Acido acetilsalicilico l.f.m 500 mg - for flu symptoms 20 tablets

Product Description

Anti-inflammatory drug indicated for flu and cold syndromes.

Therapeutic indications

Symptomatic treatment of feverish states and flu and cold syndromes. Symptomatic treatment of headache and toothache, neuralgia, menstrual pain, rheumatic and muscular pain.

Active ingredients

One tablet contains:

Active ingredient: acetylsalicylic acid 500 mg. For the full list of excipients, see section 6.1.

Excipients:Microcrystalline cellulose, corn starch, talc.

Contraindications

ACETYLSALICYLIC ACID L.F.M. tablets are contraindicated in case of: - hypersensitivity to the active substance (acetylsalicylic acid), to other analgesics (painkillers) / antipyretics (feverkillers) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1; - gastroduodenal ulcer; - haemorrhagic diathesis; - severe renal, cardiac or hepatic insufficiency; - glucose-6-phosphate dehydrogenase (G6PD/favism) deficiency; - concomitant treatment with methotrexate (at doses of 15 mg/week or more) or with warfarin (see section 4.5); - history of asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs; - last trimester of pregnancy and breastfeeding (see section 4.6); - children and adolescents with symptoms of influenza or chickenpox due to the risk of Reye's syndrome; - children and adolescents under 16 years of age.

Dosage

1-2 tablets 2-3 times a day.

The tablets should always be taken with water, tea, lemonade, etc. The medicine is intended for use by adults only. Always use the lowest effective dose and increase it only if it is not sufficient to relieve symptoms (pain and fever).
Do not exceed the recommended doses: elderly patients in particular should stick to the minimum doses indicated above. Those most at risk of serious side effects, who can use the medicine only if prescribed by a doctor, must carefully follow the instructions (see section 4.4). Use the medicine for the shortest possible period. Do not take the product for more than 3-5 days without medical advice. Consult your doctor if symptoms persist. Take the medicine preferably after main meals or, in any case, on a full stomach.

Storage

Do not store above 25°C

Warnings and precautions

Hypersensitivity reactions: Acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions (including asthma attacks, rhinitis, angioedema, or urticaria). The risk is greater in subjects who have already shown a hypersensitivity reaction after using this type of drug in the past (see section 4.3) and in subjects who have allergic reactions to other substances (e.g. skin reactions, itching, urticaria). In subjects with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be more frequent and severe. In rare cases, reactions can be very serious and potentially fatal. In the following cases, administration of the drug requires a doctor's prescription after careful evaluation of the risk/benefit ratio: - Individuals at increased risk of hypersensitivity reactions (see above). - Individuals at increased risk of gastrointestinal lesions: - Acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulceration, perforation). For this reason, these drugs should not be used by individuals suffering from peptic ulcers. It is also prudent for those who have suffered from peptic ulcers in the past to avoid their use. The risk of gastrointestinal lesions is dose-related, as gastrointestinal lesions are greater in individuals who use higher doses of acetylsalicylic acid. - Individuals who habitually consume large quantities of alcohol are also at increased risk of gastrointestinal lesions (bleeding in particular). - Subjects with coagulation defects or undergoing anticoagulant treatment: - In subjects with coagulation defects or undergoing anticoagulant treatment, acetylsalicylic acid and other NSAIDs can cause a serious reduction in haemostatic capacity, exposing them to the risk of haemorrhage. - Subjects with impaired renal, cardiac, or hepatic function: Acetylsalicylic acid and other NSAIDs can cause a critical reduction in renal function and fluid retention; the risk is greater in subjects undergoing diuretic treatment. This can be particularly dangerous for the elderly and for subjects with impaired renal, cardiac, or hepatic function. - Subjects with asthma: Acetylsalicylic acid and other NSAIDs can cause worsening of asthma. - Geriatric age (especially over 75 years): - The risk of serious adverse effects is greater in geriatric subjects. - Subjects over 70 years of age, especially in the presence of concomitant therapies, should use ACETYLSALICYLIC ACID L.F.M. only after consulting a doctor. Medicines containing acetylsalicylic acid are contraindicated (see section 4.3) in children and adolescents with viral infections, especially influenza A, influenza B, and chickenpox, due to the risk of Reye's syndrome, a very rare but life-threatening disease that requires immediate medical attention. - Subjects with hyperuricemia/gout: Acetylsalicylic acid may interfere with the elimination of uric acid: high doses have a uricosuric effect, while (very) low doses may reduce its excretion. It should also be considered that acetylsalicylic acid and other NSAIDs may mask the symptoms of gout, delaying its diagnosis. An antagonistic effect with uricosuric drugs is also possible (see section 4.5). - Combinations of drugs that are not recommended or that require special precautions or dosage adjustment. The use of acetylsalicylic acid in combination with certain drugs may increase the risk of serious side effects (see section 4.5). Do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time. Fertility: The use of acetylsalicylic acid, as with any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, may interfere with fertility; female subjects, particularly women with fertility problems or who are undergoing fertility investigations, must be informed of this. If you are undergoing surgery (even minor, such as tooth extraction) and have used acetylsalicylic acid or another NSAID in the previous few days, you must inform your surgeon due to the possible effects on coagulation. Since acetylsalicylic acid can interfere with the synthesis of prostaglandins and cyclooxygenase, you must inform your surgeon of this. If acetylsalicylic acid can cause gastrointestinal bleeding, this should be taken into account if occult blood testing is necessary. Before administering any medicine, all necessary precautions must be taken to prevent adverse reactions. It is particularly important to rule out previous hypersensitivity reactions to this or other medicines and to exclude other contraindications or conditions that may expose you to the risk of potentially serious adverse effects listed above. If in doubt, consult your doctor or pharmacist.

