Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg
Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg
PRODUCT NET WEIGHT
PRODUCT NET WEIGHT
Transact Lat is a medicated plaster that releases 40 mg of flurbiprofen with pain-relieving and analgesic action , locally absorbed by the skin. Transact Lat 10 Painkiller Patches Flurbiprofen 40mg particularly suitable for the treatment of local pain affecting the musculoskeletal system.
The absorption through the skin and the relative subcutaneous accumulation of the active ingredient of the Transact Lat Patches, flurbiprofen, allows the Transact pain-relieving patches to carry out an analgesic and anti-inflammatory action concentrated in the site of application. This limits and avoids the adverse systemic effects associated with enteral non-steroidal anti-inflammatory therapy (NSAID).
Posology and method of use of Transact Lat 10 Painkiller Patches Flurbiprofen 40 mg
How to take Transact Lat 10 Patches?
Adults : Apply only one Transact Lat patch at a time to the affected area every 12 hours.
After carefully washing and drying 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 center 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 of greater mobility , such as the elbow or knee, it is advisable to use a retention bandage to be applied to the flexed joint.
Pediatric population: Transact Lat is not recommended in pediatric patients.
Active Ingredients and Excipients Transact Lat 10 Pain Relief Patches Flurbiprofen 40mg
One Transact Lat patch contains:
Active ingredients : flurbiprofen 40.0 mg.
Excipients : Tartaric acid, purified water, titanium dioxide (E 171), kaolin, caramellose sodium, mint essence, glycerol, isopropyl myristate, sodium polyacrylate, polysorbate 80, sorbitan sesquioleate. Polyester support with polypropylene protective film, to be removed before use.
Contraindications Transact Lat 10 Pain Relief Patches Flurbiprofen 40mg
Do not use Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg in case of:
- Hypersensitivity to the active substance, or to any of the excipients.
- Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
- History of gastrointestinal bleeding or perforation related to previous NSAID treatments.
- Active or history of ulcerative colitis, Crohn's disease, recurrent peptic ulcer, or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding).
- Severe heart failure.
- Third trimester of pregnancy.
Warnings Transact Lat 10 Pain Relief Patches Flurbiprofen 40mg
The medicated plaster should only be applied to intact skin, not to open wounds or lesions and should 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 an occlusive dressing. The application of the medicated plaster should be stopped 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.
Gastrointestinal Effects: Flurbiprofen should be administered with caution to patients with a history of peptic ulcer and other gastrointestinal diseases as these conditions may be exacerbated. The risk of GI bleeding, ulceration or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with bleeding and perforation, and in the elderly. These patients should start treatment on the lowest available dose. Gastrointestinal bleeding, ulceration or perforation has 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 with 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 haemorrhage and perforation, which can be fatal. 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. When gastrointestinal bleeding or ulceration occurs in patients taking flurbiprofen, the treatment should be discontinued.
Cardiovascular and cerebrovascular effects: Appropriate monitoring and appropriate instructions are required in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment. The product is contraindicated in patients with severe heart failure. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and in long-term treatments, may be associated with a small increased 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 only be treated with flurbiprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, 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 highest 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 an increased risk of gastrointestinal 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 dose should be used for the shortest duration 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 should be taken in the treatment of patients with severely reduced renal, cardiac or hepatic function as the use of NSAIDs can cause deterioration of renal function. In such patients the dosage should be kept as low as possible and renal function monitored.
Prolonged or repeated use of products for cutaneous use can give rise to sensitization phenomena. In the presence of hypersensitivity reactions it is necessary to interrupt the therapy. To avoid any hypersensitivity or photosensitivity phenomena, avoid exposure to direct sunlight, including the solarium, during treatment and for the following two weeks. Reduced female fertility: Long-term use of some NSAIDs is associated with reduced female fertility which is reversible on stopping treatment. SLE and mixed connective tissue disease Aseptic meningitis has been reported rarely with NSAIDs. Patients with connective tissue disorders, such as systemic lupus erythematosus, may be particularly susceptible. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal.
