ILMODOL PAIN INF * CR 50G 1%
Painful and inflammatory states of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.
Dosage and method of use
Adults: apply on the skin 2-3 times a day 3-5 cm of cream or more depending on the extent of the affected part, massaging gently to favor its absorption.
Hypersensitivity to the active substance or to any of the excipients
Like all medicines, ILMODOL PAIN AND INFLAMMATION can cause side effects, although not everybody gets them. The use, especially if prolonged, of the product can give rise to sensitization phenomena and local irritation.
| System and organ classification || Adverse reaction |
| Skin and subcutaneous system disorders || Rare: hives (immediate reaction) * |
|Very rare: bullous reactions such as Stevens Johnson Syndrome and toxic epidermal necrolysis|
|Not known (frequency cannot be estimated from the available data): contact dermatitis, eczema and photosensitivity skin reactions.|
| Respiratory, thoracic and mediastinal disorders || Rare: bronchospasm (immediate reaction) * |
(*) In this case the treatment must be interrupted. Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows for continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
The quantity of active ingredient absorbed through the skin does not normally reach concentrations in circulation such as to make the warnings valid and expose to the risk of side effects related to the administration of the drug systemically. The application of topical products, especially if prolonged, can give rise to sensitization phenomena. In the presence of hypersensitivity reactions, treatment should be discontinued and appropriate therapy instituted (see also section 4.8). Serious skin reactions, some of them life-threatening, such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of piroxicam for systemic use. These reactions have not been associated with topical piroxicam, however the possibility that they may occur with topical administration cannot be excluded. Patients should be informed of the signs and symptoms, and they should also be closely monitored for skin reactions. The highest risk of developing SJS and TEN occurs in the first few weeks of treatment. If symptoms and signs of SJS or TEN occur (e.g. progressive rash often with blistering or mucosal lesions), treatment with pyroxi should be discontinued. The best results in the management of SJS and TEN are obtained with early diagnosis and immediate discontinuation of therapy with any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of ILMODOL PAIN AND INFLAMMATION, the drug should no longer be reused in this patient. Non-steroidal anti-inflammatory drugs, including piroxicam, can cause interstitial nephritis, nephrotic syndrome, and kidney failure. Furthermore, there have been reports of interstitial nephritis, nephrotic syndrome and renal failure with topical piroxicam, although a causal relationship with topical piroxicam treatment has not been established. Consequently, it cannot be excluded that these adverse events may be related to the use of topical piroxicam. The cream contains cetostearyl alcohol. This substance can cause local skin reactions (eg contact dermatitis).
Pregnancy and breastfeeding
Fertility Based on the mechanism of action, the use of NSAIDs, including piroxicam, may delay or prevent rupture of ovarian follicles, which in some women has been associated with reversible infertility. In women with difficulty conceiving or undergoing investigation for infertility, discontinuation of NSAIDs, including piroxicam, should be considered. Pregnancy The amount of active ingredient absorbed through the skin does not normally reach, in the circulation, concentrations such as to make the warnings valid, and to expose to risks of undesirable effects related to the administration of the drug systemically. However, as a precaution, unless your doctor considers it absolutely necessary, it is not recommended for use during pregnancy. Inhibition of prostaglandin synthesis could adversely affect pregnancy. Data obtained from epidemiological studies suggest an increased risk of spontaneous abortion after the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss. Feeding time The use of topical piroxicam during breastfeeding is not recommended as its clinical safety has not been evaluated.
Expiration and retention
ILMODOL PAIN AND INFLAMMATION 1% cream: This medicinal product does not require any special storage conditions
Interactions with other drugs
Based on bioavailability studies, piroxicam cream is extremely unlikely to displace other plasma protein-bound drugs. However, physicians will need to monitor patients treated with ILMODOL PAIN AND INFLAMMATION cream and high protein binding drugs for any dose adjustments.
No cases of overdosing have been reported in the literature so far.
ILMODOL PAIN AND INFLAMMATION 1% cream 100 grams of cream contain: Active ingredient: piroxicam g 1 Excipients: cetostearyl alcohol For the full list of excipients, see section 6.1
ILMODOL PAIN AND INFLAMMATION 1% cream: cetyl ether of polyethylene glycol, esters of polyglycol with fatty acids, cetostearyl alcohol, propylene glycol, sodium citrate, citric acid, benzyl alcohol, purified water.