ASPIRIN PAIN AND INFLAMMATION - PACKAGE LEAFLET - LEAFLETS

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Aspirin Pain and Inflammation - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Acetylsalicylic acid

Aspirin Pain and Inflammation 500 mg Coated Tablets

Why is Aspirin used for pain and inflammation? What is it for?

Aspirin Pain and Inflammation contains acetylsalicylic acid. Acetylsalicylic acid is an analgesic (reduces pain) and antipyretic (reduces fever).

Aspirin Pain and Inflammation is used for the symptomatic treatment of fever and / or mild to moderate pain, such as headache, flu, toothache, muscle aches.

Aspirin Pain and Inflammation is specifically reserved for adults and children aged 16 or over.

Ask your doctor or pharmacist for other forms of acetylsalicylic acid for patients weighing less than 40 kg.

Contact your doctor if you do not notice any improvement or if you notice your symptoms worsening after 3 days (for fever) or 3 - 4 days (for pain).

Contraindications When Aspirin should not be used pain and inflammation

Do not take Aspirin Pain and Inflammation:

if you are allergic to acetylsalicylic acid or other salicylates or to any of the other ingredients of this medicine (listed in section 6);
if you have suffered from asthma or allergic reactions (e.g. hives, angioedema, severe rhinitis, shock) induced by the administration of acetylsalicylic acid or related medicines (in particular non-steroidal anti-inflammatory drugs);
if you suffer from stomach or intestinal ulcer (including duodenal);
if you have a bleeding condition or are at risk of bleeding;
if you suffer from severe liver, kidney or heart failure;
if you are taking methotrexate therapy in doses above 20 mg / week.
if you are taking oral anticoagulants (medicines to 'thin' the blood and prevent blood clots);
if it is after the 5th month of pregnancy (more than 24 weeks of absence of menstruation);
Children and teenagers under 16 years of age.

If you are unsure, ask your doctor or pharmacist before taking this medicine.

Precautions for use What you need to know before taking Aspirin pain and inflammation

Talk to your doctor or pharmacist before taking Aspirin Pain and Inflammation:

if you are taking other products containing acetylsalicylic acid, to avoid the risk of overdose
if you get headaches while taking high doses of acetylsalicylic acid for a prolonged period of time, do not increase the dose but rather ask your doctor or pharmacist for advice.
if you use painkillers regularly, especially different painkillers in combination, this can lead to reduced kidney function.
if you have G6PD (glucose-6-phosphate dehydrogenase) deficiency, an inherited disease affecting red blood cells, as high doses of acetylsalicylic acid could lead to haemolysis (destruction of red blood cells);
if you have a previous history of stomach or intestinal ulcers, or stomach or intestinal bleeding or gastritis.
if you suffer from liver or kidney failure
if you suffer from asthma: the occurrence of an asthma attack, in some patients, may be linked to an allergic reaction to non-steroidal anti-inflammatory drugs or acetylsalicylic acid. In this case, the use of this medicine is not recommended. of heavy menstruation
if gastrointestinal bleeding occurs during treatment (bleeding from the mouth, blood in the stools, dark colored stools): stop the treatment and call your doctor or emergency department immediately.
if you are also taking medicines that thin the blood and prevent blood clotting (anticoagulants).
acetylsalicylic acid increases the risk of bleeding even at low doses and even several days after taking. Tell your doctor, surgeon or anesthetist or dentist if any surgery, even a minor one, is planned.
Acetylsalicylic acid changes the amount of uric acid in the blood. This should be taken into consideration if you are taking a gout medication.
It is recommended not to take this drug while breastfeeding.

Children

Reye's syndrome (a rare but very serious disease associated mainly with neurological and liver damage) has been observed in children with viral diseases and receiving acetylsalicylic acid. Consequentially:

in the case of a viral illness such as influenza or chicken pox, the administration of acetylsalicylic acid to a child should not take place without first consulting a doctor;
if you experience signs of dizziness or fainting, changes in behavior or vomiting in a child who is taking acetylsalicylic acid, tell your doctor right away.

