Active ingredients: Acetylsalicylic acid
ACETYLSALICYLIC ACID DOC Generici 100 mg gastro-resistant tablets
Why is Acetylsalicylic Acid - Generic Drug used? What is it for?
ACETYLSALICYLIC ACID DOC Generici contains acetylsalicylic acid, which in low doses belongs to a group of medicines called anti-platelet agents. Platelets are small blood cells that cause clotting and are involved in thrombosis. When a blood clot forms in an artery, blood flow is blocked and the supply of oxygen is cut off. When this occurs in the heart, it can cause a heart attack or angina; in the brain it can cause a stroke.
ACETYLSALICYLIC ACID DOC Generici is taken to reduce the risk of blood clot formation and thus prevent the following:
- heart attacks
- stroke
- cardiovascular problems in patients with stable or unstable angina (a type of chest pain).
ACETYLSALICYL ACID DOC Generici is also used to prevent blood clots from forming after certain heart surgery, which is done to widen or unblock blood vessels.
This medicine is not recommended in an emergency. It can only be used as a preventive treatment.
Contraindications When Acetylsalicylic Acid - Generic Drug should not be used
Do not take ACETYLSALICYLIC ACID DOC Generici if
- you are allergic to acetylsalicylic acid or to any of the other ingredients of ACETYLSALICYL ACID DOC Generici (see section 6 "Further information").
- you are allergic to other salicylates or to non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis or rheumatism and pain.
- you have had an asthma attack or some parts of your body have swollen eg. face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs.
- currently have or have ever had a stomach or small bowel ulcer or some other type of bleeding such as a stroke.
- have had blood clotting problems.
- suffer from severe liver or kidney problems.
- is in the last 3 months of pregnancy; you must not take doses higher than 100 mg per day (see section "Pregnancy and lactation").
- you are taking a medicine called methotrexate (eg to treat cancer or rheumatoid arthritis) at doses higher than 15 mg per week.
Precautions for use What you need to know before taking Acetylsalicylic Acid - Generic Drug
Before taking ACETYLSALICYLIC ACID DOC Generici tell your doctor if:
- have kidney, liver or heart problems
- have or have had problems with your stomach or small intestine
- have high blood pressure
- have asthma, hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid can cause an asthma attack
- have ever had gout
- have a heavy menstrual cycle
You should see your doctor immediately if your symptoms get worse or if you have any serious or unexpected side effects eg. unusual bleeding symptoms, severe skin reactions or any other signs of a severe allergic reaction (see section "Possible side effects").
Tell your doctor if you are about to have surgery (even a minor one, such as a tooth extraction), as acetylsalicylic acid makes the blood thinner and therefore there may be an increased risk of bleeding.
Acetylsalicylic acid when given to children can cause Reye's syndrome. Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening. For this reason, ACETYLSALICYL ACID DOC Generici should not be given. to children under the age of 16, unless on the advice of a doctor. You must be careful not to become dehydrated (may feel thirsty and have a dry mouth) because the simultaneous use of acetylsalicylic acid can lead to deterioration of renal function.
This medicine is not suitable as a pain reliever or to reduce fever.
If any of the above apply to you, or if you are unsure about them, consult your doctor or pharmacist.
Interactions Which drugs or foods can modify the effect of Acetylsalicylic Acid - Generic Drug
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription
The effectiveness of treatment may be affected if acetylsalicylic acid is taken at the same time as other medicines for:
- thin the blood / prevent clots (e.g. warfarin, heparin, clopidogrel)
- transplant organ rejection (cyclosporine, tacrolimus)
- high blood pressure (e.g. diuretics and ACE inhibitors)
- heart rate regulation (digoxin)
- manic-depressive illness (lithium)
- pain and inflammation (e.g. NSAIDs such as ibuprofen or steroids)
- gout (e.g. probenecid)
- epilepsy (valproate, phenytoin)
- glaucoma (acetazolamide)
- cancer or rheumatoid arthritis (methotrexate at doses less than 15 mg per week)
- diabetes (e.g. glibenclamide)
- depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine)
- use as hormone replacement therapy after destruction or removal of the adrenal or pituitary glands, or to treat inflammation, including rheumatic disease and inflammation of the intestine (corticosteroids)
Taking ACETYLSALICYLIC ACID DOC Generici with food and drink
Alcohol intake can increase the risk of gastrointestinal bleeding and prolong bleeding time.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnant women should not take acetylsalicylic acid during pregnancy except on the advice of their doctor.
