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CANESTEN

CANESTEN Extra Nail Set

Product from: 
Preussen
1 pc
Max. 3 pcs
€39.97 €39.97 /pc

Delivery within 60 minutes

Zu Risiken und Nebenwirkungen lesen Sie die Packungsbeilage und fragen Sie Ihre Ärztin, Ihren Arzt oder in Ihrer Apotheke!


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Important notes (mandatory information)

Canesten Extra Nail Set, 1%/40% cream. Area of application: for the nail-dissolving treatment of fungal nail infections on hands and feet with simultaneous anti-fungal (antimycotic) effect.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Canesten Extra Nail Set, 1%/40% cream
Active ingredients: Bifonazole/urea

Read the entire package leaflet carefully before you start using this medicine, because it contains important information for you. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.
  • Keep the package leaflet. You may want to read it again later.
  • Ask your pharmacist if you need more information or advice.
  • If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
  • If not all diseased nail parts have been removed after 7-14 days and the nail bed is not smooth, contact your doctor.

What this package leaflet contains

  1. WHAT IS CANESTEN EXTRA NAIL SET AND WHAT IS IT USED FOR?
  2. WHAT SHOULD YOU CONSIDER BEFORE USING CANESTEN EXTRA NAIL SET?
  3. HOW TO USE CANESTEN EXTRA NAIL SET?
  4. WHAT SIDE EFFECTS ARE POSSIBLE?
  5. HOW TO STORE CANESTEN EXTRA NAIL SET?
  6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT IS CANESTEN EXTRA NAIL SET AND WHAT IS IT USED FOR?

Fungi grow deep into the skin and usually "take root" there with a network of threads. Bifonazole, an active ingredient in the ointment, attacks the fungus in the skin. Urea, another active ingredient in the ointment, softens the treated diseased nail areas, making them easier to remove. Canesten Extra Nail Set is a medicine for the nail-dissolving treatment of fungal nail infections on hands and feet with simultaneous anti-fungal (antimycotic) effect.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CANESTEN EXTRA NAIL SET?

Canesten Extra Nail Set must not be used if you are allergic to bifonazole and urea or any of the other ingredients of Canesten Extra Nail Set listed in section 6. Special care should be taken when using Canesten Extra Nail Set if you have reacted with hypersensitivity (allergy) to other medicines against fungal infections (e.g. with the active ingredients econazole, clotrimazole, miconazole) in the past, you should only use Canesten Extra Nail Set with caution. Do not get the Canesten Extra Nail Set ointment in your eyes. Do not ingest. If symptoms persist after treatment, please consult a doctor.

Children

Canesten Extra Nail Set should only be used in infants and toddlers under medical supervision. Make sure that no ointment gets into the mouth of the infant/toddler.

Interactions when using Canesten Extra Nail Set with other medicines

Limited data suggest that an interaction between topically applied bifonazole and warfarin is possible, with an increase in the blood clotting factor (INR value). Therefore, appropriate monitoring should be carried out if bifonazole and warfarin are used at the same time.

Pregnancy, breastfeeding and fertility

There are no sufficient data for the use of Canesten Extra Nail Set in pregnant women. Since Canesten Extra Nail Set is a medicine that is only used topically and therefore a systemic effect (effect on other organs) is not to be expected, a risk is not to be expected. Nevertheless, as a precaution, Canesten Extra Nail Set should only be used during pregnancy after careful medical benefit-risk assessment. Canesten Extra Nail Set should be avoided during the first 3 months of pregnancy. Breastfeeding should be discontinued during treatment with Canesten Extra Nail Set. Studies with bifonazole give no indication that fertility is impaired. Information on possible effects of urea on fertility is not available. Studies with urea give no indication that there is a potential for sperm damage.

Driving and using machines

Canesten Extra Nail Set has no or negligible influence on the ability to drive and use machines.

Important information about other ingredients of Canesten Extra Nail Set

Lanolin can cause local skin irritation (e.g. contact dermatitis). Very sensitive patients may react with hypersensitivity to the plaster (plaster allergy).

