Prevention and treatment of ailments associated with dysmenorrhea, renal or hepatic colic, irritable bowel syndrome.
Composition:
1 tabl powl. contains 500 mg of Paracetamol and 10 mg of hyoscine butylbromide. The drug contains sorbitol.
Action:
The drug combines the analgesic effect of paracetamol and spasmodic hyoscynia. Paracetamol has an analgesic and antipyretic effect by inhibiting the activity of prostaglandin cyclooxygenase at o.u.n. It is well absorbed from the gastrointestinal tract. About 25% (5-50% depending on the dose) is bound to plasma proteins. T0,5 is 1-3 hours, it is prolonged (over 4 hours) in patients with liver damage. Paracetamol metabolism occurs mainly in the liver, and excretion occurs mainly in the urine after conjugation with glucuronic acid or sulfuric acid. Buthiobromide hyoscynia has a spasmolytic effect on smooth muscle by affecting the sympathetic ganglia of visceral abdominal organs (blocking muscarinic and nicotinic receptors): gastrointestinal tract, urogenital system, bile ducts. When administered orally, it is poorly absorbed in the initial section of the small intestine, reaching Cmax in the blood after 1-3 h. Buthiobromide remains at a high concentration in the site of action and does not pass through the blood-brain barrier, and therefore has a negligible effect on o.u.n. After oral administration of hyoscine, a significant fraction of it is eliminated unchanged in the first hours after administration.
Contraindications:
Hypersensitivity to atropine, Paracetamol, or any of the components of the drug. Severe hepatic failure (mainly in patients with alcoholic liver injury) or kidneys, alcoholism, anemia and congenital lack of G-6-PD (favism), myasthenia gravis and conditions in which any anticholinergic effects could be particularly dangerous (glaucoma, prostatic hypertrophy) causing urinary retention, narrowing in the gastrointestinal tract, tachycardia).
Precautions:
Carefully use in patients with mitral valve stenosis, coronary artery disease and acute myocardial infarction, as well as renal and hepatic insufficiency, intestinal ulceration, gastro-oesophageal reflux and other chronic upper gastrointestinal smooth muscle tone or pyloric stenosis. In the case of serious side effects, such as visual acuity or pain caused by increased pressure in the eye, the drug should be discontinued. Do not use other paracetamol-containing medicines during treatment. Do not use this medicine in children under 12 years of age. The drug contains sorbitol - should not be used in patients with hereditary fructose intolerance.
Pregnancy and lactation:
The medicine can only be used if the benefits to the mother outweigh the potential risk to the fetus. Do not use during breastfeeding (no data on hyoscine transfer to breast milk).
Side effects:
Very rare: methemoglobinemia, agranulocytosis, thrombocytopenia, anaphylactic reactions, symptoms of cutaneous hypersensitivity (skin rashes, angioedema, Stevens-Johnson syndrome), retinal discoloration, glaucoma, cardiac activity, hypotension, bronchospasm in patients sensitive to Aspirin and other NSAIDs, nausea, vomiting, diarrhea, impaired liver function, pruritus, urticaria, rash, erythema, angioneurotic edema, impaired renal function. In addition, there may be dry mouth, disturbed accommodation, confusion, memory problems, dizziness.
Dosage:
Orally. Adults and children> 12 years: 1-2 tablets, maximum 3 times a day, every 8 hours; do not exceed the dose of 6 tablets per day. Do not use for more than 3 days without consulting your doctor.