Canesten 10 mg/g cutaneous powder
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Canesten 10 mg/g cutaneous powder
Clotrimazole
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet (see section 4).
Leaflet contents:
- What Canesten is and what it is used for
- What you need to know before using Canesten
- How to use Canesten
- Possible side effects
- How to store Canesten
- 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, tinea of the body, groin infection (tinea cruris, or jock itch), and pityriasis versicolor (tinea versicolor).
2. What you need to know before using Canestén
Do not use Canestén
- If you are allergic (hypersensitive) to clotrimazole, imidazoles in general, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Canestén.
For external use only. Contact with mucous membranes and eyes must be avoided, as it may cause irritation. If accidental contact with the eyes 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.
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, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan 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, the doctor will evaluate the benefit of using the medicine before administration.
Breastfeeding
Clotrimazole may be used during breastfeeding. If applied topically to the nipple area, wash the area thoroughly before feeding the infant.
Driving and using machines
The effect of Canestén on the ability to drive and operate machinery is none or negligible.
3. How to use Canestén
Follow exactly the instructions for use of this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.
The recommended dose is:
Sprinkle the powder onto the affected area and surrounding skin 2–3 times a day.
The duration of treatment depends on the location and extent of the infection. In general, it is recommended:
Dermatophyte infections: 3 to 4 weeks
Pityriasis versicolor: 1 to 3 weeks
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 eliminated. 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 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.
Skin and subcutaneous tissue disorders:
Blisters, contact dermatitis (redness of the skin following direct contact with a substance), erythema, tingling sensation, pruritus, urticaria (red, raised, itchy rash), burning/itching sensation of the skin, 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 mentioned 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 Canesten
This medicine does not require special storage conditions.
Keep out of the sight and reach of children.
Do not use Canesten after the expiry date stated on the packaging, following the abbreviation EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their packaging at the Sigre Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Canestén
- The active substance is clotrimazole. Each gram of powder contains 10 mg of clotrimazole.
- The other components (excipients) are: Rice starch.
Appearance of the medicine and contents of the pack
This medicine is a fine white powder. It is supplied in a 30-gram sprinkler container containing cutaneous powder.
Marketing Authorization Holder
BAYER HISPANIA, S.L.
Av. Baix Llobregat, 3 – 5
08970 Sant Joan Despí (Barcelona)
Spain
Manufacturer
KVP Pharma + Veterinär Produkte GmbH,
Projensdorfer Straße 324,
24106 Kiel,
Germany
or
Sigmar Italia S.p.A
Via Sombreno, 11
24011 Almè (BG)
Italy
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/