Description
Release form
Tablets
Packing
12 pcs.
Indications
Pain syndrome caused by smooth muscle spasms: gastrointestinal tract (spastic constipation, irritable bowel syndrome)
of the biliary tract (gallstone disease, cholecystitis, cholangitis)
of the urinary tract (urinary, urinary (urinary) pain)
for diseases of the female genital organs (dysmenorrhea, adnexitis)
myalgia, arthralgia, neuralgia, sciatica
toothache.
Contraindications
hypersensitivity to the components of the drug
intracranial hypertension
thrombocytopenia, leukopenia, agranulocytosis
treatment with MAO inhibitors (for 14 days)
severe renal insufficiency acute liver -phosphate dehydrogenase
chronic alcoholism and drug addiction
concomitant use of other drugs containing paracetamol
children’s age (up to 6 years).
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Special instructions
When using the drug for more than 3 days and / or in high doses, it is necessary to control the picture of peripheral blood and the functional state of the liver (the number of leukocytes, platelets, as well as the level of creatinine and the activity of liver enzymes in the blood).
Clinical and laboratory symptoms of the hepatotoxic effect begin to appear within 48-72 hours after taking large doses of the drug.
Composition
1 tablet contains:
active ingredients: paracetamol 500 mg, drotaverin hydrochloride 40 mg
Dosage and Administration
Inside. The drug is recommended for use on 1-2 tablets. at one time, if necessary, you can repeat the dose after 8 hours.
The maximum daily dose is 6 tablets, with a long course it should not exceed 4 tablets / day.
To achieve a quick effect, the drug should not be taken with food.
For children aged 6 to 12 years, the drug is prescribed in a single dose of 1 / 2-1 tab. Repeated use of the drug is possible after 10-12 hours, the maximum dose is 2 tablets / day.
Elderly patients with normal liver and kidney function do not require dose adjustment.
In severely impaired liver and kidney function, the dose should be reduced.
At a glomerular filtration rate of less than 10 ml / min, the time elapsed between taking 2 doses should be more than 12 hours. In this category of patients, only occasional use of the drug is allowed.
The maximum duration of treatment without medical advice is 3 days.
Side effects of
Side effects are rare with the recommended therapeutic doses.
The following undesirable effects are presented for organ systems in accordance with the following gradation in the frequency of their occurrence: very often? 10% often -? 1 <10% infrequently -? 0.1 <1% rarely -? 0.01 0, 1% is very rare - <0.01%. On the part of the skin and subcutaneous fat: in individuals with hypersensitivity, hypersensitivity reactions (rash, hyperemia) may occur. From the CCC: rarely – lowering blood pressure, palpitations. From the nervous system: rarely – headache, dizziness, drowsiness. From the gastrointestinal tract: rarely – nausea, constipation, pancreatitis (due to the content of codeine in the preparation). From the hemopoietic system and the lymphatic system: rarely – hematopoietic disorders (agranulocytosis, thrombocytopenia). On the part of the immune system: very rarely – systemic allergic reactions, bronchospasm, hay fever, swelling of the nasal mucosa. From the liver and biliary tract: when taking the drug in high doses, especially for a long time, toxic liver damage is possible, and when taking the drug in very high doses (exceeding the recommended doses), life-threatening liver damage (irreversible necrosis of the liver tissue) can develop. From the urinary system: with prolonged use in high doses, a decrease in kidney function is possible. Drug interaction Drotaverinum reduces the effect of levodopa (tremor and stiffness may increase). When using paracetamol together with drugs that induce liver enzymes (salicylamide, barbiturates, antiepileptic, tricyclic antidepressants, alcohol, rifampicin), the concentration of toxic paracetamol metabolites increases. When using paracetamol simultaneously with chloramphenicol, the half-life of the latter increases and its toxicity increases. The simultaneous use of paracetamol with doxirubicin increases the risk of developing liver dysfunction. Paracetamol reduces the effect of uricosuric drugs. Metoclopramide and domperidone enhance paracetamol absorption, while colestyramine reduces it. With prolonged use of the drug, the risk of bleeding increases due to the presence of paracetamol. Overdose At overdosage of drotaverine, atrial ventricular conduction may be impaired, cardiac muscle excitability may be reduced, cardiac arrest and respiratory center paralysis may occur. Treatment: gastric lavage and saline laxatives are recommended. Treatment should be aimed at maintaining the vital functions of the body, in the case of respiratory depression may require artificial lung ventilation, oxygen inhalation, the introduction of naloxone, and for signs of liver damage – the use of the antidote paracetamol (acetylcysteine) and the precursor of glutathione (methionine). Storage conditions Do not store above 30 ° C in a dry place. Keep out of the reach and sight of children! Shelf life 3 years. Conditions of sale from pharmacies Without a prescription dosage form tablets Unique Pharmaceutical, India
