Aspirin 500mg (10 Tablets)

Aspirin 500mg tablets contain acetylsalicylic acid, which has analgesic, anti-inflammatory and antipyretic properties.

INDICATIONS OF ASPIRIN 500MG

Pain of mild or moderate intensity; fever

Active substance: Acidum acetylsalicylicum

COMPOSITION OF ASPIRIN 500MG

1 tablet contains the active ingredient: 500 mg of acetylsalicylic acid (Acidum acetylsalicylicum).

DOSAGE OF ASPIRIN 500MG

Adults:

from 500 mg to 1000 mg of acetylsalicylic acid at a time (i.e. from 1 to 2 tablets). If necessary, the single dose may be repeated every 4 to 8 hours. The maximum daily dose of 4 g of acetylsalicylic acid (i.e. 8 tablets) should not be exceeded.

Adolescents over 12 years of age:

The product can be used in adolescents over 12 years of age only on the recommendation of a doctor. One-time 500 mg of acetylsalicylic acid (i.e. 1 tablet). If necessary, the single dose may be repeated every 4 to 8 hours. Do not use more than 1500 mg of acetylsalicylic acid (i.e. 3 tablets) a day.

If children take this medicine accidentally or accidentally.

The tablets should be taken orally, preferably after meals, with plenty of liquid.

The drug should not be used for more than 3-5 days without consulting a doctor.

CONTRADICTIONS OF ASPIRIN 500MG

The product should not be used:

• in case of hypersensitivity to the active substance – acetylsalicylic acid, other salicylates or to any of the excipients,
• in patients with hemorrhagic diathesis,
• in patients with acute gastric or duodenal ulcer disease,
• in patients with a history of asthma attacks caused by the administration of salicylates or substances with a similar effect, especially non-steroidal anti-inflammatory drugs,
• simultaneously with methotrexate in doses of 15 mg a week or more,
• in patients with severe heart failure, severe liver failure or severe renal failure,
• in the last trimester of pregnancy,
• in children under 12 years of age.

Contents
White, round tablets packed in blisters of 10 tablets.

Storage method
15°C-25°C

Manufacturer
BAYER

WARNINGS FOR ASPIRIN 500MG

Acetylsalicylic acid should be used with caution:

• in case of hypersensitivity to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances,
• when taking anticoagulants at the same time,
• in patients with impaired liver function,
• in patients with impaired renal function or circulatory disorders (e.g. renal vascular disease, congestive heart failure, decreased blood volume, major surgery, sepsis, severe bleeding), as acetylsalicylic acid may additionally increase the risk of renal dysfunction and severe renal failure ,
• in patients with a history of (chronic or recurrent) peptic ulcer disease or history of gastrointestinal bleeding,
• in patients with glucose-6-phosphate dehydrogenase deficiency, as the administration of acetylsalicylic acid may induce haemolysis or haemolytic anemia. Factors that may increase the risk of haemolysis include: high doses of acetylsalicylic acid, fever, severe infections,  during breastfeeding.

Products containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy, unless clearly necessary.

Acetylsalicylic acid can cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Risk factors include: bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps. This warning also applies to patients who have allergic reactions (e.g. skin reactions, itching, hives) to other substances.

Acetylsalicylic acid, due to its anti-aggregation effect, which lasts for several days after use, may lead to an extended bleeding time during or after surgery (including minor procedures, e.g. tooth extraction).

Acetylsalicylic acid, even in low doses, reduces the excretion of uric acid, which may trigger gout in predisposed patients.

In the course of some viral diseases, especially in the case of infection with influenza A, influenza B or chickenpox, mainly in children and adolescents, there is a risk of Reye’s syndrome – a rare but life-threatening disease. The presence of persistent vomiting in the course of an infection may indicate Reye’s syndrome and requires immediate medical attention.

The risk of Reye’s syndrome in the course of viral infections may increase when acetylsalicylic acid is given concomitantly, although a causal relationship has not been established.

With the above For reasons of children under 12 years of age, products containing acetylsalicylic acid should not be used, and in adolescents over 12 years of age, products containing acetylsalicylic acid should be used only on the recommendation of a doctor.

Long-term use of products containing acetylsalicylic acid may cause a headache, which worsens with the use of subsequent doses.

