Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

TRANSACT Lat is indicated for the local symptomatic treatment of painful conditions affecting the musculoskeletal system.

CONTRAINDICATIONS

Hypersensitivity to the active substance, or to any of the excipients listed in paragraph 6.1. Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). History of gastrointestinal bleeding or perforation related to previous NSAID treatment. Active or anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer, or gastrointestinal hemorrhage (defined as two or more distinct episodes of demonstrated ulceration or bleeding). Severe heart failure. Third trimester of pregnancy.

WARNINGS AND PRECAUTIONS FOR USE

The medicated plaster must only be applied to intact skin, not to open wounds or lesions and must not be applied during a bath or shower. The medicated plaster must not come into contact with the eyes or be applied to mucous membranes or eyes. The medicated plaster must not be used with occlusive dressings. Application of the medicated plaster should be discontinued if a skin rash develops. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the sections below on gastrointestinal and cardiovascular risks). Gastrointestinal effects Flurbiprofen should be administered with caution to patients with a history of peptic ulcers and other gastrointestinal diseases as these conditions may be exacerbated. The risk of gastrointestinal haemorrhage, ulcer or perforation is higher with increasing dosage of flurbiprofen in patients with a history of ulcer, particularly if complicated by haemorrhage and perforation, and in the elderly. These patients should start treatment with the lowest available dose. Gastrointestinal bleeding, ulcer or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and can occur with or without warning symptoms or in case of a previous history of serious gastrointestinal events. Patients with a history of gastrointestinal disease, especially if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Flurbiprofen, treatment should be discontinued. Cardiovascular and cerebrovascular effects Adequate monitoring and appropriate instructions are necessary in patients with a history of hypertension and/or mild to moderate congestive heart failure since, in association with treatment with NSAIDs, fluid retention and edema have been found. The product is contraindicated in patients with severe heart failure (see section 4.3). Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events such as myocardial infarction or stroke. There are insufficient data to exclude a similar risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with flurbiprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. Skin reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Flurbiprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Respiratory reactions Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma. Hepatic impairment Caution is required in patients with hepatic impairment. There is a greater risk of gastro-intestinal bleeding and fluid retention. NSAIDs should be avoided in severe liver disease. Renal impairment NSAIDs should be avoided if possible or used with caution in patients with renal impairment; The lowest possible dosage should be used for the shortest time and renal function should be monitored. NSAIDs can cause kidney failure, especially in patients with pre-existing kidney problems. Other Reactions Caution should be used when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration. Particular caution must be taken when treating patients with severely reduced renal, cardiac or hepatic function as the use of NSAIDs can lead to deterioration of renal function. In such patients the dosage should be kept as low as possible and renal function should be monitored. Prolonged or repeated use of products for skin use can give rise to sensitization phenomena. In the presence of hypersensitivity reactions it is necessary to interrupt therapy. To avoid any phenomena of hypersensitivity or photosensitization, avoid exposure to direct sunlight, including the solarium, during treatment and in the following two weeks. Reduction in female fertility Long-term use of some NSAIDs is associated with reduced female fertility which is reversible by stopping treatment. SLE and mixed connective tissue disease Aseptic meningitis has rarely been reported with NSAIDs. Patients with connective tissue diseases, such as systemic lupus erythematosus, may be particularly susceptible (see section 4.8). Elderly people Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

INTERACTIONS

Caution should be exercised in patients treated with any of the medicines listed below, as interactions have been reported in some patients. Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclooxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Flurbiprofen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and on a periodic basis thereafter. Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides. Anticoagulants, such as warfarin: increased anticoagulant effect. Aspirin: As with other NSAID-containing medicines, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased side effects. Anti-aggregating agents: increased risk of gastrointestinal bleeding. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Lithium salts: decrease in lithium elimination. Methotrexate: Caution is advised in case of concomitant administration of flurbiprofen and methotrexate as NSAIDs may increase methotrexate levels. Cyclosporine: increased risk of nephrotoxicity with NSAIDs. Corticosteroids: increased risk of gastrointestinal ulcer or bleeding with NSAIDs. Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects. Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. Mifepristone: NSAIDs should not be taken for 8-12 days after administration of mifepristone as NSAIDs may reduce the effects of mifepristone. Tacrolimus: possible increased risk of nephrotoxicity in case of co-administration with NSAIDs. Zidovudine: increased risk of blood toxicity in case of co-administration with NSAIDs. There is evidence of an increased risk of haemarthrosis and haematoma in haemophilia patients affected by HIV in simultaneous treatment with Zidovudine and other NSAIDs.

SIDE EFFECTS

Adverse events that have been associated with Flurbiprofen are reported below, listed by systemic organ classification frequency. Frequencies are defined as: very common (≥1/10), common, (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (impossible to estimate from the available data). Within each frequency group, adverse events are reported in order of decreasing severity.

Classification by systems and organs | Frequency | Side effects

Pathologies of the blood and lymphatic system. | Not known: | thrombocytopenia, aplastic anemia, agranulocytosis.

neutropenia, hemolytic anemia.

Immune system disorders. | Not known: | anaphylactic reaction, angioedema, hypersensitivity.

Psychiatric disorders. | Not known: | depression.

Nervous system disorders. | Not known: | dizziness cerebrovascular accidents, optic neuritis, migraine, paraesthesia, tingling, dysesthesia, confusion, hallucination, dizziness, drowsiness, aseptic meningitis (see section 4.4).

Eye pathologies. | Not known: | vision impairment.

Ear and labyrinth disorders. | Not known: | tinnitus.

Cardiac diseases. | Not known: | edema, heart failure.

Vascular pathologies. | Not known: | hypertension, arterial thromboembolic events.

Respiratory, thoracic and mediastinal diseases. | Not known: | respiratory tract reactivity (asthma, bronchospasm and dyspnea).

Gastrointestinal disorders. | Very rare: | pancreatitis.

Not known: | abdominal pain, dyspepsia, nausea, vomiting, diarrhoea, melena, haematemesis, ulcerative stomatitis, peptic ulcer, perforated ulcer, haemorrhagic ulcer, gastritis, gastrointestinal haemorrhage, flatulence, constipation, exacerbation of colitis, Crohn's disease.

Pathologies of the skin and subcutaneous tissue. | Very rare: | bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).

Not known: | rash, itching, urticaria, erythema, purpura, eruptions.

Renal and urinary disorders. | Not known: | nephrotoxicity (including interstitial nephritis, nephrotic syndrome), renal failure.

Systemic pathologies and conditions relating to the administration site. | Not known: | malaise, fatigue.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazionireazioni-avverse.