg vaginal tablet

clotrimazole

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

Contents of the leaflet

1. What Gine-Canestén is and what it is used for
2. What you need to know before using Gine-Canestén
3. How to use Gine-Canestén
4. Possible adverse effects
5. How to store Gine-Canestén
6. Contents of the pack and other information

1. What Gine-Canestén is and what it is used for

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

This medicine is indicated for the treatment of uncomplicated vulvovaginal candidiasis (a vaginal infection caused by a fungus called Candida) (See section Warnings and precautions).

The main symptoms are itching, usually accompanied by an increase in vaginal discharge, pain and redness in the vaginal and vulvar area, burning, and a sensation of scalding during urination. These symptoms are not specific to vulvovaginal candidiasis. If in doubt, consult your doctor.

2. What you need to know before using Gine-Canesten

Do not use Gine-Canesten

• If you are allergic (hypersensitive) to clotrimazole, imidazoles in general, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

Do not ingest.

Before using this medicine, inform your doctor if you have immune system problems, for example if you are being treated with oral corticosteroids or have HIV infection, AIDS, or diabetes.

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

If you develop 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 other types of illness.

Do 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 onset of menstruation.

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

Sexual intercourse should be avoided in case of vaginal infection and while using this medicine to prevent transmission to your partner.

Contact with the eyes should be avoided, as it may cause stinging. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.

If an allergic reaction occurs during use, treatment must be discontinued and you should seek immediate medical attention. Signs of a severe allergic reaction include raised, itchy rash, swelling, sometimes in the face or mouth, causing difficulty breathing.

Use in children

Do not use in children under 12 years of age.

Use of Gine-Canesten with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking tacrolimus or sirolimus (medicines used in transplant patients).

Pregnancy and breastfeeding

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

Pregnancy

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

When treating with vaginal tablets during the last 4–6 weeks of pregnancy, it is recommended to avoid using the applicator and instead insert the tablet directly with a finger, after carefully washing hands.

Breastfeeding

Clotrimazole may be used during breastfeeding.

Driving and operating machinery

The influence of Gine-Canesten on the ability to drive and operate machinery is none or negligible.

3. How to use Gine-Canestén

Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

The recommended dose is:

Adults and adolescents over 12 years of age

This medicine is administered vaginally.

Usually, one vaginal tablet applied preferably at night before going to bed is sufficient. The tablet should be inserted deeply into the vagina (see applicator instructions), while the patient lies on her back with her knees slightly bent.

Vaginal tablets require adequate moisture conditions in the vagina for optimal dissolution of the medicine. If these conditions are not present, part of the medicine may not dissolve completely and could be expelled from the vagina. To prevent this, it is important to insert the tablet as deeply as possible into the vagina at bedtime. If the vaginal tablet does not dissolve completely after the first dose, consult your doctor or pharmacist to consider alternative treatments.

If symptoms persist after completion of treatment, recur within two months, or if you have immune system disorders, HIV infection, AIDS, or diabetes, you should consult your doctor.

Use in children

Do not use in children under 12 years of age.

If you use more Gine-Canestén than you should

Accidental ingestion may cause gastrointestinal discomfort and/or vomiting. Accidental application to the eyes may cause mild burning and eye irritation.

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

If you forget to use Gine-Canestén

If you miss a dose, wait until the next scheduled dose. Do not use a double dose to make up for the missed dose.

If you stop using Gine-Canestén

Continue using Gine-Canestén until the treatment course is complete, even if you feel better. You need to complete the full course of treatment to cure the infection. If you stop treatment early, the fungi may not have been fully eliminated.

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

4. Possible adverse effects

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

Adverse reactions with unknown frequency (cannot be estimated from the 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 welts).

Reproductive system and breast disorders:

Vaginal desquamation, vaginal discharge, vulvovaginal itching, vulvovaginal erythema, genital burning sensation, vulvovaginal discomfort, vulvovaginal pain, and vaginal haemorrhage.

General disorders and administration site conditions:

Irritation at the application site, oedema, pain.

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

Reporting of 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 leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gine-Canestén

Do not store above 25°C.

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

Do not use Gine-Canestén after the expiry date stated on the packaging, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers, medical devices, and unused medicines at the Sigre Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers, medical devices, and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gine-Canestén

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

Appearance of the medicine and contents of the pack:

This medicine consists of elongated, almost white vaginal tablets. It is supplied in packs containing 1 vaginal tablet in a composite blister (polyamide/aluminum soft sheet/polyvinyl chloride heat-sealed to a hard aluminum sheet) and an applicator composed of three parts: the applicator body (LDPE), plunger (HDPE), and red lock (HDPE). The blister containing 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

Manufacturer

GP Grenzach Produktions GmbH

Emil-Barell-Strasse 7

79639 Grenzach-Wyhlen

Germany

Date of the most recent revision of this leaflet: February 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/