You should not take ACETYLSALICYL ACID DOC Generici in the last 3 months of pregnancy, unless prescribed by your doctor and in this case the daily dose should not exceed 100 mg (see section "Do not take ACETYLSALICYL ACID DOC Generici"). Regular or high doses of this medicine during the latter part of pregnancy can cause serious complications in the mother or baby.
Breastfeeding women should not take acetylsalicylic acid except on medical advice.
Driving and using machines
ACETYLSALICYLIC ACID DOC Generici does not affect the ability to drive and use machines.
Dose, Method and Time of Administration How to use Acetylsalicylic Acid - Generic Drug: Posology
Always take ACETYLSALICYLIC ACID DOC Generici exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Adults
Heart attack prevention:
- The recommended dose is 100 mg once a day.
Stroke prevention:
- The recommended dose is 100 mg once a day.
Prevention of cardiovascular problems in patients suffering from stable or unstable angina (a type of chest pain):
- The recommended dose is 100 mg once a day.
Prevention of blood clot formation after some types of heart surgery:
- The recommended dose is 100 mg once a day.
The usual dose for prolonged treatment is 100 mg (one tablet) once a day. ACETYLSALICYL ACID DOC Generici should not be taken in higher doses unless advised by your doctor and the dose should not exceed 300 mg per day.
Senior citizens
As in adults. In general, acetylsalicylic acid should be used with caution in elderly patients who are more sensitive to adverse events. Treatment should be re-evaluated at regular intervals.
Children
Acetylsalicylic acid should not be given to children and adolescents under the age of 16 unless prescribed by your doctor (see section "Take special care with ACETYLSALICYL ACID DOC Generici"
Method of administration
Oral use.
The tablets should be swallowed whole with a sufficient amount of liquid (1/2 glass of water). The tablets have a gastro-resistant coating which prevents irritating effects on the intestine and therefore should not be crushed, broken or chewed.
Overdose What to do if you have taken an overdose of Acetylsalicylic Acid - Generic Drug
If you take more ACETYLSALICYLIC ACID DOC Generici than you should
If you (or anyone else) accidentally takes too many tablets, you should immediately seek medical attention or contact the nearest emergency department. Show the doctor what is left of the medicine or the empty pack.
Overdose symptoms may include ringing in the ears, hearing problems, headache, dizziness, confusion, nausea, vomiting, and abdominal pain. A sizable overdose can lead to rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar, coma and shock.
If you forget to take ACETYLSALICYLIC ACID DOC Generici
If you miss a dose, wait until it is time for your next dose, then proceed as usual.
If you have any further questions on the use of this product, ask your doctor or pharmacist.Side Effects What are the side effects of Acetylsalicylic Acid - Generic Drug
Like all medicines, ACETYLSALICYLIC ACID DOC Generici can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking ACETYLSALICYLIC ACID DOC Generici and tell your doctor immediately:
- Sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty in swallowing (severe allergic reaction).
- Blistering or peeling skin redness may be associated with high fever and joint pain. This can be erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome.
- Unusual bleeding, such as coughing up blood, blood in the vomit or urine, or dark stools.
Common side effects (may affect between 1 and 10 in 100 patients):
- Indigestion.
- Increased tendency to bleed.
Uncommon side effects (may affect between 1 and 10 in 1000 patients):
- Urticaria.
- A runny nose.
- Difficulty in breathing.
Rare side effects (may occur between 1 and 10 in 10,000 patients):
- Severe bleeding from the stomach or intestines, brain haemorrhage; altered number of blood cells.
- Nausea and vomit.
- Cramps in the lower respiratory tract, asthma attacks.
