Gine-Canesten 100 mg/g vaginal cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gine-Canestén 100 mg/g vaginal cream
clotrimazole
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read 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 effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 3 days.
Contents of this leaflet:
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What Gine-Canestén is and what it is used for
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What you need to know before using Gine-Canestén
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How to use Gine-Canestén
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Possible adverse effects
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How to store Gine-Canestén
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Contents of the container and additional information
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 (a 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. What you need to know before using 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, pharmacist, or nurse before starting to use Gine-Canestén.
Do not ingest.
Before using this medicine, inform your doctor if you have immune system problems, 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, lower back pain, or abundant watery vaginal discharge and/or nausea, you should consult your doctor to rule out other types of illness.
Do 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 be completed before the onset of menstruation.
Avoid contact with the eyes, as it may cause stinging. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
If an allergic reaction occurs during use, treatment must be stopped immediately and you should see your doctor without delay. Signs of a severe allergic reaction include raised, itchy rash, swelling—sometimes of the face or 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 occurs only during treatment.
It is recommended to avoid sexual intercourse in case of vaginal infection and while using this medicine to prevent infecting your partner.
Use in 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 might 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.
If treatment is required during the last 4 to 6 weeks of pregnancy, the use of an applicator is not recommended. Therefore, the use of vaginal tablets is advised instead of vaginal cream, as the tablets can be inserted directly with a finger after carefully washing the hands.
Breastfeeding
Clotrimazole may be used during breastfeeding.
Driving and using machines
The influence of Gine-Canestén on the ability to drive and operate machinery is none or negligible.
Gine-Canestén contains cetyl alcohol and benzyl alcohol
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.
This medicine contains 10 mg of benzyl alcohol per gram of cream.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause moderate local irritation.
3. How to use Gine-Canestén
Follow exactly the administration instructions for this medicine provided 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.
Usually, a single application is sufficient. Apply the vaginal cream contained in the applicator directly using the applicator, preferably at night before going to bed. The cream should be inserted deeply into the vagina (see applicator instructions for use), while the patient is lying on her back with her legs 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.
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 application to the eyes may cause 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 (91) 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Gine-Canestén
If you miss a dose, wait until the next scheduled dose. Do not apply a double dose to make up for the missed dose.
If you stop treatment with Gine-Canestén
Continue using Gine-Canestén until the treatment is complete, even if you feel better. You need to complete the full course of treatment to cure the infection. If you stop treatment prematurely, the fungi may not have been completely eliminated.
If you have any further questions about the use of this medicine, ask your doctor.
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 pruritus, vulvovaginal erythema, genital burning sensation, vulvovaginal discomfort, vulvovaginal pain and vaginal haemorrhage.
General disorders and administration site conditions:
Application site irritation, oedema, pain.
These symptoms usually do not require discontinuation of treatment and are more frequent during the first days of treatment.
Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: 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
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, 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 medicines and their containers at the Sigre Point located at the pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Gine-Canestén
- The active substance is clotrimazole. Each gram of cream contains 100 mg of clotrimazole.
- The other components (excipients) are: Sorbitan stearate (E491), polysorbate 60 (E435), cetostearyl palmitate, cetyl alcohol, isopropyl myristate, benzyl alcohol (E1519) and purified water.
Appearance of the medicine and contents of the pack
This medicine is a white cream. It is supplied in a pack with a single-use 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
Manufacturer
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
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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
INSTRUCTIONS FOR USE OF THE APPLICATOR
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