Active ingredients: acetylsalicylic acid
ASPIRIN 325 mg tablets
Aspirin package inserts are available for pack sizes:- ASPIRIN 325 mg tablets
- ASPIRIN 400 mg effervescent granules with vitamin C
- ASPIRIN 500 mg tablets
- ASPIRIN 500 mg acetylsalicylic acid granules
- ASPIRIN rapid 500 mg chewable tablets
Why is Aspirin used? What is it for?
Aspirin 325 mg is an analgesic (painkiller: reduces pain), anti-inflammatory and antipyretic (antipyretic: reduces fever).
Aspirin 325 mg is used for the symptomatic treatment of headache and toothache, neuralgia, menstrual pain, rheumatic and muscle pain and for the symptomatic treatment of feverish states and flu and cold syndromes.
Contraindications When Aspirin should not be used
- hypersensitivity to the active substance (acetylsalicylic acid) or to other analgesics (painkillers) / antipyretics (antipyretics) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients;
- gastroduodenal ulcer;
- hemorrhagic diathesis;
- severe kidney, heart or liver failure;
- glucose-6 phosphate dehydrogenase deficiency (an enzyme whose absence, genetically determined, leads to a disease characterized by reduced survival of red blood cells);
- concomitant treatment with methotrexate (at doses of 15 mg / week or more) or with warfarin (see: Interactions);
- 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: What to do during pregnancy and breastfeeding)
- children and young people under the age of 16.
Precautions for use What you need to know before taking Aspirin
Before administering any medicine, all necessary precautions must be taken to prevent unwanted reactions:
- rule out the existence of previous hypersensitivity reactions to this or other medicines
- exclude the existence of other contraindications or conditions that may expose you to risk of potentially serious side effects.
If in doubt, consult your doctor or pharmacist. The product must be taken on a full stomach.
Interactions Which drugs or foods can modify the effect of Aspirin
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription. Aspirin 325 mg should not be used together with these medicines (see: When it should not be used):
- Methotrexate (doses greater than or equal to 15 mg / week);
- Warfarin
Aspirin 325 mg can be used together with these medicines only on prescription and under medical supervision:
Selective Serotonin Re-uptake Inhibitors (SSRIs)
Ace inhibitors;
Acetazolamide;
Valproic Acid;
Other NSAIDs (excluding those for topical use);
Antacids;
Antiplatelet agents;
Oral or parenteral thrombolytics or anticoagulants;
Antidiabetics (e.g. insulin and oral hypoglycemic agents);
Digoxin;
Diuretics;
Phenytoin;
Corticosteroids (excluding those for topical use and those used in replacement therapy in adrenocortical insufficiency);
Metoclopramide;
Methotrexate (doses below 15 mg / week);
Uricosurics (e.g. probenecid, benzbromarone);
Zafirlukast
Aspirin 325 mg contains a buffer system which may reduce the effects of the thyroid hormone Levothyroxine. If you are using any other medicines ask your doctor or pharmacist for advice.
Alcohol
The sum of the effects of alcohol and acetylsalicylic acid causes an increased risk of gastrointestinal bleeding.
It is however advisable not to administer other drugs by mouth within 1-2 hours of using the product.
Warnings It is important to know that:
The use of the product is reserved for adult patients only.
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, like any drug that inhibits prostaglandin synthesis and cyclooxygenase, may interfere with fertility, and women who have fertility problems or who are undergoing fertility investigations should be aware of this.
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 experienced a hypersensitivity reaction in the past after the use of this type of drug (see: When it should not be used) and in subjects who have allergic reactions to other substances (eg skin reactions, itching , hives).
In subjects with asthma and / or rhinitis (with or without nasal polyposis) and / or urticaria, the reactions may be more frequent and severe.
Geriatric age (especially over 75 years)
The risk of serious side effects is greater in people of geriatric age.
You should tell your doctor if:
You must undergo surgery [even small ones such as tooth extraction] since pre-operative use can hinder intraoperative haemostasis.
Since acetylsalicylic acid can cause gastrointestinal bleeding, it must be taken into account in case it is necessary to perform a search for occult blood. When it can be used only after consulting the doctor In the following cases the administration of the drug requires a doctor's prescription after careful assessment of the risk / benefit ratio:
You are at an increased risk of hypersensitivity reactions:
- if you suffer from asthma and / or rhinitis (with or without nasal polyposis) and / or hives;
You are at an increased risk of gastrointestinal injury:
- acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcer, perforation); for this reason these drugs should not be used in subjects who suffer or have suffered in the past from gastrointestinal ulcer or gastrointestinal bleeding;
- if you use large amounts of alcohol;
- if you use higher doses of acetylsalicylic acid (dose related effect);
You are a person with blood clotting defects or taking anticoagulant drugs
- You are a person with impaired renal or cardiac or hepatic function
- You are suffering from asthma
- You are a person with hyperuricemia / gout
- Combinations of drugs not recommended or requiring special precautions or dosage adjustment (see: Which medicines or foods can change the effect of the medicine).
