ASPIRIN-BASED PRODUCTS

ASPIRINAACT ONLY AND INFIAMMATION 1000 MG COMPRESSE RIVESTITES

active ingredients

Each coated tablet contains 1000 mg of acetylsalicylic acid. Excipient with known effects: A coated tablet contains 6 mmol (143 mg) of sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: Silicon colloidal dioxide, Sodium carbonate. Coating: Carnauba wax, Ipromellosa 5cP, Zinc stearate.

Therapeutic indications

Symptomatic treatment of mild fever and/or pain to moderateAspirinact pain and inflammation is indicated in adults and adolescents aged 16-65 years.

Contraindications

• Hypersensitivity to acetylsalicylic acid or other salicylates, or to any of the excipients listed in paragraph 6.1, • asthma anamnesi or hypersensitivity reactions (e.g. octaine, angioedema, severe rhinitis, shock) induced by the administration of salicylates or substances with a similar action, in particular nonsteroidal anti-inflammatory drugs (NSAID), • acute gastrointestinal ulcers, • hemorrhagic diathesis, • severe kidney failure, • severe liver failure, • uncontrolled heart failure, • concurrent administration with metotrex.

Population

Population Adults and teenagers (16-65 years of age) 1 tablet, dose to be repeated according to need after a minimum period of 4-6 hours. The maximum daily dose should not exceed 3 tablets. Acetylsalicylic acid should not be taken for more than 3 days (for fever) or 3-4 days (for pain) unless otherwise indicated by the doctor. Special popularity Renal/Hepatic Comprogation Acetylsalicylic acid should be used carefully in patients with reduced liver or kidney function or with circulatory problems (see paragraph 4.4). Senior Patients (from 65 years on) This product is not suitable for use in patients over 65 years of age. Other pharmaceutical forms and dosages of acetylsalicylic acid are available. Pediatric population The use of this product is not indicated in children and adolescents under the age of 16. Method of administration For oral use. Tablets should be taken with plenty of water.

Conservation

Store in the original strips to protect the medicine from moisture.

Warnings

Acetylsalicylic acid (ASA) should be used with particular caution in the following cases: • To avoid possible risks of overdose, it must be ascertained whether the composition of any medicinal product administered at the same time contains acetylsalicylic acid. • Products containing acetylsalicylic acid should not be used in children and adolescents for the treatment of viral infections in the presence or absence of fever, without first consulting the doctor. In some viral diseases, especially affect A, influence B and chickenpox, there is the risk that Reye syndrome is manifested, a very rare but potentially fatal disease that requires immediate medical intervention. The risk can be increased when administered in conjunction with acetylsalicylic acid; however, there was no direct correlation. If persistent vomiting occurs in the presence of such diseases, it may be a sign of Reye's syndrome. • In case of long-term administration of high dose analgesics, the onset of headache should not be treated with higher doses. • Regular use of analgesics, in particular combinations of analgesics, can lead to persistent kidney injuries, with risk of kidney failure. • In severe forms of glucose-6-phosphate dehydrogenase deficiency (G6PD), acetylsalicylic acid may induce haemolysis or haemolytic anemia. Factors that can induce hemolysis are - for example - high dosage, fever or acute infections. In case of G6PD deficiency, acetylsalicylic acid must be administered under medical supervision. • Treatment monitoring must be intensified in the following cases: - in patients with gastric ulcer or duodenal anamnesis, gastrointestinal bleeding, or gastritis - in patients with kidney failure - in patients with liver failure - in patients with asthma: the occurrence of an asthma attack, in some patients, may be connected to an allergy to non-steroidal anti-inflammatory drugs or acetylsalicylic acid; in this case, this medicine is contraindicated (see paragraph 4.3) - in patients with metrorrhagia or menorrhagia (risk of an increase in volume and duration of the cycle) • Due to its inhibitory effect on the piastrinic aggregation that continues for several days after administration, acetilsalicylic acid can lead to a greater tendency to bleeding during and after surgery, even of small entities. • Gastrointestinal bleeding or ulcers/perforations may occur at any time during treatment, without any prior or anamnesi signs in the patient. The relative risk increases in the elderly, in subjects with reduced body weight, and in patients receiving anticoagulants or inhibitors of the platelet aggregation (see paragraph 4.5). In case of gastrointestinal bleeding, the treatment must be immediately stopped. • Acetylsalicylic acid reduces uric acid excretion. This can likely trigger gout attacks in predisposed patients. • Use of this medicine is not recommended during breastfeeding (see paragraph 4.6). • In patients with compromised kidney function or patients with impaired cardiovascular circulation (e.g. kidney vascular pathology, congestive heart failure, volemic depletion, important surgery, sepsis or major hemorrhagic events), since acetyllic acid can further increase the risk of kidney failure and acute kidney failure. The administration of acetylsalicylic acid is not recommended with: • Oral anticoagulants in patients without anamnes of gastro-duodenal ulcers (see paragraph 4.5) • Clopidogrel (other than approved indications for this combination in patients with acute coronary syndrome) (see paragraph 4.5) • Ticlopidine (see paragraph 4.5) • Anagrelide: increased risk of hemorrhage and decrease of the anti-thrombotic effect (see paragraph 4.5) • Eparine with low molecular weight (and related molecules) and eparine not fractionated at curative doses (see paragraph 4.5clear) • Other non-steroidal anti-inflammatory drugs (see paragraph 4.5) • Glucocorticoids (except replacement therapy with hydrocortisone) (see paragraph 4.5) This medicine contains 143 mg of sodium per tablet, equivalent to 7% of the maximum daily dose recommended by WHO for sodium intake. The maximum daily dose of this product is equivalent to 22% of the maximum recommended dose for taking sodium from the WHO. Aspirinact pain and inflammation is considered to be high in sodium. This element is to be taken into consideration in patients who follow an hypoxodic diet.

