Name
TRANSACT Lat 40 mg medicated plasters
Flurbiprofen


What it is and what it is used for
TRANSACT Lat contains the active substance flurbiprofen and belongs to the category of non-steroidal anti-inflammatory drugs 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 treatments with NSAIDs.
- If you suffer or have suffered from ulcerative colitis or Crohn's disease (chronic inflammation of the intestine), recurrent peptic ulcer (painful sores or ulcers of the stomach and upper intestine) or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding).
- If you have severe heart failure (a condition where the heart is unable to pump enough blood).
- If you are in your 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, unbroken skin: do not apply the patch to skin wounds or open lesions. Remove the patch when bathing or showering.
- The patch should not come into contact with or be applied to mucous membranes (membranes that line and protect the inside of the body) or eyes.
- Do not use with occlusive dressings (air- and water-impermeable dressings).
- Stop treatment if a skin rash appears.

Gastrointestinal effects
- The risk of stomach and intestinal bleeding, ulceration or perforation is higher with increasing flurbiprofen dosage in patients with a history of peptic ulcer (painful sores or ulcers of the stomach and upper intestine), particularly if complicated by bleeding and perforation, and in elderly patients. In these situations, you should inform your doctor of the occurrence of abnormal symptoms, especially during the initial phase of treatment.
You should start treatment with the lowest effective dose possible.
- Flurbiprofen should be given with caution if you have a history of ulcerative colitis and Crohn's disease (chronic inflammation of the intestine), as treatment with the medicine may aggravate these conditions.
- Treatment should be discontinued in case of gastrointestinal bleeding or ulceration.

Effects on the heart, brain and blood vessels
- If you have a history of high blood pressure and/or heart failure, you will need to be monitored by your doctor who will also provide you with appropriate instructions on how to manage your therapy since fluid retention and swelling have been reported in association with treatment with NSAIDs.
The use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with a small increased risk of myocardial infarction (heart attack) or stroke.

- If you suffer from uncontrolled high blood pressure, heart failure, ischaemic 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 should only be carried out after careful consideration by your doctor (see section 2).

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

- 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 with long-term treatment. 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
Serious skin reactions, some of them fatal, have been reported very rarely, including exfoliative dermatitis (exfoliation of large areas of skin), Steve-Johnson syndrome (severe allergic reaction with characteristic skin rash), toxic epidermal necrolysis (a rare skin condition, which can be fatal, caused by a reaction to a drug, associated with the administration of NSAIDs [see section 4 “Possible side effects”]). The risk of these reactions appears to be higher at the beginning of treatment, with the majority of them occurring during the first month of treatment. At the first signs of appearance of rash, oral lesions or manifestations 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 history of non-allergic asthma.
Cases of bronchospasm (closure of the bronchi) have been reported with the use of flurbiprofen in patients with a history of asthma.

Effects on the liver
Flurbiprofen should be given with caution if you have liver problems: you may be at increased risk of bleeding and fluid retention. NSAIDs should be avoided if you have 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 dose should be used for the shortest time and renal function should be monitored. NSAIDs may cause renal 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 may 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 (lack of fluids).
- If you have systemic lupus erythematosus (a multisystem autoimmune disease that mainly affects the skin and joints, although all parts of the body can be involved) and mixed connective tissue disease (autoimmune disorder) you may be at increased risk of aseptic meningitis (a disease characterized by severe inflammation of the membranes covering the brain).
- Since the active ingredient of TRANSACT Lat can be absorbed through the skin, the occurrence of general effects cannot be excluded. The risk of occurrence of these effects depends, among other things, on the exposed area, the amount applied and the exposure time.

Elderly people
The elderly have an increased frequency of adverse effects from NSAIDs, especially gastrointestinal bleeding and perforation, which can be very serious and life-threatening.

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 up to 1 in 10,000 people)
• Pancreatitis (inflammation of the pancreas)
• Bullous dermatitis (an autoimmune disorder with blistering of the skin)
• Stevens-Johnson syndrome (serious allergic reaction with characteristic skin rash), toxic epidermal necrolysis (serious skin condition, which can be fatal, caused by a 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 (severe decrease in blood cell production)Agranulocytosis (low level of white blood cells)
• Neutropenia (decrease in neutrophils, a type of white blood cell)
• Hemolytic anemia (a condition 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 allergic reactions with rapid onset)
• Depression
• Dizziness
• Cerebrovascular accident (stroke)
• Optic neuritis (inflammation of the optic nerve which can cause partial or total vision loss)
• Migraine
• Paresthesia (sensation of tingling, itching, stinging or burning of the skin)
• Tingling
• Dysesthesia (an abnormal and unpleasant sensation perceived by touch)
• Confusion
• Hallucinations
• Dizziness
• Drowsiness
• Aseptic meningitis (serious inflammation of the membranes covering the brain), particularly in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus (an autoimmune disease that mainly 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 disturbances
• 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. closing of the bronchi and dyspnea, difficulty breathing)
• Abdominal pain
• Dyspepsia (digestive disorder)
• Nausea
• Diarrhea
• Vomit
• Melena (emission of black stools, due to the presence of blood)
• Hematemesis (vomiting blood)
• Ulcerative stomatitis (sore and inflamed mouth)
• Peptic ulcer (painful sore or ulcer in the lining of the stomach)
• Perforated ulcer (a very serious condition where an untreated ulcer can perforate the stomach wall) and hemorrhagic ulcer
• Gastritis (inflammation of the stomach)
• Gastrointestinal bleeding
• Flatulence (air in the belly)
• Constipation
• Worsening of colitis (inflammation of the colon)
• Crohn's disease (a chronic inflammatory disease of the intestine)
• Interstitial nephritis (inflammation of the kidney tissue) and nephrotic syndrome (a kidney problem characterized by a set of signs or symptoms)
• Renal failure (poor kidney function)
• Malaise (feeling of general discomfort or uneasiness)
• Fatigue
• Eruptions
• Redness
• Hives (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. This includes any possible side effects 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.