Each enteric-coated tablet contains:
Each tablet contains: Acetyl Salicylic Acid (micronized)          81 mg

Excipients:
Avicel 102, Colloidal silicon dioxide,Croscarmellose sodium, Stearic acid, , Titanium dioxide, Talc, PEG 6000.

Acpophar 81 tablets should preferably be taken after meals, with plenty of liquid 
Acpophar 81is for oral administration to adults only.
Acpophar 81, being enteric coated tablets, should be swallowed whole and not chewed.
Usual recommended dose:
The recommended dose is 1-4 tablets daily.
Suspected acute myocardial infarction:
An initial dose of at least 162 mg (two tablets) chewed or crushed to ensure rapid absorption as soon as a myocardial infarction is suspected.
The same dose should be given as maintenance over the next 30 days.
After 30 day, consider further therapy based on dosage and administration for prevention of recurrent MI (see prior myocardial infarction).
Prevention of a first non-fatal myocardial infarction: 81 -325 mg (1-4 tablets) once daily, according to the individual needs of the patient, as determined by the physician.
Prior myocardial infarction or unstable angina pectoris: 81-325 mg (1-4 tablets) daily, according to the individual needs of the patient, as determined by the physician.
Transient ischemic attack and secondary prevention of atherothrombotic cerebral infarction: 81-325 mg (1-4 tablets) daily according to the individual needs of the patient, as determined by the physician.
Prophylaxis of venous thromboembolism after total hip  replacement: 162-325 mg (2-4 tablets) daily according to the individual needs of the patient, as determined by the physician.
Children:
Do not give to children aged under 18 years, unless specifically indicated (e.g. for Kawasakiks disease).
Contraindications
Patients who are hypersensitive to acetylsalicylic acid , salicylates ( non steroidal anti-inflammatory drugs) NSAIDs , analgesics, antipyretics or other ingredients.
Acute gastrointestinal ulcer
History of gastrointestinal ulcers.
Haemorrhagic diathesis
Active or severe hepatic failure , renal failure, or congestive heart failure 
Patients with a history of asthma induced by the administration of salicylate or substances with a similar action notably NSAIDs
Combination with methotrexate at doses of 15mg/week or more (see drug interactions) 

Women attempting to conceive:
During the first and second trimester of pregnancy,acetylsalicylic acid containing drugs should not be given unless clearly necessary . if acetylsalicylic acid containing drugs are used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and duration of treatment as short as possible.

Pregnant women:
Acetylsalicylic acid inhibits prostaglandin synthesis. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies raise concern about an increased risk of miscarriage and of malformations after the use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is belived to increase with dose and duration of therapy. Available data do not support any association between intake of acetylsalicylic acid and an increased risk for miscarriage. For acetylsalicylic acid the available epidemiological data regarding malformation are not consistent, but an increased risk of gastroschisis could not be excluded. A prospective study with exposure in early pregnancy (1st -4th month) of about 14.800 mother-child pairs has not yielded any association with an elevated rate malformations.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:
Cardiopulmonary toxicity (with premature closure of the ducts arteriosus and pulmonary hypertension)
Renal dysfunction, wich may progress to renal failure with oligo-hydroamniosis

Use of any prostaglandin synthesis inhibitors at the end of pregnancy may expose the mother and the child to:
Possible prolongation of bleeding time, an anti-aggregating effect which may occur even after very low doses
Inhibition of uterine contractions resulting in delayed or prolonged labour consequently; acetylsalicylic acid is contraindicated in the third trimester of pregnancy.

Nursing women:
Acetylsalicylic acid and its metabolites pass into breast milk in small quantities .since no adverse effects on the infant have been observed after occasional use, interruption of breast feeding is usually unnecessary. However, on regular use or on intake of high doses , breast feeding should be discontinued early.

Many adverse reactions due to acetylsalicylic acid ingestion are dose related. The following is a list of adverse reactions that have been reported in the literature anf from both clinical and post marketing experience.