Interactions

• Metotrexate at doses >20 mg/week is contraindicated (see paragraph 4.3). Increased metotrexate toxicity, in particular hematological toxicity (due to reduction in renal clearance of metotrexate by acetylsalicylic acid). • Metotrexate at doses ≤20 mg/sett. It must be used with caution. Increased metotrexate toxicity, in particular hematological toxicity (due to reduction in renal clearance of metotrexate by acetylsalicylic acid). The hemochrome must be monitored weekly during the first weeks of co-administration. Strict monitoring is required in patients with kidney damage (even mild) as well as in elderly patients. • Different substances are involved in interactions, for their properties of piastrinic aggregation inhibitors (e.g. abciximab, acetylsalicylic acid, cylostazole, chlopidogrel, epoprostenol, eptifibatide, iloprost, iloprost tromethylprost, prasugrel, thyclopidine, thyrofiban the concomitant use of multiple inhibitors of the platelet aggregation increases the risk of bleeding, as well as their association with heparin or related molecules, oral anticoagulants or other trombolitics; the increase of risk must be taken into account by establishing regular clinical monitoring. Consequently the following combinations are, depending on the case, contraindicated (see paragraph 4.3), not recommended or require precautions for use/ warnings for use: • Oral anticoagulants and in patients with or without an amnesi of gastroduodeal ulcer: increased risk of hemorrhage. • Eparine with low molecular weight (and related molecules) and eparine not fractionated at curative doses: increased risk of hemorrhage (inhibition of platelet aggregation and aggression of gastroduodenal mucosa by acetylsalicylic acid): another anti-inflammatory drug, or another analgesic or antipyretic. Preventive doses: Co-administration, acting at different levels of homeostasis, increases the risk of hemorrhage. Co-administration of eparine at preventive doses (or related molecules), and acetylsalicylic acid, regardless of dose, should be taken into consideration maintaining clinical monitoring, and laboratory monitoring if necessary. • Trombolitics: increased risk of hemorrhage • Clopidogrel (other than the indications approved for this combination in patients with Acute Coronary Syndrome): increased risk of hemorrhage. If co-administration cannot be avoided, clinical monitoring is recommended. (in approved indications for this combination in patients with acute coronary syndrome): increased risk of hemorrhage. Clinical monitoring is recommended. • Ticlopidine: increased risk of hemorrhage. If co-administration cannot be avoided, clinical monitoring is recommended • Anagrelide: increased risk of hemorrhage and decreased antithrombotic effect. If co-administration cannot be avoided, clinical monitoring is recommended • Other nonsteroidal anti-inflammatory drugs (NSAIDs), with acetylsalicylic acid or other salicylates, at higher dosages): Increased risk of ulcers and bleeding of the gastrointestinal tract due to the possible synergistic effect. • Systemic Glucocorticoids (except hydrocortisone substitute therapy): Unrecommended combinations to be taken into account respectively: increased risk of bleeding due to possible synergistic effects. • Selective serotonin reuptake inhibitors (SSRI) - e.g. citalopram, escitalopram, fluoxetine, fluvoxamina, paroxetine, sertralin: increased risk of hemorrhagia. • Diuretics, inhibitors of angiotensin conversion enzyme (ACE-inhibitionrs) and antagonists of angiotensin receptor II: In dehydrated patients, acute renal failure can occur due to the reduction of glomerular filtration speed depending on the decreased synthesis of kidney prostaglandins. Also, there may be a reduction of the antihypertensive effect. Make sure that the patient is hydrated and that the kidney function is monitored at the beginning of the treatment. • Uricosurici (e.g. benzbromarone, probenecid): Reduction of the uric effect due to the competition for the elimination of uric acid in the renal tubules. • Pemetrexed: increased risk of toxicity from pemetrexed due to the decrease of renal clearance of pemetrexed caused by acetylsalicylic acid. • Deferasirox: increased risk of gastrointestinal ulcers and hemorrhage. • Gastrointestinal, antacid and coal tops: increased renal excretion of acetylsalicylic acid due to alcalinization of urine. It is recommended to administer gastrointestinal and antacids at least 2 hours before using acetylsalicylic acid. • Alcohol: increased risk of damage to gastrointestinal mucosa and prolongation of bleeding time due to an additive effect of acetyl acid and alcohol.