- Inflammation of the blood vessels.
- Bruising with purple spots (skin bleeding).
- Severe skin reactions such as rashes known as erythema multiforme and its life-threatening variants, Stevens-Johnson syndrome and Lyell syndrome.
- Hypersensitivity reactions, such as swelling of, for example, lips, face or body, or shock.
- Very heavy or prolonged menstrual period.
Undesirable effects with frequency not known
- Ringing in the ears (tinnitus) or impaired hearing.
- Headache.
- Dizziness.
- Stomach or small bowel ulcers and perforation.
- Prolongation of bleeding time.
- Impaired renal function.
- Impaired liver function.
- High levels of uric acid in the blood.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Expiry and Retention
Keep out of the reach and sight of children.
Store below 25 ° C.
Store in the original package to protect the medicine from moisture.
Do not use ACETYLSALICYL ACID DOC Generici after the expiry date which is stated on the carton or blister after "EXP". The expiry date refers to the last day of the month.
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.
What ACETYLSALICYLIC ACID DOC Generici contains
The active ingredient is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
The other ingredients are: tablet core: microcrystalline cellulose, maize starch, anhydrous colloidal silica, stearic acid; coating: methacrylic acid - ethyl acrylate copolymer (1: 1), polysorbate 80, sodium lauryl sulfate, triethyl citrate, talc.
Description of the appearance of ACETYLSALICYL ACID DOC Generici and contents of the pack
ACETYLSALICYLIC ACID DOC Generici gastro-resistant tablets 100 mg are round, white, biconvex, film-coated tablets with a diameter of 7.2 mm.
Packaging:
Blister packs: 30 gastro-resistant 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
ACETYLSALICYLIC ACID DOC GENERICI
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Gastro-resistant tablet 100 mg: Round, white, biconvex, film-coated tablet, 7.2 mm in diameter.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
• Secondary prevention of myocardial infarction.
• Prevention of cardiovascular morbidity in patients with stable angina pectoris.
• History of unstable angina pectoris, except during the acute phase.
• Prevention of bypass occlusion after Coronary Artery Bypass Grafting (CABG).
• Coronary angioplasty, except during the acute phase.
• Secondary prevention of transient ischemic attacks (TIA) and cerebrovascular ischemic accidents (CVA), provided that the presence of intracerebral haemorrhages has been ruled out.
ACETYLSALICYLIC ACID DOC Generici is not recommended in emergency situations. Use is limited to secondary prevention with chronic treatment.
04.2 Posology and method of administration
Adults
Secondary prevention of myocardial infarction: the recommended dose is 100 mg once a day.
Prevention of cardiovascular morbidity in patients with stable angina pectoris: the recommended dose is 100 mg once a day.
History of unstable angina pectoris, except during the acute phase: the recommended dose is 100 mg once a day.
Prevention of bypass occlusion after Coronary Artery Bypass Grafting (CABG): the recommended dose is 100 mg once a day.
Coronary angioplasty, except during the acute phase: the recommended dose is 100 mg once a day.
Secondary prevention of transient ischemic attacks (TIA) and cerebrovascular ischemic accidents (CVA), provided that the presence of intracerebral haemorrhages has been ruled out: the recommended dose is 100 mg once a day.
The usual dose for prolonged use is 100 mg once a day. ACETYLSALICYL ACID DOC Generici should not be used in higher doses unless advised by a physician, and the prescribed dose should not exceed 300 mg.
Senior citizens
In general, acetylsalicylic acid should be used with caution in elderly patients, who are more prone to experience adverse events. It is recommended to administer the usual dose to adults in the absence of severe renal or hepatic impairment (see sections 4.3 and 4.4). Treatment should be re-evaluated at regular intervals.
Pediatric population
Acetylsalicylic acid should not be given to children and adolescents under 16 years of age, except on medical advice when the benefits outweigh the risks (see section 4.4).
Method of administration
For oral use.
The tablets should be swallowed whole with a sufficient amount of liquid (1/2 glass of water).Due to the gastro-resistant coating, the tablets should not be crushed, broken or chewed, because the coating prevents irritating effects on the intestine.