Children and young people under the age of 16 (see: When it should not be used).
Individuals over the age of 70, especially in the presence of concomitant therapies, should use Aspirin 325 mg only after consulting a doctor.
During the first and second trimester of pregnancy the medicine can only be used after consulting your doctor (see: What to do during pregnancy and breastfeeding).
Patients on a low-sodium diet.
It is advisable to consult your doctor even in cases where these disorders have also occurred in the past.
What to do during pregnancy and breastfeeding
Aspirin 325 mg is contraindicated in the last trimester of pregnancy and in breastfeeding.
In the first and second trimester of pregnancy, Aspirin 325 mg should only be used after consulting your doctor and evaluating with him the risk / benefit ratio in your case.
Consult your doctor if you suspect pregnancy or wish to plan a maternity leave.
Aspirin 325 mg is contraindicated during lactation.
Driving and using machines
Due to the possible onset of headache or dizziness, this medicine may impair the ability to drive and use machines.
Important information about some of the ingredients
Sodium
This medicinal product contains sodium: it may not be suitable for people who must follow a low sodium diet.
Dosage and method of use How to use Aspirin: Dosage
How many
1 or 2 tablets of Aspirin 325 mg as a single dose, repeating the dose at intervals of 4-8 hours up to 2-3 times a day if necessary.
Warning: do not exceed the indicated doses without medical advice. Elderly patients should adhere to the minimum dosages indicated above.
When and for how long
The product should be taken on a full stomach, preferably after main meals. Always use the minimum effective dosage and increase it only if it is not sufficient to relieve symptoms (pain and fever). Subjects most at risk of serious side effects , who can use the drug only if prescribed by their doctor, must strictly follow its instructions.
Use the medicine for the shortest possible time. Do not take the product for more than 3-5 days without medical advice.See your doctor if symptoms persist.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
Aspirin 325 mg tablet should be taken with water.
Overdose What to do if you have taken too much Aspirin
In case of accidental ingestion of an excessive dose of Aspirin 325 mg, notify your doctor immediately or go to the nearest hospital.
Salicylate toxicity (a dosage greater than 100 mg / kg / day for 2 consecutive days can induce toxicity) may be the consequence of a "chronic overdose or acute overdose, which is potentially life-threatening and also includes "accidental ingestion in children.
Chronic salicylate poisoning can be insidious since the signs and symptoms are nonspecific. Mild chronic salicylate poisoning, or salicylism, usually occurs only after repeated use of large doses. Symptoms include dizziness. , dizziness, 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 micrograms / ml, while more serious adverse events occur at concentrations above 300 micrograms / ml.
The main characteristic of acute intoxication is a severe 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 concentration alone; Absorption of acetylsalicylic acid may be delayed due to reduced gastric emptying, formation of concrements in the stomach, or as a consequence of the ingestion of gastro-resistant preparations. Management of acetylsalicylic acid intoxication is determined by the extent, the stage and clinical symptoms of the latter, and must be implemented according to conventional poisoning management techniques. The main measures to be taken consist in "accelerating" the excretion of the drug and in restoring the 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:
Signs and symptoms of mild / moderate overdose: tachypnea, hyperventilation, respiratory alkalosis, sweating, nausea, vomiting, headache, dizziness.
Signs and symptoms of moderate / severe overdose: respiratory alkalosis with compensatory metabolic acidosis, fever, hyperventilation, pulmonary edema, respiratory failure, asphyxia, arrhythmias, hypotension, cardiovascular arrest, dehydration, oliguria up to renal failure, ketosis, hyperglycemia, severe hypoglycemia, tinnitus, deafness, gastrointestinal bleeding, ulcer gastric, coagulopathy, encephalopathy, and CNS depression with manifestations ranging from lethargy and confusion to coma and convulsions, cerebral edema, liver damage.
At high dosages, the following may also appear:
Iron deficiency anemia (only after prolonged treatment).
Changes in taste.
Skin rashes (acneiform, erythematous, scarlet-like, eczematoid, desquamative, bullous, purpuric), itching.