Long-term use of painkillers, especially those containing several active substances, can lead to severe renal impairment and kidney failure.

There is evidence that drugs that inhibit cyclooxygenase (prostaglandin synthesis) can impair female fertility by influencing ovulation. This effect is transient and disappears after the end of therapy.

PREGNANCY AND BREASTFEEDING

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and / or the embryo-fetal development. Epidemiological studies have shown that the use of a prostaglandin synthesis inhibitor in early pregnancy increases the risk of miscarriage, congenital heart disease and gastroschisis. The overall risk of developing congenital cardiovascular defects increases from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy.

In animals, an increased risk of pre-and post-implantation death of a fertilized egg and an increased risk of embryofoetal death have been observed following administration of a prostaglandin synthesis inhibitor. In addition, an increased number of various malformations, including cardiovascular defects, have been reported in animals following administration of prostaglandin synthesis inhibitors during the period of organogenesis. Products containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy, unless clearly necessary. If acetylsalicylic acid is used by women attempting to become pregnant, or during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest possible time.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:

• toxic effects on the cardiovascular and respiratory systems (including premature closure of the ductus arteriosus and pulmonary hypertension),
• renal dysfunction, which may lead to renal failure and oligohydramnios;

Towards the end of pregnancy, all prostaglandin inhibitors can expose the mother and the newborn to:

• possible prolongation of bleeding time and an anti-aggregating effect, which may become apparent even at low doses,
• inhibition of uterine contractions leading to delayed or prolonged labor.

As a consequence, acetylsalicylic acid is contraindicated during the third trimester of pregnancy.

Breast-feeding
Acetylsalicylic acid and its metabolites are excreted in small amounts into breast milk. As so far no adverse effects have been reported in the breastfed infants with short term maternal use of salicylates, it is not usually necessary to discontinue breastfeeding. However, if high doses of acetylsalicylic acid are taken regularly, breastfeeding should be stopped earlier.

Fertility
There is evidence that drugs that inhibit cyclooxygenase (prostaglandin synthesis) can impair female fertility by influencing ovulation. This effect is transient and disappears after the end of therapy.

DRIVING VEHICLES

Aspirin has no influence on the ability to drive and use machines.

OVERDOSAGE OF ASPIRIN 500MG

Poisoning with salicylates (may occur in the case of taking doses >100 mg / kg bw / day for more than 2 days) may be caused by long-term intake of therapeutic doses or acute poisoning (as a result of overdose) potentially life-threatening, e.g. after accidental ingestion of the drug by children or accidental poisoning.

Symptoms of poisoning as a result of long-term use of the drug are non-specific and therefore easy to ignore. Mild poisoning, or salicylism, usually occurs after repeated ingestion of overdoses. Symptoms of poisoning include dizziness (including vertigo), tinnitus, deafness, sweating, nausea and vomiting, headache, confusion and may disappear when the dose is reduced. Tinnitus can occur at blood concentrations of 150 to 300 micrograms / ml. More serious side effects occur with blood levels of acetylsalicylic acid above 300 micrograms / ml.

Severe poisoning is characterized by severe acid imbalance and symptoms vary with the age and severity of poisoning. It most often manifests itself in children with metabolic acidosis. The concentration of acetylsalicylic acid in the blood does not allow to estimate the degree of intoxication. The absorption of acetylsalicylic acid may be reduced by delayed gastric emptying, by the formation of concrements in the stomach or by taking the medicine in the form of film-coated tablets.

Treatment of severe poisoning depends on the dose taken, stage and clinical symptoms. Standard techniques should be used in case of poisoning. The main steps to be taken are to increase the excretion of the active ingredient and restore the electrolyte and acid-base balance.

