Vervex for children powder for oral solution, 8pcs

Composition

Powder for the preparation of a solution for oral use is light pink in color with white and dark pink inclusions.

Auxiliary substances:

mannitol-2.26 g,

citric acid-0.03 g,

povidone K30-0.006 g,

magnesium citrate-0.242 g,

potassium acesulfame-0.036 g,

raspberry flavor* – 0.036 g

. * composition of raspberry flavor:

maltodextrin,

E1450 modified corn starch,

E129 charming red dye,

E133 brilliant blue

dye, E110 sunset yellow dye,

permastabil 505528 RI,

raspberry 054428 A (ethyl acetate, isoamyl acetate, acetic acid, benzyl alcohol, triacetin, vanillin, p-hydroxy-benzylacetone), sodium chloride and/or sodium sulfate.

Pharmacological action

Fervex® for children is a combination drug that contains paracetamol, phenyramine maleate and ascorbic acid. Paracetamol is a nonsteroidal anti-inflammatory drug that blocks cyclooxygenase, mainly in the central nervous system, affecting the centers of pain and thermoregulation; it has analgesic and antipyretic effects. Paracetamol has analgesic and antipyretic effects. Phenyramine maleate is a histamine H1-receptor blocker. Narrows the nasal vessels, eliminates swelling and hyperemia of the nasal mucosa, nasopharynx and paranasal sinuses. Ascorbic acid takes part in the regulation of redox processes, reduces vascular permeability and increases the body’s resistance. Pharmacokineticsparacetamolabsorption of paracetamol is complete and rapid. Peak plasma concentrations are reached 30-60 minutes after use. The distribution of paracetamol in the tissues is rapid. Comparable concentrations of the drug in blood, saliva and plasma are achieved. Binding to plasma proteins is low,10-25%. Penetrates the blood-brain barrier. Metabolism occurs in the liver,80% is conjugated with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which are conjugated with glutathione to form already inactive metabolites. When glutathione is deficient, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme is also involved in drug metabolism. T 1/2 – 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates. Less than 5% is displayed unchanged. T 1/2 is about 2 h. Phenyramine maleate is well absorbed in the digestive tract. T 1/2 from the blood plasma is from 1 to 1.5 h. It is excreted from the body mainly by the kidneys. Ascorbic acid is well absorbed in the digestive tract. TSMAKH after oral use – 4 h. It is mainly metabolized in the liver. It is excreted by the kidneys, through the intestines, with sweat in unchanged form and in the form of metabolites.

Indications

For children aged 6 to 15 years for short-term treatment of conditions accompanied by:

– increased body temperature, runny nose with “colds”;

– rhinitis and rhinopharyngitis of infectious-inflammatory and allergic natures.

Use during pregnancy and lactation

The drug is contraindicated in the first and third trimesters of pregnancy. The drug should be used with caution in the second trimester of pregnancy. The use of the drug during lactation is contraindicated.

Contraindications

-Hypersensitivity to one of the components of the drug;- severe liver function disorders;— severe renal dysfunction— – blood diseases; – deficiency of the enzyme glucose-6-phosphate dehydrogenase— – I and III trimesters of pregnancy— – lactation period;— under 6 years of age; – phenylketonuria— – sucrose/isomaltase deficiency;— fructose intolerance, glucose-galactose malabsorption. With caution: benign hyperbilirubinemia (including Gilbert’s syndrome), with impaired liver or kidney function, with diabetes mellitus, the second trimester of pregnancy.

Side effects

The drug is well tolerated in the recommended doses. Possible: dry mouth, nausea, vomiting, abdominal pain, urination disorders, constipation, allergic reactions (skin rash, pruritus, urticaria, angioedema), drowsiness, accommodation disorders, anemia, leukopenia, agranulocytosis, thrombocytopenia. With prolonged use in doses exceeding the recommended ones, hepatotoxic and nephrotoxic effects, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia are possible. If adverse reactions occur, the patient should stop taking the drug and consult a doctor.

Interaction

Fervex ® for children, due to the phenyramine maleate included in the composition, enhances the effect of sedatives, and when used together with antipsychotics (phenothiazine derivatives), the risk of side effects of the drug increases (urinary retention, dry mouth, constipation). Consideration should be given to the possibility of enhancing central atropine-like effects when used in combination with other substances with anticholinergic properties (other antihistamines, imipramine group antidepressants, phenothiazine-type neuroleptics, anticholinergic antiparkinsonian agents, atropine-like antispasmodics, disopyramide). When using the drug together with barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxic effects (due to the paracetamol included in the composition) significantly increases. Concomitant use with salicylates increases the risk of nephrotoxic effects. When used concomitantly with levomycetin (chloramphenicol), the toxicity of the latter increases. Paracetamol contained in the preparation enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs. Caution should be exercised when concomitantly using paracetamol and inducers of microsomal liver enzymes (for example, ethanol, barbiturates, isoniazid, rifampicin, carbamazepine, zidovudine, anticoagulants, amoxicillin + clavulanic acid, phenylbutazone, tricyclic antidepressants) due to the increased risk of hepatotoxic effects. Myelotoxic drugs increase the manifestations of paracetamol hematotoxicity, metoclopramide increases its absorption.

How to take, course of use and dosage

The drug is used inside. Before use, the contents of the sachet should be dissolved in a glass (200 ml) of warm water.

Depending on the age of the child, the drug is used in the following doses: :

– children from 6 to 10 years – 1 sachet 2 times/day;

– children from 10 to 12 years – 1 sachet 3 times/day;

– children from 12 to 15 years-1 sachet 4 times/day.

The interval between doses of the drug is at least 4 hours. The duration of treatment is no more than 3 days.

Overdose

Symptoms:  signs of acute paracetamol poisoning include anorexia, nausea, vomiting, epigastric pain, sweating, pallor of the skin, and drowsiness. After 1-2 days, signs of liver damage appear. In severe cases, liver failure, hepatonecrosis, encephalopathy and coma develop. Treatment: if you experience symptoms of poisoning, stop using the drug and immediately consult a doctor. Gastric lavage, use of enterosorbents (activated carbon, hydrolytic lignin), intravenous use of the antidote acetylcysteine, and methionine are recommended.

Special instructions

Fervex® for children should not be used simultaneously with other medications containing paracetamol. When using the drug for more than a week, it is necessary to monitor the functional state of the liver and the picture of peripheral blood. Paracetamol distorts the results of laboratory tests of glucose and uric acid in blood plasma. In the absence of a therapeutic effect (fever persists for more than 3 days and pain for more than 5 days), a doctor’s consultation is required. Effects on the ability to drive vehicles and mechanicsaccepting the possibility of adverse reactions such as drowsiness, impaired accommodation, you should refrain from driving vehicles and working with mechanisms.

Form of production

Powder for the preparation of a solution for oral use,0.280 g + 0.010 g + 0.100 g. 3 g of powder in a bag made of paper / A1 / polyethylene. 8 sachets together with the instructions for use in a cardboard box.

Storage conditions

The drug should be stored out of the reach of children at a temperature of 15° to 25°C.

Shelf

life is 3 years.

Active ingredient

Paracetamol, Phenyramine, Ascorbic acid

Dosage form

solution for oral use

Purpose

Pregnant women only in the second trimester as prescribed by a doctor, Children over 6 years of age

Indications

Tonsillitis, Flu, Cold, Pharyngitis, Respiratory Tract Infections, Runny Nose, Otitis Media, Sore Throat