Others:
Conjunctivitis, anorexia, visual acuity decreased, somnolence.
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 the intake of acetylsalicic acid can be treated, if necessary, with the administration of adrenaline, corticosteroids and an antihistamine.
In case of emergency and in the absence of contraindications (such as: conditions of reduction / absence of protective reflexes in the airways or reduced consciousness or of subjects at risk of gastrointestinal bleeding or perforation or in case of simultaneous intake of corrosives) it may attempt to promote the elimination of acetylsalicylic acid taken orally by administering activated charcoal or performing a gastric lavage. Fluid and electrolyte management and forced alkaline diuresis may be necessary.
Acetylsalicylic acid is dialyzable.
What to do if you have forgotten to take one or more doses
Continue therapy as per the recommended dosage.
Effects due to discontinuation of treatment
No effect.
If you have any further questions on the use of Aspirin 325 mg ask your doctor or pharmacist.
Side Effects What are the side effects of Aspirin
Like all medicines, this can cause side effects, although not everybody gets them.
The most frequently observed side effects are related to the gastrointestinal system. These disorders can be partially alleviated by taking the medicine on a full stomach. Most side effects are dependent on both the dose and the duration of treatment. "acetylsalicylic acid are generally common to other NSAIDs.
Disorders of the blood and lymphatic system
Prolonged bleeding time, gastrointestinal bleeding anemia, reduced platelets (thrombocytopenia), in extremely rare cases. Following haemorrhage, acute and chronic post-haemorrhagic / iron deficiency anemia may occur (due, for example, to occult micro-haemorrhages) with the relative alterations of the laboratory parameters and the relative 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).
Respiratory, thoracic, and mediastinal disorders
Asthmatic syndrome, rhinitis (profuse rhinorrhea), nasal congestion (associated with hypersensitivity reactions).
Cardiac pathologies
Cardiorespiratory distress (associated with hypersensitivity reactions).
Eye disorders
Conjunctivitis (associated with hypersensitivity reactions).
Gastrointestinal disorders
Gastrointestinal bleeding (occult), gastric upset, heartburn, gastrointestinal pain, gingivorrhagia.
Vomiting, diarrhea, nausea, crampy abdominal pain (associated with hypersensitivity reactions).
Rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, haematemesis (vomiting of blood or "coffee" material), melaena (emission of black faeces, picee), esophagitis.
Very rarely: haemorrhagic gastrointestinal ulcer and / or gastrointestinal perforation with related clinical signs and symptoms and changes in laboratory parameters.
Hepatobiliary disorders
Rarely: hepatoxicity (usually 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
Alteration of renal function (in the presence of conditions of impaired renal haemodynamics), urogenital bleeding.
General disorders and administration site conditions
Peri-operative haemorrhages, hematomas.
Disorders of the immune system
Rarely: anaphylactic shock with related changes in laboratory parameters and clinical manifestations.
(*) Reye's Syndrome (SDR)
The SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of brain pain of various entities: from listlessness, drowsiness or personality changes (irritability or aggression) to disorientation, confusion or delirium up to convulsions or loss of consciousness . The variability of the clinical picture should be kept in mind: vomiting may also be absent or be replaced by diarrhea.
If these symptoms arise in the days immediately following a flu episode (or flu-like or chickenpox or other viral infection), during which acetylsalicylic acid or other salicylate-containing medicinal products have been administered, the doctor's attention should immediately be directed to the possibility of an SDR.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety. of this medicine
Expiry and Retention
Warning: do not use the medicine after the expiry date indicated on the package.
Store at a temperature below 30 ° C.
Keep this medicine out of the sight and reach of children
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition
One tablet contains: active ingredient: acetylsalicylic acid 325 mg, excipients: magnesium hydroxide 100 mg, dihydroxyaluminiumaminoacetate 50 mg, corn starch, croscarmellose sodium
How it looks
Aspirin 325 mg comes in tablet form.
The contents of the pack are 4, 10 and 20 tablets.
Not all pack sizes may be marketed
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ASPIRINA 325 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
active principle:
acetylsalicylic acid 325.0 mg
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of headache, neuralgia, toothache, menstrual pain, rheumatic and muscular pain.
Symptomatic therapy of feverish states and flu and cold syndromes.
04.2 Posology and method of administration
Adults
1-2 tablets as a single dose, repeating, if necessary, the dose at intervals of 4-8 hours up to 2-3 times a day.
The use of the product is reserved for adult patients only.
