BREXIDOL 8CER MED 14MG

BREXIDOL 14 MG MEDICAL CERTO

active ingredients

A patch of size 100 x 70 mm (70 cm2) contains 14 mg of piroxicam. For the full list of excipients, see paragraph 6.1.

Excellent

Acrylic copolymer, Eudragit E 100; nonwoven fabric, silicone polyester.

Therapeutic indications

BREXIDOL is indicated for the treatment of painful and phlogistic states of rheumatic and traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

Hypersensitivity to the active ingredient (piroxicam) or any of the excipients listed in the paragraph 6.1.. Patients in which substances with a similar mechanism of action (ANS) have caused hypersensitivity reactions (see paragraph 4.4). BREXIDOL is contraindicated in patients with active peptic ulcer, patients with bronchial asthma, amnesi of gastrointestinal hemorrhage by NSAIDs. Patients in anticoagulant therapy. Pregnancy and nursing (see paragraph 4.6) Children under the age of 12.BREXIDOL patch should not be used on open wounds or lesions, but only on integral skin. Avoid contact with eyes and mucosa.

Population

Population It is recommended to use only one medicated patch at a time and replace it every 24 hours for a period not exceeding 8 days. Do not apply two patches during the same day. Pediatric population BREXIDOL CEROTTO is contraindicated in children under 12 years of age. Method of administration BREXIDOL is to be used exclusively on the skin integral. After carefully washed and dried the sore area, rub between the fingers one of the corners of BREXIDOL to remove the protective film and apply the adhesive part directly on the skin. In case BREXIDOL should be applied to greater mobility joints, such as elbow or knee, it is advisable to use a retention bandage to be applied to the flexural joint, in order to maintain the plaster in place. Do not exceed the recommended doses.

Conservation

This medicine does not require any special condition for conservation.

Warnings

The serum levels achieved with BREXIDOL results are significantly lower than those obtained by oral administration but with a strong individual variability for which the occurrence of undesirable systemic effects cannot be excluded especially at gastroenteric level. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs, including piroxicam, can cause hypersensitivity reactions, potentially serious even in individuals not previously exposed to this type of medication. These include asthma attacks, skin rashes, allergic rhinitis and anaphylactic type reactions. BREXIDOL should be used with caution in subjects with chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa ( nasal polyps) in which are more frequent asthmatic attacks or localized inflammatory reactions of the skin and mucosa ( Quincke edema). Use caution in patients with peptic ulcer anamnesis, in patients with gastrointestinal hemorrhage no secondary to administration of NSAIDs or other hemorrhagic disorders, in patients with Crohn disease or ulcerative colitis, with severe liver or kidney dysfunctions or with heart failure. Prolonged or repeated use of skin products can give rise to sensitization phenomena. In the presence of hypersensitivity reactions it is necessary to interrupt therapy. You should use caution in the treatment of elderly patients who are generally more predisposed to adverse events. After short therapy without results consult your doctor. To avoid any hypersensitivity or photosensitization phenomena avoid exposure to direct sunlight. Skin reactions Piroxicam has been reported cases of eruption fixed by drugs (FDE). Piroxicam should not be reintroduced in patients with anamnesi of FDE related to piroxicam. There may be a potential crusade reaction with other oxicams.

Interactions

It is unlikely that the use of pyroxicam-based patches has interactions with other medicines. It is not however to exclude the possibility of competition between the absorbed pyroxicam and other high-linked drugs with plasma proteins. Do not use the product along with other oral or local medicines, containing piroxicam or other NSAIDs.

Effects

The use of the product can cause local irritative or allergic skin reactions such as erythema, itching, burning, contact dermatitis, numbness and formicolii on the application site; with this type of medicines have been reported cases of extensive and severe dermatological lesions such as hives, edema of Quincke, multiform erythema. There are possible photosensitivity reactions and skin reactions of the more extensive and severe mucosa, including asthma attacks. Systemic undesirable reactions as a result of the topical use of piroxicam are unlikely; since the plasma levels obtained are lower than those measured after systemic administration but very variable from individual to individual, it is not possible to exclude, especially in the case of prolonged therapies beyond the recommended term and non-observance of contraindications and warnings, the appearance of undesirable systemic effects, especially at gastroenteric level (see sections 4.4 and 5.2). Any appearance of general side effects or at the point of application requires suspension of therapy. Cases of eruption fixed by unknown frequency drugs (see paragraph 4.4) have been reported. Reports of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

No known overdose cases. In case of overdose with obvious clinical manifestations, immediately establish symptomatic therapy and apply the common emergency measures of the case.

Brexidol is contraindicated during pregnancy and breastfeeding and is not recommended in women who intend to start a pregnancy. The administration is to be suspended in women with fertility problems or who are subject to fertility surveys.

Source: Farmadati