Descrizione Clinica
Fever Acetylsalic Acid lfm 20cpr500
ACIDO ACETILSALICIL L.F.M. 500 MG COMPRESENT
active ingredients
One tablet contains: active ingredient: acetylsalicylic acid 500 mg. For the full list of excipients, see paragraph 6.1Excellent
Microcrystalline cellulose, corn starch, talc.Therapeutic indications
Syntomatic therapy of fever states and flu and cooling syndromes. Syntomatic treatment of headaches and teeth, nerves, menstrual pain, rheumatic and muscle pain.Contraindications
ACIDO ACETILSALICIL L.F.M. tablets is contraindicated in the case of: - hypersensitivity to the active ingredient (acetylsalicylic acid), to other analgesics (antidolorphic) / antipyretics (antifebbril) / non-steroidal anti-inflammatory drugs (NSAID) or to any of the excipients listed in paragraph 6.1; - gastroduodenal ulcer; - hemorrhagic diathesis; - kidney, heart or severe liver failure; - glucose deficiency-6-phosphate dehydrogenase (G6PD/favism); - concomitant treatment with metotrexate (at doses of 15 mg/week or more) or with warfarin (see paragraph 4.5); - anamnesi of asthma induced by the administration of salicylates or substances to similar activity, in particular non-steroidal anti-inflammatory drugs; - last trimester of pregnancy and nursing (see paragraph 4.6); - children and adolescents with symptoms of flu or chickenpox due to the risk of Reye syndrome; - children and children under the age of 16.Population
1-2 tablets 2- 3 times a day. Tablets should always be taken with water, tea, lemonade, etc. The use of the medicine is reserved for adults only. Always use the effective minimum dosage and increase it only if it is not enough to relieve symptoms (sweet and fever). Do not exceed the recommended doses: especially older patients should comply with the above minimum dosages. Persons most exposed to the risk of serious undesirable effects, which may use the drug only if prescribed by the doctor, must carefully follow the instructions (see paragraph 4.4). Use the medicine for the shortest period possible. Do not take the product for more than 3 - 5 days without the advice of your doctor. Consult your doctor if your symptoms persist. Take the medicine preferably after main meals or, however, on a full stomach.Conservation
Do not store at temperature above 25 °CWarnings
Hypersensitivity reactions: Acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions (including asthma, rhinitis, angioedema or urticaria). The risk is greater in the subjects that have already presented a reaction of hypersensitivity after the use of this type of medicines (see paragraph 4.3) and in those who have allergic reactions to other substances (e.g. skin, itching, hives). In subjects with asthma and/or rhinitis (with or without nasal polyposes) and/or urticaria reactions can be more frequent and severe. In rare cases reactions can be very serious and potentially fatal. In the following cases the administration of the drug requires the doctor's prescription after careful assessment of the risk/benefit ratio: - Subjects with greater risk of hypersensitivity reactions (see above). - Persons with greater risk of gastrointestinal injury: - Acetylsalicylic acid and other NSAIDs can cause serious undesirable gastrointestinal effects (blood, ulcer, perforation). For this reason, these medications should not be used by individuals with peptic ulcer. It is prudent that they avoid the use even those who have suffered from peptic ulcer in the past. The risk of gastrointestinal lesions is a related dose effect, as gastrointestinacy is greater in individuals who make use of higher doses of acetylsalicylic acid. - Persons with a habit of taking strong amounts of alcohol are also more exposed to the risk of gastrointestinal lesions (bloods in particular). - Subjects with clotting defects or in treatment with anticoagulants: - In subjects suffering from clotting defects or in treatment with anticoagulants acetylsalicylic acid and other NSAIDs can cause a serious reduction in hemostatic capacity by exposing at risk of hemorrhage. - Subjects with impairment of renal or cardiac or liver function - Acetylsalicylic acid and other NSAIDs can be a critical reduction in kidney function and water retention; the risk is greater in subjects in treatment with diuretics. This can be particularly dangerous for the elderly and