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indications:
Prevention and treatment of ailments related to dysmenorrhea, renal colic, hepatic and irritable bowel syndrome.
Composition:
1 suppository contains 800 mg of Paracetamol and 10 mg of hyoscine butylbromide.
Action:
A complex drug with analgesic and diastolic effects. Paracetamol has an analgesic and antipyretic effect, has no anti-inflammatory effect and does not affect platelet aggregation. The hyoscine butyl chromium acts mainly on sympathetic ganglia in the walls of visceral abdominal organs. Has a spasmolytic effect, causes smooth muscle relaxation in the gastrointestinal tract, urogenital system and bile ducts. Paracetamol is well absorbed from the gastrointestinal tract. It is quickly and easily distributed to most body tissues. On average, about 25% of the administered dose is associated with plasma proteins, and the degree of binding varies between 5 and 50% depending on the dose. Paracetamol passes through the placental barrier and into the breast milk of the nursing mother. Metabolism of paracetamol occurs mainly in the liver, and excretion occurs mainly in the urine after conjugation with glucuronic acid or sulfuric acid. T0,5 is about 1-3 hours. Hyoscyl butylbromide after rectal administration is poorly absorbed. Its distribution in humans is not exactly known. Poor absorption causes that it remains in high concentration at the site of action and does not pass through the blood-brain barrier, therefore it has a slight effect on o.u.n. After rectal administration of hyoscine butylbis, a significant portion of it is eliminated unchanged in the first hours after administration.
Contraindications:
Hypersensitivity to atropine, paracetamol or any of the excipients. Severe hepatic failure (mainly in patients with alcoholic liver damage) or kidneys. Alcoholic disease. Anemia. Congenital deficiency of glucose-6-phosphate dehydrogenase. Myasthenia gravis. Conditions in which any anticholinergic activity could be particularly dangerous (glaucoma, prostatic hypertrophy causing urinary retention, narrowing in the gastrointestinal tract, tachycardia).
Precautions:
Caution should be exercised in patients with mitral valve stenosis, coronary artery disease, acute myocardial infarction, hepatic or renal failure, and gastroesophageal reflux and other chronic upper GI tumesor motor or pyloric stenosis. In patients with intestinal ulceration, the drug may reduce intestinal motility and cause constipation. In the elderly, the drug may cause disorders on the part o.u.n., dry mouth and in men - urinary retention; if the symptoms are serious, stop taking the medicine. In addition, the drug should be discontinued if visual acuity or pain occurs due to increased pressure in the eye. You should not drink alcohol during treatment. Co-administration of several paracetamol-containing medicines (risk of overdose) is not recommended. The special risk of liver damage associated with the use of paracetamol exists in people who are starved and regularly consuming alcohol. Less than 5% of patients allergic to Acetylsalicylic acid can also be allergic to paracetamol.
Pregnancy and lactation:
It can only be used during pregnancy if the benefits of treatment outweigh the potential risk to the fetus. No studies have been carried out on hyoscine transfer to breast milk, hence the drug should not be used during breastfeeding.
Side effects:
Very rare: methemoglobinemia, agranulocytosis, thrombocytopenia, anaphylactic reactions, symptoms of cutaneous hypersensitivity (skin rash, angioedema, Stevens-Johnson syndrome), retinal discoloration and 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, you may experience: accommodation disorders, dry mouth, confusion, memory problems, dizziness.
Dosage:
Rectally. Adults and adolescents> 12 years: 1 suppository, if indicated 3-4 times daily, every 6 hours. Do not use more than 4 cones per day. Without clear indications, the drug should not be used regularly for more than 3 days.