IRUXOL 1% + 60 IU Maść
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Treść ulotki
Iruxol 1g (1%)/60 U.I. Unguento
Chloramphenicol/Collagenase (Clostridiopeptidase A)
Read this leaflet carefully before using this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What is Iruxol and what is it used for
- 2. What you need to know before you use Iruxol
- 3. How to use Iruxol
- 4. Possible side effects
- 5. How to store Iruxol
- 6. Contents of the pack and other information
- 1. What is Iruxol and what is it used for Iruxol ointment contains Clostridiopeptidase A (collagenase enzyme) and other proteases, and chloramphenicol. Collagenase and proteases are used for wound debridement because they are able to remove (clean) dry and moist crusts or scabs (necrotic, fibrinous tissue) normally present on wounds, leg ulcers, pressure ulcers, diabetic ulcers, burns, sluggish sores (e.g. post-operative, from X-rays, from accidents). Chloramphenicol is an antibiotic used in local applications to fight infections of these lesions. By removing crusts and scabs and fighting infections, Iruxol accelerates cicatrization and the healing process. See a doctor if you do not notice any improvement or if you feel worse after 14 days of treatment.
- 2. What you need to know before you use Iruxol
Do not use Iruxol
- if you are allergic to clostridiopeptidase, proteases, proteolytic enzymes, chloramphenicol or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breastfeeding
- in paediatric patients
Warnings and precautions
Talk to your doctor or pharmacist before using Iruxol if:
- you are diabetic and have been told you have gangrene, as excessive humidification of the lesion may promote infections; in this case, the lesion must therefore be carefully and regularly monitored.
Rare cases of bone marrow hypoplasia have been reported following prolonged use of chloramphenicol for topical use; for this reason, the product must be used for short periods, unless explicitly indicated by the doctor.
The use, especially if prolonged, of products for topical application (on the skin) can cause sensitization phenomena with symptoms such as local pain, itching, burning and erythema; in this case, immediately discontinue treatment and consult your doctor or pharmacist.
The use, especially if prolonged, of products for topical use (on the skin) containing an antibiotic, can cause bacterial resistance; if you notice persistence or worsening of symptoms, discontinue treatment and consult your doctor.
Avoid contact with eyes and mouth. Do not ingest.
Children and adolescents
The medicine is not indicated for use in children and adolescents.
Other medicines and Iruxol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, and/or other local treatments, e.g. dressings.
Iruxol ointment should not be used if you are applying other products to the wound that may interfere with this medicine by inhibiting its enzymatic activity, such as:
- antiseptics or disinfectants (e.g. denatured alcohol, hydrogen peroxide, quaternary ammonium salts)
- heavy metals
- detergents
- medicated soaps
- topical antibiotics (tyrothricin, gramicidin and tetracyclines)
- other deproteinizing products
Iruxol with food, drinks and alcohol
There are no known effects of food, drinks and alcohol on the use of Iruxol.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
There are no data on the use of Iruxol during pregnancy or breastfeeding; therefore, as a precautionary measure, avoid using Iruxol during pregnancy and breastfeeding.
Driving and using machines
It is unlikely that Iruxol will interfere with the ability to drive and operate machinery.
- 3. How to use Iruxol Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.
- Before application, disinfect the lesion with physiological solution (0.9% NaCl) or sterile distilled water;
- Apply this medicine only to the skin. Avoid contact with eyes and mouth (mucous membranes).
- Apply a thin layer of Iruxol (about 2 mm) directly to the wound or onto a dressing to be applied to the wound. Make sure the ointment is in close contact with the wound and covers it.
- Apply the ointment once a day; it is possible, on the advice of the doctor, to repeat the application twice a day if a greater cleaning effect of the wound is necessary.
- Before re-applying the product, make sure that any detached dead (necrotic) tissue is removed using sterile tweezers, spatula, swab or curette and with washes.
- It is advisable to cover the perilesional area with zinc oxide paste or similar preparations, regardless of the presence or absence of irritation of the area.
- Suspend the application of Iruxol when the wound is cleaned and good granulation has begun. Continue treatment with ointments that promote granulation and re-epithelialization.
- Dry, hard crusts can be softened by applying a dressing (a gauze or wet bandage) before applying Iruxol, as moisture increases the effectiveness of the product.
- In the therapy of varicose and post-phlebitic ulcers, in addition to the use of Iruxol, the use of compression bandages and, in cases of arterial irrigation disorders, specific drugs may be useful.
In case of diabetic ulcers with gangrene, an excessive degree of humidity induced by the medicine may promote the risk of infections; in this case, the lesion must therefore be carefully and regularly monitored.
If you do not observe an improvement after a maximum of 14 days of treatment, consult your doctor or pharmacist.
Sometimes, especially in case of prolonged use of topical preparations, irritative or sensitization phenomena may occur. In this case, discontinue treatment promptly (even before 14 days) and consult your doctor.
If you use more Iruxol than you should
To date, no cases of problems related to an overdose of the active ingredients contained in the preparation have been reported. If you think you have applied too much Iruxol, contact your doctor or pharmacist.