Interactions Transact Lat Patches and other drugs
Caution should be exercised in patients receiving any of the medicinal products listed below, as interactions have been reported in some patients.
Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclooxygenase system may lead to an further deterioration of renal function, including possible acute renal failure, 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 monitoring of renal function should be considered after initiation of concomitant therapy and on a periodic basis thereafter.
Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce the glomerular filtration rate and increase plasma levels of cardiac glycosides.
Anticoagulants, such as warfarin: Increased anticoagulant effect.
Aspirin: As with other NSAID-containing medicinal products, co-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 elimination of lithium.
Methotrexate: Caution is advised when co-administering flurbiprofen and methotrexate as NSAIDs may increase methotrexate levels.
Cyclosporine: Increased risk of nephrotoxicity with NSAIDs.
Corticosteroids: Increased risk of gastrointestinal ulceration 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 mifepristone administration as NSAIDs can 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 hematoma in HIV-infected haemophilia patients concomitantly treated with zidovudine and other NSAIDs.
Side effects Transact Lat 10 Pain Relief Patches Flurbiprofen 40mg
The adverse events that have been associated with the flurbiprofen contained in Transact Lat 10 Pain Relief Patches are listed below,
- Pathologies of the hemolymphopoietic system. Not known: thrombocytopenia, aplastic anemia, agranulocytosis. neutropenia, haemolytic anemia.
- Immune system disorders. Not known: anaphylactic reaction, angioedema, hypersensitivity.
- Psychiatric disorders. Not known: depression.
- Pathologies of the nervous system. Not known: dizziness cerebrovascular accident, optic neuritis, migraine, paraesthesia, tingling, dysesthesia, confusion, hallucination, vertigo, somnolence, aseptic meningitis.
- Pathologies of the eye. Not known: Visual impairment.
- Pathologies of the ear and labyrinth. Not known: tinnitus.
- Heart pathologies. Not known: oedema, heart failure.
- Vascular pathologies. Not known: hypertension, arterial thromboembolic events.
- Respiratory, thoracic and mediastinal diseases. Not known: Respiratory tract reactivity (asthma, bronchospasm and dyspnoea).
- Gastrointestinal pathologies. Very rare: pancreatitis. Not known: Abdominal pain, dyspepsia, nausea, vomiting, diarrhoea, melaena, haematemesis, ulcerative stomatitis, peptic ulcer, perforated ulcer, haemorrhagic ulcer, gastritis, gastrointestinal haemorrhage, flatulence, constipation, crohn's disease colitis exacerbation.
- Skin and subcutaneous tissue disorders. Very rare: Bullous dermatoses (including Stevens Johnson syndrome, toxic epidermal necrolysis and erythema multiforme). Not known: rash, pruritus, urticaria, erythema, purpura, eruptions.
- Renal and urinary disorders. Not known: nephrotoxicity (including interstitial nephritis, nephrotic syndrome), renal failure. General disorders and administration site conditions. Not known: malaise, fatigue.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Pregnancy and breastfeeding Transact Lat 10 Pain Relief Patches Flurbiprofen 40mg
Can I use Transact Lat 10 Patches when pregnant or breastfeeding?
Pregnancy : Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of 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 dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given prostaglandin synthesis inhibitors 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 prostaglandin synthesis inhibitors may expose the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which can progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of bleeding time, an antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently Transact Lat 10 Patches Flurbiprofen is contraindicated during the third trimester of pregnancy.
Lactation : 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 nursing mothers .
Fertility : Long-term use of some NSAIDs is associated with reduced female fertility which is reversible upon discontinuation of treatment.
Expiration and storage of Transact Lat 10 Flurbiprofen Pain Relief Patches 40mg
How to store Transact Lat 10 Patches?
Store at a temperature not exceeding 25 degrees C.
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