subjects with impairment of renal or cardiac or liver function. - Subjects with asthma: - Acetylsalicylic acid and other NSAIDs can cause asthma aggravation. - Geriatric age (especially over 75 years): - The risk of serious side effects is greater in geriatric age subjects. - Subjects over 70 years of age, especially in the presence of concomitant therapies, must use ACETILSALICICAL ACIDO L.F.M. only after consulting the doctor. Drugs containing acetylsalicylic acid are contraindicated (see paragraph 4.3) in children and adolescents with viral infections, especially affect A, influence B and chickenpox, due to the risk of Reye Syndrome, a very rare disease, but dangerous for life, requiring immediate medical intervention. - Subjects with hyperuricemia/gotta: Acetylsalicylic acid may interfere with the elimination of uric acid: high doses have an uric effect while low doses (very) can reduce their excretion. It should also be considered that acetylsalicylic acid and other NSAIDs can mask the symptoms of gout by delaying diagnosis. Antagonist effect with uric drugs is also possible (see paragraph 4.5). - Association of unrecommended drugs or requiring special precautions or adjustment of the dosage. The use of acetylsalicylic acid in conjunction with certain drugs may increase the risk of serious side effects (see paragraph 4.5). Do not use acetylsalicylic acid along with another NSAID or, however, do not use more than one NSAID at a time. Fertility: The use of acetylsalicylic acid as of any drug inhibitor of the synthesis of prostaglandins and cyclooxygenase could interfere with fertility; women who have fertility problems or who are subject to fertility surveys must be informed of this. If surgery is to be performed (even of a small entity, for example the extraction of a tooth) and in the previous days it has been made use of acetylsalicylic acid or another NSAID it is necessary to inform the surgeon for the possible effects on coagulation. Since acetylsalicylic acid can be caused by gastrointestinal bleeding, it is necessary to take into account in case it is necessary to perform a search for occult blood. Before administering any medicinal product, all precautions should be taken to prevent unwanted reactions; particularly important is the exclusion of previous hypersensitivity reactions to this or to other medicines and the exclusion of other contraindications or conditions that can expose at risk of potentially serious unwanted effects mentioned above. In case of doubt consult your physician or pharmacist.Interactions
Contraindicated associations (avoid concomitant use -see paragraph 4.3). - Metotrexate (dose greater or equal to 15 mg/week): increased plasma levels and metotrexate toxicity; the risk of toxic effects is greater if the kidney function is compromised. - Warfarin: a serious increase in the risk of hemorrhage for strengthening the anticoagulant effect. Unrecommended associations (concurrent use of the two drugs requires doctor’s prescription after careful assessment of the risk/benefit ratio - see paragraph 4.4) Anti-platelet aggregates: increased risk of hemorrhage by sum of the anti-aggregating effect. Trombolitics or Oral or parental anticoagulants: increased risk of hemorrhage by enhancing the pharmacological effect. FANS (top use excluded): increased risk of serious side effects. Metotrexate (doses less than 15mg/week): the increase in the risk of toxic effects (see above) must also be considered for treatment with Metotrexato at low dosages. Serotonin re-uptake selective inhibitors (SSRI): increase of the risk of bleeding of the gastrointestinal apparatus higher due to a possible synergistic effect. Associations requiring special precautions or adjustment of the dosage (the concomitant use of the two drugs requires the doctor’s prescription after careful assessment of the risk/benefit ratio - see paragraph 4.4). . ACE inhibitors: reduction of hypotensive effect; increased risk of renal function compromise. Valproic acid: increased effect of valproic acid (toxicity risk). Antiacids: antacids taken at the same time as other drugs can reduce their absorption; the excretion of acetylsalicylic acid increases in alkalineized urine. Antidiabetics (e.g. insulin and oral hypoglycemics): increase of the hypoglycemic effect; the use of acetylsalicylic acid in the