Ilmodol Pain and Inflammation Cream 1% Piroxicam Farmitalia 50g

Ilmodol Pain and Inflammation Cream 1% Piroxicam Farmitalia - Medical Device

1% Piroxicam

ACTIVE PRINCIPLES

100 grams of cream contain: 1 g of piroxicam.

EXCIPIENTS

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.

INDICATIONS

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

CONTRAINDICATIONS / SECONDARY EFFECTS

Hypersensitivity to the active substance or to any of the excipients.

DOSAGE

Adults: apply 2-3 times on the skin of 3-5 cm of cream or more depending on the extent of the affected part, massaging gently to favor its absorption.

STORAGE

This medicine does not require any special storage conditions.

WARNINGS

The quantity of active principle 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 systemic administration of the drug.
The application of products for topical use, especially if prolonged, can give rise to sensitization phenomena.
In the presence of hypersensitivity reactions, treatment must be interrupted and appropriate therapy instituted.
Serious skin reactions, some of them life-threatening, such as dermatitis and exfoliative, 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 piroxicam for topical use, 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 carefully monitored for skin reactions.
The highest risk of developing SJS and TEN occurs in the first weeks of treatment.
If symptoms and signs of SJS or TEN occur (eg progressive skin 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 an 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 this drug, 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 and twenty 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, it is extremely unlikely that piroxicam cream will displace other drugs bound to plasma proteins.
However, physicians will need to monitor patients treated with this cream and high protein binding drugs for any dose adjustments.

SIDE EFFECTS

Like all medicines, this cream can cause side effects although not everybody gets them.
The use, especially if prolonged, of the product can give rise to sensitization and local irritation phenomena.
Skin and subcutaneous system disorders.
R aro: urticaria (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 case of urticaria and bronchospasm it is necessary to stop the treatment.
Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING

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 in conception or undergoing investigations for infertility ta 'it is necessary to consider the suspension of NSAIDs, including piroxicam.
The amount of active principle 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 pros taglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss.
The use of topical piroxicam during breastfeeding is not recommended as its clinical safety has not been evaluated.

Format

50 g tube.