No-Spa Duo, 40 mg+500 mg tablets 12 pcs
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ATC: N.02.B.E.51 Paracetamol in combination with other drugs, excluding psycholeptics
A combination drug whose action is due to its constituent components.
Drotaverine is an isoquinoline derivative with antispasmodic effects on smooth muscle (inhibition of the enzyme phosphodiesterase IV, increased concentration of cAMP, which, by inactivating the enzyme myosin kinase, leads to relaxation of smooth muscle). Drotaverine also has a weak inhibitory effect on calmodulin-dependent calcium channels.
Regardless of the type of autonomic innervation, drotaverine is effective in smooth muscle spasms. It acts on smooth muscles in the vascular, gastrointestinal, biliary and urogenital systems (the content of phosphodiesterase IV in different tissues is different).
Paracetamol has analgesic and antipyretic effect mainly by inhibiting the synthesis of prostaglandins in the central nervous system. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol, which explains the almost complete absence of anti-inflammatory effect. The absence of blocking effect on the synthesis of Pg in peripheral tissues determines the absence of negative effects of paracetamol on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract.
Paracetamol is rapidly absorbed in the gastrointestinal tract and distributed to most organs and tissues. Absorption is high, time to reach maximum concentration is reached in 0.5-2 h; maximum concentration is 5-20 mcg/ml. Binding with plasma proteins is 15%. Penetrates through the blood-brain barrier. Less than 1% of the dose taken by a nursing mother passes into breast milk.
It is metabolized in the liver (90-95%): 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which conjugate with glutathione to form already inactive metabolites. In case of glutathione deficiency these metabolites can block enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme is also involved in metabolism of the drug.
The elimination half-life is 1-4 hours. It is excreted by the kidneys as metabolites, mainly conjugates, only 3% is unchanged.
In elderly patients the drug clearance decreases and the elimination half-life increases.
Drotaverine when administered orally is rapidly and almost completely absorbed, absorption is high, the half-absorption period is 12 minutes. Bioavailability is 100%. It is evenly distributed in the tissues, penetrates into the smooth muscle cells.
Time to reach maximum concentration – 2 hours.
The binding to plasma proteins is 95-98%.
The elimination half-life is 1-4 hours. It is mainly excreted by kidneys, to a lesser extent – with bile.
It does not pass through the blood-brain barrier.
Pain syndrome of mild to moderate intensity (toothache, headache, joint and muscle pain, neuralgia, algodysmenorrhea), caused, among other things, by spasms of smooth muscles of internal organs (renal colic, biliary colic, hyperkinetic dyskinesia of the biliary tract and gallbladder, intestinal colic, spastic constipation, spastic colitis, tenesms).
Drotaverine hydrochloride – 40.
Paracetamol – 500 mg
Excipients: corn starch, pregelatinized starch, quinoline yellow dye, sodium carboxymethyl starch, magnesium stearate, talc, microcrystalline cellulose RH-102.
How to take, the dosage
Overly, with plenty of fluid 1-2 hours after a meal (taking the drug immediately after a meal leads to delayed onset of action).
In children aged 6 to 12 years the drug is prescribed in a single dose of 1/2 tablet, reapplication of the drug is possible after 10-12 hours, the maximum dose is 2 tablets per day.
Adults and adolescents over 12 years of age are recommended to take the drug in a single dose of 1 -2 pills, and if necessary the drug can be repeated after 8 hours. If the course of treatment is short (not more than 3 days), the maximum daily dose is 6 tablets; if the course of treatment is longer, it should not exceed 4 tablets a day.
In elderly patients with normal hepatic and renal function no adjustment of the dose of the drug is required; in patients with hepatic and/or renal insufficiency the dose of the drug should be reduced and set individually.
The maximum duration of treatment without medical consultation is 3 days.
Drotaverine reduces the effect of levodopa (tremor and rigidity may increase).
The co-administration of paracetamol with chloramphenicol increases the elimination half-life of chloramphenicol and increases its toxicity.
The concomitant use of paracetamol with doxyrubicin increases the risk of liver function abnormalities.
Metoclopramide and domperidone increase the absorption of paracetamol and colestyramine reduces it.
Concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (decrease in the synthesis of procoagulant factors in the liver).
Inducers of microsomal oxidation in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase production of hydroxylated active metabolites, which causes the possibility of severe intoxication even in a small overdose.
The risk of liver damage increases in patients with alcoholic hepatosis.
In mild to moderate renal and hepatic insufficiency, the dose should be adjusted individually.
When using the drug for more than 3 days and/or high doses it is necessary to monitor the picture of peripheral blood (number of leukocytes, platelets) and functional state of the liver (activity of “liver” enzymes). Clinical and laboratory symptoms of hepatotoxic effect begin to appear within 48-72 hours after taking high doses of the drug.
During treatment it is necessary to refrain from driving motor transport and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.
Hypersensitivity; severe renal and hepatic insufficiency; severe chronic heart failure (III-IV functional class according to NYHA classification), II-III degree atrioventricular block, cardiogenic shock; respiratory failure, bronchial asthma; chronic alcoholism; blood diseases (thrombocytopenia, leukopenia, agranulocytosis); glucose-6-phosphate dehydrogenase deficiency; intracranial hypertension; use of other drugs containing paracetamol simultaneously; treatment with monoamine oxidase inhibitors (and within 14 days after their withdrawal); pregnancy and lactation; children under 6 years old.
With caution: Caution is prescribed for patients with benign hyperbilirubinemia (Gilbert syndrome), patients with atrioventricular block of degree I and the elderly.
Central nervous system disorders (usually developed with high doses): dizziness, headache, somnolence.
Cardiovascular system: arterial hypotension, arrhythmia, tachycardia, “hot flashes”.
Digestive system disorders: nausea, constipation, rarely (in high doses) – toxic liver damage.
Hematopoietic system disorders: with prolonged use in high doses – aplastic anemia, agranulocytosis, thrombocytopenia.
Allergic reactions: skin rash, very rarely – bronchospasm, nasal mucous membrane edema.
Symptoms due to paracetamol overdose: during the first 24 hours after ingestion – pale skin, nausea, vomiting, anorexia, abdominal pain; impaired glucose metabolism, metabolic acidosis.
The symptoms of hepatic dysfunction may appear 12-48 hours after overdose. In severe overdose – hepatic failure with progressive encephalopathy, coma; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. Hepatotoxic effect in adults occurs when taking 10 g or more.
Treatment: gastric lavage, saline laxatives, administration of donators of SH-groups and precursors of glutathione-methionine synthesis in 8-9 hours after overdose and N-acetylcysteine – in 12 hours. The need for additional therapeutic measures (further administration of methionine, intravenous N-acetylcysteine) is determined depending on the concentration of paracetamol in blood, as well as on the time elapsed after its administration. In severe damage to the central nervous system, artificial lung ventilation and oxygen therapy may be necessary.
2 years. Do not use after the expiration date printed on the package.
|Conditions of storage|
Store in the original package (blister in the pack), at a temperature not exceeding 25 ° C. Store out of reach of children.
Hinoin Pharmaceutical and Chemical Works, Hungary
Hinoin Pharmaceutical and Chemical Works
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