04.3 Contraindications
- Hypersensitivity to salicylic acid compounds or prostaglandin synthesis inhibitors (eg some asthmatic patients who may suffer a fit or faint) or to any of the excipients;
- peptic ulcer and / or gastric / intestinal haemorrhage in acute phase or in history or other types of haemorrhage such as cerebrovascular haemorrhages;
- hemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia;
- severe hepatic impairment;
- severe renal impairment;
- doses above 100 mg per day in the third trimester of pregnancy (see section 4.6);
- methotrexate used at doses above 15 mg / week (see section 4.5).
04.4 Special warnings and appropriate precautions for use
ACETYLSALICYLIC ACID DOC Generici is not suitable for use as an anti-inflammatory / analgesic / antipyretic.
It is recommended for use in adults and adolescents over the age of 16. This medicine is not recommended for use in adolescents / children under the age of 16 unless the expected benefits outweigh the risks. Acetylsalicylic acid may be a factor behind Reye's syndrome in some children.
There is an increased risk of bleeding, particularly during or after surgery (even with minor operations, such as tooth extraction). Use with caution before surgery, including tooth extraction. Temporary interruption of treatment may be necessary.
ACETYLSALICYLIC ACID DOC Generici is not recommended in case of menorrhagia, where menstrual flow can increase.
ACETYLSALICYL ACID DOC Generici should be used with caution in cases of hypertension and when patients have a previous history of gastric or duodenal ulcer or bleeding episodes or are undergoing anticoagulant therapy.
Patients should report any unusual bleeding events to their physician. If gastrointestinal bleeding or ulcer occurs, treatment should be discontinued.
Acetylsalicylic acid should be used with caution in patients with moderate renal or hepatic impairment (contraindicated if severe) or in dehydrated patients, as the use of NSAIDs may result in deterioration of renal function. Liver function tests should be performed regularly in patients with mild or moderate hepatic insufficiency.
Acetylsalicylic acid can trigger bronchospasm and asthma attacks or other hypersensitivity reactions. Risk factors are pre-existing asthma, hay fever, nasal polyps or chronic respiratory disease. The same applies to patients who also have allergic reactions to other substances (eg with skin reactions, itching or hives).
Serious skin reactions, including Steven-Johnsons syndrome, have rarely been reported in association with the use of acetylsalicylic acid (see section 4.8). Acetylsalicylic acid should be discontinued at the first occurrence of skin rash, mucosal lesions or any other signs of hypersensitivity.
Elderly patients are particularly sensitive to NSAID adverse events, including acetylsalicylic acid, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). In case of prolonged therapy, patients should be re-examined regularly.
Concomitant treatment with ACETYLSALICYLIC ACID DOC Generici and other drugs that alter haemostasis (eg anticoagulants such as warfarin, thrombolytic and antiplatelet agents, anti-inflammatory drugs and selective serotonin reuptake inhibitors) is not recommended unless strictly indicated. as they may increase the risk of haemorrhage (see section 4.5) If the combination cannot be avoided, careful monitoring for signs of bleeding is recommended.
Caution is advised in patients taking concomitant medicinal products that may increase the risk of ulcer, such as oral corticosteroids, selective serotonin reuptake inhibitors and deferasirox (see section 4.5).
Low-dose acetylsalicylic acid reduces uric acid excretion. For this reason, patients who tend to have low uric acid excretion may have gout attacks (see section 4.5).
The risk of sulfonylurea and insulin-induced hypoglycaemia may be increased with higher dose ACETYLSALICYLIC ACID (see section 4.5).
04.5 Interactions with other medicinal products and other forms of interaction
Contraindicated associations
Methotrexate (used at doses> 15 mg / week): the combination of the drugs methotrexate and acetylsalicylic acid increases the haematological toxicity of methotrexate due to the reduced renal clearance of methotrexate induced by acetylsalicylic acid. Therefore concomitant use of methotrexate (at doses> 15 mg / week) with ACETYLSALICYLIC ACID DOC Generici is contraindicated (see section 4.3).