Always use the lowest effective dosage and only increase it if it is not sufficient to relieve symptoms (pain and fever).
Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above.
Those most at risk of serious side effects, who can use the drug only if prescribed by a doctor, must strictly follow its instructions (see section 4.4).
Use the medicine for the shortest possible time. 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.
Pediatric population
Aspirin 325 mg tablets are not indicated for use in the pediatric population (see section 4.4).
04.3 Contraindications
Aspirin 325 mg is contraindicated in case of:
- hypersensitivity to the active substance (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);
- a 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 lactation (see section 4.6);
- children and young people under the age of 16.
04.4 Special warnings and appropriate precautions for use
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 experienced a hypersensitivity reaction in the past after the use of this type of drug (see section 4.3) and in subjects who have allergic reactions to other substances (eg skin reactions, itching, hives).
In subjects with asthma and / or rhinitis (with or without nasal polyposis) and / or urticaria, the reactions may be more frequent and severe.
In rare cases, the 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:
- People at increased risk of hypersensitivity reactions (see above)
- Subjects at increased risk of gastrointestinal lesions
Acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcer, perforation). For this reason these drugs should not be used by patients suffering from gastrointestinal ulcer or gastrointestinal bleeding. It is prudent that they avoid them ". I also use those who in the past have suffered from gastrointestinal ulcer or gastrointestinal bleeding. The risk of gastrointestinal lesions is a dose related effect, as gastric injury is 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) (see section 4.5).
- Subjects with coagulation defects or treated with anticoagulants
In subjects suffering from bleeding defects or treated with anticoagulants, acetylsalicylic acid and other NSAIDs can cause a severe reduction in haemostatic capacities, exposing them to the risk of bleeding.
- Subjects with impaired renal or 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 particularly dangerous for the elderly and for subjects with impaired function. renal or cardiac or hepatic.
- People with asthma
Acetylsalicylic acid and other NSAIDs can cause aggravation of asthma.
- Geriatric age (especially over 75 years)
The risk of serious side effects is greater in people of geriatric age.
People over the age of 70, especially in the presence of concomitant therapies, should use Aspirin 325 mg only after consulting their doctor.
Aspirin 325 mg should not be used in the pediatric population (see section 4.3).
Products containing acetylsalicylic acid should not be used in children and adolescents under the age of 16 with viral infections, regardless of whether or not they have a fever. In certain viral diseases, 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 in case of concomitant intake of acetylsalicylic acid, although a causal relationship has not been demonstrated.Persistent vomiting in patients with these diseases can be a sign of Reye's Syndrome.
- Subjects with hyperuricemia / gout
Acetylsalicylic 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 by delaying their diagnosis. An antagonistic effect with uricosuric drugs is also possible (see section 4.5).
- Combination of drugs 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 must be informed of this and in particular women who have fertility problems or who are undergoing investigations. on fertility (see section 4.6).
Sodium
This medicine contains sodium: it may not be suitable for people who must follow a low sodium diet.
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 for the possible effects on coagulation .
Since acetylsalicylic acid can cause gastrointestinal bleeding, it must be taken into account in case it is necessary to perform 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 previous hypersensitivity reactions to this or other medicinal products and the exclusion of other contraindications or conditions that may expose you to 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.
04.5 Interactions with other medicinal products and other forms of interaction
Contraindicated combinations (avoid concomitant use - see section 4.3)
Methotrexate (doses greater than or equal to 15 mg / week): increased plasma levels and methotrexate toxicity; the risk of toxic effects is greater if renal function is impaired.
Warfarin: serious increase in the risk of haemorrhage due to the enhancement 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 - see section 4.4)
Antiplatelet agents: increased risk of haemorrhage due to the sum of the antiplatelet effect.
Thrombolytics or oral or parenteral anticoagulants: increased risk of haemorrhage due to enhancement of the pharmacological effect.
NSAIDs (topical use excluded): increased risk of serious side effects.
Methotrexate (doses below 15mg / week): The increased risk of toxic effects (see above) should also be considered for treatment with low dose methotrexate.
Selective Serotonin Re-uptake 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 assessment of the benefit / risk ratio - see 4.4)
ACE inhibitors: reduced 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 drugs can reduce their absorption; the excretion of acetylsalicylic acid increases in alkalized urine.
Antidiabetics (e.g. insulin and oral hypoglycemic agents): increased hypoglycemic effect; the use of acetylsalicylic acid in subjects treated with antidiabetics must take into account the risk of inducing hypoglycaemia.
