Iruxol Mono pomada
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Iruxol Mono ointment
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents
- What Iruxol Mono ointment is and what it is used for
- Before you use Iruxol Mono ointment
- How to use Iruxol Mono ointment
- Possible side effects
- How to store Iruxol Mono ointment
- Further information
1. What Iruxol Mono ointment is and what it is used for
The active substances are proteolytic enzymes, which act on components of skin ulcers. It is used for the debridement (cleaning and removal) of necrotic (dead) tissue in cutaneous ulcers.
2. Before using Iruxol Mono ointment
Do not use Iruxol Mono ointment
- If you are allergic (hypersensitive) to the active substances or to any of the other components of this medicine.
Take special care with Iruxol Mono ointment
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If you have an infection in the ulcer, consult your doctor, who will apply appropriate treatment, preferably orally. Some antibiotics should not be used together with this medicine in the same area (see section Use with other medicines).
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If you use certain soaps or antiseptics together with the ointment, they may eliminate the effect of this medicine (see section Use with other medicines).
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If you are weakened, caution is required and you should consult your doctor due to the risk of infection spreading.
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If after 14 days from the start of treatment the dead tissue has not decreased, consult your doctor, who will discontinue the treatment and replace it with another.
Use with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
The following products should not be used together with Iruxol Mono ointment because they may reduce or suppress its activity:
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Locally applied antibiotics such as tyrothricin, gramicidin, and tetracyclines.
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Detergents, soaps, acidic solutions, or antiseptics such as hexachlorophene and those containing heavy metals (e.g. merbromin).
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Other enzymatic preparations.
The following products may be used together with Iruxol Mono ointment:
- Antibiotics such as neomycin-bacitracin-polymyxin B and framycetin.
- Sterile saline solution.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
There are insufficient data on the use of this medicine in pregnant women or women planning pregnancy. As a precautionary measure, Iruxol Mono ointment should not be used during pregnancy and breastfeeding unless your doctor considers it clearly necessary, weighing the potential risks against the benefits.
Driving and using machines
The use of Iruxol Mono has no effect on driving or operating machinery.
3. How to use Iruxol Mono ointment
Follow exactly the instructions for administration of Iruxol Mono ointment as given by your doctor. If you have any doubts, consult your doctor or pharmacist.
For topical use. To pierce the sealed tube, press using the back of the cap.
The usual dose is:
Adults
Apply a layer of ointment approximately 2 mm thick once daily, directly onto the slightly moistened area to be treated, for example with physiological saline. It may also be applied onto a sterile gauze or dressing placed over the ulcer. Occasionally, it may be necessary to apply the ointment twice daily.
Strict aseptic (cleanliness) conditions must be maintained. Before each application, gently clean the lesion with gauze soaked in physiological saline or another cleaning solution compatible with the ointment, in order to remove necrotic (dead) tissue (see section Use of other medicines).
If no reduction in necrotic tissue is observed after 14 days from the start of treatment, inform your doctor, who will discontinue the treatment and switch to another method of debridement.
Use in children
The safety and efficacy of Iruxol Mono ointment in children has not been established; therefore, it should not be used in children.
If you use more Iruxol Mono ointment than you should
Due to the characteristics of this medicine, intended for topical use, intoxication is not expected.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to a medical center, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Iruxol Mono ointment
Do not use a larger amount of ointment to make up for missed doses. If you have missed a dose, apply it as soon as possible and continue with your regular schedule.
If you stop using Iruxol Mono ointment
Do not stop the treatment unless instructed by your doctor, otherwise the desired results may not be achieved.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Iruxol Mono ointment can cause adverse effects, although not everyone will experience them.
Adverse effects such as pain, burning, irritation, inflammation or redness of the skin have been observed, which usually do not require discontinuation of treatment.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Iruxol Mono ointment
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Iruxol Mono ointment after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Information for users
Composition of Iruxol Mono ointment
- The active substances are Collagenase A (Clostridiopeptidase A) and other proteolytic enzymes.
Each gram of ointment contains 1.2 IU of Collagenase A (Clostridiopeptidase A) and 0.24 IU of other proteolytic enzymes.
- The other components are liquid paraffin and solid paraffin.
Description of the product and contents of the pack
Iruxol Mono is presented as an ointment. The ointment is translucent, colourless or slightly brown. Each package contains 15 g or 30 g of ointment in an aluminium tube.
Marketing Authorisation Holder and Manufacturer
Smith & Nephew GmbH
Friesenweg 30, 22763 Hamburg, Germany
Manufacturer
Nordmark Pharma GmbH
Pinnauallee 4, 25436 Uetersen, Germany.
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Local representative
Smith & Nephew, S.A.U
Fructuós Gelabert, 2-4
08970 Sant Joan Despí, Barcelona, Spain
Tel: +34 93 373 7301
Fax: +34 93 373 7453
This Patient Information Leaflet was last approved in APRIL 2018.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/