ANGENERIC ACETYLSALICYLIC ACID 500 MG TABLETS

ANGENERIC ACETYLSALICYLIC ACID 500 MG TABLETS

Therapeutic indications

Symptomatic therapy of feverish states and flu and cold syndromes. Symptomatic treatment of headaches, toothaches, neuralgia, menstrual pain, rheumatic and muscular pain.

Dosage and method of use

1–2 tablets 2–3 times a day. The tablets should always be taken with water, tea, lemonade, etc. The use of the medicine is reserved for adult patients only. Always use the minimum effective dosage and increase it only if it is not sufficient to relieve symptoms (pain and fever). Do not exceed the recommended doses: in particular, elderly patients should stick to the minimum dosages indicated above. Those most exposed to the risk of serious side effects, who can only use the drug if prescribed by their doctor, must follow the instructions scrupulously (see section 4.4). Use the medicine for the shortest period possible. Do not take the product for more than 3–5 days without your doctor's advice. Consult your doctor if symptoms persist. Take the medicine preferably after main meals or in any case on a full stomach.

Contraindications

Acetylsalicylic acid Angeneric tablets are contraindicated in case of: – hypersensitivity to the active ingredient (acetylsalicylic acid), to other analgesics (painkillers) / antipyretics (antipyretics) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients; – Gastroduodenal ulcer; – Hemorrhagic diathesis; – Severe renal, cardiac or hepatic insufficiency; – Glucose-6-phosphate dehydrogenase deficiency (G6PD/favism); – 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 flu or chickenpox due to the risk of Reye's syndrome; – Children and young people under 16 years of age.

Side effects

The most frequently observed side effects affect the gastrointestinal system and can occur in approximately 4% of subjects taking acetylsalicylic acid as an analgesic-antipyretic. 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 side effects are dependent on both the dose and duration of treatment. The side effects observed with acetylsalicylic acid are generally common to other NSAIDs. Pathologies of the blood and lymphatic system Prolongation of gastrointestinal bleeding time, reduction of platelets (thrombocytopenia) in extremely rare cases. Following haemorrhage, acute and chronic post-haemorrhagic anemia/sideropenia may occur (due for example to occult microhaemorrhages) 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 hemorrhage, especially in patients with uncontrolled hypertension and/or on anticoagulant therapy, which, in isolated cases, can be potentially lethal. Ear and labyrinth disorders Tinnitus (buzzing/rustling/ringing/ringing in the ears). Respiratory, thoracic and mediastinal disorders Asthma, rhinitis, epistaxis Gastrointestinal disorders Gastrointestinal bleeding (occult), disorders, heartburn, epigastric pain, abdominal pain, vomiting, diarrhoea, nausea, gingivorrhagia. Rarely: erosion and/or ulceration and/or perforation and/or gastrointestinal haemorrhage, hematemesis (vomiting of blood or "coffee-like" material), melena (emission of black faeces, esophagitis). Hepatobiliary disorders Rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular injury) manifested by an increase in transaminases. Pathologies of the skin and subcutaneous tissues Angioedema and/or urticaria and/or erythema (associated with hypersensitivity reactions). Renal and urinary disorders Alteration of renal function (in the presence of conditions of altered renal hemodynamics), urogenital bleeding. General disorders and administration site conditions Perioperative hemorrhages, hematomas. Immune system disorders Hypersensitivity reactionsAsthma, angioedema, urticaria, nausea, vomiting, abdominal pain, cramps, diarrhea, erythema, rhinitis (profuse rhinorrhea), nasal congestion, conjunctivitis. Rarely: anaphylaxis. Pregnancy, puerperium and perinatal conditions : delayed birth. (*) Reye's Syndrome (SdR) SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of encephalic distress of varying degrees: from listlessness, drowsiness or personality changes (irritability or aggressiveness) to disorientation, confusion or delirium leading to convulsions or loss of consciousness. The variability of the clinical picture must be kept in mind: vomiting may also be absent or replaced by diarrhea. If these symptoms arise in the days immediately following a flu episode (or flu-like or chickenpox or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates have been administered, the doctor's attention must immediately be paid to the possibility of an SdR. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency website: www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

