GINE-CANESTEN 500 MG SOFT VAGINAL CAPSULE

Introduction

Leaflet: information for the user

Gine-Canestén 500 mg soft vaginal capsule

clotrimazole

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

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

You should consult a doctor if your symptoms worsen or do not improve after 3 days.

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

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

This medicine 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, usually accompanied by an increase in vaginal discharge, pain, and redness of the vaginal and vulvar areas, burning, and a feeling of burning when urinating. These symptoms are not specific to vulvovaginal candidiasis. If in doubt, consult your doctor.

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

Do not use Gine-Canestén

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

Warnings and precautions

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

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

You should consult a doctor if your symptoms worsen during treatment or persist after 3 days, or if you notice 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, lumbar pain, abundant watery vaginal discharge, and/or nausea, you should consult your doctor to rule out other types of illness.

In case of an allergic reaction during use, treatment should be discontinued and your doctor should be consulted immediately. The signs of a severe allergic reaction include a swollen and itchy rash, swelling, sometimes on the face or mouth, which can cause difficulty breathing.

Tampons, vaginal douches, spermicides, or other vaginal products should not be used while using this medicine. For more information, see the section "Use of Gine-Canestén with other medicines".

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

This medicine 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 medicine to prevent the partner from becoming infected.

Children

Do not use in children under 12 years of age.

Use of Gine-Canestén with other medicines

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

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 medicine.

Pregnancy

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

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

Breastfeeding

Clotrimazole can be used during breastfeeding.

Driving and using machines

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

3. How to use Gine-Canestén

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

This medicine is administered vaginally. Do not ingest.

The recommended dose is:

Adults and adolescents over 12 years

Usually, one vaginal capsule administered preferably at night before bedtime is sufficient. The vaginal capsule should be inserted deeply into the vagina (see applicator instructions), with the patient lying on their back and with their legs slightly bent.

If symptoms persist after completing treatment or recur after 2 months, or if you have problems with your immune system, HIV, AIDS, or diabetes, you should 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, inserting the vaginal capsule directly with the finger, after careful hand washing.

INSTRUCTIONS FOR USE

If you use more Gine-Canestén than you should

An accidental ingestion may cause gastrointestinal discomfort and/or vomiting. Accidental administration in the eyes may cause burning and mild eye irritation.

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 medicine and the amount ingested.

4. Possible side effects

Like all medicines, Gine-Canestén can cause side effects, although not everyone will experience them.

Adverse reactions with unknown 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:

Breathing difficulties.

Gastrointestinal disorders:

Abdominal pain, nausea.

Skin and subcutaneous tissue disorders:

Rash, urticaria (elevated red patches that cause itching).

Reproductive system and breast disorders:

Vaginal scaling, vaginal discharge, vulvovaginal itching, vulvovaginal erythema, burning sensation in the genital area, vulvovaginal discomfort, vulvovaginal pain, and vaginal bleeding.

General disorders and administration site conditions:

Irritation at the application site, edema, pain.

These symptoms usually do not determine the suppression of treatment and are more frequent during the first days of treatment.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Gine-Canestén

Keep in the original package to protect it from moisture.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Gine-Canestén

• The active ingredient is clotrimazole. Each vaginal capsule contains 500 mg of clotrimazole.
• The other components (excipients) are: Soft white paraffin, liquid paraffin, gelatin, glycerol (E-422), purified water, titanium dioxide (E-171), quinoline yellow (E-104), orange yellow S (E-110), lecithin, medium-chain triglycerides.

Appearance of the product and package contents:

This medicine is a yellow, drop-shaped vaginal capsule. It is available in packages containing 1 vaginal capsule and a vaginal applicator.

Marketing authorization holder

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

GP Grenzach Produktions GMBH

Emil-Barrel-Strasse 7

79639 Grenzach-Whylen

Germany

Date of the last revision of this leaflet:March 2022

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