Label: information for the user

Gine-Canestén 100 mg/g vaginal cream

clotrimazol

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this label or those indicated by your doctor, pharmacist, or nurse.

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

6. Contents of the package and additional information

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

This medication 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 scalding when urinating. These symptoms are not specific to vulvovaginal candidiasis. If in doubt, consult your doctor.

No use Gine-Canestén

• If you are allergic (hypersensitive) to clotrimazol, imidazoles in general or to 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, for example if you are being treated with oral corticosteroids or have HIV, AIDS or diabetes.

You must consult a doctor if symptoms worsen during treatment or persist after 3 days or if you observe 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 secretions and/or nausea, you must consult your doctor to rule out another type of disease.

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

Do not start treatment during menstruation. Treatment should have ended before the start of menstruation.

Avoid contact with the eyes, as it would cause irritation. If accidental contact with the eyes occurs, wash with abundant water and consult an ophthalmologist if necessary.

In case of an allergic reaction during its use, treatment should be suspended and you should immediately consult your doctor. Signs of a severe allergic reaction include swollen and itchy rash, swelling, sometimes on the face or in the mouth that causes difficulty breathing.

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

Use in children

Do not use in children under 12 years old.

Use of Gine-Canestén with other medications

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

Pregnancy

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

In case of treatment during the last 4 or 6 weeks of pregnancy, the use of the applicator is not recommended. Therefore, the use of vaginal tablets instead of vaginal cream is recommended, as these can be inserted directly with the finger, after careful washing of the hands.

Breastfeeding

Clotrimazol can be used during breastfeeding.

Driving and operating machinery

The influence of Gine-Canestén on the ability to drive and operate machinery is negligible or insignificant.

Gine-Canestén contains alcohol cetoestearílico and alcohol bencílico

This medication may cause local reactions on the skin (such as contact dermatitis) because it contains alcohol cetoestearílico.

This medication contains 10 mg of alcohol bencílico in each gram of cream.

Alcohol bencílico may cause allergic reactions.

Alcohol bencílico may cause moderate local irritation.

Follow exactly the administration instructions of this medication contained in this leaflet or those 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 old

This medication is administered via the vagina.

Usually, one application is sufficient. Apply the vaginal cream contained in the applicator directly with the applicator preferably at night before going to bed. The cream must be inserted deeply into the vagina (see applicator usage instructions), with the patient lying on her back and her legs slightly bent.

If symptoms persist after completing treatment or recur within two months or if you have problems with your immune system, HIV infection, AIDS or diabetes, consult your doctor.

Use in children

Do not use in children under 12 years old.

If you use more Gine-Canestén than you should

An accidental ingestion may cause gastrointestinal discomfort and/or vomiting. An accidental administration in the eyes may cause burning and eye irritation without severity.

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

If you forgot to use Gine-Canestén

In case of forgotten dose, wait for the next one. Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with Gine-Canestén

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

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

Like all medications, Gine-Canestén can produce adverse effects, although not all people will experience them.

Unknown frequency adverse reactions (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:

Dyspnea (difficulty breathing).

Gastrointestinal disorders:

Abdominal pain, nausea.

Skin and subcutaneous tissue disorders:

Rash , urticaria (raised red itchy patches).

Reproductive and mammary disorders:

Vaginal desquamation, vaginal discharge, vulvovaginal pruritus, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal discomfort, vulvovaginal pain, and vaginal hemorrhage.

General and local administration site disorders:

Application site irritation, edema, pain.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 25°C.

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

Do not use Gine-Canestén after the expiration date that appears on the packaging, afterthe abbreviation CAD. Theexpiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and the medication that you no longer need at the Pharmacy Take-BackPoint. If in doubt, ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition of Gine-Canestén

• The active ingredient is clotrimazol. Each gram of cream contains 100 mg of clotrimazol.
• The other components (excipients) are: Sorbitan estearate (E491), polisorbate 60 (E435), cetyl palmitate, cetoestearic alcohol, isopropyl myristate, benzyl alcohol (E1519) and purified water.

Appearance of the product and contents of the packaging:

This medication is a white cream. It is presented in a container with a disposable applicator containing 5 g of vaginal cream.

Marketing Authorization Holder

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Kern Pharma, S. L.

Polígono Ind. Colón II

C/Venus, 72

08228 Terrassa (Barcelona)

Spain

GP Grenzach Produktions GmbH

Emil-Barell-Str.7

79639 Grenzach-Wyhlen

Germany

Last review date of this leaflet: March 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/