3. HOW TO USE CANESTEN EXTRA NAIL SET?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Type of application

Apply as much ointment from the Canesten Extra Nail Set tube to the diseased nails once a day until the entire nail surface is thinly covered. The consistency of the ointment is very firm to allow precise application without spreading. Therefore, you must press the tube firmly to apply the desired amount. Then seal the affected fingernails or toenails with the plaster. The plaster may have to be halved depending on the size of the nail. To maintain the adhesive strength of the plaster, please ensure that no ointment penetrates the gap between the skin and the adhesive surface when applying the plaster. You should also avoid touching the adhesive surface of the plaster with your fingers. After 24 hours, the plaster is removed and the affected fingers or toes are bathed in warm water for about 10 minutes. Then carefully remove the softened diseased nail substance with the spatula. Finally, the treated nails are dried thoroughly, the ointment is applied again as described above and sealed with the plaster. It is generally not necessary to cover the skin area surrounding the nail. If this is nevertheless necessary due to irritation, zinc paste, for example, can be applied to the skin edges surrounding the nail.

Duration of application

The treatment must be carried out daily until all diseased nail parts have been removed and the nail bed is smooth. (The ointment only works on diseased nail substance, healthy parts remain unaffected). This generally takes 7-14 days, depending on the extent of the disease and the thickness of the nail. After nail removal, consistent anti-fungal (antimycotic) treatment should be carried out for about 4 weeks once a day with a bifonazole cream (urea-free). If not all diseased nail parts have been removed after 7-14 days and the nail bed is not smooth, you should consult a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Canesten Extra Nail Set is too strong or too weak.

If you stop using Canesten Extra Nail Set

In order to achieve complete healing of the fungal infection and to prevent a relapse, you should not stop or interrupt the treatment prematurely without consulting your doctor. If you do so, the symptoms are likely to recur, as your fungal infection is probably not yet properly healed. You should not stop the treatment after the symptoms have subsided, but continue it consistently (as recommended under "Duration of application").

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What else can you do?
Change towels and clothing that have come into contact with the diseased areas daily. This will help you avoid spreading the fungal infection to other parts of your body or to other people.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Canesten Extra Nail Set can cause side effects, although not everybody gets them.
The following frequency information is used to evaluate side effects:
Very common: more than 1 in 10 treated persons
Common: 1 to 10 in 100 treated persons
Uncommon: 1 to 10 in 1,000 treated persons
Rare: 1 to 10 in 10,000 treated persons
Very rare: less than 1 in 10,000 treated persons
Not known: frequency cannot be estimated from the available data.


The following side effects have been identified during the use of this medicine after approval. Since these reactions have been reported voluntarily from patient groups of uncertain size, it is not possible to estimate the frequency on the basis of the available data.

Significant side effects or signs to watch out for, and what to do if you are affected

If you are affected by any of the following side effects, stop using Canesten Extra Nail Set and see your doctor as soon as possible. The following side effects have been observed in the nail area (nail, nail edge, nail bed) after using Canesten Extra Nail Set

Skin and subcutaneous tissue disorders (frequency not known)

Skin irritation, inflammatory skin reactions (contact dermatitis), skin softening, skin peeling, nail malformations, nail discolouration, itching and rash as well as pain at the site of application, pain in the limbs. These side effects are only temporary and will subside after the end of treatment.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CANESTEN EXTRA NAIL SET?

Keep this medicine out of the reach of children! Do not use this medicine after the expiry date which is stated on the folding box and the tube. The expiry date refers to the last day of the month. Storage conditions: Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Canesten Extra Nail Set contains

The active ingredients are: Bifonazole and urea. 1 g of ointment contains 10 mg of bifonazole and 400 mg of urea. The other ingredients are: Lanolin, bleached wax, white petroleum jelly.

What Canesten Extra Nail Set looks like and contents of the pack

Canesten Extra Nail Set contains an aluminium tube with 10 g of ointment, 15 waterproof hygiene plasters and a spatula for removing the softened nail parts. The ointment is yellowish and has a firm consistency. The hygiene plasters in the Canesten Extra Nail Set are not available in stores. If you need more, it is recommended to buy waterproof plasters and cut them to size.

Pharmaceutical entrepreneur

Bayer Vital GmbH
51368 Leverkusen
Germany
Telephone: (0214) 301
Telefax: (0214) 30 57 209
E-mail address: bayer-vital@bayerhealthcare.com

Manufacturer

Kern Pharma S.L.
Poligon Industrial Colon II, C/Venus, 72
08228 Terassa
Spain

This package leaflet was last revised in March 2014.

Source: Information from the package leaflet
Status: 09/2017

Information leaflet

Download the information leaflet


Wirkstoff: Bifonazol/Harnstoff