TRANSACT LAT 10CER MEDIC 40MG

TRANSACT LAT 40 MG MEDICAL CEROTTS

active ingredients

A medicated patch contains: Active ingredient: Flurbiprofene 40,0 mg For full list of excipients see section 6.1

Excellent

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

Therapeutic indications

TRANSACT Lat is indicated for the local symptomatic treatment of the painful states dependent on the musculoskeletal system.

Contraindications

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

Population

Population Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4). Seniors and patients with kidney impairment In elderly patients, especially those with kidney impairment, slow elimination of non-mo steroids anti-inflammatory drugs is possible and, in such cases, Transact Lat, should be administered with caution (see section 4.4) Method of administration TRANSACT Lat is used exclusively on the skin. After carefully washed and dried the sore area, grab both hands the two shorter sides of the TRANSACT Lat patch and pull slightly in the opposite direction as indicated by the arrows. This will cause the lifting of the protective film in the middle of the patch. Remove the protective film and apply the adhesive side directly on the skin. Should TRANSACT Lat be applied to more mobility joints, such as elbow or knee, it is advisable to use a retention bandage to be applied to flexural joints. Apply only one medicated patch at a time on the affected part every 12 hours. Dispose the plaster in safety conditions to avoid accidental ingestion. Pediatric population TRANSACT Lat is not recommended in pediatric patients.

Conservation

Store at a temperature not exceeding 25°C.

Warnings

The medicated plaster must be applied only on integral skin, not on wounds or open injuries and should not be applied during bath or shower. The medicated patch should not come in contact with the eyes nor be applied on mucosa or eyes. The medicated patch should not be used with occlusive bandage. The application of the medicated patch should be interrupted if a rash develops. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2 and below paragraphs on gastrointestinal and cardiovascular risks). Gastrointestinal effects Flurbiprofen should be administered with caution to patients with peptic ulcer anamnesis and other gastrointestinal diseases as such conditions can be re-acutized. The risk of gastrointestinal hemorrhage, ulcer or perforation is higher when the dosage of flurbiprofen increases in patients with a history of ulcer, especially if complicated by hemorrhage and perforation and in the elderly. These patients must begin treatment with the lowest dose available. Gastrointestinal bleeding, ulcer or drilling have been reported with all NSAIDs at any time of treatment. These adverse events may be fatal and may occur with or without warning symptoms or in case of previous history of serious gastrointestinal events. Patients with anamnesi of gastrointestinal diseases, especially if elderly, must report any unusual symptom of abdominal type (especially gastrointestinal hemorrhage) in the early stages of treatment. Senior patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage and perforation, which can be fatal. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must 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 paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking Flurbiprofen the treatment must be suspended. Cardiovascular and cerebrovascular effects Adequate monitoring and appropriate instructions are necessary in patients with positive anamnesiums for hypertension and/or congestive heart failure from mild to moderate as, in association with treatment with NSAIDs, fluid and edema retention has been found. The product is contraindicated in patients with severe heart failure (see paragraph 4.3). Clinical studies and epidemiological data suggest that the use of some NSAIDs especially at high doses and long-term treatments may be associated with a modest increase in the risk of arterial thrombotic events such as myocardial infarction or stroke. There is no sufficient data to exclude a similar risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with flurbiprofen only after careful evaluation. Analogue considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular disease (p.es. hypertension, hyperlipidemia, diabetes mellitus, smoking). Flurbiprofen, like other NSAIDs, can inhibit piastrinic aggregation and prolong bleeding time. Skin reactions Severe skin reactions, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. Flurbiprofen should be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Respiratory reactions Cases of bronchospasm with flurbiprofen have been reported in patients with bronchial asthma anamnesi. Epathetic Comprogation Caution is required in patients with liver impairment. There is a greater risk of gastro-intestinal bleeding and fluid retention. NSAIDs must be avoided in case of severe liver disease. Renal Compromise NSAIDs must be avoided if possible or used with caution in patients with renal impairment; the lowest dosage possible for the shortest time must be used and the kidney function must be monitored. NSAIDs can cause kidney failure, especially in patients with pre-existing kidney problems. Other operations Caution should be used when starting 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, heart or liver function as the use of NSAIDs can determine the deterioration of kidney function. In such patients the dosage must be kept as low as possible and the kidney function must be monitored. 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. To avoid any phenomena of hypersensitivity or photosensitization avoid exposure to direct sunlight, including solarium, during treatment and in the next two weeks. Female fertility reduction The long-term use of some NSAIDs is associated with reduced female fertility which is reversible by interrupting treatment. LES and mixed connective tissue disease Rarely with the NSAIDs was reported assettic meningitis. Patients with connective tissue diseases, such as systemic erythematous lupus, may be particularly susceptible (see paragraph 4.8). Seniors Senior patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage and perforation, which can be fatal.