Combinations not recommended
Uricosuric agents, eg. probenecid: salicylates antagonize the effect of probenecid. The association should be avoided.
Associations that require precautions for use or that need to be considered
Anticoagulants, eg. coumarin, heparin, warfarin: increased risk of bleeding due to inhibition of thrombocyte function, lesion of the duodenal mucosa and displacement of oral anticoagulants from plasma protein binding sites. Bleeding time should be monitored (see section 4.4).
Anti-platelet aggregating agents (e.g. clopidogrel and dipyridamole) and selective serotonin reuptake inhibitors (SSRIs; such as sertraline or paroxetine): increased risk of gastrointestinal bleeding (see section 4.4).
Antidiabetics, eg. sulfonylureas: salicylates can increase the hypoglycemic effect of sulfonylureas.
Digoxin and lithium: Acetylsalicylic acid impairs renal excretion of digoxin and lithium, resulting in increased plasma concentrations. Monitoring of plasma digoxin and lithium concentrations is recommended at the beginning and end of treatment with acetylsalicylic acid. Dosage adjustment may be necessary.
Diuretics and antihypertensives: NSAIDs may reduce the antihypertensive efficacy of diuretics and other antihypertensive agents. As with other NSAIDs, concomitant administration with ACE inhibitors increases the risk of acute renal failure.
Diuretics: risk of acute renal failure due to impaired glomerular filtration caused by impaired renal synthesis of prostaglandins. It is recommended to hydrate the patient and to monitor renal function at the start of treatment.
Carbonic anhydrase inhibitors (acetazolamide): severe acidosis and increased toxicity on the central nervous system may occur.
Systemic corticosteroids: Co-administration of acetylsalicylic acid and corticosteroids may lead to an increased risk of gastrointestinal ulcer and bleeding (see section 4.4).
Methotrexate (used at doses: the combination of the drugs methotrexate and acetylsalicylic acid, may increase the haematological toxicity of methotrexate due to the reduced renal clearance of methotrexate induced by acetylsalicylic acid.
A blood check should be done weekly in the first few weeks of treatment with the combination. Closer monitoring should also be done in the presence of mildly impaired renal function as well as in the elderly.
Other NSAIDs: an increased risk of gastrointestinal ulcer and bleeding is due to a synergistic effect.
Ibuprofen: Experimental data suggest that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are co-administered. However, the limitedness of these data and the uncertainties related to the extrapolation of data ex vivo clinical situation mean that no firm conclusions can be drawn on the regular use of ibuprofen and that a clinically relevant effect for occasional use of ibuprofen is not considered likely (see section 5.1).
Ciclosporin, tacrolimus: The concomitant use of NSAIDs with cyclosporine or tacrolimus may result in an increase in the nephrotoxic effect of cyclosporine and tacrolimus. Renal function should be monitored in case of concomitant use of these agents with acetylsalicylic acid.
Valproate: Acetylsalicylic acid has been reported to reduce the binding of valproate to serum albumin, thereby increasing steady-state free plasma concentrations.
Phenytoin: Salicylates reduce the binding of phenytoin to plasma albumin. This can lead to a reduction in plasma levels of total phenytoin, but can lead to an increased fraction of free phenytoin. The unbound concentration, and hence the therapeutic efficacy, does not appear to be significantly changed.
Alcohol: Concomitant administration of alcohol with acetylsalicylic acid increases the risk of gastrointestinal bleeding.
04.6 Pregnancy and lactation
Pregnancy
Low doses (up to 100 mg / day): gClinical studies indicate that doses up to 100 mg / day can be considered safe for use only in obstetrics, which require specialist monitoring.
Doses of 100-500 mg / day: Clinical experience on the use of doses above 100 mg / day and up to 500 mg / day is insufficient. Therefore, the recommendations below apply to this dose range as well, for doses of 500 mg / day and above.
Doses of 500 mg / day and higher: Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. The results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformations and gastroschisis after the use of a synthesis inhibitor prostaglandins in the early stages of pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to produce increased pre- and post-implantation loss and embryo / fetal lethality. Furthermore, in animals, the administration of prostaglandin synthesis inhibitors during the period of organogenesis has been shown to produce an increased incidence of various malformations, including cardiovascular ones.