Digoxin: increase in the plasma concentration of digoxin due to a decrease in renal elimination.
Diuretics: increased risk of nephrotoxicity of acetylsalicylic acid and other NSAIDs; decreased 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 for the treatment of adrenocortical insufficiency):
a) increased risk of gastrointestinal lesions;
b) due to the increased elimination of salicylates induced by corticosteroids there is a reduction in plasma levels of salicylate. On the other hand, after discontinuation of corticosteroid treatment, an overdose of salicylates may occur.
Metoclopramide: increase in the effect of acetylsalicylic acid by increasing the absorption rate.
Uricosurics (ex: probenecid, benzbromarone): decreased uricosuric effect.
Zafirlukast: increased plasma concentration of zafirlukast.
Aspirin 325 mg contains a buffer system which may reduce the effects of the thyroid hormone Levothyroxine.
Alcohol (see section 4.4)
The sum of the effects of alcohol and acetylsalicylic acid causes increased damage to the gastrointestinal mucosa and prolonged bleeding time.
It is however advisable not to administer other drugs by mouth within 1-2 hours of using the product.
04.6 Pregnancy and lactation
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 must be informed of this and in particular women who have fertility problems or who are undergoing investigations. on fertility (see section 4.4)
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of abortion 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%. The risk has been estimated to increase with dose and duration of therapy.
In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimester of pregnancy, acetylsalicylic acid should not be given unless clearly needed. If drugs containing acetylsalicylic acid are used by a woman trying to become pregnant, or during the first and second trimester of pregnancy. pregnancy, treatment should be as short as possible and the dose as low as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;
& bul; the mother and the unborn child, at the end of pregnancy, to:
- possible prolongation of bleeding time, an antiplatelet effect that can 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.
Feeding time
Aspirin 325 mg is contraindicated during lactation (see section 4.3).
04.7 Effects on ability to drive and use machines
Due to the possible onset of headache or dizziness, this medicine can
impair the ability to drive and use machines.
04.8 Undesirable effects
The most frequently observed undesirable effects are related to the gastrointestinal system and can occur in about 4% of subjects who take 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 of the undesirable effects are dependent on both the dose and the duration of treatment.
Side effects seen with acetylsalicylic acid are generally common to other NSAIDs.
Disorders of the blood and lymphatic system
Prolonged bleeding time, gastrointestinal bleeding anemia, reduced platelets (thrombocytopenia) in extremely rare cases. Following haemorrhage, acute and chronic post-haemorrhagic / iron deficiency anemia may occur (due, for example, to occult micro-haemorrhages) with the relative alterations of the laboratory parameters and the relative 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
Asthmatic syndrome, rhinitis (profuse rhinorrhea), nasal congestion (associated with hypersensitivity reactions).
Epistaxis.
Cardiac pathologies
Cardiorespiratory distress (associated with hypersensitivity reactions).
Eye disorders
Conjunctivitis (associated with hypersensitivity reactions).
Gastrointestinal disorders
Gastrointestinal bleeding (occult), gastric upset, heartburn, gastrointestinal pain, gingivorrhagia.
Vomiting, diarrhea, nausea, crampy abdominal pain (associated with hypersensitivity reactions).
Rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration haematemesis (vomiting of blood or "coffee" material), melaena (emission of black stools, picee), esophagitis.
Very rarely: haemorrhagic gastrointestinal ulcer and / or gastrointestinal perforation with related clinical signs and symptoms and changes in laboratory parameters.
Hepatobiliary disorders
Rarely: hepatotoxicity (usually 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
Alteration of renal function (in the presence of conditions of impaired renal haemodynamics), urogenital bleeding.
General disorders and administration site conditions
Peri-operative haemorrhages, hematomas.
Disorders of the immune system
Rarely: anaphylactic shock with related changes in laboratory parameters and clinical manifestations.
(*) Reye's Syndrome (SdR)
The SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of brain pain of various entities: from listlessness, drowsiness or personality changes (irritability or aggression) to disorientation, confusion or delirium up to convulsions or loss of consciousness . The variability of the clinical picture should be kept in mind: vomiting may also be absent or be replaced by diarrhea.
If these symptoms arise in the days immediately following a flu (or flu-like or chicken pox or "other viral infection) episode during which acetylsalicylic acid or other salicylate-containing medicinal products have been administered, medical attention should be directed immediately. to the possibility of an SDR.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring 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 national reporting system. "Italian Medicines Agency.
website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
Salicylate toxicity (a dose greater than 100 mg / kg / day for 2 consecutive days can induce toxicity) may be the consequence of a "chronic overdose, or acute overdose, which is potentially life-threatening and also includes accidental ingestion in children.
