Active ingredients: Clotrimazole
Canesten 1% cream
Why is Canesten used? What is it for?
Canesten contains clotrimazole which is an antifungal (antifungal) for dermatological use, i.e. it acts locally by eliminating skin fungi.
Canesten is used to treat mycoses (fungi) of the skin and skin folds, such as pityriasis versicolor, candidiasis of the skin, tinea pedis or athlete's foot, tinea corporis.
Contraindications When Canesten should not be used
Do not use Canesten
- if you are allergic to clotrimazole, or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Canesten
Talk to your doctor or pharmacist before using Canesten if you have suffered from these problems in the past (mycosis relapses).
The use of non-breathable nappies is not recommended after application of the drug in nappy rash.
Avoid contact with eyes. Do not ingest.
The use, especially if prolonged, of products for topical use (applied to the skin), can give rise to sensitization phenomena, such as erythema (localized redness in the area of the skin where the medicine is applied) and itching. In this case, stop the treatment and consult your doctor or pharmacist.
Interactions Which drugs or foods may change the effect of Canesten
Other medicines and Canesten
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no known medicines that can modify the effect of Canesten.
Canesten with food
There are no known foods that can modify the effect of Canesten.
Warnings It is important to know that:
Pregnancy and breastfeeding
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 using this medicine.
Pregnancy
There are limited data on the use of clotrimazole in pregnancy. As a precautionary measure, avoid the use of Canesten in the first trimester of pregnancy.
Feeding time
Stop breast-feeding during treatment with Canesten as the medicine may pass into breast milk.
Driving and using machines
The medicine has no or negligible influence on the ability to drive or use machines.
Canesten contains cetostearyl alcohol
It can cause local skin reactions (e.g. contact dermatitis).
Dose, Method and Time of Administration How to use Canesten: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The cream is particularly suitable for the treatment of hairless (hairless) skin areas.
Canesten cream should be applied in small quantities 2-3 times a day, in correspondence with the parts to be treated.
Given the high fungicidal activity of Canesten, the application of a small amount of cream is usually sufficient to treat a surface the size of the palm of a hand.
Canesten cream should be applied by rubbing lightly, after having carefully washed and dried the part to be treated.
Warning: do not exceed the indicated doses without medical advice.
Duration of treatment
Generally, a treatment period of three to four weeks is sufficient for the disappearance of the manifestations.
Continue treatment with Canesten cream for at least 2 weeks after the symptoms have disappeared in order to consolidate the therapeutic results obtained and avoid reinfections.
In the event that after 3-4 weeks of continuous use you do not notice appreciable results, consult your doctor. Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Health education notes
To prevent mycosis and its relapses, it is useful to follow some health and hygiene rules, such as:
- Avoid walking barefoot in public places such as swimming pools, gyms, hotel rooms etc.
- If you practice sports, use breathable and comfortable footwear, whose insoles should be changed or washed periodically.
- Limit the use of clothing containing synthetic fibers.
- Change your baby's diapers frequently to prevent urine or feces from pooling on the skin.
- Subject dogs and cats to veterinary examination before welcoming them into the home environment.
- Observe additional hygiene precautions, such as keeping clothing separate and washing it at a high temperature, if a family member develops mycosis.
Overdose What to do if you have taken too much Canesten
If you use more Canesten than you should
No risk of acute intoxication is anticipated since it is unlikely to occur after a single cutaneous application of an overdose (extended application under conditions conducive to absorption) or by inadvertent oral intake. There is no specific antidote.
In case of accidental ingestion / intake of Canesten cream, notify your doctor immediately or go to the nearest hospital.
If you forget to use Canesten
Continue treatment at the dose prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Canesten
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Canesten, the frequency of which is not known:
Immune system disorders: allergic reaction (manifested by fainting, drop in blood pressure, breathlessness, hives).