subjects in treatment with antidiabetics must take into account the risk of inducing hypoglycemia. Digoxin: increased plasma concentration of digoxin by decreased kidney elimination. Diuretics: increased risk of nephrotoxicity of acetylicylic acid and other NSAIDs; reduction of the effect of diuretics. Acetazolamide: reduced elimination of acetazolamide (toxicity risk). Fenitoin: increased effect of phenytoin. Courtesy (excluding topical use and substitute therapy in corticosurrenal failure): increased risk of gastrointestinal injury; reduction of plasma levels of salicylate. Metoclopramide: an increase in the effect of acetylsalicylic acid by increase in absorption speed. Resurrection (e.g. probenecid): decrease in the uric effect. Zafirlukast: increased plasma concentration of zafirlukast. Alcohol: The sum of the effects of alcohol and acetylsalicylic acid causes increased gastrointestinal mucosa damage and prolongation of bleeding time. It is however appropriate not to administer other oral medication within 1 or 2 hours of use of the product.Effects
The most frequently observed side effects are on the gastrointestinal apparatus and can occur in about 4% of individuals taking acetylsalicylic acid as an antipyretic analgesic. This percentage increases significantly in the risk of gastrointestinal disturbances. These disorders can be partially alleviated by taking the medicine on a full stomach. Most side effects are dependent on both dose and duration of treatment. The undesirable effects observed with acetylsalicylic acid are generally common to other NSAIDs. Emolinfopoietic system pathologies: Extension of bleeding time, gastrointestinal bleeding anemia, reduction of platelets (trombocytopenia) in extremely rare cases. As a result of hemorrhage, acute and chronic post-emorrhagic/sideropenia may occur (due, for example, to occult microemorrhages) with alterations of laboratory parameters and related clinical signs and symptoms such as as astenia, pallor and hypoperfusion. Diseases of the nervous system: Cephalea, dizziness. Rarely: Reye syndrome (*). From seldom to very rarely: Brain hemorrhage, especially in patients with uncontrolled hypertension and/or in therapy with anticoagulants, which in isolated cases may be potentially lethal. Ear and labyrinth pathologies: Tinnitus (rontium/fruit/tintintinnium/auricular whistle). Respiratory, chest and mediastinic pathologies: Asthma, reiterate, epistassi. Gastrointestinal diseases: Gastrointestinal bleeding (occult), gastric disorders, pirosis, epigastric pain, abdominal pain, vomiting, diarrhea, nausea, gum. Rarely: erosion and/or ulceration and/or perforation and/or gastrointestinal hemorrhage, hematomesis (vomite of blood or material “coffee mail”), melena (emission of black feces, picee), esophagitis. Hepatobiliary pathologies: Rarely: hepatotoxicity (hepatocellular lesion generally mild and asymptomatic) that manifests with an increase of transamines. Skin and subcutaneous tissue disorders: Angioedema and/or urticaria and/or erythema (associated with hypersensitivity reactions). Renal and urinary disorders: Impaired renal function (in the presence of conditions of altered renal haemodynamics), urogenital bleeding. Systemic disorders and conditions related to the administration site: Peri-operative bleeding, hematomas. Immune disorders. Reactions of hypersensitivity: asthma, angioedema, hives, nausea, vomiting, abdominal cramping pain, diarrhea, erythema, rhinitis (prouse renorrhea), nasal congestion, conjunctivitis. Rarely, anaphylaxis. Pregnancy, Puerperio and Perinatali: Childbirth. (*) The Reye Syndrome (SdR) The SdR initially manifests itself with vomiting (persistent or recurring) and with other signs of encephalic suffering of different entities: from sorrow, drowsiness or personality alterations (irritability or aggressiveness) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture must be taken into account: vomiting can also be lacking or replaced by diarrhea. If these symptoms occur in the days immediately after an influenza episode (or flu or varicella or other viral infection) during which acetylsalicylic acid or other medicines containing salicylates the attention of the doctor must immediately be addressed to the possibility of a SdR. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.Overdosing
