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Like all medicines, Momentact Analgesico can cause side effects, although not everybody will experience them. The side effects of the medicine can be minimised if the patient uses the lowest recommended dose or if they only use the medicine for the period of time necessary to control the symptoms. If the patient gets an ulcer or stomach and/or intestinal bleeding occurs, or if they find lesions of the skin and/or mucosa, they must discontinue treatment with Momentact Analgesico and contact the doctor. Usually these side effects are more common in the elderly.
Use of Momentact Analgesico can cause side effects that are generally minor or moderate or, albeit rarely, more severe allergic reactions. If any of the following symptoms arise, IMMEDIATELY DISCONTINUE the use of Momentact Analgesico and contact a doctor or go to the nearest hospital where they can administer appropriate and specific treatment: rashes or skin lesions; mucosal lesions; signs of allergic reaction, including severe symptoms (erythema, itching, urticaria, asthma, swelling of the skin and mucosa, anaphylactic shock); flaking skin; severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome); visual disturbances,; liver disease (liver dysfunction); bleeding, ulcer and perforation of the stomach or intestine, which could prove fatal, particularly in the elderly.
In the event of an allergic reaction as listed previously, go to a hospital, as the patient needs to have immediate access to equipment, medication and staff qualified to treat emergencies. In rare cases, severe side effects have been reported following the use of ibuprofen, sometimes with a fatal outcome, even in the absence of a known allergy.
The risk of developing such symptoms is higher in the initial stages of treatment. In most cases, the reaction occurs within the first month of treatment.
Furthermore, additional side effects may occur which have also been reported with other medicines similar to Momentact Analgesico and which are listed as follows by frequency: Common (may affect up to 1 in 10 people): dizziness; malaise; fatigue.
Uncommon (may affect up to 1 in 100 people): inflammation of the stomach (gastritis); insomnia, anxiety; numbness in the limbs or in other parts of the body, drowsiness; nasal congestion (rhinitis) (particularly in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease); difficulty breathing (bronchospasm, dyspnoea); momentary interruption of breathing (apnoea); hearing impairment; ringing in the ears (tinnitus); vertigo; liver disorders (impaired liver function); liver inflammation (hepatitis); yellowing of the skin and eyes (jaundice); kidney disease (damage to kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure); allergic reactions such as skin rash, urticaria, itching, formation of red spots on the skin (purpura), swelling of the skin and mucosa (angioedema), asthma, difficulty breathing (bronchospasm or dyspnoea) and asthmatic attacks with lowered blood pressure; skin reactions to light (photosensitivity); visual disturbances.
Rare (may affect up to 1 in 1,000 people): reduced number of blood cells: reduction in white blood cells (leukopenia, neutropaenia and agranulocytosis), in red blood cells (haemolytic anaemia and aplastic anaemia) and in blood platelets (thrombocytopenia); depression, confusional state, hallucinations; inflammation of the optic nerve (optic neuritis); inflammation of the meninges, the membranes covering the brain (aseptic meningitis), especially in patients with pre-existing autoimmune disorders (see "Precautions"), with symptoms of nuchal rigidity, headache, nausea, vomiting, fever or disorientation; eye disorders with visual disturbances and optic nerve disorder (toxic optic neuropathy); swelling due to the accumulation of fluid in tissues; disease that can affect various organs and tissues of the body (lupus erythematosus); worsening of inflammation caused by an already present infection (for example development of necrotising fasciitis).
Very rare (may affect up to 1 in 10,000 people): inflammation of the pancreas, a gland involved in digestive processes (pancreatitis); sensation of feeling one's own heartbeat (palpitations)*; heart disease (heart failure)*; heart attack (myocardial infarction); increase in fluid around the lungs (acute pulmonary oedema)*; liver disease (liver failure)*; hypertension*; severe allergic reactions, which may include symptoms such as swelling of the face, tongue and throat making breathing difficult, fast heartbeat, severe allergic reaction with rapid onset which can cause death (anaphylaxis), severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme). In exceptional cases, severe skin infections with soft-tissue disorders may occur during a varicella infection.
*these side effects are generally reversible on discontinuation of treatment.
Not known (cannot be estimated from the available data): feeling of indigestion; nausea; vomiting; diarrhoea; flatulence; constipation; difficult digestion; stomach ache; heartburn; blood in stool; blood in vomit; lesions inside the mouth; worsening of inflammatory diseases of the colon and intestine (colitis, Crohn's disease); increased risk of heart attack (myocardial infarction) or lack of blood supply to the brain (stroke); high blood pressure; severe heart disease (heart failure); drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). There is a possibility of a serious skin reaction known as DRESS syndrome. The symptoms of DRESS include skin rash, fever, swelling of lymph nodes and increased eosinophil count (a type of white blood cell); a red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Momentact Analgesico if the patient develops these symptoms and seek medical attention immediately. See also Contraindications and Precautions.
Reporting of side effects: If the patient gets any side effects, talk to the doctor. This includes any possible side effects not listed in this monograph. The patient can also report side effects directly via the national reporting system. By reporting side effects, the patient can help provide more information on the safety of this medicine.