Skin and subcutaneous tissue disorders: blisters, discomfort or pain, swelling, erythema (redness of the skin), irritation, peeling (loss of cells from the outermost layer of the skin), itching, rash, burning.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month. The expiry date refers to the unopened product and correctly stored.
Do not use Canesten 1% cream after 3 months of first opening.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Composition and pharmaceutical form
What Canesten contains
- The active ingredient is clotrimazole. 100 g of cream contains 1 g of clotrimazolog.
- The other ingredients are: sorbitan monostearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water.
What Canesten looks like and contents of the pack
Canesten comes in the form of a cream for skin use.
The package content is 30 g.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CANESTEN UNIDIE 1% CREAM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1% cream
100 g of cream contain:
active principle:
bifonazole 1 g.
Excipients with known effects: cetylstearyl alcohol, sorbitan monostearate, polysorbate 60.
For the full list of excipients see 6.1.
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of dermatomycoses caused by dermatophytes, saccharomycetes, other pathogenic fungi: mycosis of the foot and hand, mycosis of the trunk (tinea corporis), mycosis of the skin folds (tinea inguinalis), onychomycosis, pityriasis versicolor, superficial candidiasis.
04.2 Posology and method of administration
For a complete recovery, the controlled and sufficiently prolonged use of Canesten Unidie is essential.
However, it is advisable not to interrupt therapy immediately after the disappearance of the acute inflammatory manifestations and subjective symptoms, but to adhere to the following average treatment times, depending on the type of infection, the extent and location of the infection itself:
Method of administration
Unless otherwise prescribed, Canesten Unidie should be applied in small quantities to the infected parts with a light massage once a day, preferably in the evening before going to bed.
A small amount of cream is generally sufficient to treat a surface roughly equal to the palm of the hand.
Pediatric population
In children, the safety and efficacy of Canesten Unidie have not been demonstrated; until sufficient data are acquired, the use of the product in such individuals is not indicated.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena that manifest themselves with redness and itching; in this case, it is necessary to interrupt the treatment and institute a suitable therapy.
The same will be done in case of development of resistant microorganisms.
Patients with known hypersensitivity reactions to other imidazole antifungals (e.g. econazole, clotrimazole, miconazole) should use medicinal products containing bifonazole with caution.
04.5 Interactions with other medicinal products and other forms of interaction
Available data suggest a possible interaction between topical bifonazole and warfarin with increased prothrombin time.
If Canesten Unidie is used in warfarin-treated patients, they should be monitored appropriately.
04.6 Pregnancy and lactation
Pregnancy
Preclinical safety data and human pharmacokinetic data do not give any indication on the effects on mother and child when using bifonazole during pregnancy (see section 5.3).
It is best to avoid the use of bifonazole during the first trimester of pregnancy.
Feeding time
Excretion into milk has been studied in animals. Available pharmacodynamic / toxicology data in animals have shown that bifonazole and its metabolites pass into breast milk (see section 5.3).
It is not known whether bifonazole is excreted in human milk.
Breastfeeding should be discontinued during treatment with bifonazole.
Fertility
Preclinical studies have not shown impairment of male or female fertility (see section 5.3).
04.7 Effects on ability to drive and use machines
Canesten Unidie has no or negligible influence on the ability to drive and use machines
04.8 Undesirable effects
The following adverse reactions are derived from post-marketing spontaneous reports and it is not possible to define their frequency.
General disorders and administration site conditions
Pain on administration site, peripheral edema (on administration site).
Skin and subcutaneous tissue disorders
Contact dermatitis, allergic dermatitis, erythema, pruritus, rash, hives, blisters, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, burning sensation.
These side effects are reversible after discontinuation of treatment.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
• There are no reported cases of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: imidazole and triazole derivatives.
ATC code: DO1AC10.
Bifonazole inhibits ergosterol biosynthesis on two different levels, distinguishing itself from both other azole derivatives and other antifungals which act only at a single level. Inhibition of ergosterol synthesis leads to structural and functional damage to the cytoplasmic membrane of the fungus.
