ILMODOL 1% Farmitalia Skin Foam 50g

ILMODOL 1% Cutaneous Foam Farmitalia - Medical Device

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

Excipients

ILMODOL PAIN AND INFLAMMATION 1% cream: polyethylene glycol cetyl ether, polyglycol esters with fatty acids, cetostearyl alcohol, propylene glycol, sodium citrate, citric acid, benzyl alcohol, purified water.

Therapeutic indications

Painful and inflammatory states of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

Contraindications / Undesirable Effects

Hypersensitivity to the active substance or to any of the excipients

Dosage

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.

storage

ILMODOL PAIN AND INFLAMMATION 1% cream: This medicine does not require any special storage conditions

Warnings

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 products for topical use, 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. There have also 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).

Interactions

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.

Side effects

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.

(*) In this case it is necessary to interrupt the treatment. Reporting of suspected adverse reactions The reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Overdose

No cases of overdosing have been reported in the literature so far.

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 the risk 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. Breastfeeding The use of topical piroxicam during breastfeeding is not recommended as its clinical safety has not been evaluated.

Format

50 g tube.