Interactions What drugs or foods can modify the effect of Aspirin on pain and inflammation

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In the following text, the following definitions are used: Acetylsalicylic acid can be used for the treatment of rheumatic diseases in high doses (called "anti-inflammatory doses") defined as: 1 g or more as a single dose and / or 3 g or more per day .

Acetylsalicylic acid can be used for the treatment of pain and fever in defined doses as follows: 500 mg or more as a single dose and / or no more than 3 g per day.

Do not take Aspirin Pain and Inflammation:

if you are being treated with methotrexate at doses above 20 mg / week. In this case, acetylsalicylic acid should be avoided when used in high doses (anti-inflammatory) or for the treatment of pain and fever.
if you are being treated with oral anticoagulants and if you have a previous history of gastroduodenal ulcer. In this case, acetylsalicylic acid should be avoided when used in high doses (anti-inflammatory) or for the treatment of pain and fever.

Talk to your doctor or pharmacist before taking acetylsalicylic acid with any of the following medicines:

oral anticoagulants, when acetylsalicylic acid is used to treat pain and fever and there is no previous history of gastro-duodenal ulcers
non-steroidal anti-inflammatory drugs when acetylsalicylic acid is used in high doses (anti-inflammatory) or for the treatment of pain and fever.
heparins used at curative doses, or in elderly subjects (≥ 65 years) when acetylsalicylic acid is used in high doses (anti-inflammatory) particularly for the treatment of rheumatic diseases or for the treatment of pain and fever.
thrombolytics
clopidogrel
ticlopidine
uricosuric medicines used to treat gout (for example: benzobromarone, probenecid)
glucocorticoids (except hydrocortisone replacement therapy) when acetylsalicylic acid is used in high doses (anti-inflammatory);
pemetrexed, in patients with mild to moderate renal function
anagrelide
medicines to treat water retention (diuretics);
angiotensin converting enzyme inhibitors, angiotensin receptor antagonists
Methotrexate used at doses of 20mg / week or less;
topical gastrointestinal treatments, antacids and activated charcoal;
deferasirox
selective serotonin reuptake inhibitors (for example: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

To avoid any drug interaction effects, you should tell your doctor or pharmacist about any other medicines you take.

Aspirin Pain and Inflammation with alcohol

Do not take Aspirin Pain and Inflammation with alcohol.

Warnings It is important to know that:

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this or any other medicine.

Pregnancy

In the first five months of pregnancy you should consult your doctor before taking this drug or any other product containing acetylsalicylic acid. From the beginning of the 6th month of pregnancy (more than 24 weeks of absence of menstruation), you should under no circumstances take this medicine as it may cause serious harm to you and your baby. If you have taken this medicine during pregnancy, you must immediately contact your doctor.

Feeding time

This medicine can pass into breast milk. As a precaution, Aspirin Pain and Inflammation is not recommended while breastfeeding.

Fertility

The product belongs to a group of drugs that can impair fertility in women. This effect is reversible once use of the drug is discontinued.

Driving and using machines

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

Dosage and method of use How to use Aspirin pain and inflammation: Dosage

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to. If in doubt, consult your doctor or pharmacist.

Dosage

For oral use only. Take the tablets with an adequate amount of liquid.

Adults and children (over 16 years):

The single recommended dose is 1 tablet, which can be taken again if needed after at least 4 hours have elapsed. In case of more intense fever or pain, the dosage is 2 tablets, which can be taken again if necessary after at least 4 hours have elapsed.
The total daily dosage should not exceed 6 tablets.

Elderly (aged 65 and over)

The single recommended dose is 1 tablet, which can be taken again if needed after at least 4 hours have elapsed.
The total daily dosage should not exceed 4 tablets.

Particular groups of patients:

Patients with abnormal liver or kidney function, or circulatory problems (e.g. with heart failure or major bleeding events): ask your doctor or pharmacist for advice.
Children and young people under the age of 16: Do not use the medicine without a prescription.

Do not take this medicine for more than 3 days (in case of fever) or 3-4 days (in case of pain) unless your doctor tells you otherwise.

Overdose What to do if you have taken too much Aspirin pain and inflammation

If you take more Aspirin Pain and Inflammation than you should:

During treatment, you may experience ringing in the ears, a feeling of loss of hearing, headache, dizziness - these are typical signs of overdose.

