“Directions
Ilmodol pain and inflammation 1% skin foam is a non-steroidal anti-inflammatory and antirheumatic drug.
Composition
Active ingredients
100 g of solution contain: active ingredient: piroxicam 1g.
Excipients
Propylene glycol, hydrochloric acid, sodium hydroxide, sodium phosphate monobasic monohydrate, nicotinamide, polysorbate 80, povidone, ethyl alcohol, benzyl alcohol, lavender essence, nerolene essence, purified water.
Propellant: propane-butane-isobutane.
Method of administration and dosage
Adults: apply 3-5 cm of foam or more to the skin 2-3 times a day depending on the size of the affected area, gently massaging for better absorption.
Ilmodol pain and inflammation 1% skin foam: remove the protective cap; Apply foam to the affected area and close again.
Warnings
The amount of active ingredient absorbed through the skin does not usually reach concentrations in the bloodstream that would justify warnings and expose the individual to the risk of adverse effects associated with systemic use of the drug.
The use of topical agents, especially long-term, may cause sensitization phenomena.
If hypersensitivity reactions occur, treatment should be discontinued and appropriate therapy instituted.
Serious skin reactions, some of which are life-threatening, such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with systemic use of piroxicam.
These reactions have not been associated with topical use of piroxicam, but their occurrence with topical use cannot be excluded.
Patients should be informed of the signs and symptoms and closely monitored for skin reactions.
The risk of developing Stevens-Johnson syndrome and TEN is highest during the first few weeks of treatment.
If symptoms and signs of Stevens-Johnson syndrome or TEN occur (e.g. progressive skin rash, often with blisters or mucosal lesions), piroxicam treatment should be discontinued.
The best results in the treatment of Stevens-Johnson syndrome and TEN are achieved with early diagnosis and immediate discontinuation of any suspected drug.
Early discontinuation of the drug is associated with a better prognosis.
If a patient develops pain and inflammation due to Stevens-Johnson syndrome or TEN while taking ilmodol, the drug should not be re-administered to that patient.
Non-steroidal anti-inflammatory drugs, including piroxicam, can cause interstitial nephritis, nephrotic syndrome, and renal failure.
Cases of interstitial nephritis, nephrotic syndrome, and renal failure have also been reported with topical piroxicam, although a causal relationship to topical piroxicam treatment has not been established.
Therefore, it cannot be excluded that these adverse events may be related to the use of topical piroxicam.
Contraindications
Hypersensitivity to the active substance or any of the excipients.”
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