Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg

Transact Lat is a medicated patch that releases 40 mg of flurbiprofen with analgesic and pain-relieving action , absorbed locally by the skin. Transact Lat 10 Pain-Relieving Patches Flurbiprofen 40mg particularly suitable for the treatment of local painful conditions affecting the musculoskeletal system.

The absorption through the skin and the relative subcutaneous accumulation of the active ingredient of Transact Lat Patches, flurbiprofen, allows Transact pain-relieving patches to perform an analgesic and anti-inflammatory action concentrated at the application site. This limits and avoids the adverse systemic effects associated with enteral nonsteroidal anti-inflammatory therapy (NSAIDs).

ACTIVE INGREDIENTS

Active ingredients contained in Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg - What is the active ingredient in Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg?

One medicated plaster contains: flurbiprofen 40.0 mg. For a full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg - What does Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg contain?

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

DIRECTIONS

Therapeutic indications Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg - Why is Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg - When should Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg not be used?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). History of gastrointestinal bleeding or perforation related to previous NSAID therapy. Active or previous 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.

DOSAGE

Quantity and method of taking Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg - How do you take Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg?

Posology. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Elderly and patients with renal impairment: In elderly patients, particularly those with renal impairment, a 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). Paediatric population: TRANSACT Lat is not recommended in paediatric patients. Method of administration: TRANSACT Lat is for cutaneous use only. 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 opposite directions 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. If TRANSACT Lat is to 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. Place the plaster in a safe place to avoid accidental ingestion.

CONSERVATION

Storage Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg - How do you store Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg?

Store at a temperature not exceeding 25 degrees C.

WARNINGS

Warnings Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg - About Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg it is important to know that:

The medicated plaster should only be applied to intact skin, not to open wounds or lesions and should not be applied while bathing or showering. The medicated plaster should not come into contact with the eyes or be applied to mucous membranes or eyes. The medicated plaster should not be used under occlusive dressing. Application of the medicated plaster should be discontinued if a skin rash develops. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary 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 ulcer and other gastrointestinal diseases as these conditions may be exacerbated. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with haemorrhage and perforation and in the elderly. These patients should start treatment on the lowest available dose. Gastrointestinal bleeding, ulceration or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and may occur with or without warning symptoms or with a previous history of serious GI events. Patients with a history of GI disease, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) in the early stages of treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs especially GI bleeding and perforation, which may be fatal. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking low dose aspirin or other drugs likely to increase GI risk (see below and section 4.5). When GI bleeding or ulceration occurs in patients receiving Flurbiprofen, the treatment should be withdrawn. Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are necessary in patients with a history of hypertension and/or mild to moderate congestive heart failure since fluid retention and oedema have been reported in association with NSAID therapy. The product is contraindicated in patients with severe heart failure (see section 4.3). Clinical trial and epidemiological data suggest that use of some NSAIDs, particularly at high doses and in long term treatment, may be associated with a small increased risk of arterial thrombotic events, for example myocardial infarction or stroke. There are insufficient data to exclude such a risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with flurbiprofen after careful consideration. Similar consideration 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, may 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. Patients appear to be at highest risk early in the course of therapy: the onset of the reaction occurring in the majority of 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 time and renal function should be monitored. NSAIDs may cause renal failure, especially in patients with pre-existing renal problems. Other reactions: Caution should be exercised when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration. Particular caution should be exercised in treating patients with severely reduced renal, cardiac or hepatic function as the use of NSAIDs may result in 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 cutaneous use may give rise to sensitization phenomena. In the event of hypersensitivity reactions, therapy should be discontinued. To avoid any hypersensitivity or photosensitivity phenomena, avoid exposure to direct sunlight, including solarium, during treatment and for two weeks thereafter. Reduced female fertility: long-term use of some NSAIDs is associated with reduced female fertility which is reversible upon discontinuation of treatment. SLE and mixed connective tissue disease Aseptic meningitis has been reported rarely 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

Interactions Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg - Which medicines or foods can modify the effect of Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg?'

Caution should be exercised in patients treated with any of the following medicinal products, 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) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclooxygenase system may result in 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 periodically thereafter. Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides. Anticoagulants, such as warfarin: increased anticoagulant. Aspirin: as with other NSAID-containing medicinal products, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased adverse effects. Anti-platelet agents: increased risk of gastrointestinal bleeding. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Lithium salts: decreased lithium elimination. Methotrexate: caution is advised when flurbiprofen and methotrexate are co-administered as NSAIDs may increase methotrexate levels. Ciclosporin: increased risk of nephrotoxicity with NSAIDs. Corticosteroids: Increased risk of gastrointestinal ulceration or haemorrhage with NSAIDs. Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to potential additive effects. Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. Mifepristone: NSAIDs should not be taken for 8-12 days after mifepristone administration since NSAIDs may reduce the effects of mifepristone. Tacrolimus: Possible increased risk of nephrotoxicity when co-administered with NSAIDs. Zidovudine: Increased risk of haematotoxicity when co-administered with NSAIDs. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-infected haemophiliac patients receiving concomitant treatment with Zidovudine and other NSAIDs.

SIDE EFFECTS

Like all medicines, Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg can cause side effects - What are the side effects of Transact Lat 10 Pain Relief Patches Flurbiprofen 40 mg?

Adverse events that have been associated with Flurbiprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (>=1/10), common (>=1/100 to <1/10), uncommon (>=1/1,000 to <1/100), rare (>=1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness. Blood and lymphatic system disorders. Not known: thrombocytopenia, aplastic anaemia, agranulocytosis. neutropenia, haemolytic anaemia. Immune system disorders. Not known: anaphylactic reaction, angioedema, hypersensitivity. Psychiatric disorders. Not known: depression. Nervous system disorders. Not known: dizziness, cerebrovascular accident, optic neuritis, migraine, paraesthesia, tingling, dysesthesia, confusion, hallucination, vertigo, somnolence, aseptic meningitis (see section 4.4). Eye disorders. Not known: visual impairment. Ear and labyrinth disorders. Not known: tinnitus. Cardiac disorders. Not known: oedema, cardiac failure. Vascular disorders. Not known: hypertension, arterial thromboembolic events. Respiratory, thoracic and mediastinal disorders. Not known: respiratory tract reactivity (asthma, bronchospasm and dyspnoea). Gastrointestinal disorders. 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, exacerbation of colitis, Crohn's disease. Skin and subcutaneous tissue disorders. Very rare: bullous dermatitis (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 that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazionireazioni-avverse.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Transact Lat 10 Pain Relieving Patches Flurbiprofen 40 mg

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increases from less than 1%, up to approximately 1.5%. The risk has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has 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 clearly 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 may progress to renal failure with oligohydroamniosis; the mother and the neonate, at the end of pregnancy, to: possible prolongation of bleeding time, an antiaggregant effect which may 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. 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.