GINE-CANESTEN 100 mg VAGINAL TABLETS

Introduction

Package Leaflet: Information for the User

Gine-Canestén 100 mg vaginal tablets

clotrimazole

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

• Keep this leaflet, 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, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

Contents of the package leaflet:

1. What is Gine-Canestén and what is it used for
2. What you need to know before you start using Gine-Canestén
3. How to use Gine-Canestén
4. Possible side effects
5. Storage of Gine-Canestén
6. Package contents and further information

1. What is Gine-Canestén and what is it 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 (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 sensation of burning when urinating. These symptoms are not specific to vulvovaginal candidiasis. In case of doubt, consult your doctor.

2. What you need to know before you start 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, pharmacist, or nurse before starting to use Gine-Canestén.

Do not ingest.

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.

You should 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 have ended before the start of menstruation.

You should avoid contact with the eyes, as it would cause irritation. If accidental contact with the eyes occurs, wash with plenty of water and consult an ophthalmologist if necessary.

In case of an allergic reaction during use, treatment should be discontinued and you should immediately consult your doctor. The signs of a severe allergic reaction include swollen and itchy hives, swelling, sometimes on the face or in the mouth, causing difficulty breathing.

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.

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 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 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 washing of the hands.

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 exactly the administration instructions of this medicine contained in this leaflet or as 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 of age

This medicine is administered vaginally.

It is usually sufficient to apply one vaginal tablet, preferably at night before going to bed, for 6 consecutive days. 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.

The vaginal tablets need adequate moisture conditions in the vagina for optimal dissolution of the medicine. If these conditions are not met, part of the medicine 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 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 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.

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 doubts about the use of this medicine, ask your doctor.

4. Possible side effects

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

Adverse reactions with frequency not known (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 (elevated red itchy hives).

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 side effects, 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 online system: http://www.notificaram.es. By reporting side 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, after the abbreviation CAD. The expiry date is the last day of the month indicated.

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

6. Package contents and further information

Composition of Gine-Canestén

• The active ingredient is clotrimazole. Each vaginal tablet contains 100 mg of clotrimazole.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose (E460i), lactic acid (E270), calcium lactate pentahydrate, corn starch, hypromellose, colloidal anhydrous silica, crospovidone (E1202), magnesium stearate.

Appearance of the product and package contents:

This medicine is vaginal tablets, almost white in color. It is presented in packaging containing 6 vaginal tablets and a vaginal applicator consisting of three elements: applicator body (LDPE), plunger (HDPE), and red lock (HDPE).

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-Whylen

Germany

Date of the last revision of this leaflet: February 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/