10 mg / g cream 
clotrimazole

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information, see section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 4 weeks.

This leaflet contains information on: 
1. What Canesten is and what it is used for 
2. What you need to know before you use Canesten 
3. How to use Canesten 
4. Possible side effects 
5. How to store Canesten 
6. Contents of the packaging and other information 

1. What Canesten is and what it is used for

Clotrimazole is a fungicide that has an effect on various types of microorganisms, such as dermatophytes (fungi in the skin), yeasts, and molds.

Canesten 10 mg / g cream is used to treat athlete’s foot.

Please note that the doctor may have prescribed the medicine for another use and/or with a different dosage than that stated in the package leaflet. Always follow your doctor’s prescription and the instructions on the label on the medicine pack.

You must talk to a doctor if you do not feel better or if you feel worse after 4 weeks.

2. What you need to know before using Canesten

Do not use Canesten

  • if you are allergic (hypersensitive) to clotrimazole or to any of the other ingredients of Canesten (listed in section 6).

Take special care with Canesten

Treatment should not be started without consulting a doctor if you are between 12 and 15 years old, to rule out other diseases. Canesten should not be used by children under 12 years of age.

When you applied the cream one, avoid cream one comes in contact with eyes. Therefore, wash your hands after each treatment.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: Canesten should be used with caution during pregnancy, especially during the first trimester, and only as prescribed by a doctor. There are limited data from the treatment of clotrimazole in pregnant women. However, animal studies have not shown any adverse effects on the offspring.

Breast-feeding: Canesten should be used with caution during breastfeeding and only as prescribed by a doctor, as animal studies have shown that clotrimazole is excreted in milk.

Fertility: There have been no studies examining fertility. However, animal studies have not shown any effects of the drug on fertility.

Driving and using machines

The drug does not affect the ability to drive or use machines.

Canesten contains cetostearyl alcohol and benzyl alcohol

Canesten cream contains cetostearyl alcohol which may cause local skin reactions (eg contact dermatitis). Canesten cream also contains 20 mg of benzyl alcohol per gram. Benzyl alcohol can cause allergic reactions and mild local irritation.

3. How to use Canesten

Always use Canesten exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

Skin infections ( athlete’s foot ): Apply Canesten 10 mg / g cream thinly on the infected skin area 2 to 3 times daily for 2 – 4 weeks, continue treatment all this time even if the symptoms have disappeared.

When treating feet, it is important to wash and dry thoroughly between the toes before applying a cream.

About ½ cm of cream one is suitable for treating an area equivalent to a palm.

4. Possible side effects

Like all medicines, Canesten can cause side effects, although not everybody gets them.

Uncommon side effects ( 
affects less than 1 user in 100) Skin reactions such as itching, rash, burning sensation/burning, irritation, or discomfort/pain.

Rare side effects (affects less than 1 user in 1,000) 
Allergic reactions such as fainting, low blood pressure , shortness of breath, or rash.

Has been reported (occurs in an unknown number of users)

Fluid retention ( edema ), redness of the skin ( erythema ), blisters on the skin, scaly skin.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Canesten

No special storage instructions.

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

10 mg / g cream:

  • The active substance is clotrimazole. 1 g of cream contains 10 mg of clotrimazole.
  • The other ingredients are sorbitan stearate, polysorbate, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, water.

What the medicine looks like and the contents of the pack

What 
Canesten looks like 10 mg / g cream: white opaque cream.

Pack 
sizes Canesten 10 mg / g cream: 20 g aluminum tube.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder of the marketing authorization: 
Bayer AB 
Box 606 
169 26 Solna 
Tel: 08-580 223 00

Manufacturer: 
Kern Pharma SL 
E-08228 Terrassa (Barcelona)


or

GP Grenzach Produktions GmbH

Emil Barell-Strasse 7

79639 Grenzach-Wyhlen

Germany

Muhammad Nadeem

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