GINE-CANESTEN 500 mg VAGINAL TABLET

2. What you need to know before starting to use 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 medication (listed in section 6).

Warnings and precautions

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

Do not ingest.

Before using this medication, inform your doctor if you have problems with your immune system, such as 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, lower back pain, abundant watery vaginal discharge, and/or nausea, you should consult your doctor to rule out other types of illness.

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 occurs 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.

Eye contact should be avoided, as it may cause irritation. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.

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

Use in children

Do not use in children under 12 years of age.

Use of Gine-Canestén with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

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

Breastfeeding

Clotrimazole may 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 for this medication exactly as contained in this prospectus or as 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 medication is administered vaginally.

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

Vaginal tablets require adequate moisture conditions in the vagina for optimal dissolution of the medication. If these conditions are not met, part of the medication may not dissolve completely and may come out of 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 your doctor or pharmacist to assess the use of alternative treatments.

If symptoms persist after completing treatment or recur after two months, or if you have problems with your immune system, HIV, 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 administration in the eyes may cause burning and eye irritation without gravity.

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 medication and the amount ingested.

If you forget to use Gine-Canestén

In case of forgetting a dose, wait for the next one. Do not apply a double dose to make up for the forgotten dose.

If you interrupt treatment with Gine-Canestén

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

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

4. Possible side effects

Like all medications, Gine-Canestén can cause side effects, although not everyone experiences 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:

Difficulty breathing.

Gastrointestinal disorders

Abdominal pain, nausea.

Skin and subcutaneous tissue disorders:

Rash, urticaria (elevated red itchy patches).

Reproductive system and breast disorders:

Vaginal scaling, vaginal discharge, vulvovaginal itching, vulvovaginal erythema, genital burning sensation, 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 prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gine-Canestén

Do not store above 25°C.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging, medical devices, and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging, medical devices, and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Gine-Canestén

• The active ingredient is clotrimazole. Each vaginal tablet contains 500 mg of clotrimazole.
• 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 package contents:

This medication is a vaginal tablet, almost white in color. It is presented in packaging containing 1 vaginal tablet in a blister pack (polyamide film/aluminum foil/polyvinyl chloride film) and an applicator consisting of three elements: applicator body (LDPE), plunger (HDPE), and red lock (HDPE). The blister pack 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

Manufacturer

GP Grenzach Produktions GmbH

Emil-Barell-Strasse 7

79639 Grenzach-Wyhlen

Germany

Date of the last revision of this prospectus: February 2022

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