Canesten Unidie exerts its action against infections sustained by dermatophytes, saccharomyces (yeasts), molds and other pathogenic fungi, such as Malassezia furfur.
The MIC value for the types of fungi mentioned is in the range below 0.062-4 (-16) mcg / ml of substrate. Bifonazole exhibits pronounced fungicidal activity against dermatophytes, in particular Tricophyton spp. A complete fungicidal effect is already achieved at a concentration of about 5 mcg / ml and after an exposure of 6 h. On yeasts, eg Candida, at a concentration of 1-4 mcg / ml the action of bifonazole is primarily fungistatic, while in concentrations of 20 mcg / ml it is fungicidal.
Variants of primary resistance of susceptible fungal species are very rare.
The research does not provide evidence for the development of secondary resistance in primary susceptible species.
05.2 Pharmacokinetic properties
Bifonazole penetrates the infected skin layers well.
6 h after administration the concentrations in the various layers of the skin reach from 1000 mcg / cm3 in the outer layers of the epidermis (stratum corneum) to 5 mcg / cm3 in the papillary layer. All the concentrations determined are thus in a range of antifungal activity in vitro.
The residence time in the skin, measured by the protective action against infection in guinea pigs, is 48-72 hours.
Pharmacokinetic studies after topical application to intact human skin have shown that only a small amount of bifonazole is absorbed (0.6-0.8% of the dose); the resulting serum level concentrations were always below the limit of detection (i.e.
Bifonazole crosses the placental barrier in rats.
05.3 Preclinical safety data
Preclinical data are based on conventional single dose toxicity and genotoxicity studies.
Hepatic enzyme induction effects have been observed with doses above 50mg / kg for up to 13 weeks); repeated doses equal to or greater than 3 mg / kg have determined clear signs of suffering at the level of various organs and, in particular, of hepatic adipose degeneration.
However, the exposure levels are higher than the maximum exposure of relevance to clinical use.
Bifonazole did not demonstrate mutagenic effects in the following tests: the "Salmonella / microsome", the "Micronucleus test" and the "dominant lethal" test.
Studies in rabbits were performed to evaluate dermal tolerability. After subacute topical application of bifonazole cream (corresponding to 3mg / kg of Bifonazole) for 3 weeks, a mild irritant effect (swelling) was observed. In the primary irritation test, mucosal and ocular skin tolerability was good.
Carcinogenicity studies have not been conducted with bifonazole.
No impairment of male and female fertility (in rats) was observed at oral doses above 40mg / kg.
In reproductive toxicology studies in rabbits, the oral dose of 30 mg / kg body weight and higher doses gave embryo and fetotoxic results including lethality. In rats, bifonazole at oral doses up to 100 mg / kg is not embryotoxic but delays the development of the fetal skeleton, possibly as a side effect of maternal toxicity (weight reduction).
Given the low absorption of the active ingredient through the skin, these results have little relevance for clinical use.
Studies in rats have shown that bifonazole crosses the placental barrier and is excreted in milk.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
1% cream:
sorbitan monostearate;
polysorbate 60;
spermaceti;
cetylstearyl alcohol;
octyldodecanol;
benzyl alcohol;
purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
Being a multi-dose preparation, repeated opening of the container can expose the medicine to microbial contamination, proliferation and / or chemical-physical degradation; therefore the medicine should no longer be used after 16 months from the first opening.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C
06.5 Nature of the immediate packaging and contents of the package
Aluminum tube internally protected with epoxy resins.
Cream: tube of 30 g.
06.6 Instructions for use and handling
Avoid contact with eyes.
07.0 MARKETING AUTHORIZATION HOLDER
Bayer S.p.A. - Viale Certosa 130 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
Canesten Unidie AIC 026045029
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
20.08.1985 31/5/2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of: February 2015