Interactions

Attention should be provided in patients treated with any of the medicines listed below, as interactions have been reported in some patients. Diuretics, ACE inhibitors and antagonists of angiotensin II: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system may lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking Flurbiprofen in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and should be taken into account the monitoring of renal function after the start of concomitant therapy and subsequently on a periodic basis. Heart glycosides: NSAIDs can exacerbate heart failure, reduce the degree of glomerular filtration and increase the plasma levels of cardiac glycosides. Antiagulants, like warfarina: increased anticoagulant effect. Aspirin: As with other medicines containing NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended due to the potential increase in unwanted effects. Aggregating agents: increased risk of gastrointestinal hemorrhage. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage. Salts of Litio: decrease in lithium elimination. Methods: caution is recommended in case of concomitant administration of flurbiprofen and metotrexate as NSAIDs can increase metotrexate levels. Ciclosporin: increased risk of nephrotoxicity with NSAIDs. Courtesy: increased risk of gastrointestinal ulcer or hemorrhage with NSAIDs. Cox-2 inhibitors and other NSAIDs: Concurrent use of other NSAIDs, including selective cycloxygenase-2 inhibitors, must be avoided due to potential additive effects. Chinolonic Antibiotics: Patients taking NSAIDs and kinolones may have an increased risk of developing seizures. Mifepristone: NSAIDs should not be taken for 8-12 days after mifepristone is administered as NSAIDs can reduce the effects of mifepristone. Tacrolimus: increased risk of nephrotoxicity in case of co-administration with NSAIDs. Zidovudina: increased risk of blood toxicity in case of co-administration with NSAIDs. There is evidence of an increase in the risk of hematoma and hematoma in hemophiliac patients with HIV in contemporary treatment with Zidovudine and other NSAIDs.

Effects

Adverse events that have been associated with Flurbiprofene are listed below, listed by organic frequency systemic classification. The frequencies are defined as: very common (≥1/10), common (from ≥1/100 to Classification for systems and organs Frequency Undesirable effects Emolinfopoietic system pathologies not known Trombocytopenia, aplastic anemia, agranulocytosis not known Neutropenia, hemolytic anemia Immune system disorders not known Anaphylaxis, angioedema, allergic reaction Psychiatric disorders not known Depression Diseases of the nervous system not known Capitalisms cerebrovascular accidents, optic neuritis, migraines, paresthesia, tingling, dysthesia, confusion, hallucination, dizziness, drowsiness, aseptic meningitis (see paragraph 4.4) Pathologies of the eye not known View disturbances Ear and labyrinth pathologies not known Tinnitus Heart disease not known Edema, heart failure Vascular diseases not known Hypertension, arterial thromboembolic events Respiratory, chest and mediastinic diseases not known Reactivity of the respiratory tract (asthma, bronchospasmo and dispnea) Gastrointestinal diseases not known Abdominal pain, dyspepsia, nausea, vomiting, diarrhea, melena, ematemesis, ulcerative stomatitis, peptic ulcer perforated ulcer, hemorrhagic ulcer, gastritis, gastrointestinal hemorrhage, flatulence, stipsi, exacerbation of Crohn's disease colitis very rare Pancreatis Pathologies of skin and subcutaneous tissue very rare Bollose dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and multiform erythema) not known rash urticaria red porpora eruptions Kidney and urinary disorders not known Nephrotoxicity (including interstitial nephritis, nephrosic syndrome), kidney failure Systemic pathologies and conditions for administration not known Malessere, 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdose

Synonyms Overdose symptoms may include nausea, vomiting, abdominal pain and gastrointestinal irritation. Treatment There is no specific antidote for flurbiprofen. Support measures suitable for overdosing non-steroidal anti-inflammatory drugs must be implemented, including, if necessary, correction of the sierial electrolytic framework.

Pregnancy The inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in pre- and post-system loss and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, Flurbiprofen should not be administered if not in strictly necessary cases. If Flurbiprofen is used by a woman waiting for conception or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: · cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); · Renal dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: · Possible prolongation of bleeding time, an anti-aggregating effect that can occur even at very low doses; · Inhibition of uterine contractions resulting in delay or extension of labor. Therefore Flurbiprofen is contraindicated during the third trimester of pregnancy. Breastfeeding Flurbiprofen is excreted in breast milk; however the excreta quantity is only a small fraction of the maternal dose. Flurbiprofene administration is not recommended in nursing mothers. Fertility The long-term use of some NSAIDs is associated with reduced female fertility which is reversible by interrupting treatment.

Source: Farmadati