If you suspect an overdose of this product, stop the treatment and contact your doctor immediately.

If you forget to take Aspirin Pain and Inflammation:

Do not take a double dose to make up for a forgotten dose.

Side Effects What are the side effects of Aspirin pain and inflammation

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequencies: not known: frequency cannot be estimated from the available data.

Possible side effects due to acetylsalicylic acid are:

These side effects are all very serious and you may need urgent medical attention or hospitalization. Tell your doctor or go to the nearest hospital immediately if you notice any of the following symptoms:

bleeding (bleeding from the nose or gums, red spots under the skin)
allergic reactions such as skin rash, asthma attack or swelling of the face accompanied by difficulty in breathing.
headache, dizziness, feeling of hearing loss, tinnitus (ringing in the ears) which are usually signs of overdose
cerebral hemorrhage
stomach ache
gastrointestinal bleeding. See section "Warnings and precautions". These occur more frequently when high doses are taken.
Elevation of liver enzymes usually reversible on discontinuation of treatment, impairment of liver function (particularly liver cells)
hives, skin reactions
Reye's syndrome (altered consciousness or abnormal behavior, or vomiting) in children with viral diseases and taking acetylsalicylic acid (see Section 2: What you need to know before taking Aspirin Pain and Inflammation)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This advice also applies to any side effects not listed in this leaflet.You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not store above 30 ° C.

Do not use this product if you notice visible signs of deterioration.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition and pharmaceutical form

What Aspirin contains Pain and Inflammation

The active ingredient is acetylsalicylic acid

Each coated tablet contains 500 mg of acetylsalicylic acid.

The other ingredients are:

Colloidal silicon dioxide, anhydrous sodium carbonate

Coating:

Carnauba wax, Hypromellose, Zinc stearate

What Aspirin Pain and Inflammation Looks Like and Contents of the Pack

This medicine comes in the form of white to off-white, round biconvex coated tablets of 12 mm. The tablets have "BA 500" printed on one side and the Bayer cross printed on the other.

The contents of the pack are 8, 12, 20 or 24 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.

More information on Aspirin pain and inflammation can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

ASPIRIN PAIN AND INFLAMMATION 500 MG

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 500 mg of acetylsalicylic acid.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Coated tablets.

White or whitish, round biconvex, coated, 12 mm with the word "BA 500" on one side and the Bayer cross on the other.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Symptomatic treatment of fever and / or mild to moderate pain, such as headache, flu syndrome, toothache, muscle aches.

04.2 Posology and method of administration

Dosage

Adults and children (from 16 years onwards):

1 to 2 tablets for each dose to be repeated as needed after a minimum period of 4 hours. The maximum daily dose should not exceed 6 tablets.

Elderly (from 65 years):

1 tablet for each dose to be repeated as needed after a minimum period of 4 hours. The maximum daily dose should not exceed 4 tablets.

Acetylsalicylic acid should not be taken for more than 3 days (in case of fever) or 3 - 4 days (in case of pain) unless otherwise indicated by the doctor.

Pediatric population:

Acetylsalicylic acid should not be used in children and adolescents under the age of 16 without a prescription.

Acetylsalicylic acid should be used with caution in patients with abnormal liver or kidney function or circulatory problems.

Method of administration

For oral use. The tablets should be taken with an adequate amount of liquid.

04.3 Contraindications

• Hypersensitivity to acetylsalicylic acid or other salicylates, or to any of the excipients listed in section 6.1,

• history of asthma or hypersensitivity reactions (eg urticaria, angioedema, severe rhinitis, shock) induced by the administration of salicylates or substances with a similar action, in particular non-steroidal anti-inflammatory drugs (NSAIDs),

• peptic ulcer in active phase,

• bleeding diathesis,

• severe renal insufficiency,

• severe hepatic insufficiency,

• severe uncontrolled heart failure,

• concomitant administration of methotrexate in doses above 20 mg per week, for anti-inflammatory doses of acetylsalicylic acid, or for analgesic or antipyretic doses (see section 4.5),

• concomitant administration of oral anticoagulants for anti-inflammatory doses of acetylsalicylic acid, or for analgesic or antipyretic doses and in patients with a history of gastroduodenal ulcers (see section 4.5),

• from the beginning of the 6th month of pregnancy (beyond the 24th week of amenorrhea) (see section 4.6),

• children and young people under 16 years of age.