Hypersensitivity reactionsAcetylsalicylic acid and other NSAIDs may cause hypersensitivity reactions (including asthma attacks, rhinitis, angioedema or urticaria). The risk is greater in subjects who have already presented a hypersensitivity reaction in the past after the use of this type of drug (see section 4.3) and in subjects who present allergic reactions to other substances (e.g. skin reactions, itching, urticaria) . In subjects with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria the reactions may be more frequent and serious. In rare cases, reactions can be very serious and potentially fatal. In the following cases, the administration of the drug requires a doctor's prescription after careful evaluation of the risk/benefit ratio; –subjects at increased risk of hypersensitivity reactions (see above)–subjects at greater risk of gastrointestinal lesions– Acetylsalicylic acid and other NSAIDs can cause serious side effects at the gastrointestinal level (bleeding, ulcer, perforation). For this reason these drugs should not be used by people suffering from peptic ulcers. It is also prudent for those who have suffered from peptic ulcers in the past to avoid its use. The risk of gastrointestinal lesions is a dose-related effect, as gastrointestinal lesions are greater in subjects who use higher doses of acetylsalicylic acid. – Even subjects with a habit of drinking large quantities of alcohol are more exposed to the risk of gastrointestinal lesions (bleeding in particular).–Subjects with coagulation defects or being treated with anticoagulants– In subjects suffering from coagulation defects or being treated with anticoagulants, 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 water retention; the risk is greater in subjects treated with diuretics. This can be especially dangerous for the elderly and for those with impaired kidney, heart or liver function. –Subjects suffering from asthma– Acetylsalicylic acid and other NSAIDs can cause an aggravation of asthma. –Geriatric age (especially above 75 years)– The risk of serious side effects is greater in geriatric subjects. – Subjects over the age of 70, especially in the presence of concomitant therapies, must use Angeneric acetylsalicylic acid only after consulting their 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. which requires immediate medical intervention. –Subjects with hyperuricemia/goutAcetylsalicylic acid can interfere with the elimination of uric acid: high doses have a uricosuric effect while (very) low doses can reduce its excretion. It should also be considered that acetylsalicylic acid and other NSAIDs can mask the symptoms of gout, delaying its diagnosis. An antagonistic effect with uricosuric drugs is also possible (see section 4.5): –Drug combinations not recommended or requiring special precautions or dosage adjustment.The use of acetylsalicylic acid in combination with some 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 well as any drug that inhibits the synthesis of prostaglandins and cyclooxygenase could interfere with fertility; female subjects and in particular women who have fertility problems or who are undergoing fertility investigations must be informed of this. If you have to undergo surgery (even a small one, for example the extraction of a tooth) and in the previous days you have used acetylsalicylic acid or another NSAID, you must inform the surgeon due to the possible effects on coagulation . Since acetylsalicylic acid can cause gastrointestinal bleeding, this must be taken into account if it is necessary to carry out a search for occult blood. Before administering any medicine, all necessary precautions must be taken to prevent unwanted reactions; particularly important is the exclusion of other contraindications and conditions that can expose you to the risk of potentially serious side effects listed above. If in doubt, consult your doctor or pharmacist.

Pregnancy and breastfeeding

PregnancyInhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo-foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations was increased from less than 1% to approximately 1.5%. It has been estimated that the risk increases with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered unless strictly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose or duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can exposethe fetusa: • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • renal dysfunction, which can progress to renal failure with oligo-hydramnios;the mother and the newborn, at the end of pregnancy, a: • possible prolongation of bleeding time, and anti-aggregating effect which may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid at doses > 100mg/day is contraindicated during the third trimester of pregnancy.Feeding timeAngeneric acetylsalicylic acid 500 mg tablets are contraindicated during breastfeeding (see section 4.3).

Expiration and conservation

The package must be kept tightly closed. Store at a temperature not exceeding 25° C.

