Ailments associated with colds and flu with fever. Pain complaints of various origin of light and medium intensity, including: headache, muscles, joints, neuropathic pain and others.
Composition:
1 tabl contains 400 mg of Acetylsalicylic acid and 8 mg of codeine phosphate.
Action:
Acetylsalicylic acid is a non-steroidal anti-inflammatory drug with anti-inflammatory, antipyretic and analgesic effects. Inhibits the synthesis of prostaglandins and thromboxane A2. In addition, it inhibits platelet aggregation. It is absorbed almost entirely from the gastrointestinal tract. It binds to plasma albumin in 33%. It is metabolized in the liver and excreted in the urine in unchanged form and in the form of metabolites. T0,5 is 2-3 h. The codeine contained in the preparation has a strong antitussive and analgesic effect synergistic with the action of acetylsalicylic acid. It is well and quickly absorbed from the gastrointestinal tract, it is metabolized in the liver to morphine and norectodeine, it is excreted in the urine mainly in bound form (glucuronates). T0,5 is 2-4 hours.
Contraindications:
Hypersensitivity to the components of the preparation. Hypersensitivity to other NSAIDs, with symptoms such as: bronchospasm, hay fever, shock. Bronchial asthma, chronic respiratory diseases, hay fever or nasal edema, as patients with these conditions may respond to NSAIDs with asthma attacks, limited by swelling of the skin and mucous membrane (angioneurotic edema) or urticaria more often than other patients. Active gastric and / or duodenal ulcer, inflammation or gastrointestinal bleeding. Respiratory depression. acute alcoholic intoxication. States where there is a risk of paralytic bowel obstruction. Severe hepatic or renal failure. Severe heart failure. Blood coagulation disorders (eg haemophilia, thrombocytopenia) and concomitant treatment with anticoagulants (eg coumarin derivatives, heparin). Glucose-6-phosphate dehydrogenase deficiency. Co-administration with Methotrexate at doses of 15 mg per week or more, due to myelotoxicity. Co-administration with MAO inhibitors and up to 2 weeks after discontinuation. Children under 12 years, especially in the course of viral infections, due to the risk of Reye's syndrome. Head injuries or intracranial haemorrhages, because codeine can increase respiratory depression and cerebrospinal fluid pressure. Pregnancy and breastfeeding. Do not use in patients addicted to opioids.
Precautions:
It should not be used in patients taking oral anti-diabetic medicines from the sulphonylurea group due to the risk of increased hypoglycaemic effect and in patients taking anti-gout medicines. Use cautiously in patients with adrenal insufficiency, with renal dysfunction, chronic renal failure, prostatic hyperplasia and with impaired urinary outflow, with bile duct diseases (eg cholelithiasis) and after surgical procedures in the bile ducts. Use with caution in patients with juvenile rheumatoid arthritis and systemic lupus erythematosus and liver failure; liver function should be monitored. Exercise caution in case of uterine haemorrhage, excessive menstrual bleeding and use of the intrauterine contraceptive pad, hypertension, and heart failure. Caution should be exercised when co-administered with methotrexate at doses of <15mg / week due to the increase of its toxic effect on the bone marrow. Alcohol consumption should be avoided during treatment due to the risk of gastrointestinal adverse reactions and respiratory depression. In elderly patients, the dose should be reduced and the intervals between doses should be increased due to the increased occurrence of gastric mucosal irritation and gastrointestinal bleeding. The abuse of codeine-containing medicines can lead to dependence with the occurrence of withdrawal symptoms after the sudden end of treatment.
Pregnancy and lactation:
Do not use during pregnancy and breast-feeding.In women, a transient fertility disorder may occur by affecting ovulation that subsides after completion of therapy.
Side effects:
The following may occur: heart failure, thrombocytopenia, anemia due to gastrointestinal bleeding, hemolytic anemia in patients deficient in glucose-6-phosphate dehydrogenase, leukopenia, agranulocytosis, eosinopenia, increased risk of bleeding, prolonged bleeding time and prothrombin time; tinnitus, impaired hearing, dizziness, drowsiness, mood disorders, hallucinations, convulsions (children), sedation; miosis; respiratory depression, bronchospasm; indigestion, heartburn, feeling of fullness in the epigastrium, nausea, vomiting, lack of appetite, stomachache, dry mouth, constipation, gastrointestinal bleeding, damage to the gastric mucosa, ulcer disease, perforations; proteinuria, presence of leucocytes and erythrocytes in the urine, renal papillary necrosis, interstitial nephritis, urinary retention, urinary retention, ureteral contraction; itching, rash; hypertension, orthostatic decrease in blood pressure; rash, urticaria, angioneurotic edema, bronchospasm, shock; focal liver cell necrosis, tenderness and hepatomegaly, especially in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, rheumatic fever or a history of liver disease, transient increase in serum transaminases and alkaline phosphatase, bilirubin, acute abdominal pain and pain characteristic for diseases of the bile ducts or pancreas, indicating the contraction of Oddi's sphincter (this applies mainly to patients after removal of the gallbladder); lowering libido or potency.
Dosage:
Orally. Adults: 1-2 tablets at a time, if necessary, the dose may be repeated 2-3 times a day, not more often than every 4 hours. Do not take more than 6 tablets. per day. Youth over 12 years: 1-2 tabl. per day. The tablets are taken with or without water, with a large amount of water. The lowest effective dose should be used.
(C)