04.4 Special warnings and appropriate precautions for use

In case of combination with other medicinal products, to avoid any risk of overdose, check that acetylsalicylic acid is absent from the composition of these other medicines.

• Reye's syndrome, a very rare and life-threatening disease, has been described in children with symptoms of viral infections (particularly chicken pox and flu) with or without acetylsalicylic acid. Consequently, acetylsalicylic acid should only be given to children in these conditions after medical advice and when other measures have proved ineffective. In case of persistent vomiting, altered consciousness or abnormal behavior, treatment with acetylsalicylic acid must be stopped.

• In case of prolonged administration of high-dose analgesics, the headache attack should not be treated with higher doses.

• The regular use of analgesics, particularly a combination of analgesics, can lead to permanent kidney damage, with the risk of kidney failure.

• In some severe forms of G6PD deficiency, high doses of acetylsalicylic acid can cause hemolysis. In case of G6PD deficiency, acetylsalicylic acid should be administered under medical supervision.

• Treatment monitoring should be intensified in the following cases:

• in patients with a history of gastric or duodenal ulcer, gastrointestinal bleeding, or gastritis.

• in patients with renal insufficiency

• in patients with hepatic insufficiency

• in patients with asthma: the occurrence of an asthma attack, in some patients, may be linked to an allergy to non-steroidal anti-inflammatory drugs or acetylsalicylic acid; in this case, this medicine is contraindicated (see section 4.3)

• in patients with metrorrhagia or menorrhagia (risk of an increase in volume and duration of the cycle)

• Gastrointestinal bleeding or ulcers / perforations can occur at any time during treatment, without necessarily having any warning signs or history of the patient. The relative risk is increased in elderly subjects, in subjects with low body weight, and in patients receiving anticoagulants or platelet aggregation inhibitors (see section 4.5). In case of gastrointestinal bleeding, treatment should be stopped immediately.

• Given the inhibitory effect of acetylsalicylic acid on platelet aggregation, which occurs even at very low doses and persists for several days, the patient should be aware of the risk of haemorrhage in the event of surgical interventions, even small ones ( e.g. tooth extraction).

• In analgesic or antipyretic doses, acetylsalicylic acid inhibits the excretion of uric acid; in the doses used in rheumatology (anti-inflammatory doses), acetylsalicylic acid has a uricosuric effect.

• The use of this medicinal product is not recommended during lactation (see section 4.6).

Administration of acetylsalicylic acid is not recommended with:

• Oral anticoagulants with analgesic or antipyretic doses of acetylsalicylic acid (≥500 mg per administration and / or gastro-duodenal ulcers (see section 4.5)

• Other non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per administration and / or ≥ 3 g per day) or with analgesic or antipyretic doses of acetylsalicylic acid (≥ 500 mg per administration and / or

• Low molecular weight heparins (and related molecules) and unfractionated heparins with therapeutic doses or in elderly patients (> 65 years) regardless of the dose of heparin, and for anti-inflammatory doses of acetylsalicylic acid (≥ 1g per administration and / or ≥ 3 g per day) or with analgesic or antipyretic doses of acetylsalicylic acid (≥500 mg per administration and / or

• Clopidogrel (beyond the approved indications for this combination in patients with acute coronary artery disease) (see section 4.5)

• Ticlopidine (see section 4.5)

• Uricosurics (see section 4.5)

• Glucocorticoids (except for hydrocortisone replacement therapy) for anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per administration and / or ≥ 3 g per day) (see section 4.5)

• Pemetrexed in patients with mildly to moderately impaired renal function (creatinine clearance between 45 ml / min and 80 ml / min) (see section 4.5)

• Anagrelide: increased risk of haemorrhage and decreased antithrombotic effect (see section 4.5)

04.5 Interactions with other medicinal products and other forms of interaction

In the following text, the following definitions apply:

- anti-inflammatory doses of acetylsalicylic acid are defined as "≥ 1g per administration and / or ≥ 3g per day".

