Aspirin 500 mg - anti-inflammatory granules - 10 sachets

Warnings

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. 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:

• Subjects at greater risk of hypersensitivity reactions (see above).
• Subjects at greater 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 patients suffering from gastrointestinal ulcers or gastrointestinal bleeding.
  It is also prudent for those who have suffered from gastrointestinal ulcers or gastrointestinal bleeding in the past to avoid their use.
  The risk of gastrointestinal lesions is a dose-related effect, as gastrointestinal damage is greater in subjects who use higher doses of acetylsalicylic acid.
  Even individuals who are accustomed to consuming large quantities of alcohol are at increased risk of gastrointestinal lesions (bleeding in particular).
• Individuals with coagulation defects or undergoing treatment with anticoagulants: acetylsalicylic acid and other NSAIDs can cause a serious reduction in haemostatic capacity, exposing them to the risk of haemorrhage.
• Individuals 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 individuals undergoing treatment with diuretics.
  This can be particularly dangerous for the elderly and for subjects with impaired renal, cardiac or hepatic function.
• Subjects suffering from 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 Aspirin 500 mg granules only after consulting a doctor.
  Aspirin 500 mg granules should not be used in the pediatric population.
  Products containing acetylsalicylic acid should not be used in children and adolescents under 16 years of age with viral infections, regardless of whether or not they have fever.
  In certain viral infections, especially influenza A, influenza B, and chickenpox, there is a risk of Reye's syndrome, a very rare but life-threatening disease that requires immediate medical attention.
  The risk may be increased if acetylsalicylic acid is taken concomitantly, although a causal relationship has not been demonstrated.
  Persistent vomiting in patients with these diseases may be a sign of Reye's syndrome.
• 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 can mask the symptoms of gout, delaying its diagnosis.
  An antagonistic effect with uricosuric drugs is also possible.
• Drug combinations that are not recommended or that require special precautions or dosage adjustment.
  The use of acetylsalicylic acid in combination with certain drugs can increase the risk of serious side effects.
  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 who have fertility problems or who are undergoing fertility investigations, must be informed of this.
  This medicine contains sodium: it may not be suitable for people on a low-sodium diet.
  Aspartame: The aspartame in the product is a source of phenylalanine and makes the medicine unsuitable for people with phenylketonuria.
  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 cause gastrointestinal bleeding, this must be taken into account if a test for occult blood is necessary.
  Before administering any medicine, all necessary precautions must be taken to prevent adverse reactions; It is particularly important to exclude 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 side effects listed above.
  If in doubt, consult your doctor or pharmacist.
  The product must be taken on a full stomach.

Contraindications

Aspirin 500 mg granules 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; 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; 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;
• children and adolescents under 16 years of age.

Interactions

Contraindicated combinations (avoid concomitant use):

• 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 impaired.
• Warfarin: seriously increased risk of haemorrhage due to potentiation of the anticoagulant effect. Combinations not recommended (concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk/benefit ratio).
  Antiplatelet agents: increased risk of haemorrhage due to the addition of the antiplatelet effect. Thrombolytics or oral or parenteral anticoagulants: increased risk of haemorrhage due to the enhancement of the pharmacological effect.
  NSAIDs (excluding topical use): increased risk of serious adverse effects.
  Methotrexate (doses less than 15 mg/week): the increased risk of toxic effects (see above) must also be considered for treatment with low-dose methotrexate.
  Selective serotonin reuptake inhibitors (SSRIs): increased risk of upper gastrointestinal bleeding due to a possible synergistic effect.
  Combinations requiring special precautions or dosage adjustment (concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk/benefit ratio).
  ACE inhibitors: reduced hypotensive effect; increased risk of renal impairment.
  Valproic acid: increased effect of valproic acid (risk of toxicity).
  Antacids: antacids taken simultaneously with other drugs may reduce their 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 undergoing antidiabetic treatment must take into account the risk of inducing hypoglycemia.
  Digoxin: increased plasma concentration of digoxin due to decreased renal elimination. Diuretics: Increased risk of nephrotoxicity of acetylsalicylic acid and other NSAIDs; reduced effect of diuretics.
  Acetazolamide: Reduced elimination of acetazolamide (risk of toxicity).
  Phenytoin: Increased effect of phenytoin.
  Corticosteroids (excluding those for topical use and those used to treat adrenocortical insufficiency):
1. Increased risk of gastrointestinal lesions;
2. Due to the increased elimination of salicylates induced by corticosteroids, plasma salicylate levels are reduced.

