Canesten 10 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Canestén 10 mg/g cream
Clotrimazole
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. (See section 4)
Leaflet contents:
- What Canestén is and what it is used for
- What you need to know before using Canestén
- How to use Canestén
- Possible adverse effects
- How to store Canestén
- Contents of the pack and other information
1. What Canesten 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 superficial skin infections: athlete's foot (tinea pedis), tinea of the hands, body ringworm (tinea corporis), groin ringworm (tinea cruris, or "jock itch"), pityriasis versicolor (also known as tinea versicolor), candidal balanitis (inflammation of the glans), and vulvovaginal candidiasis (characterized by itching, usually accompanied by increased vaginal discharge, inflammation of the vaginal mucosa and vulvar area, burning, and a burning sensation when urinating).
2. What you need to know before starting to use Canestén
Do not use 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 Canestén.
Avoid contact with the eyes, as this may cause stinging. If accidental contact occurs, rinse thoroughly with water and consult an ophthalmologist if necessary. Do not ingest.
If a hypersensitivity reaction occurs during use, treatment must be discontinued and you should seek immediate medical advice.
The use of additional contraceptive methods besides the condom and diaphragm is recommended during treatment, as this medicine may affect latex. This effect on latex is temporary and occurs only during treatment.
Your doctor will assess the most appropriate treatment depending on the infection and if you have certain medical conditions, such as a weakened immune system or diabetes.
Use of Canestén with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breast-feeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
No risks to mother or child are expected following topical use of clotrimazole during pregnancy; however, your doctor will evaluate the benefit of using the medicine before administration.
Breast-feeding
Clotrimazole may be used during breast-feeding. If used topically on the nipple area, wash the area thoroughly before feeding the baby.
Driving and using machines
The influence of Canestén on the ability to drive and use machines is none or negligible.
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.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause moderate local irritation.
3. How to use Canestén
Follow exactly the instructions for administration of this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.
Clean and thoroughly dry the affected areas before applying the medicine.
The recommended dose is:
Apply a thin layer of cream to the affected area and surrounding skin, gently massaging until completely absorbed, 2–3 times daily.
A strip of cream approximately 2 cm long is sufficient to treat an area the size of the hand (dorsal and palm surfaces). As a guide, 2 cm corresponds to the length of the distal phalanx of the index finger.
The duration of treatment depends on the location and extent of the infection. In general, the following is recommended:
Dermatophyte infections: 3 to 4 weeks
Pityriasis versicolor: 1 to 3 weeks
Vaginal candidiasis or candidal balanitis: 1 to 2 weeks
In the case of vaginal candidiasis, apply this medicine to the labia or adjacent areas.
Other formulations are available on the market for the intravaginal treatment of vulvovaginitis, such as vaginal tablets and vaginal cream with applicator, depending on the location of the infection. Follow your doctor's recommendations.
If you use more 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 number (91) 562 04 20, indicating the medicine and the amount ingested.
If you forget to use 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 using Canestén
If you stop treatment, the fungi may not have been completely eradicated. If you have any further questions about the use of this medicine, ask your doctor.
4. Possible adverse effects
Like all medicines, 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.
Skin and subcutaneous tissue disorders:
Blisters, contact dermatitis (redness of the skin after direct contact with a substance), erythema, tingling sensation, pruritus, urticaria (raised red itchy rashes), burning/itching sensation of the skin, exfoliation (peeling of the skin), and skin rash.
General disorders and administration site conditions:
Irritation at the application site, reaction 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.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Canestén
This medicine does not require any special storage conditions.
Keep out of the sight and reach of children.
Do not use Canestén after the expiry date stated on the packaging, following the abbreviation CAD. The expiry date refers to the last day of the month indicated.
This medicine should be used within 3 months after opening.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Canesten
- The active substance is clotrimazole. Each gram of cream contains 10 mg of clotrimazole.
- The other components (excipients) are: sorbitan stearate, polysorbate 60, cetyl palmitate, cetyl alcohol, octyldodecanol, benzyl alcohol, purified water.
Appearance of the medicine and contents of the pack
This medicine is a white cream. It is supplied in aluminum tubes with screw caps containing 30 grams of cream.
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: July 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/