THEMODOL INF CR 120G 1%

1% CREMA

active ingredients

1% cream 100 grams of cream contain: Active Ingredient: piroxicam g 1 Excipients: cetostearilic alcohol For the full list of excipients, see paragraph 6,1

Excellent

1% cream: cetilic ether of polyethyleneglycol, polyglycol esters with fatty acids, cetostearilic alcohol, propyleneglycol, citrate sodium, citric acid, benzilic alcohol, purified water.

Therapeutic indications

Painful and phlogistic states of rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

Hypersensitivity to the active ingredient or any excipient

Population

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, gently massaging to favor its absorption.

Conservation

1% cream: This medicine does not require any special condition of conservation

Warnings

The amount of active ingredient absorbed through the skin does not normally reach concentrations in circulation such as to make warnings valid and expose at risk of side effects related to the administration of the drug by systemic means. The application of topical products, especially when protracted, can give rise to awareness-raising phenomena. In the presence of hypersensitivity reactions you will have to stop treatment and establish appropriate therapy (see also section 4.8). With the use of pyroxicam for systemic use, serious skin reactions have been reported, some of which potentially fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These reactions have not been associated with topical pyroxicams, but the possibility of topical administration cannot be excluded. Patients should be informed about signs and symptoms, and should also be carefully monitored for skin reactions. The highest risk of onset of SJS and TEN is in the first weeks of treatment. If symptoms and signs of SJS or TEN occur (for example progressive skin rash often with blisters or mucosa lesions) treatment with pyroxi should be suspended. The best results in the management of SJS and TEN are obtained with an early diagnosis and the immediate interruption of therapy with any suspect drug. An early suspension is associated with a better prognosis. If the patient has developed SJS or TEN with the use of ILMODOL DOLORE and INFIAMMATION, the drug should not be reused in this patient. Nonsteroidal anti-inflammatory drugs, including piroxicam, can cause interstitial nephritis, nephrosic syndrome and kidney failure. With the topical pyroxicam there were also reports of interstitial nephritis, nephrosic syndrome and kidney failure even if a causal relationship with topical pyroxicam was not established. Consequently, it cannot be excluded that these adverse events may be related to the use of topical pyroxicam. The cream contains cetostearilic alcohol. This substance can cause local skin reactions (e.g. contact dermatitis).

Interactions

Based on bioavailability studies it is extremely unlikely that piroxicam cream will spy on other drugs related to plasma proteins. However, doctors will have to monitor patients treated with ILMODOL DOLORE and INFIAMMATION cream and high-binding protein drugs for any dosage adjustments.

Effects

Like all medicines, ILMODOL DOLORE AND INFIAMMATION, can cause undesirable effects though not all people manifest them. The use, especially if prolonged, of the product can give rise to phenomena of local sensitization and irritation.

Classification for systems and organs	Action against
Pathologies of skin and subcutaneous system	Rare: hives (immediate reaction)*
	Very rare: Bollose reactions such as Stevens Johnson Syndrome and Toxic Epidermal Necrolysis
	Notable (frequency cannot be defined on the basis of available data): contact dermatitis, eczema and photosensitivity skin reactions.
Respiratory, chest and mediastinic pathologies	Rare: bronchospasm (immediate reaction)*

(*) In this case the treatment must be stopped. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows for a consistent monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

No hyperdose cases have been reported in literature so far.

Fertility According to the mechanism of action, the use of NSAIDs, including pyroxicam, may delay or prevent the breakdown of ovarian follicles, which in some women, has been associated with reversible infertility. In women with difficulty in conceiving or under investigations for infertility it is necessary to consider the suspension of the NSAIDs, including pyroxicam. Pregnancy The active ingredient absorbed through the skin does not normally reach, in circles, concentrations such as to render valid warnings, and to expose to risks of unwanted effects related to the administration of the drug by systemic way. However, in a precautionary way, unless the doctor considers it absolutely necessary, we do not recommend the use during pregnancy. The inhibition of prostaglandin synthesis could adversely affect pregnancy. Data obtained from epidemiological studies suggest an increase in the risk of miscarriage after the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. In animals, the administration of prostaglandin synthesis inhibitors has shown to cause an increase in pre- and post-system loss. Food We do not recommend using topical pyroxicam during breastfeeding since its clinical safety has not been evaluated.

Source: Farmadati