Effects

Frequency: not known (frequency cannot be defined on the basis of available data). Emolinfopoietic system pathologies: Blood and tendency to hemorrhages (epistaxis, bleeding of the gums, purple, hematomas, urogenital hemorrhage, etc.) with increased bleeding time. The risk of bleeding may persist for 4-8 days after the interruption of the intake of acetylsalicylic acid. It can cause an increase in the risk of hemorrhage in case of surgery. Intracranial and gastrointestinal bleeding may also occur. Cases of hemolysis and hemolytic anemia were reported in patients with severe forms of glucose-6-phosphate dehydrogenase deficiency (G6PD). Immune system disorders: Reactions from hypersensitivity with related clinical manifestations including anaphylactic reactions, asthma, angioedema. Diseases of the nervous system: Cephalea, dizziness, feeling of hearing loss, tinnitus, which usually indicate an overdose. Intracranial bleeding. Gastrointestinal diseases: Abdominal pain. Hidden or conclaimed gastrointestinal hemorrhage (ematemesis, melena, etc.) resulting in anemia from iron deficiency. The risk of bleeding is dose-dependent. Ulcere and gastric perforations. Disease of intestinal diaphragms (especially in long-term treatment). Hepatobiliary pathologies: Increased liver enzymes usually reversible with the interruption of treatment, give to the liver, mainly at hepatocellular level. Renal diseases: Renal failure and acute kidney injuries were reported. Pathologies of skin and subcutaneous tissue: Orticaria, skin reactions. Systemic pathologies: Reye Syndrome (see paragraph 4.4). 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/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

The risk of overdose is of concern in elderly people and especially in small children (therapeutic or, more frequently, accidental poisoning) in which it can be fatal. Synonyms Moderate poisoning: Symptoms such as buzz in the ears, hearing loss sensation, headache and dizziness are indicative of overdose and can be kept under control by reducing the dosage. Serious poisoning: Symptoms include: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, severe hypoglycemia. Emergency management • Immediate transfer to a specialized hospital unit • Gastrointestinal washing and active carbon administration • Acid-base balance control • Alcalinization of urine with urinary pH monitoring. • Hemodialysis in case of severe intoxication • Syntomatic treatment

Pregnancy

Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo-fetal development. The data from epidemiological studies suggest an increase in the risk of miscarriage, heart malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to about 1.5%. It seems that the risk increases with dose and duration of therapy. In animals, it has been shown that the administration of an inhibitor of the synthesis of prostaglandine causes an increase in the loss of pre and post-system embryo and embryo-fetal lethal. In addition, an increased incidence of various malformations, including cardiovascular malformations, was reported in animals to which an inhibitor of prostaglandin synthesis was given during the organogenetic period of gestation. During the first and second trimester of pregnancy, medicines containing acetylsalicylic acid should not be administered unless it is absolutely necessary. If medicinal products containing acetylsalicylic acid are used by a woman who seeks to have a child, or during the first and second quarter of pregnancy, the dose and duration of treatment must be maintained at the lowest possible levels. 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 evolve in kidney failure with oligohydromnium. During the third trimester of pregnancy, all the inhibitors of the synthesis of prostaglandins can expose both the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, anti-aggregating effect that can occur even at very low doses; • inhibition of uterine contractions that determines the delay or protraction of labor. Therefore, acetylsalicylic acid is contraindicated during the third trimester of pregnancy (see paragraph 4.3).

Food

Acetylsalicylic acid passes into breast milk: therefore the use of acetylsalicylic acid is not recommended during feeding (see paragraph 4.4).

Fertility

There are some evidence that medicines that inhibit cycloxygenase/prostaglandin synthesis may result in the impairment of female fertility through an effect on ovulation. This is reversible to the suspension of treatment.

Source: Farmadati