Composition, form of production and packaging
Granules for solution for ingestion of 1 sachet (5 g)
paracetamol 500 mg
Pheniramine maleate 25 mg
sodium ascorbate 200 mg
5 g - sachets (8) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Combined drug.
Paracetamol has an analgesic and antipyretic effect. Phenyramin - a blocker of histamine H 1 -receptors, reduces rhinorrhea and lacrimation, eliminates spastic phenomena.
Ascorbic acid (vitamin C) replenishes the increased demand for vitamin C in acute respiratory viral diseases and influenza.
PHARMACOKINETICS
No pharmacokinetics studies have been conducted.
INDICATIONS
- symptomatic therapy of acute respiratory viral diseases, incl. influenza, accompanied by rhinorrhea, lacrimation, rhinopharyngitis, myalgia, headache.
DOSING MODE
Inside. Content of 1 sachet is dissolved in a glass of warm water and consumed regardless of food intake.
Single dose - 1 sachet. Repeated dose, if necessary, is taken every 4 hours, but no more than 4 times within 24 hours.
In case of impaired renal function, liver, elderly, the interval between doses should be increased to 8 hours.
If within 3 days after the beginning of taking the drug, there is no reduction in the symptoms of the disease, it is necessary to consult a doctor.
SIDE EFFECT
Allergic reactions: skin rash, itching, hives, angioedema.
On the part of the digestive system: dry mouth, nausea, vomiting, constipation, pain in the epigastric region, with prolonged use in large doses - hepatotoxic effect, erosive and ulcerative gastrointestinal lesions, bleeding in the gastrointestinal tract.
From the cardiovascular system: tachycardia, increased blood pressure.
From the side of the central nervous system: a decrease in the speed of psychomotor reactions, a feeling of fatigue, drowsiness, dizziness, sleep disturbance.
From the urinary system: urine retention, glucosuria, with prolonged use in large doses - nephrotoxic effect.
From the hemopoietic system: with prolonged use in large doses - thrombocytopenia, anemia, methemoglobinemia.
CONTRAINDICATIONS
- portal hypertension;
- the state of alcoholic or narcotic intoxication;
- kidney failure;
- phenylketonuria;
- deficiency of glucose-6-phosphate dehydrogenase;
- diabetes;
- hemochromatosis, sideroblastic anemia, thalassemia;
- Pregnancy;
- lactation period;
- Children under 15 years.
- hypersensitivity to one of the components of the drug;
With caution:
- Congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome and Rotor syndrome);
- an angle-closure glaucoma;
- liver failure;
- viral, alcoholic hepatitis;
- elderly age;
- Hyperoxaluria, nephrolithiasis;
- Prostatic hyperplasia.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in renal failure. With caution: hyperoxaluria, nephrolithiasis;
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution:
- Congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome and Rotor syndrome);
- liver failure;
- Viral, alcoholic hepatitis.
APPLICATION FOR CHILDREN
Contraindicated for children under 15 years.
APPLICATION IN ELDERLY PATIENTS
Carefully. In the elderly, the interval between doses of the drug should be increased to 8 hours.
SPECIAL INSTRUCTIONS
The drug should not be taken concurrently with other drugs containing paracetamol and ascorbic acid. High doses of ascorbic acid increase the excretion of oxalates, promoting the formation of kidney stones.
In connection with the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor the function of the adrenals and blood pressure.
Ascorbic acid as a reducing agent can distort the results of various laboratory tests (blood and urine glucose content, blood plasma - bilirubin, hepatic transaminase and lactate dehydrogenase activity, uric acid).
Impact on the ability to drive vehicles and manage mechanisms
During the treatment it is necessary to refrain from using ethanol (it is possible to develop hepatotoxic action), driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
OVERDOSE
Symptoms (due to paracetamol): pallor of the skin, decreased appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose). Toxic effect in adults is possible after taking more than 10-15 g of paracetamol: increased activity of prothrombin time (12-48 hours after administration). A detailed clinical picture of liver damage appears after 1-6 days. Rarely, liver failure develops at a lightning speed and can be complicated by renal insufficiency (tubular necrosis).
Treatment: in the first 6 hours after an overdose - gastric lavage, administration of SH-group donors and glutathione-methionine synthesis precursors for 8-9 hours after an overdose and acetylcysteine ​​for 8 hours. The need for additional therapeutic (further introduction of methionine, in the introduction of acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as the time that has passed since it was taken.
DRUG INTERACTION
Conditioned with paracetamol
Reduces the effectiveness of uricosuric medicines (LS). The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a 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 the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a slight overdose.
Long-term use of barbiturates reduces the effectiveness of paracetamol.
Ethanol promotes the development of acute pancreatitis.
Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic effects.
Long-term combined use of paracetamol and other NSAIDs increases the risk of developing analgesic nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure. Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.
Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.
Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
Due to phenyramine
Antidepressants, antiparkinsonian and antipsychotic (phenothiazine derivatives) drugs increase the risk of side effects of phenyramine (urinary retention, dry mouth, constipation), and SCS increase the risk of glaucoma.
Due to ascorbic acid
Increases the concentration in the blood of benzylpenicillin and tetracyclines; in a dose of 1 g / day increases the bioavailability of ethinyl estradiol (including those included in oral contraceptives).
Improves absorption in the intestines of iron preparations (converts trivalent iron into bivalent).
Reduces the effectiveness of heparin and indirect anticoagulants.
Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drink reduce absorption and absorption. With simultaneous application with ASA, urinary excretion of ascorbic acid increases and the excretion of ASA decreases.
Increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood.
Increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body.
LS quinoline series, calcium chloride, salicylates, GCS with prolonged use deplete the stores of ascorbic acid.
With prolonged use or use in high doses, it can interfere with the interaction of disulfiram and ethanol.
In high doses increases the excretion of mexiletine by the kidneys.
Barbiturates and primidon increase the excretion of ascorbic acid in the urine.
Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) - phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The preparation should be stored in a dry, dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 3 years. Do not use after the expiry date printed on the package.
