Gine-Canesten 20 mg/g vaginal cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gine-Canesten 20 mg/g vaginal cream
clotrimazole
Read the 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 reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days.
Leaflet contents:
- What Gine-Canesten is and what it is used for
- What you need to know before using Gine-Canesten
- How to use Gine-Canesten
- Possible adverse effects
- How to store Gine-Canesten
Pack contents 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 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, lower back pain, abundant watery vaginal secretions and/or nausea, you should consult your doctor to rule out other types of illness.
Avoid contact with the eyes, as this may cause irritation. If accidental contact occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
Do not use tampons, intravaginal 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.
If an allergic reaction occurs during use, treatment must be discontinued and you should seek immediate medical attention. 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.
Sexual intercourse should be avoided in case of vaginal infection and while using this medicine to prevent transmission to 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 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.
If treatment is required during the last 4 to 6 weeks of pregnancy, the use of an applicator is not recommended. Therefore, vaginal tablets are recommended instead of vaginal cream, as they can be inserted directly with a finger after careful hand washing.
Breastfeeding
Clotrimazole may be used during breastfeeding.
Driving and using machines
The effect of Gine-Canestén on the ability to drive and operate machinery is negligible or none at all.
Gine-Canestén contains cetyl stearyl alcohol and benzyl alcohol
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl stearyl alcohol.
This medicine contains 20 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 as described in this leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Recommended dose:
Adults and adolescents over 12 years of age
This medicine is administered vaginally.
Generally, it is sufficient to apply one applicatorful (approximately 5 g) once daily, preferably at night before going to bed, for 3 consecutive days. The cream should be inserted deeply into the vagina (see applicator instructions for use), while lying on your back with your 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, contact 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 full course of treatment is completed, 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 will experience 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 (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:
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 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 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
No special storage conditions are required.
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 empty containers and unused medicines at the Sigre collection point in your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of containers and medicines you no longer need. 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 20 mg of clotrimazole.
- The other components (excipients) are: sorbitan stearate (E491), polysorbate 60 (E435), cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol (E1519), purified water.
Appearance of the product and contents of the pack:
This medicine is a white cream. It is supplied in a cardboard box containing an aluminium tube with a plastic cap, holding 20 g of cream, and 3 disposable plastic vaginal applicators.
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-Str. 7
79639 Grenzach-Wyhlen
Germany
Date of the most recent revision of this leaflet: February 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/
INSTRUCTIONS FOR USE OF THE APPLICATOR
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