Gine-Canesten 500 mg soft vaginal capsule
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Gine-Canestén 500 mg Soft Vaginal Capsule
clotrimazole
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
You should consult a doctor if your condition worsens or if you do not improve within 3 days.
1. What Gine-Canestén is and what it is 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 section Warnings and precautions).
The main symptoms are itching, usually accompanied by an increase in vaginal discharge, pain and redness in the vaginal and vulvar area, burning and a sensation of scalding when urinating. These symptoms are not specific to vulvovaginal candidiasis. If in doubt, consult your doctor.
2.2. 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 to 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 infection, AIDS, or diabetes.
You should consult a doctor if symptoms worsen during treatment or persist beyond 3 days, or if there is an increase in vaginal discharge or changes in its appearance or odor, or if you experience vaginal bleeding.
If you develop fever (38°C or higher), abdominal or back pain, flank pain, abundant watery vaginal discharge, and/or nausea, you must consult your doctor to rule out other types of illness.
If an allergic reaction occurs during use, treatment must be stopped immediately and you should seek medical advice without delay. Signs of a severe allergic reaction include raised, itchy rash, swelling, sometimes affecting the face or mouth and causing difficulty breathing.
Do not use tampons, vaginal douches, spermicides, or other vaginal products 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 be completed before the onset of menstruation.
This medicine may reduce the effectiveness and safety of latex products such as condoms and diaphragms. This effect is temporary and occurs only during treatment.
It is recommended to avoid sexual intercourse in case of vaginal infection and while using this medicine to prevent transmission to your partner.
Children
Do not use in children under 12 years of age.
Use of Gine-Canestén with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking tacrolimus or sirolimus (medicines used in transplant patients).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Clotrimazole may be used during pregnancy, but only under the supervision of a healthcare professional.
When treating with this medicine during the last 4–6 weeks of pregnancy, it is recommended to avoid using the applicator and instead insert the vaginal capsule directly with a finger, after carefully washing your hands.
Breastfeeding
Clotrimazole may be used during breastfeeding.
Driving and using machines
The effect of Gine-Canestén on the ability to drive and use machines is none or negligible.
3. How to use Gine-Canestén
Follow exactly the instructions for administration of this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
This medicine is administered vaginally. Do not swallow.
The recommended dose is:
Adults and adolescents over 12 years of age
Generally, one vaginal capsule is sufficient, preferably administered at night before going to bed. The vaginal capsule should be inserted deeply into the vagina (see applicator instructions for use), while the patient is lying on her back with knees slightly bent.
If symptoms persist after completion of treatment or recur within two months, or if you have problems with your immune system, HIV infection, AIDS, or diabetes, you should consult your doctor.
Pregnant women
If treatment is required during the last 4–6 weeks of pregnancy, it is recommended not to use the applicator; instead, the vaginal capsule should be inserted directly with the finger after carefully washing the hands.
INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE OF THE APPLICATOR Wash your hands and dry them thoroughly before removing the vaginal capsule from the blister pack, as it is sensitive to moisture, and before removing the applicator from its packaging. Wash your hands again after using the applicator.
After use, dispose of the applicator safely, out of the reach of children. The applicator must not be flushed down the toilet. |
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INTRODUCTION OF THE VAGINAL CAPSULE WITHOUT AN APPLICATOR Warning Pregnant women must strictly follow their doctor's administration instructions. |
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If you use more Gine-Canestén than you should
Accidental ingestion may cause gastrointestinal discomfort and/or vomiting. Accidental application to the eyes may result in mild burning and eye irritation.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medication and the amount ingested.
4. Possible adverse effects
Like all medicines, Gine-Canestén may cause adverse effects, although not everyone experiences them.
Adverse reactions with unknown frequency (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 (raised red itchy welts).
Reproductive system and breast disorders:
Vaginal desquamation, 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 require discontinuation of treatment and are more common during the first days of treatment.
Reporting of adverse effects:
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Gine-Canestén
Keep in the original packaging to protect from moisture.
Keep this medicine out of the sight and reach of children.
Do not use Gine-Canestén after the expiry date stated on the packaging, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Point collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Package contents and other information
Composition of Gine-Canestén
- The active substance is clotrimazole. Each vaginal capsule contains 500 mg of clotrimazole.
- The other components (excipients) are: White soft 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 contents of the package:
This medicine is a yellow, oval-shaped vaginal capsule. It is supplied in packs 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 most recent revision of this leaflet: March 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/