- Analgesic or antipyretic doses of acetylsalicylic acid are defined as "≥500 mg per administration and / or

Several substances give rise to interactions, due to their properties of platelet aggregation inhibitors: abciximab, acetylsalicylic acid, cilostazol, clopidogrel, epoprostenol, eptifibatide, iloprost, iloprost trometamol, prasugrel, ticlopidine, tirofiban, ticagrelor.

The risk of bleeding increases with the use of multiple platelet aggregation inhibitors as well as with their use in combination with heparin or related molecules, oral anticoagulants or other thrombolytics, and must be evaluated by constant clinical monitoring.

Combinations contraindicated (see section 4.3):

• Methotrexate in doses greater than 20 mg per week, with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, in particular haematological toxicity (due to the reduced renal elimination of methotrexate caused by " acetylsalicylic acid).

• Oral anticoagulants with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid and in patients with a history of gastroduodenal ulcers: increased risk of bleeding.

Combinations not recommended:

• Oral anticoagulants with analgesic or antipyretic doses of acetylsalicylic acid and in patients without a history of gastroduodenal ulcers: increased risk of bleeding.

• Other non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: increased risk of gastrointestinal ulcers and bleeding.

• Low molecular weight heparins (and related molecules) and unfractionated heparins at curative doses, or in elderly patients (≥65 years) regardless of the dose of heparin, and for anti-inflammatory doses of acetylsalicylic acid or analgesic or antipyretic doses of acetylsalicylic acid: increased risk of bleeding (inhibition of platelet aggregation and aggression of the gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory drug, or another analgesic or antipyretic, should be used.

• Clopidogrel (outside the approved indication for this combination in patients with acute coronary syndrome): increased risk of haemorrhage If concomitant administration cannot be avoided, clinical monitoring is recommended.

• Ticlopidine: increased risk of bleeding. If concomitant administration cannot be avoided, clinical monitoring is recommended.

• Uricosurics (benzbromarone, probenecid): reduction of the uricosuric effect due to competition for the elimination of uric acid in the renal tubules.

• Glucocorticoids (excluding replacement therapy with hydrocortisone) for anti-inflammatory doses of acetylsalicylic acid: increased risk of bleeding.

• Pemetrexed in patients with mild to moderate renal function impairment (creatinine clearance between 45 ml / min and 80 ml / min); increased risk of pemetrexed toxicity (due to decreased renal elimination of pemetrexed by 'acetylsalicylic acid) with anti-inflammatory doses of acetylsalicylic acid.

• Anagrelide: increased risk of haemorrhage and decreased antithrombotic effect. If concomitant administration cannot be avoided, clinical monitoring is recommended.

Combinations that require precautions for use:

• Diuretics, angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists, with anti-inflammatory doses of acetylsalicylic acid or with analgesic or antipyretic doses of acetylsalicylic acid: Acute renal failure may occur in dehydrated patients caused by the reduction of the glomerular filtration rate due to the decreased synthesis of renal prostaglandins. In addition, there may be a reduction in the antihypertensive effect. Make sure the patient is hydrated and that renal function is monitored at the start of treatment.

• Methotrexate in doses ≤ 20 mg per week, with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, in particular haematological toxicity (due to the reduced renal elimination of methotrexate caused by the acid acetylsalicylic) CBC should be monitored weekly during the first few weeks of concomitant administration. Patients with (even mild) decreased renal function and elderly patients should be closely monitored.

• Clopidogrel (in the approved indication for this combination in patients with acute coronary syndrome): increased risk of haemorrhage. Clinical monitoring is recommended.

• Topical gastrointestinal treatments, antacids and activated charcoal: increased renal excretion of acetylsalicylic acid due to alkalinization of the urine. It is recommended to administer antacids and topical gastrointestinal treatments at least two hours after taking acetylsalicylic acid.

• Pemetrexed in patients with normal renal function: increased risk of pemetrexed toxicity (due to the decreased renal elimination of pemetrexed caused by 'acetylsalicylic acid) with anti-inflammatory doses of acetylsalicylic acid. Renal function should be monitored.

Combinations that must be taken into account:

• Glucocorticoids (excluding replacement therapy with hydrocortisone) for analgesic and antipyretic doses of acetylsalicylic acid: increased risk of bleeding.

