Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg

INDICATIONS

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

ACTIVE INGREDIENTS

A medicated plaster contains: Active ingredient: Flurbiprofen 40.0 mg. For the full list of excipients see section 6.1.

EXCIPIENTS

Tartaric acid, purified water, titanium dioxide (E 171), kaolin, sodium caramellose, mint essence, glycerol, isopropyl myristate, sodium polyacrylate, polysorbate 80, sorbitan sesquioleate. Polyester support with protective polypropylene film, to be removed before use.

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

Dosage Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). Elderly and patients with renal impairment In elderly patients, particularly those with renal impairment, slow elimination of non-steroidal anti-inflammatory drugs is possible and, in such cases, Transact Lat should be administered with caution (see section 4.4). Pediatric population TRANSACT Lat is not recommended in pediatric patients. Method of administration TRANSACT Lat is for cutaneous use only. After having carefully washed and dried the painful area, grasp the two shorter sides of the TRANSACT Lat patch with both hands and pull slightly in the opposite direction as indicated by the arrows. This will cause the protective film in the central part of the patch to lift. Remove the protective film and apply the adhesive side directly to the skin. In the event that TRANSACT Lat must be applied to joints with greater mobility, such as the elbow or knee, it is advisable to use a retention bandage to be applied to the flexed joint. Apply only one medicated plaster at a time to the affected area every 12 hours. Dispose of the patch in safe conditions to avoid accidental ingestion.

CONSERVATION

Store at a temperature not exceeding 25°C.

WARNINGS

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 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.

Pathologies of the blood and lymphatic system. - Frequency: Not known:. Side effects: thrombocytopenia, aplastic anemia, agranulocytosis.

Pathologies of the blood and lymphatic system. - Frequency: Not known:. Side effects: neutropenia, hemolytic anemia.

Immune system disorders. - Frequency: Not known:. Side effects: anaphylactic reaction, angioedema, hypersensitivity.

Psychiatric disorders. - Frequency: Not known:. Side effects: depression.

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

Eye pathologies. - Frequency: Not known:. Side effects: visual impairment.

Ear and labyrinth disorders. - Frequency: Not known:. Side effects: tinnitus.

Cardiac diseases. - Frequency: Not known:. Side effects: edema, heart failure.

Vascular pathologies. - Frequency: Not known:. Side effects: hypertension, arterial thromboembolic events.

Respiratory, thoracic and mediastinal diseases. - Frequency: Not known:. Side effects: respiratory tract reactivity (asthma, bronchospasm and dyspnoea).

Gastrointestinal disorders. - Frequency: Very rare:. Side effects: pancreatitis.

Gastrointestinal disorders. - Frequency: Not known:. Side effects: abdominal pain, dyspepsia, nausea, vomiting, diarrhea, melena, hematemesis, ulcerative stomatitis, peptic ulcer, perforated ulcer, hemorrhagic ulcer, gastritis, gastrointestinal hemorrhage, flatulence, constipation, exacerbation of colitis, Crohn's disease.

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

Pathologies of the skin and subcutaneous tissue. - Frequency: Not known:. Side effects: rash, itching, urticaria, erythema, purpura, eruptions.

Renal and urinary disorders. - Frequency: Not known:. Side effects: nephrotoxicity (including interstitial nephritis, nephrotic syndrome), renal failure.

Systemic pathologies and conditions relating to the administration site. - Frequency: Not known:. Side effects: 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.

OVERDOSE

Symptoms Symptoms of overdose may include nausea, vomiting, abdominal pain, and gastrointestinal irritation. Treatment There is no specific antidote for flurbiprofen. Supportive measures appropriate for the management of overdose of non-steroidal anti-inflammatory drugs should be implemented, including, if necessary, correction of the serum electrolyte picture.

PREGNANCY AND BREASTFEEDING

Pregnancy Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was thought to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. During the first and second trimester of pregnancy, Flurbiprofen should not be administered unless strictly necessary. If Flurbiprofen is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: • Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • Renal dysfunction, which may progress to renal failure with oligohydroamnios; the mother and the newborn, at the end of pregnancy, to: • Possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; • Inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Flurbiprofen is contraindicated during the third trimester of pregnancy. Breastfeeding Flurbiprofen is excreted in breast milk; however the amount excreted is only a small fraction of the maternal dose. The administration of flurbiprofen is not recommended in breastfeeding mothers. Fertility Long-term use of some NSAIDs is associated with reduced female fertility which is reversible by stopping treatment.

EFFECTS ON DRIVING ABILITY

TRANSACT Lat does not affect the ability to drive or use machines.