TRANSACT LAT*10CER MEDIC 40MG

What it is and what it is used for
TRANSACT Lat contains the active ingredient flurbiprofen and belongs to the category of non-steroidal anti-inflammatory medicines for topical use (local use).

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

Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment (a few days).

What you need to know before taking the medicine
Do not use TRANSACT Lat
- if you are allergic to flurbiprofen, acetylsalicylic acid, other NSAIDs (non-steroidal anti-inflammatory drugs) or any of the other ingredients of this medicine (listed in section 6).
- If you suffer or have suffered from gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
- If you suffer or have suffered from ulcerative colitis or Crohn's disease (chronic inflammation of the intestine), recurrent peptic ulcer (painful lesions or ulcers of the stomach and first part of the intestine) or gastrointestinal bleeding (defined as two or more episodes distinct cases of demonstrated ulceration or bleeding).
- If you have severe heart failure (a condition in which the heart is unable to pump enough blood).
- If you are in the third trimester of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using TRANSACT Lat.
- The patch should only be applied to intact skin, without lesions: do not apply the patch to skin wounds or open lesions. Remove the patch when bathing or showering.
- The patch must not come into contact with or be applied to the mucous membranes (membranes that cover and protect the inside of the body) or the eyes.
- Do not use with occlusive dressings (air- and water-impermeable dressings).
- Stop treatment if a rash appears on your skin.

Gastrointestinal effects
- The risk of bleeding, ulcer or perforation of the stomach and intestine is higher with increasing dosage of flurbiprofen in patients with a history of peptic ulcer (painful wounds or ulcers of the stomach and first part of the intestine), particularly if complicated from hemorrhage and perforation and in elderly patients. In these situations, you should inform your doctor of any abnormal symptoms, especially during the initial phase of treatment. You should start treatment with the lowest effective dose possible.
- Flurbiprofen should be administered with caution if you have a history of ulcerative colitis and Crohn's disease (chronic inflammation of the intestine), as treatment with the medicine can aggravate these situations.
- Treatment must be stopped in case of bleeding or gastrointestinal ulceration.

Effects on the heart, brain and blood vessels - If you have a medical history of high blood pressure and/or heart failure, you will need to be monitored by your doctor who will also provide you with adequate instructions on the management of the therapy since, in association with treatment with NSAIDs, fluid retention and swelling have been noted.
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 myocardial infarction (heart attack) or stroke.
- If you suffer from uncontrolled high blood pressure, heart failure, ischemic heart disease (reduced blood supply to the heart), peripheral arterial disease (involvement of blood vessels) and/or cerebrovascular disease (problems with blood circulation in the brain) treatment with flurbiprofen can only be carried out after careful evaluation by the doctor (see paragraph 2).

- Similar considerations must be observed before starting long-term treatment if you have risk factors for heart and blood vessel diseases (increased levels of fat in the blood, diabetes mellitus, smoking habit): ask your doctor or doctor for advice. pharmacist.

- Medicines such as TRANSACT Lat may be associated with an increased risk of myocardial infarction (heart attack) or stroke. The risk is higher at high doses and in long-term treatments. Do not exceed the recommended dose and duration of treatment.

- Flurbiprofen, like other NSAIDs, can block the aggregation of platelets (which are the blood cells responsible for clotting) and prolong bleeding time.

Effects on the skin:
Very rarely, serious skin reactions, some of them fatal, have been reported, including exfoliative dermatitis (peeling of large areas of skin), Steve-Johnson syndrome (severe allergic reaction with characteristic skin rash), toxic epidermal necrolysis (rare skin condition, which can be fatal, caused by a reaction to a medicine, associated with the administration of NSAIDs [see paragraph 4 "Possible side effects"]). The risk of these reactions appears to be greatest at the start of treatment, as most of these occur during the first month of treatment. At the first signs of the appearance of rash, oral lesions or signs of hypersensitivity it is necessary to stop treatment with TRANSACT Lat and inform your doctor.

Effects on the respiratory system
TRANSACT Lat should be used with caution if you have a clinical history of non-allergic asthma. Cases of bronchospasm (closure of the bronchi) have been reported with the use of flurbiprofen in patients with a clinical history of asthma.

Effects on the liver Flurbiprofen should be administered with caution if you suffer from liver problems: you may be at greater risk of bleeding and fluid retention. NSAIDs should be avoided in severe liver disease.

Effects on the kidneys
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 who have or have had kidney problems.