Conversely, after discontinuation of corticosteroid treatment, salicylate overdose may occur. Metoclopramide: increased effect of acetylsalicylic acid by increasing the rate of absorption.
Uricosurics (e.g. probenecid, benzbromarone): decreased uricosuric effect.
Zafirlukast: increased plasma concentration of zafirlukast.
Aspirin 500 mg granules contains buffer systems that could reduce the effects of the thyroid hormone levothyroxine.
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 oral drugs within 1 or 2 hours of using the product.

Side effects

The most commonly observed side effects are: They frequently affect the gastrointestinal tract and may 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. Blood and lymphatic system disorders: Prolonged bleeding time, anemia due to gastrointestinal bleeding, reduction in platelets (thrombocytopenia) in extremely rare cases.
Following haemorrhage, a blood clot may be seen. Acute and chronic post-haemorrhagic/iron deficiency anaemia may occur (due, for example, to occult microhaemorrhages) with related 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/ringing in the ears).
Respiratory, thoracic and mediastinal disorders: Asthma syndrome, rhinitis (profuse rhinorrhea), nasal congestion (associated with hypersensitivity reactions).
Epistaxis.
Cardiac disorders: Cardiorespiratory distress (associated with hypersensitivity reactions).
Eye disorders: Conjunctivitis (associated with hypersensitivity reactions).
Gastrointestinal disorders: Gastrointestinal bleeding (occult), upset stomach, heartburn, gastrointestinal pain, gum bleeding. Vomiting, diarrhoea, nausea, crampy abdominal pain (associated with hypersensitivity reactions).
Rarely: Gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, haematemesis (vomiting blood or coffee-ground material), melaena (passage of black, tarry stools), oesophagitis.
Very rarely: haemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with related clinical signs and symptoms and alterations in laboratory parameters.
Hepatobiliary disorders Rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular injury) manifested by an increase in transaminases. Skin and subcutaneous tissue disorders Rash, edema, urticaria, pruritus, erythema, angioedema (associated with hypersensitivity reactions).
Renal and urinary disorders Altered renal function (in the presence of altered renal haemodynamics), urogenital bleeding.
Systemic disorders and administration site conditions Peri-operative haemorrhages, haematomas.
Immune system disorders Rarely: anaphylactic shock with related alterations in laboratory parameters and clinical manifestations.
Reye's Syndrome (RS) RS initially manifests itself with vomiting (persistent or recurrent) and other signs of brain damage 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 kept in mind: vomiting may also be absent or replaced by diarrhea.
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 physician's attention should immediately be drawn to the possibility of RSD.

Overdose

Salicylate toxicity (a dose greater than 100 mg/kg/day for 2 consecutive days can induce toxicity) can result from chronic ingestion of excessive doses, or from acute, potentially life-threatening overdose, which also includes accidental ingestion in children. Chronic salicylate poisoning can be insidious since the signs and symptoms are nonspecific.
Mild chronic salicylate intoxication, or salicylism, usually 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 may occur at plasma concentrations between 150 and 300 mcg/ml, while more serious adverse events occur at concentrations above 300 mcg/ml.
The main characteristic of acute intoxication is a severe alteration of the acid-base balance, which may 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; acetylsalicylic acid absorption may be delayed due to reduced gastric emptying, the formation of gastric concretions, or the ingestion of enteric-coated preparations.
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 of accelerating drug excretion and restoring electrolyte and acid-base metabolism.
Due to the complex pathophysiological effects associated with salicylate poisoning, the signs and symptoms/results of biochemical and instrumental investigations may include:

At high doses, the following may also occur: Taste disturbances.
Skin rashes (acneiform, erythematous, scarlatiniform, eczematoid, desquamative, bullous, purpuric), pruritus.
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 (presence of blood in the urine). Acute allergic reactions following acetylsalicylic acid intake can be treated, if necessary, with adrenaline, corticosteroids, and an antihistamine.
In case of overdose, contact a poison control center or the nearest hospital immediately.
Acetylsalicylic acid is dialyzable.

Pregnancy and breastfeeding

Fertility: The use of acetylsalicylic acid, as with any drug inhibiting prostaglandin synthesis and cyclooxygenase, may interfere with fertility; female subjects, particularly women who have fertility problems or who are undergoing fertility investigations, must be informed of this.
Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.
The absolute risk of cardiac malformations was 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 drugs containing acetylsalicylic acid are used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, treatment should be as short as possible and the dose as low as possible. possible low.
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 the unborn child, at the end of pregnancy, to:
• possible prolongation of bleeding time, an antiaggregant effect that may occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy. Breastfeeding: Aspirin 500 mg granules are contraindicated during breastfeeding.

Storage

Store below 25°C

Format

10 sachets