The toxicity from salicylates (a dosage greater than 100 mg/kg/day for 2 consecutive days may induce toxicity) may be the result of chronic intake of excessive doses, or acute overdose, potentially dangerous for life and also includes accidental ingestion in children. Poisoning chronic from salicylates can be insidious since signs and symptoms are aspecific. A mild chronic intoxication from salicylates, or salicylism, usually occurs only after repeated use of considerable doses. Symptoms include dizziness, dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage. Tinnitus can occur at plasma concentrations between 150 and 300 micrograms/ml, while at concentrations above 300 micrograms/ml there are more serious adverse events. The main feature of intoxication acute is a serious alteration of the acid-base balance, which may vary with the age and severity of intoxication; the most common presentation, in the child, is metabolic acidosis. It is not possible to estimate the severity of poisoning by plasma concentration alone; acetylsalicylic acid absorption can be delayed due to reduced gastric emptiness, concretion formation in the stomach, or as a result of ingestion of gastro-resistant preparations. The management of an intoxication from acetyllic acid is determined by the extent, stage and clinical symptoms of the latter, and must be implemented according to conventional poisoning management techniques. The main measures to be taken consist of the acceleration of the excretion of the drug and the restoration of electrolytic metabolism and acid-base. For complex physiopathological effects, connected with salicylate poisoning, signs and symptoms/results of biochemical and instrumental investigations, may include:| Signs and symptoms | Results of biochemical and instrumental investigations | Therapeutic measures |
| DALIEVE INTOSSICATION | Gastric lavender, repeated administration of activated carbon, forced alkaline diuresis | |
| Tachypnea, hyperventilation, respiratory alkalosis | Alcalemia, Alcaluria | Liquid and electrolyte management |
| South Africa | ||
| Nausea, vomiting, headache, dizziness | ||
| DAMORING INTOSSICATION | Gastric lavender, repeated administration of activated carbon, forced alkaline diuresis, hemodialysis in severe cases | |
| Respiratory alkalosis with compensatory metabolic acidosis, | Acidemia, aciduria | Liquid and electrolyte management |
| Hyperpiressia | Liquid and electrolyte management | |
| Respirators: variables from non cardiogenic hyperventilation and pulmonary edema to respiratory arrest and asphyxiation | ||
| Cardiovascular: variables from arrhythmias and hypotension to cardiocirculation arrest | For example, alteration of blood pressure, alteration of ECG | |
| Loss of liquids and electrolytes: dehydration, from oliguria to kidney failure | For example hypokaliemia, hypernatriemia, hyponatriemia, altered kidney function | Liquid and electrolyte management |
| Alterations of glucidic metabolism, ketosis | Hyperglycemia, hypoglycemia (especially in children) Increased levels of ketones | |
| Tinnitus, deafness | ||
| Gastrointestinal: gastrointestinal hemorrhage, ulcer | ||
| gastric | ||
| Hematological: coagulopathy, sideropenia anemia | For example, PT extension, hypoprotrombinemia | |
| Neurologic: Toxic encephalopathy and SNC depression with manifestations varying from letargy and confusion to coma and convulsions. Brain edema. | ||
| Hepatics: hepatitis damage | Increased liver enzyme levels |
Pregnancy:
The inhibition of prostaglandin synthesis may 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 had increased from less than 1% to about 1.5%. It has been estimated that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant 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, acetylsalicylic acid should not be administered if not in strictly necessary cases. If acetylsalicylic acid 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); - kidney 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, and anti-aggregating effect that may also take place at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, acetylsalicylic acid at doses > 100 mg/die is contraindicated during the third trimester of pregnancy.Nursing:
ACIDO ACETILSALICIL L.F.M. 500 mg tablets are contraindicated during lactation (see paragraph 4.3).Source: Farmadati