• Deferasirox: with anti-inflammatory doses of acetylsalicylic acid, or with analgesic or antipyretic doses of acetylsalicylic acid: increased risk of gastrointestinal ulcers and bleeding.

• Low molecular weight heparins (and related molecules) and unfractionated heparins in preventive doses in patients under 65 years of age: by affecting haemostasis to varying degrees, concomitant administration increases the risk of bleeding. Therefore, in patients under the age of 65. 65 years of age, concomitant administration of heparins (or related molecules) in preventive doses, and acetylsalicylic acid in any dose, should be considered in conjunction with clinical and laboratory monitoring as needed.

• Thrombolytics: increased risk of bleeding.

• Selective Serotonin Reuptake Inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline): increased risk of bleeding.

04.6 Pregnancy and lactation

Pregnancy

Inhibition of prostaglandin synthesis may have adverse effects on the course of pregnancy and / or embryo-fetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformations and gastroschisis following the use of inhibitors. of prostaglandin synthesis in the early stages of pregnancy.

The absolute risk of cardiovascular malformations increased from no less than 1% to approximately 1.5%. The risk appears to increase with dose and duration of treatment.

In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular ones, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period of gestation.

Unless absolutely essential, acetylsalicylic acid should not be given during the first 24 weeks of amenorrhea. If acetylsalicylic acid is given to women who wish to become pregnant or are pregnant during the first 24 weeks of amenorrhea, the dose should be as low as possible and duration of treatment as short as possible.

Beyond the 24th week of amenorrhea, 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 lead to renal failure with oligohydroamniosis;

In the final stage of pregnancy, the mother and baby may experience:

• Prolongation of the bleeding time, due to the inhibition of platelet aggregation which can occur even at very low doses of acetylsalicylic acid;

• inhibition of uterine contractions which causes the delay or prolongation of labor.

Therefore acetylsalicylic acid is contraindicated after the 5th month of pregnancy (over 24 weeks of amenorrhea) (see section 4.3).

Feeding time

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

Fertility

There is some evidence that drugs that inhibit cyclooxygenase / prostaglandin synthesis can cause impaired female fertility due to an effect on ovulation. This effect is reversible upon discontinuation of treatment.

04.7 Effects on ability to drive and use machines

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

04.8 Undesirable effects

Frequencies: not known (cannot be estimated from the available data)

Disorders of the blood and lymphatic system

Bleeding and bleeding tendency (epistaxis, gum bleeding, purpura, etc.) with increased bleeding time. The risk of bleeding may persist for 4-8 days after stopping the intake of acetylsalicylic acid. It can cause an increased risk of bleeding in case of surgery. Intracranial and gastrointestinal bleeding can also occur.

Disorders of the immune system

Hypersensitivity reactions, anaphylactic reactions, asthma, angioedema

Nervous system disorders

Headache, dizziness, sensation of hearing loss, tinnitus, usually indicating an overdose. Intracranial haemorrhage

Gastrointestinal disorders

Abdominal pain

Occult or overt gastrointestinal bleeding (haematemesis, melaena, etc.) resulting in iron deficiency anemia. The risk of bleeding is dose related.

Gastric ulcers and perforations

Hepatobiliary disorders

Elevation of liver enzymes usually reversible on discontinuation of treatment, liver damage, mainly of a hepatocellular nature

Skin and subcutaneous tissue disorders

Hives, skin rashes

General ailments

Reye's syndrome (see section 4.4)

Reporting of side effects

It is important to report undesirable effects of the medicine after authorization. This allows for continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the Website: www.agenziafarmaco.gov.it/ it / responsible.

04.9 Overdose

Overdose can be harmful in the elderly and particularly in young children (therapeutic overdose or, more frequently, accidental intoxication) in which it can be fatal.

Symptoms

Moderate intoxication:

Symptoms such as ringing in the ears, feeling of hearing loss, headache and dizziness are indicative of an overdose and can be controlled by reducing the dosage.

Severe intoxication:

Symptoms include: Fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, severe hypoglycemia.

In children, overdose can be fatal starting at a single dose of 100 mg / kg.