Interactions with other drugs

Contraindicated combinations (avoid concomitant use – see section 4.3)–Methotrexate (doses greater than or equal to 15 mg/week): increased plasma levels and toxicity of methotrexate; the risk of toxic effects is greater if renal function is compromised. –Warfarin: serious increase in the risk of haemorrhage due to enhancement of the anticoagulant effect.Associations not recommended (concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk/benefit ratio - see section 4.4) Antiplatelet agents: increased risk of hemorrhage due to the addition of the anti-aggregating effect.Oral or parenteral thrombolytics or anticoagulants:increased risk of hemorrhage due to enhancement of the pharmacological effect.NSAIDs:(topical use excluded): increased risk of serious side effects.Methotrexate (doses less than 15 mg/week): the increased risk of toxic effects (see above) must also be considered for treatment with methotrexate at low doses.Selective serotonin re-uptake inhibitors (SSRIs): increased risk of upper gastrointestinal bleeding due to a possible synergistic effect.Associations requiring particular precautions or dosage adjustment (concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk/benefit ratio - see section 4.4) ACE inhibitors: reduction of the hypotensive effect; increased risk of impaired renal function.Valproic acid: increased effect of valproic acid (risk of toxicity).Antacids: Antacids taken at the same time as other medications may reduce absorption; the excretion of acetylsalicylic acid increases in alkalinized urine.Antidiabetics: (e.g. insulin and oral hypoglycemics): increased hypoglycemic effect; the use of acetylsalicylic acid in subjects being treated with antidiabetics must take into account the risk of inducing hypoglycemia.Digoxin: increase in plasma concentration of digoxin due to decreased renal elimination.Diuretics:increased risk of nephrotoxicity of acetylsalicylic acid and other NSAIDs; reduction of the effect of diuretics. Acetazolamide: reduced elimination of acetazolamide (risk of toxicity).Phenytoin: increased effect of phenytoinCorticosteroids: (excluding topical use and replacement therapy in adrenocortical insufficiency): increased risk of gastrointestinal lesions; reduction in plasma levels of salicylate.Metoclopramide: increase in the effect of acetylsalicylic acid due to an increase in the speed of absorption.Uricosurics (e.g: probenecid): decrease in the uricosuric effect.Zafirlukast: increased plasma concentration of zafirlukast.Alcohol: The sum of the effects of alcohol and acetylsalicylic acid causes increased damage to the gastrointestinal mucosa and prolongation of bleeding time. However, it is advisable not to administer other drugs orally 1 or 2 hours after using the product.

Overdose

Salicylate toxicity (a dosage exceeding 100 mg/kg/day for 2 consecutive days can induce toxicity) can be the consequence of a chronic intake of excessive doses, or of acute overdose, potentially life-threatening and which also includes accidental ingestion in children. The poisoningchronicfrom salicylates can be insidious since the signs and symptoms are nonspecific. Mild chronic salicylate intoxication, or salicism, typically occurs only following 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 can occur at plasma concentrations between 150 and 300 mcg/ml, while more serious adverse events occur at concentrations above 300 mcg/ml. The main feature of intoxicationacuteit is a serious alteration of the acid-base balance, which can vary with age and the severity of the intoxication; the most common presentation in children is metabolic acidosis. It is not possible to estimate the severity of poisoning from plasma concentrations alone; the absorption of acetylsalicylic acid may be delayed due to reduced gastro emptying, the formation of concretions in the stomach, or as a consequence of the ingestion of gastrointestinal preparations. The management of acetylsalicylic acid poisoning is determined by the extent, stage and clinical symptoms of the poisoning, and should be implemented according to conventional poisoning management techniques. The main measures to be adopted consist in accelerating drug excretion and restoring electrolyte and acid-base metabolism. Due to the complex pathophysiological effects connected with salicylate poisoning, the signs and symptoms/results of biochemical and instrumental investigations may include:

At high doses the following may also appear: alterations in taste. Skin rashes (acneiform, erythematous, scarlet, eczematoid, desquamative, bullous, purpuric), itching. Others: conjunctivitis, anorexia, reduced visual acuity, drowsiness. Rarely: aplastic anemia, agranulocytosis, disseminated intravascular coagulation, pancytopenia, leukopenia, thrombocytopenia, eosinopenia, purpura, eosinophilia associated with drug-induced hepatotoxicity, nephrotoxicity (allergic tubulointerstitial nephritis), hematuria. Acute allergic reactions following the intake of acetylsalicylic acid can be treated, if necessary, with the administration of adrenaline, corticosteroids and an antihistamine. In case of overdose, the patient should be asked to immediately contact a poison control center or go to the nearest hospital. Acetylsalicylic acid is dialyzable.

Active principles

Each tablet contains 500 mg of acetylsalicylic acid. For the complete list of excipients see section 6.1

Excipients

Microcrystalline cellulose, corn starch, talc.