During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered unless clearly needed. If acetylsalicylic acid is used by a woman expecting conception, or during the first and second trimester of pregnancy. pregnancy, the dose should be as low as possible and the duration of treatment should be as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose
the fetus a:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydramnios;
the mother and the newborn, at the end of pregnancy, a:
- 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 at doses of 100 mg / day and higher is contraindicated during the third trimester of pregnancy.
Feeding time
Salicylates and their metabolites are excreted in breast milk in small quantities.
Since no undesirable effects have been observed in the newborn to date, short-term use of the recommended doses does not require interruption of breastfeeding. In case of prolonged use and / or taking higher doses, breastfeeding should be discontinued.
04.7 Effects on ability to drive and use machines
No studies on the effects of ACETYLSALICYL ACID DOC Generici on the ability to drive and use machines have been performed.
Based on the pharmacodynamic properties and undesirable effects of acetylsalicylic acid, an effect on reactivity and ability to drive and use machines is not expected.
04.8 Undesirable effects
Side effects are grouped according to a system organ classification. Within each system organ class, frequency is defined as: very common (≥1 / 10); common (≥1 / 100,
04.9 Overdose
Although considerable inter-individual variations are involved, the toxic dose can be considered to be approximately 200 mg / kg in adults and 100 mg / kg in children. The lethal dose of acetylsalicylic acid is 25-30 grams. Plasma concentrations of salicylate above 300 mg / l indicate intoxication. Plasma concentrations above 500 mg / l in adults and 300 mg / l in children generally cause severe toxicity.
Overdose can be harmful to elderly patients and especially young children (therapeutic overdose or frequent accidental poisoning can be fatal).
Symptoms of moderate intoxication
Tinnitus, impaired hearing, headache, dizziness, confusion and gastrointestinal symptoms (nausea, vomiting and abdominal pain).
Symptoms of severe intoxication
Symptoms are related to severe acid-base imbalance. In the first instance hyperventilation occurs, which produces respiratory alkalosis. Respiratory acidosis occurs due to suppression of the respiratory center. In addition, metabolic acidosis occurs as a result of the presence of salicylates.
Intoxication in younger children is often diagnosed at an advanced stage, so they have usually already reached the acidotic stage.
In addition, the following symptoms may occur: hyperthermia and sweating, which produces dehydration: feeling restless, convulsions, hallucinations and hypoglycemia. Depression of the nervous system can lead to coma, cardiovascular collapse, or respiratory arrest.
Treatment of overdose
If a toxic dose has been ingested, hospitalization is required. In case of moderate intoxication, one should try to induce vomiting.
If this is not successful, gastric lavage can be performed within the first hour after ingesting a large amount of the drug. Subsequently, activated charcoal (adsorbent) and sodium sulphate (laxative) are administered.
Activated charcoal can be given as a single dose (50 g for an adult, 1 g / kg body weight for a child up to 12 years old).
Urine alkalinization (250 mmol NaHCO3, for three hours) while maintaining a controlled urinary pH level.
In case of severe intoxication, hemodialysis is preferred.
Other symptoms need to be treated symptomatically.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antithrombotic agents, inhibitors of platelet aggregation excluding heparin.
ATC code: B01AC06.
Acetylsalicylic acid inhibits platelet activation: by blocking platelet cyclooxygenase by acetylation, it inhibits the synthesis of thromboxane A2, a substance that activates physiological processes, released by platelets, which appears to play a role in the complications of atheromatous lesions.
The inhibition of TXA2 synthesis is irreversible, because the thrombocytes, which have no nucleus, are unable (lacking the ability to synthesize proteins) to synthesize new cyclooxygenase, after the existing one has been acetylated by acetylsalicylic acid.
Repeated doses between 20 and 325 mg lead to an "inhibition of" enzymatic activity between 30 and 95%.