Emergency management

• Immediate transfer to a specialized hospital unit

• Gastrointestinal washing and administration of activated charcoal

• Control of acid-base balance

• Alkalization of urine with monitoring of urinary pH

• Hemodialysis in case of severe intoxication

• Symptomatic treatment

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: nervous system, other analgesics and antipyretics.

ATC code: N02BA01.

Acetylsalicylic acid belongs to the group of non-steroidal anti-inflammatory drugs and has analgesic, antipyretic and anti-inflammatory properties. Its mechanism of action is based on the irreversible inhibition of cyclooxygenase enzymes involved in the synthesis of prostaglandins.

Clinical studies of acetylsalicylic acid in oral doses generally 0.3 to 1.0 g have shown efficacy in pain relief, such as tension headache, migraine, toothache, sore throat, primary dysmenorrhea, joint and muscle pain, and in febrile conditions such as colds or flu, for the reduction of body temperature It is also used in acute and chronic inflammatory disorders such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

Acetylsalicylic acid also inhibits platelet aggregation by blocking the synthesis of thromboxane A2 in platelets. Therefore, it is used for various vascular indications in doses typically of 75 to 300 mg per day.

05.2 Pharmacokinetic properties

Absorption:

This formulation offers rapid pain relief in mild to moderate acute pain conditions. The rapid relief of pain is attributed to a rapid onset of action thanks to a reduced time to reach the maximum plasma concentration. The formulation combines small particles of the active ingredient acetylsalicylic acid and an effervescent component, thus obtaining a rapidly disintegrating core. Thanks to the rapid dissolution of the product it is possible to obtain a faster absorption of acetylsalicylic acid (registered trademark: MicroActive).

Following oral administration, the gastrointestinal absorption of the acetylsalicylic acid in this formulation is very rapid and complete. During and after absorption, acetylsalicylic acid is converted into its main active metabolite: salicylic acid. On average, the maximum plasma concentration is reached in about 17.5 minutes for acetylsalicylic acid and in about 45 minutes for acetylsalicylic acid. salicylic acid, according to the quantifications performed in the bioavailability studies. Compared to traditional acetylsalicylic acid tablets (Aspirin), with this formulation the time to reach the maximum plasma concentration of acetylsalicylic acid and salicylic acid was reduced by 2.6 and 4 respectively , 0 times.

As a result, "faster action from a clinical point of view has been demonstrated in comparative efficacy trials involving over 1000 patients with postoperative dental pain. In these studies, the time to first perceptible pain relief, the time to first confirmed perceptible relief and time to significant pain relief were statistically significantly reduced compared to that obtained with traditional acetylsalicylic acid tablets, while the overall efficacy (duration and intensity of the effect) was not The time to significant pain relief was twice as fast compared to traditional acetylsalicylic acid tablets (49 minutes vs. 99 minutes).

Distribution:

Both acetylsalicylic acid and salicylic acid are extensively bound to plasma proteins and are rapidly distributed throughout the body. Salicylic acid passes into breast milk and crosses the placenta.

Elimination:

Salicylic acid is eliminated predominantly by hepatic metabolism. Its metabolites are: salicyluric acid, salicylphenolic glucuronide, salicylicacyl glucuronide, gentisic acid and gentisuric acid.

The kinetics of salicylic acid elimination are dose-dependent, since metabolism is limited by the capacity of liver enzymes. Thus, the elimination half-life ranges from 2 to 3 hours after low dose intake up to a maximum of approximately 15 hours with high doses. Salicylic acid and its metabolites are excreted primarily via the kidney.

05.3 Preclinical safety data

The preclinical safety profile of acetylsalicylic acid is well documented.

In animal studies, salicylates caused kidney damage in high dosages but no other organic lesions were observed. Acetylsalicylic acid has been extensively studied in vitro and in vivo to determine its mutagenicity; no relevant evidence of mutagenic potential has been discovered. The same is true for carcinogenicity studies.

Salicylates have exhibited teratogenic effects in animal studies and on several different species (e.g. cardiac and skeletal malformations, midline defects). Implantation dysfunction, embryotoxic and foetotoxic effects and impaired learning ability of the offspring following prenatal exposure have been described.