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 section Warnings and precautions).

The main symptoms are itching generally accompanied by increased vaginal discharge, pain and redness in the vaginal area and vulvar area, burning and burning sensation when urinating. These symptoms are not specific to a vulvovaginal candidiasis. If in doubt, see your doctor.

Do not use Gine-Canestén

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

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using Gine-Canesten.

Do not eat.

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

You should consult a doctor if symptoms worsen during treatment or persist after 3 days or if you notice increased vaginal discharge or changes in its appearance or odor, or if you have vaginal bleeding.

In case of fever ( 38ºC or more), pain in the abdomen or back, lumbar pain, abundant watery vaginal secretions and / or nausea, you should consult your doctor to rule out another type of illness.

Contact with the eyes should be avoided as it will sting. If accidental contact with the eyes occurs, wash with plenty of water and consult an ophthalmologist, if necessary.

In the event that an allergic reaction occurs during use, the treatment should be discontinued and seek medical advice immediately. Signs of a severe allergic reaction include a raised, itchy rash, swelling, sometimes on the face or in the mouth that causes difficulty breathing.

This medicine can reduce the effectiveness and safety of latex products, such as condoms and diaphragms. This effect is temporary and appears only 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.

Use in children

Do not use in children under 12 years of age.

Use of Gine-Canestén with other medicines

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

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, or think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The doctor will evaluate the benefit of using the medicine against the possible risks.

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.

Driving and using machines

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

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

The recommended dose is:

Adults and adolescents over 12 years of age

This medicine is administered vaginally.

Generally, one vaginal tablet applied preferably at night before going to bed for 6 consecutive days is sufficient. The tablet should be inserted deeply into the vagina (see instructions for use of the applicator), with the patient lying on her back and with her legs slightly bent.

Vaginal tablets need adequate conditions of humidity in the vagina for optimal dissolution of the drug. If you do not have these conditions, some of the medicine may not dissolve completely and leak out of 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 administration, consult your doctor or pharmacist to consider the use of alternative treatments.

If symptoms persist at the end of treatment or recur after two months or have problems with your immune system, HIV infection, AIDS or diabetes, you should consult your doctor.

You should not use tampons, douches, spermicides, or other vaginal products while using this medicine.

It is not recommended to start treatment during menstruation . The treatment must have finished before the beginning of the menstruation.

Use in children

Do not use in children under 12 years of age.

If you use more Gine-Canestén than you should

Accidental ingestion can cause gastrointestinal upset and / or vomiting. Accidental administration to the eyes may cause mild eye irritation and burning.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist 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 for the next one. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gine-Canestén

Keep using Gine-Canestén until the treatment is finished, even if you feel better. You need to use the full treatment to cure the infection. If you stop the treatment, the fungus may not have disappeared.

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

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

Adverse reactions with unknown frequency (cannot be estimated from the available data) are:

Immune system disorders:

Allergic reactions: syncope (sudden loss of consciousness, fainting), hypotension (low blood pressure), difficulty breathing, hives ( raised red itchy bumps).

Reproductive system and breast disorders:

Peeling, itching, rash, edema, erythema, burning or irritation of the genital area, vaginal discomfort, pelvic pain and vaginal bleeding.

Gastrointestinal disorders

Abdominal pain.

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

Communication of adverse effects:

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: http; // www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

Do not store above 25ºC .

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

Do not use Gine-Canestén after the expiry date which is stated on the carton, after the abbreviation EXP. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines you do not need at the Sigre Point of the pharmacy. If in doubt ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Gine-Canestén

•                   The active substance is clotrimazole. Each vaginal tablet contains 100 mg of clotrimazole.
•                   The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, lactic acid, calcium lactate pentahydrate, corn starch, hypromellose, anhydrous colloidal silica, crospovidone, magnesium stearate.

Appearance of the product and contents of the container:

This medicine is almost white elongated vaginal tablets. It comes in packs containing 6 vaginal tablets and a vaginal applicator.

Marketing authorization holder

BAYER HISPANIA, SL

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

or

GP Grenzach Produktions GmbH

Emil-Barell-Strasse 7

79639 Grenzach-Whylen

Germany

Date of the last revision of this leaflet: March 2017

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