Chronic salicylate poisoning can be insidious since the signs and symptoms are nonspecific. Mild chronic salicylate poisoning, or salicylism, usually occurs only after repeated use of large doses. Symptoms include dizziness. , dizziness, 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 micrograms / ml, while more serious adverse events occur at concentrations above 300 micrograms / ml.
The main characteristic of acute intoxication is a severe 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 concentration alone; Absorption of acetylsalicylic acid may be delayed due to reduced gastric emptying, formation of concrements in the stomach, or as a consequence of the ingestion of gastro-resistant preparations. Management of acetylsalicylic acid intoxication is determined by the extent, the stage and clinical symptoms of the latter, and must be implemented according to conventional poisoning management techniques. The main measures to be taken consist in "accelerating" the excretion of the drug and in restoring the 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 dosages, the following may also appear:
Changes in taste.
Skin rashes (acneiform, erythematous, scarlet-like, eczematoid, desquamative, bullous, purpuric), itching.
Others:
Conjunctivitis, anorexia, visual acuity decreased, somnolence.
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 the intake of acetylsalicylic acid can be treated, if necessary, with the administration of adrenaline, corticosteroids and an antihistamine.
In the event of an overdose, contact a poison control center or the nearest hospital immediately.
Acetylsalicylic acid is dialyzable.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics; other analgesics (non-opioids) and antipyretics; acetylsalicylic acid and derivatives.ATC code: N02BA01.
Acetylsalicylic acid belongs to the group of acidic non-steroidal anti-inflammatory drugs with analgesic, antipyretic and anti-inflammatory properties.
Its mechanism of action is based on the irreversible inhibition of the enzyme cyclo-oxygenase involved in the synthesis of prostaglandins. Acetylsalicylic acid in oral doses from 0.3 to 1.0 g is generally used for pain relief in generally, for the lowering of body temperature and for the relief of joint and muscle pain.
ASPIRIN 325 mg exerts a rapid pain relieving action.
ASPIRIN 325 mg has a good tolerability thanks to the "buffer system" consisting of magnesium hydroxide and aluminum glycinate which, protecting the gastro-duodenal mucosa, tend to limit any local unwanted effects.
05.2 Pharmacokinetic properties
After oral administration, acetylsalicylic acid is rapidly and completely absorbed from the gastrointestinal tract. During and after absorption, acetylsalicylic acid is converted to its main metabolite, salicylic acid. Maximum plasma levels are reached after 10-20 minutes for acetylsalicylic acid and after 0.3 - 2 hours for salicylic acid, respectively.
Both acetylsalicylic acid and salicylic acid bind extensively to plasma proteins and are rapidly distributed throughout the body. Salicylic acid appears in breast milk and crosses the placenta.
Salicylic acid is eliminated primarily by metabolism in the liver; metabolites include salicyluric acid, salicylic phenolic glucuronide, salicylic acyl glucuronide, gentisic acid and gentisuric acid.
The elimination kinetics of salicylic acid are dose-dependent, as metabolism is limited by the capacity of liver enzymes. Therefore, the elimination half-life ranges from 2 - 3 hours after low doses to approximately 15 hours after high doses. Salicylic acid and its metabolites are mainly excreted via the kidney.
The presence of buffer substances in the formulation of ASPIRIN 325 mg modifies the pharmacokinetics of acetylsalicylic acid: these substances in fact increase the dissolution rate of the tablet making the active principle available for absorption more quickly. The buffering effect exerted on the gastric contents also facilitates stomach emptying. Consequently, the absorption of acetylsalicylic acid occurs faster and reaches higher plasma peaks.
05.3 Preclinical safety data
There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Excipients:
Magnesium hydroxide 100.0 mg; dihydroxyaluminium aminoacetate 50.0 mg; corn starch 54.0 mg; croscarmellose sodium 11.0 mg.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store at a temperature below 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Polyamide / Aluminum / PVC / Aluminum blisters
4 tablets of 0.325 g
10 tablets of 0.325 g
20 tablets of 0.325 g
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Bayer S.p.A. - Viale Certosa 130 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
4 tablets - AIC: 004763241
10 tablets - AIC: 004763254
20 tablets - AIC: 004763266
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
4 tablets: 20.07.1989 / 31.05.2010
10 tablets: 20.07.1989 / 31.05.2010
20 tablets: 20.07.1989 / 31.05.2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of: October 2014