Due to the complex pathophysiology of the effects of salicylate poisoning, symptoms and test results may include:

Symptoms	Findings	Procedure
Slight to moderate intoxication		Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis
Rapid breathing hyperventilation, respiratory alkalosis	Alkalemia, alkaluria	Fluid administration and electrolyte monitoring
Profuse sweating
Nausea, vomiting
Moderate to severe poisoning		Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis, hemodialysis in severe cases
Respiratory alkalosis with compensatory metabolic acidosis	Acidosis, aciduria	Fluid administration and electrolyte monitoring
High fever		Fluid administration and electrolyte monitoring
Respiratory disorders: from hyperventilation, non-cardiac pulmonary edema to respiratory arrest and asphyxia
Disorders of the heart and blood vessels from arrhythmia, low pressure to cardiac arrest	Blood pressure, ECG changes
Loss of fluids and electrolytes: from dehydration to oliguria to kidney failure	Hypokalemia, hypernatraemia, hyponatraemia, renal dysfunction	Fluid administration and electrolyte monitoring
Glucose metabolism disorders, ketosis	Hyperglycaemia, hypoglycaemia (especially in children) Increased levels of ketones
Tinnitus, deafness
Digestive system disorders: gastrointestinal bleeding
Blood disorders: from inhibition of platelet aggregation to coagulopathy	e.g. prolongation of prothrombin time, hypoprothrombinemia
Neurological disorders: toxic encephalopathy and CNS depression manifested by lethargy, confusion up to coma and seizures

INTERACTIONS WITH OTHER DRUGS

Drugs contraindicated for simultaneous use with acetylsalicylic acid:

• Methotrexate in doses of 15 mg per week or more.

Increased bone marrow toxicity of methotrexate (decreased renal clearance of methotrexate when used concomitantly with anti-inflammatory products – including acetylsalicylic acid – and the displacement of methotrexate from plasma protein binding by salicylates.

Interactions which require special care:

• Methotrexate in doses less than 15 mg per week.

Increased bone marrow toxicity of methotrexate (decreased renal clearance of methotrexate during concomitant use with anti-inflammatory drugs – including acetylsalicylic acid – and the displacement of methotrexate from plasma protein binding by salicylates – see above).

• Anticoagulants, thrombolytics or other drugs that inhibit platelet aggregation. Concomitant use of acetylsalicylic acid with anticoagulants and thrombolytic drugs may increase the anticoagulant effect: increased risk of prolongation of bleeding time and haemorrhages, resulting from the displacement of anticoagulants from their connections with plasma proteins and anticoagulant properties acetylsalicylic acid.
• Other non-steroidal anti-inflammatory drugs, including high-dose salicylates.

Concomitant use of non-steroidal anti-inflammatory drugs with acetylsalicylic acid increases the risk of peptic ulcer disease, gastrointestinal bleeding and kidney damage due to the synergistic effect of these drugs.

• Selective Serotonin Reuptake Inhibitors (SSRIs). Increased risk of upper gastrointestinal bleeding due to the synergistic effect of these drugs.  Drugs that increase uric acid excretion in urine, eg benzbromarone, probenecid Acetylsalicylic acid, when used simultaneously with drugs that increase uric acid excretion, reduces the effect of anti-additive drugs (competition in the process of uric acid excretion through the renal tubules).

Digoxin

Concomitant administration of acetylsalicylic acid with digoxin increases the plasma digoxin concentration, resulting from a decreased renal excretion of digoxin.

• Medicines for diabetes, eg insulin, sulfonylureas

Due to its hypoglycaemic properties and displacement of sulfonylureas from plasma protein connections, acetylsalicylic acid enhances the effect of antidiabetic drugs.

• Diuretics when used simultaneously with high doses of acetylsalicylic acid – attenuation of the diuretic effect due to sodium and water retention due to decreased glomerular filtration due to reduced prostaglandin synthesis in the kidneys.
• Systemic glucocorticosteroids, with the exception of hydrocortisone used as replacement therapy in Addison’s disease, when used concomitantly with acetylsalicylic acid, to reduce plasma salicylate levels during corticotherapy and increase the risk of salicylate overdose upon discontinuation of corticosteroids (increased risk of ulceration and bleeding).
• Angiotensin converting enzyme (ACE) inhibitors, when used concomitantly with high doses of acetylsalicylic acid – Reduction of the antihypertensive effect by reduction of glomerular filtration resulting from inhibition of the production of vasodilating prostaglandins.
• Valproic acid

Acetylsalicylic acid increases the toxicity of valproic acid by displacing it from its plasma protein connections. Valproic acid enhances the anti-aggregating effect of acetylsalicylic acid due to the synergistic anti-aggregating effect of both drugs.

• Alcohol

Alcohol may increase the risk of gastrointestinal side effects such as mucosal ulceration or bleeding.

SIDE EFFECTS OF ASPIRIN 500MG