Side effects

The most frequently observed adverse effects involve the gastrointestinal tract and may occur in approximately 4% of subjects taking acetylsalicylic acid as an antipyretic analgesic. This percentage increases significantly in subjects at risk of gastrointestinal disorders. These disorders can be partially alleviated by taking the medicine on a full stomach. Most adverse effects are dependent on both the dose and the duration of treatment. The adverse effects observed with acetylsalicylic acid are generally common to other NSAIDs. Blood and lymphatic system disorders: Prolonged bleeding time, anemia due to gastrointestinal bleeding, decreased platelet count (thrombocytopenia) in extremely rare cases. Acute and chronic post-hemorrhagic anemia/iron deficiency (due, for example, to occult microhemorrhages) may occur following haemorrhage, with alterations in laboratory parameters and related clinical signs and symptoms such as asthenia, pallor, and hypoperfusion. Nervous system disorders: Headache, dizziness. Rarely: Reye's syndrome (*). Rarely to very rarely: Cerebral haemorrhage, especially in patients with uncontrolled hypertension and/or on anticoagulant therapy, which, in isolated cases, can be life-threatening. Ear and labyrinth disorders: Tinnitus (buzzing/rustling/ringing/whistling in the ears). Respiratory, thoracic, and mediastinal disorders: Asthma, rhinitis, epistaxis. Gastrointestinal disorders: Gastrointestinal bleeding (occult), stomach upset, heartburn, epigastric pain, abdominal pain, vomiting, diarrhea, nausea, gum bleeding. Rarely: gastrointestinal erosion and/or ulceration and/or perforation and/or haemorrhage, haematemesis (vomiting blood or “coffee-ground” material), melaena (passage of black, tarry stools), esophagitis. Hepatobiliary disorders: Rarely: hepatotoxicity (usually mild and asymptomatic hepatocellular injury) manifested by increased transaminases. Skin and subcutaneous tissue disorders: Angioedema and/or urticaria and/or erythema (associated with hypersensitivity reactions). Renal and urinary disorders: Altered renal function (in the presence of altered renal haemodynamic conditions), urogenital bleeding. Systemic disorders and conditions related to the administration site: Perioperative haemorrhages, haematomas. Immune system disorders. Hypersensitivity reactions: asthma, angioedema, urticaria, nausea, vomiting, crampy abdominal pain, diarrhoea, erythema, rhinitis (profuse rhinorrhea), nasal congestion, conjunctivitis. Rarely: anaphylaxis. Pregnancy, puerperium and perinatal conditions: Delayed delivery. (*) Reye's Syndrome (RS) RS initially manifests itself with vomiting (persistent or recurrent) and other signs of encephalic distress of varying degrees: from listlessness, drowsiness or personality changes (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 may also be absent or replaced by diarrhoea. If these symptoms occur in the days immediately following an episode of influenza (or flu-like illness, or chickenpox, or another viral infection) during which acetylsalicylic acid or other salicylate-containing medicines were administered, the doctor's attention must immediately be drawn to the possibility of a salicylate-containing reaction. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important as 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/it/responsabili.

Overdose

Salicylate toxicity (a dose greater than 100 mg/kg/day for 2 consecutive days can induce toxicity) can cause serious adverse reactions. Salicylate poisoning may result from chronic ingestion of excessive doses, or from acute, potentially life-threatening overdoses, including accidental ingestion in children. Chronic salicylate poisoning can be insidious, as the signs and symptoms are nonspecific. Mild chronic salicylate poisoning, or salicylism, usually occurs only after repeated use of large doses. Symptoms include dizziness, vertigo, tinnitus, deafness, sweating, nausea and vomiting, headache, and confusion. These symptoms can be controlled by reducing the dosage. Tinnitus may occur at plasma concentrations between 150 and 300 micrograms/ml, while more serious adverse events occur at concentrations above 300 micrograms/ml. The main characteristic of acute poisoning is a severe alteration of acid-base balance, which can vary with age and the severity of the intoxication; the most common presentation in children is metabolic acidosis. The severity of poisoning cannot be estimated from plasma concentrations alone; aspirin absorption may be delayed due to impaired gastric emptying, the formation of gastric concretions, or the ingestion of enteric-coated preparations. Management of aspirin poisoning is determined by the severity, stage, and clinical symptoms and should be implemented according to conventional poisoning management techniques. The main measures to be taken are to accelerate drug excretion and restore electrolyte and acid-base metabolism.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo-fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters of pregnancy, acetylsalicylic acid should not be administered unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and antiplatelet effect which may affect the fetus. may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid at doses > 100 mg/day is contraindicated during the third trimester of pregnancy. Breastfeeding: ACETYLSALICYLIC ACID L.F.M. 500 mg tablets is contraindicated during breastfeeding (see section 4.3).

Format

Pack of 20 tablets.