- 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everyone gets them. The side effects associated with Iruxol, classified according to how often they can occur, are reported below:
Common (may affect up to 1 in 10 people)
- Hypersensitivity reactions including allergic skin reactions (with symptoms such as local pain, itching, erythema, burning) Pain at the application site
- Burning sensation
- Localized skin reactions, including eczematous reactions (contact dermatitis).
Uncommon (may affect up to 1 in 100 people)
- Erythema
- Itching
Very rare (may affect up to 1 in 10,000)
Alterations in blood cell production (blood dyscrasias), due to absorption of chloramphenicol, up to idiosyncratic aplastic anemia, irreversible and potentially fatal.
In case of serious side effects, the doctor will decide whether it is necessary to interrupt the treatment.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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.
- 5. How to store Iruxol Keep this medicine out of the sight and reach of children. Store Iruxol at a temperature below 25°C. Do not use this medicine after the expiry date which is stated on the carton and the tube after Exp. The expiry date refers to the last day of that month. Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
- 6. Contents of the pack and other information
What Iruxol contains
The active ingredients are a mixture of enzymes composed of Clostridiopeptidase and proteases, and chloramphenicol. One gram of ointment contains Clostridiopeptidase A not less than 60 Units and chloramphenicol 1g (1%).
The other ingredients are liquid paraffin and white petrolatum.
Description of Iruxol and contents of the pack
Iruxol is a transparent or slightly brownish ointment, available in aluminium tubes of 30g.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Smith & Nephew GmbH
Friesenweg 30
22763 Hamburg
Germany
Manufacturer
Nordmark Pharma GmbH
Pinnauellee 4,
D-25436 Uetersen
Germany
Representative for Italy
Smith & Nephew S.r.l.
Viale T. Edison, 110
20099 Sesto San Giovanni (MI)
Italy
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The following information is intended exclusively for doctors or healthcare professionals
Method of administration
To obtain the best results with the enzymatic debridement of wounds using Iruxol, the following rules must be observed:
- Disinfect the skin lesion with physiological solution (0.9% NaCl) or sterile distilled water before applying Iruxol.
- Iruxol ointment must be brought uniformly into contact with the surface of the wounds, applying it with a thickness of a few millimeters (about 2 mm).
- It must be avoided that the surface of the wound dries out, as the presence of humidity increases the enzymatic activity. Therefore, completely dry crusts, as well as hardened ones, must first be softened with a wet bandage.
- In case of stubborn necrosis, the effect of Iruxol can be improved by incising at the margins or in the middle, trying in this way to allow part of the ointment to penetrate under the necrosis.
- When changing the dressing, the detached necrotic material must be removed using sterile tweezers, spatula, swab or curette and with washes. It is advisable to cover the perilesional area with zinc oxide paste or similar preparations, regardless of the presence or absence of irritation of the area.
- The application of Iruxol must be suspended when the wound is cleaned and good granulation has begun. Continue with treatments that promote granulation and re-epithelialization.
- In the therapy of varicose and post-phlebitic ulcers, in addition to the use of Iruxol, compression bandages can be advantageously used, and, in cases of arterial irrigation disorders, the appropriate drugs. If there is no improvement in the wound after a maximum of 14 days of treatment, consider alternative treatments for wound debridement. In case of signs of sensitization, therapy must be discontinued even before 14 days.
Special warnings and precautions for use
Although the risk is rare, bone marrow hypoplasia, including aplastic anemia and death, has been reported following the use of chloramphenicol. Rare conditions must be taken into consideration when evaluating the expected benefits of using the medicine. The product must therefore be used for short periods, unless explicitly indicated by the doctor. It may be advisable to perform a routine blood profile before therapy and subsequently at appropriate time intervals to detect hematopoietic abnormalities.
The use, especially if prolonged, of topical preparations can give rise to irritative or sensitization phenomena. In this case, treatment must be discontinued promptly (even before 14 days) and appropriate therapy instituted.
Treatment must be discontinued and appropriate therapy instituted also in case of development of germs not sensitive to the antibiotic.
In the treatment of diabetic patients with a dry wound or gangrene, an excessive degree of humidity induced by the medicine may increase the risk of infections; therefore, careful and regular monitoring of the lesion is required.
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- Kraj rejestracji
- Postać farmaceutycznaOintment, 1% + 60 IU
- Kod ATCD03BA52
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki IRUXOLPostać farmaceutyczna: Cream, 30 GSubstancja czynna: collagenase, combinationsProducent: SMITH AND NEPHEW S.R.L.Bez receptyPostać farmaceutyczna: Gel, 2 GSubstancja czynna: bromelainsProducent: MEDIWOUND GERMANY GMBHWymaga receptyPostać farmaceutyczna: Cream, 0.2%Substancja czynna: hyaluronic acidProducent: FIDIA FARMACEUTICI S.P.A.Bez recepty
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IRUXOL wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w IRUXOL jest collagenase, combinations. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
IRUXOL jest produkowany przez SMITH & NEPHEW GMBH. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie IRUXOL jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić IRUXOL w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (collagenase, combinations) to m.in. NORUXOL, NEXOBRID, KONNETTIVINA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
