FLECTOR UNIDIE 8CER MED 14MG

FLECTOR UNIDIE 14 MG MEDICAL CEROTTOM

active ingredients

A medicated patch contains: • active ingredient: piroxicam 14 mg. For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

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

Contraindications

FLECTOR UNIDIE is contraindicated in the following cases: • hypersensitivity to the active ingredient (piroxicam) or to any of the excipients listed in paragraph 6.1; • patients in whom substances with a similar mechanism of action (FANS) have caused hypersensitivity reactions (see paragraph 4.4); • patients with active peptic ulcer; • patients with bronchial asthma; • patients with gastrointestinal hemorrhage anamnesis from FANS; • patients in anticoagulant therapy; • pregnancy and nursing (see paragraph 4.6); • children under 12 years of age. FLECTOR UNIDIE plaster should not be used on open wounds or lesions, but only on integral skin.

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. FLECTOR UNIDIE is used exclusively on the skin. Method of administration Only for skin use. After carefully washed and dried the sore area, rub between the fingers one of the corners of FLECTOR UNIDIE to remove the protective film and apply the adhesive part directly on the skin. In case FLECTOR UNIDIE should be applied to greater mobility joints, such as elbow or knee, it is advisable to use a retention bandage to be applied to flexural joint, in order to maintain the plaster in place. Do not exceed the recommended doses. Avoid contact with eyes and mucosa.

Conservation

Special conservation conditions are not necessary.

Warnings

The serum levels achieved with FLECTOR UNIDIE has been significantly lower than those obtained by oral administration but with a strong individual variability, so it is not possible to exclude the occurrence of systemic side effects, 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. FLECTOR UNIDIE must be used with caution in subjects with chronic obstructive diseases of bronchi, allergic rhinitis or inflammation of the nasal mucosa ( nasal polyps) in which 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. Pediatric population Keep the medicine out of sight and reach of children.

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 medicine along with other oral or local drugs, containing piroxicam or other NSAIDs.

Effects

The use of the medicinal product may 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. Photosensitivity reactions and skin and mucosa reactions are possible more extensive and more severe, including asthma attacks. Systemic undesirable reactions as a result of the topical use of pyroxicam 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 paragraphs 4.4 and 5.2). Any appearance of general side effects or at the point of application requires suspension of therapy. Piroxicam has been reported cases of eruption fixed by unknown frequency drugs (frequency cannot be defined on the basis of available data) (see paragraph 4.4). 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 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.

Pregnancy and nursing

FLECTOR UNIDIE is contraindicated during pregnancy and breastfeeding and is not recommended in women who intend to start a pregnancy.

Fertility

The administration is to be suspended in women with fertility problems or who are subject to fertility surveys.

Source: Farmadati