Effects on fertility
Long-term use of some NSAIDs is associated with a reduction in female fertility, which resolves after discontinuation of treatment. The use of NSAIDs during pregnancy can delay labor and increase its duration (see section 2).

Other effects
- At the beginning of treatment, flurbiprofen, like all NSAIDs, should be administered with caution if you are dehydrated (fluid deficiency).
- If you have systemic lupus erythematosus (a multisystem autoimmune disease that predominantly affects the skin and joints, although all parts of the body may be affected) and mixed connective tissue disease (autoimmune disorder) there may be an increased risk of meningitis aseptic (a disease characterized by severe inflammation of the membranes lining the brain).
- Since absorption of the active ingredient of TRANSACT Lat is possible through the skin, the manifestation of general effects cannot be excluded. The risk of these effects occurring depends, among other things, on the exposed area, the quantity applied and the exposure time.

Elderly people
The elderly have an increased frequency of adverse effects to NSAIDs, especially gastrointestinal bleeding and perforation, which can be very serious and life-threatening. The risk of adverse effects in case of dehydration and heart, kidney and liver diseases.

Children
Use is not recommended in children.

Possible side effects
Like all medicines, TRANSACT Lat can cause side effects, although not everybody gets them.

Very rare (may affect 1 in 10,000 people)
• Pancreatitis (inflammation of the pancreas)
• Bullous dermatitis (an autoimmune disorder with blistering of the skin)
• Stevens-Johnson syndrome (severe allergic reaction with characteristic skin rash), toxic epidermal necrolysis (serious skin condition, which can be life-threatening, caused by reaction to a medicine), erythema multiforme (skin reaction caused by allergy or infection)

Not known (cannot be estimated from the available data)
• Thrombocytopenia (decrease in platelets)
• Aplastic anemia (severely decreased production of blood cells) Agranulocytosis (low level of white blood cells)
• Neutropenia (decrease in neutrophils, a type of white blood cell)
• Hemolytic anemia (pathology in which the destruction of red blood cells exceeds their production by the bone marrow)
• Allergic reactions
• Angioedema (localized swelling of the skin and mucous membranes)
• Anaphylactic reactions (severe, rapid-onset allergic reactions)
• Depression
• Dizziness
• Cerebrovascular accident (stroke)
• Optic neuritis (inflammation of the optic nerve that can cause partial or total loss of vision)
• Migraine
• Paraesthesia (tingling, itching, stinging or burning sensation of the skin)
• Tingling
• Dysesthesia (an abnormal and unpleasant sensation felt by touch)
• Confusion
• Hallucinations
• Dizziness
• Drowsiness
• Aseptic meningitis (severe inflammation of the membranes lining the brain), particularly in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus (an autoimmune disease that predominantly affects the skin and joints, but can affect any part of the body) and mixed connective tissue disease with symptoms of stiff neck, headache, nausea, vomiting, fever, or disorientation)
• Vision disorders
• Tinnitus (perception of noise or ringing in the ear)
• Edema (Swelling)
• Heart failure
• Arterial hypertension (high blood pressure)
• Arterial thromboembolic events (obstruction of blood vessels)
• Reactivity of the respiratory tract (asthma, bronchospasm, i.e. closure of the bronchi and dyspnea, difficulty breathing)
• Abdominal pain
• Dyspepsia (digestive disorder)
• Nausea
• Diarrhoea
• Vomit
• Melena (emission of black stools, due to the presence of blood)
• Hematemesis (emission of blood with vomiting)
• Ulcerative stomatitis (inflamed and painful mouth)
• Peptic ulcer (painful wound or ulcer of the stomach lining)
• Perforated ulcer (a very serious condition in which an untreated ulcer can perforate the stomach wall) and hemorrhagic ulcer
• Gastritis (inflammation of the stomach)
• Gastrointestinal bleeding
• Flatulence (air in the belly)
• Constipation
• Aggravation of colitis (inflammation of the colon)
• Crohn's disease (a chronic inflammatory bowel disease)
• Interstitial nephritis (inflammation of kidney tissue) and nephrotic syndrome (a kidney problem characterized by a number of signs or symptoms)
• Renal failure (poor kidney function)
• Malaise (feeling of annoyance or generalized discomfort)
• Fatigue
• Eruptions
• Redness
• Urticaria (skin rash with redness and nodules, mild localized swelling)
• Itching
• Rash
• Purpura (red or purple coloration of the skin that does not disappear when pressed)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist, including any not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.