Due to the irreversible nature of the bond, the effect persists for the entire lifespan of the thrombocyte (7-10 days). The inhibitory effect is not exhausted during prolonged treatment and the enzymatic activity gradually resumes after renewal of the 24 platelets. 48 hours after stopping treatment.
Acetylsalicylic acid prolongs bleeding time on average by about 50 to 100%, but individual variations can be observed.
Experimental data suggest that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. In one study, following administration of a single 400 mg dose of ibuprofen, taken within 8 hours before or 30 minutes after administration of immediate-release acetylsalicylic acid (81 mg), there was a decrease in the effect of acetylsalicylic acid on thromboxane formation or platelet aggregation. However, the lack of data and the uncertainties related to data extrapolation ex vivo on the clinical situation do not allow to draw firm conclusions for the regular use of ibuprofen; and no clinically relevant effect can be considered probable with the occasional use of ibuprofen.
05.2 "Pharmacokinetic properties
Absorption
After oral administration, acetylsalicylic acid is rapidly and completely absorbed from the gastrointestinal tract. The main site of absorption is the proximal small intestine. However, a significant portion of the dose is already hydrolyzed to salicylic acid in the intestinal wall during the absorption process. The degree of hydrolysis is a function of the rate of absorption.
After taking ACETYLSALICYLIC ACID DOC Generici gastro-resistant tablets, the maximum plasma levels of acetylsalicylic acid and salicylic acid are reached after about 5 hours and 6 hours respectively, if the administration was carried out fasting. If the tablets are taken with food , maximum plasma levels are reached approximately 3 hours later than when taken in the fasted state.
Distribution
Both acetylsalicylic acid and the main metabolite, salicylic acid, are extensively bound to plasma proteins, mainly albumin, and are distributed rapidly in the body.
The degree of protein binding of salicylic acid strongly depends on the concentration of both salicylic acid and albumin. The volume of distribution of acetylsalicylic acid is approximately 0.16 l / kg body weight. Salicylic acid slowly diffuses into the synovial fluid, crosses the placental barrier and passes into breast milk.
Metabolism
Acetylsalicylic acid is rapidly metabolized to salicylic acid with a half-life of 15-30 minutes. Salicylic acid is subsequently mainly converted into conjugates of glycine and glucuronic acid and traces of gentisic acid.
The kinetics of elimination of salicylic acid are dose-dependent, since the metabolism is limited by the capacity of liver enzymes. The elimination half-life therefore varies from 2 - 3 hours after administration of low doses, 12 hours after the usual doses. in analgesia and up to 15-30 hours after high therapeutic doses or in case of intoxication.
Elimination
Salicylic acid and its metabolites are mainly excreted via the kidneys.
05.3 Preclinical safety data
The preclinical safety profile of acetylsalicylic acid is well documented.
In experimental animal studies, salicylates did not cause damage to organs other than the kidneys.
In studies in rats, foetotoxic and teratogenic effects were observed with acetylsalicylic acid at maternally toxic doses. The clinical relevance is unknown as the doses used in the non-clinical studies are much higher (at least 7 times) than the maximum recommended dose in the approved cardiovascular indications.
The mutagenicity and carcinogenicity of acetylsalicylic acid have been extensively studied.
Overall results show no signs of any mutagenic or carcinogenic potential in mouse and rat studies.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Tablet core: cmicrocrystalline ellulose; cornstarch; anhydrous colloidal silica; stearic acid.
Coating: amethacrylic acid-ethyl acrylate copolymer (1: 1); polysorbate 80; sodium lauryl sulfate; triethyl citrate; talc.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Store below 25 ° C.
Blisters: Store in the original package to protect the medicine from moisture.
06.5 Nature of the immediate packaging and contents of the package
Blister (PVC / Aluminum).
Packs
Blister packs: 30 gastro-resistant tablets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
DOC Generici S.r.l.
Via Turati 40, 20121 Milan, Italy.
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 042179010 - "100 MG GASTRORESISTANT TABLETS" 30 TABLETS IN PVC / AL BLISTER.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
August 2013.
10.0 DATE OF REVISION OF THE TEXT
August 2013.