Gastrointestinal :The frequency and severity of theses adverse effects are dose related: nausea, vomiting, diarrhea, gastrointestinal bleeding and/or ulceration, dyspepsia, heartburn, hematemesis, melena, abdominal pain, and rarely gastrointestinal inflammation.

Bleeding: due to platelet inhibition bleedings e.g. perioperative hemorrhage, hematomas, epistaxis, urogenital bleedings and gingival bleedings may occur.
Serious bleedings such as gastrointestinal tract hemorrhages, and cerebral hemorrhages are rare.
Isolated cases of potentially life threatening bleedings have been reported, especially in patients with uncontrolled hypertension and/or concomitant antihemostatic agents.

Ear: dizziness, tinnitus, vertigo, hearing loss. Dizziness and tinnitus have been reported, wich may be indicative of an overdose.

Hematologic
Thrombocytopenia, purpura, anemia. Anemia with respective laboratory and clinical signs and symptoms, such as asthenia, pallor, and hypo perfusionis generally caused by bleeding (e.g. occult micro bleeding, acute or chronic bleeding). Hemolysis and hemolytic anemia in patients with severe forms of glucose-6-phosphate dehydrogenase (G6PD) deficiency has been reported. 

Dermatologic and hypersensitivity:
Urticarial, pruritus, skin eruptions, asthma, anaphylaxis, edema, nasal congestion and rhinitis. Severe allergic reactions, including anaphylactic shock are very rarely reported.

Miscellaneous:
Mental confusion, drowsness, sweating, thirst. Transient hepatic impairment with increase in liver transaminases has very rarely been reported .renal impairment and acute renal failure have been reported.
Overdosage
Mild overdose or early poisoning-burning in the mouth , lethargy, nausea, vomiting, tinnitus, sweating, thirst, tachycardia or dizziness.
Moderate overdose –all of the symptoms from mild overdose plus tachypnea, hyperpyrexia, sweating, dehydration, loss of coordination, restlessness, mental confusion.
Severe overdose-all of the symptoms from moderate overdose plus hypotension, hallucinations , stupor , hypoglycemia, convulsions, cerebral edema , oliguria, renal failure, cardiovascular failure, coma, hemorrhage, metabolic acidosis, respiratory alkalosis and/or failure.

Emergency management:
Immediate transfer to hospital and maintain cardiovascular and respiratory support.
Gastric lavage, administration of activated charcoal, check of acid-base balance and correct if necessary.
Alkaline diuresis so as to obtain urine pH between 7.5 and 8 should be considered when plasma salicylate concentration is greater than 500mg/L (3.6 mmol/L) in adults or 300mg/L (2.2 mmol/L) in children 
Hemodialysis should be considered in severe poisoning 800 mg/L (5.8 mmol/L) in adults and 700 mg/L (5.0 mmol/L) in children , as renal elimination of salicylates may be slow due to the presence of acidic urine and renal failure. Haemodialysis should also be considered if the patient is experiencing severe systemic metabolic acidosis ( arterial pH < 7.2), acute renal failure , pulmonary oedema or CNS symptoms such as : drowsiness, agitation, coma or convulsions.
Fluid losses should be replaced with hypotonic solution ( e.g. half saline) and supplemented with glucose 50 to 100g/L.
Symptomatic treatment
Fatal dose: various from 10 to 30 gm of acetylsalicylic acid.however, (in one case) 130g of acetylsalicylic acid was ingested without fatal outcome.

Drug interactions
Overview
Acetylsalicylic acid should be used with caution with other products that have anticoagulation or antiplatelet effects as these effects maybe potentiated. Drugs that bind to protein binding sites should also be used cautiously since acetylsalicylic acid may displace drugs from their protein binding sites.

Contraindicated interactions
Methotrexate, used at doses of 15mg/week or more: increased hematological toxicity of methotrexate (due to decreased renal clearance of methotrexate by anti-inflammatory agents in general and displacement of methotrexate from its plasma protein binding by salicylates). See contraindications.

