Lab Medinfar


Full Prescribing Info
Acetylsalicylic acid.
Each tablet contains 100 mg of acetylsalicylic acid (active substance).
Excipients/Inactive Ingredients: The other ingredients are Microcrystalline cellulose 112 and Mannitol.
When used in low doses, acetylsalicylic acid, the active substance in ASP 100, inhibits platelet aggregation. Therefore, this agent is used in situations where prevention of thromboembolic phenomena is required.
ASP 100 is indicated in situations requiring inhibition of platelet aggregation, namely: Prevention of myocardial infarction in patients with unstable angina; Acute myocardial infarction; Prevention of myocardial re-infarction; Secondary prevention of transient ischemic attacks (TIA) and thrombotic cerebrovascular accidents (CVA); Prevention of thromboembolic accidents following vascular surgery or other surgical procedures.
Dosage/Direction for Use
The patient should always take ASP 100 exactly as the doctor has told the patient. Check with the doctor or pharmacist if the patient is not sure. ASP 100 tablets should be administered orally. Tablets should be taken with water. The usual dose is one tablet daily, depending on clinical condition and physician's advice.
If the patient forgets to take ASP: Do not take a double dose to make up for a forgotten dose. Resume treatment as usual, taking the next tablet at the usual time. However, bear in mind that taking the medication regularly is an essential factor for treatment success.
In case of excessive intake of ASP 100 (overdose), the patient may experience fast breathing, nausea, vomiting, dizziness, tinnitus, drowsiness, fever, confusion, coma, acute respiratory failure, hypoglycaemia and bleeding. Chronic overdose (salicylism) essentially manifests itself as nervous system disorders, predominantly affecting the central nervous system. Contact a doctor immediately in any case of overdose with ASP 100.
If the patient is allergic (hypersensitive) to acetylsalicylic acid, other salicylates or any of the other ingredients of this medicine; If the patient has a history of gastrointestinal bleeding or perforations, related to previous NSAIDs therapy; If the patient suffers from peptic ulcer or has a history of recurrent peptic ulcer/bleeding or if the patient bleeds easily; During pregnancy; In children and adolescents younger than 16 years, with or without fever, given the risk of triggering a potentially severe disease (Reye's syndrome).
Special Precautions
Take special care with ASP 100: The doctor who prescribed ASP 100 to the patient should be aware of the patient's clinical history and the patient's current condition.
Concomitant administration of ASP 100 with other medicines used to treat pain and inflammation, including selective cyclooxygenase-2 inhibitors (NSAIDs), should be avoided.
If the patient experiences abdominal symptoms, vomiting of blood or tarry stools, please contact the doctor.
In these patients, treatment should be started with the lowest effective dose. Co-administration of protective agents (e.g., misoprostol or proton pump inhibitors) should be considered in these patients, as well as in patients concomitantly treated with other medicines likely to increase the risk of ulceration or bleeding, such as corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors and antiplatelet agents.
Elderly patients; because of the risk of gastrointestinal bleeding and perforations, continuous prolonged use of ASP should be avoided.
ASP 100 should be administered with caution in the following situations, and only if the expected benefits outweigh potential risks: During pregnancy; Breast-feeding; Allergy to other non-steroidal anti-inflammatory agents; Concomitant treatment with other antiplatelet and/or anticoagulant agents; Glucose-6-phosphate dehydrogenase deficiency; History of hypoprothrombinaemia; Vitamin K deficiency; Severe hepatic disease; Chronic alcoholism, since these patients have an increased risk of upper gastrointestinal bleeding; Severe renal disease; History of gastrointestinal disease; Uncontrolled hypertension; Proliferative diabetic retinopathy; Bronchial asthma, chronic obstructive pulmonary disease, hay fever and nasal polyps; Prolonged periods without clinical monitoring.
Warnings and Precautions: Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk of serious gastrointestinal events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal disease: No information is available from controlled clinical studies regarding the use of ASP 100 in patients with advanced renal disease. Therefore, treatment with ASP 100 is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.
Driving and using machines: Not applicable.
Use In Pregnancy & Lactation
Ask the doctor or pharmacist for advice before taking any medicine.
The patient should not take ASP 100 while breast-feeding, unless the expected benefits outweigh potential risks. Please seek medical advice before taking.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequently side effects are gastrointestinal events, such as abdominal pain, peptic ulcer, gastrointestinal bleeding or perforations, haematemesis, melaena, dyspepsia, vomiting, nausea. Other possible side effects are dizziness, tinnitus, diarrhoea, hypoglycaemia, ferropenic anaemia, haemolytic anaemia associated in patient with G6PD deficiency, dyspnoea, bronehospasm, rhinitis, urticarial, angioedema.
If any of the side effects gets serious, or if the patient notices any side effect not listed in this monograph, please tell the doctor or pharmacist.
Drug Interactions
Treatment may be influenced if acetylsalicylic acid is administered concomitantly with the following medicines or medicines used in the treatment of the following conditions: Blood coagulation (e.g., warfarin); Selective serotonin reuptake inhibitors: the risk of gastrointestinal bleeding is increased; Pain and inflammation (e.g., steroids or anti-inflammatory agents); Corticosteroids: concomitant use with ASP 100 may increase the risk of gastrointestinal bleeding or ulceration; Diabetes (e.g., sulphonylureas); Gout (e.g., probenecid); Cancer or rheumatoid arthritis (e.g., methotrexate); Organ rejection after transplant (cyclosporin, tacrolimus); Sulphonylureas; Vatproic acid (used in the treatment of epilepsy); Insulin; Phenytoin; Triiodothyronine; Increased plasma digoxin concentrations (used in the treatment of heart failure), Barbiturates and lithium (used in the treatment of psychiatric disorders); Diuretics; Concomitant administration of ASP 100 decreases the effect of uricosuric agents (medicines that increase uric acid excretion) and alpha-interferon; Acetylsalicylic acid should never be administered simultaneously with live influenza virus vaccines.
Patients who have received a varicella virus (chickenpox) vaccine are advised not to take acetylsalicylic acid for 6 weeks after vaccination, since cases of a potentially severe disease (Reye's syndrome) have been observed following infection by the varicella virus.
Please tell the doctor if the patient is taking any other medicines before taking acetylsalicylic acid. If the patient takes acetylsalicylic acid on a regular basis, please seek medical advise before taking any other medicines (including medicines not subject to medical prescription).
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines the patient no longer uses. These measures will help protect the environment.
Store below 25°C and keep out of reach of children.
Patient Counseling Information
This medicine should not be given to children under 16 except on medical advice; Consult your physician before taking aspirin during pregnancy or when nursing.
Aspirin irritates the stomach and can cause bleeding. It should not be taken by patients with stomach ulcers, persistent indigestion or liver disease.
ATC Classification
B01AC06 - acetylsalicylic acid ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Tab (white, round) 100 mg x 6 x 10's.
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