Methotrexate, used at 15 mg/week or less:
Salicylated may retard the elimination of methotrexate by decreasing renal clearance of methotrexate, displacing methotrexate from protein binding sites, and thereby increasing hematological toxicity
Anti-coagulants, thrombolytic/other inhibitors of platelet aggregation/ hemostasis, e.g. warfarin, heparin: caution is necessary when salicylates and anticoagulants , thrombolytic/other inhibitors of platelet aggregation / homeostasis prescribed concurrently, as salicylates can depress the concentration of prothrombin in the plasma , leading to an increased risk of bleeding.
Oral hypoglycemic, e.g. insulin, sulfonylureas: large doses of acetylsalicylates have a hypoglycemic agent. Diabetics receiving concurrent salicylate and hypoglycemic therapy should be monitoredclosely: reduction of the sulfonylurea hypoglycemic drug dosage may be necessary.
Diuretics: diuretics in combination with acetylsalicylic acid at higher doses leads to decreased glomerular filtration via decreased prostaglandin synthesis. As a result, sodium excretion may be decreased by salicylate administration.
Uricosuric agents: salicylates in large doses are uricosuric agents; smaller amounts may depress uric acid clearance and thus decrease the uricosuric effects of other drugs.
Valproicacid: salicylates may alter valproic acid (VPA) metabolism and may displace VPA from protein binding sites, possibly intensifying the effects of VPA. Cautionis recommended when VPA is administered concomitantly with salicylates.
Glucocorticoids (systemic), except hydrocortisone used as replacement therapy in Addison’s disease: decreased blood salicylate levels during corticosteroide treatment and risk of salicylate overdose after this treatment and risk of salicylate overdose after this treatment is stopped via increased elimination of salicylates by corticosteroids.
Angiotensin converting enzyme (ACE) inhibitors: the hyponatremic and hypotensive effects of ACE inhibitors may be diminished by the concomitant administration of acetylsalicylic acid due to its indirect effect on the renin-angiotensin conversion pathway (i.e. inhibition of vasodilatory prostaglandins leading to decreased glomerular filtration). The potential interaction maybe related to the dose of acetylsalicylic acid (3g/day or more).
Selective serotonin Re-uptake inhibitors (SSRIs): increased risk of upper gastrointestinal bleeding due to possibly synergistic effect.
Digoxin: plasma concentrations of digoxin are increased due to a decrease in renal excretion.
Acetylsalicylic acid and other NSAIDs:
The use of other NSAIDs with salicylates at high doses (≥3g/day) may increase the risk of ulcers and gastrointestinal bleeding due to a synergistic effect.
Ibuprofen: ibuprofen can interfere with anti-platelet effect of low dose acetylsalicylic acid (81-325 mg per day0.long term daily use of ibuprofen may render acetylsalicylic acid less effective when used for cardio protection and stroke prevention.to minimize this interaction, regular users of ibuprofen and of low-dose, immediate release acetylsalicylic acid should take the ibuprofen at least one hour after and 11 hours before the daily acetylsalicylic acid dose. The use of delayed release (e.g. enteric coated) acetylsalicylic acid is not recommended when using ibuprofen regularly. Healthcare professionals should advise consumers and patients regarding the appropriate concomitant use of ibuprofen and acetylsalicylic acid.
Drug-food interactions
Interactions with food have not been established.
Drug-herb interactions
Interactions with herb have not been established.
Drug-laboratory interactions:
Salicylates can produce changes in thyroid function tests.
Drug-lifestyle interactions
Alcohol: increased damage to gastrointestinal mucosa and prolonged bleeding time due to additive effects of acetylsalicylic acid and alcohol. Patients having 3 or more alcoholic drinks per day should consult their physician before use.

Acpophar 81 enteric coated tablets are available in carton boxes containing 3 or 1 (opaque AL/PVC) strips of 10 tablets and inner leaflet.
Store at temperature not exceeding 30 °c, in a dry place.