Powder for preparation of oral solution [raspberry with sugar], 8 pcs

Composition

1 sachet sodezhit

Active ingredients:

paracetamol 500 mg,

phenyramine maleate 25 mg,

ascorbic acid 200 mg;

Auxiliary substances:

sucrose-11.555 g,

citric acid-0.2 g,

acacia gum-0.1 g,

sodium saccharinate dihydrate-0.02 g,

raspberry flavor* – 0.15 g.

* the composition of raspberry flavoring: ethyl acetate, isoamyl acetate, acetic acid, benzyl alcohol, triacetin, vanillin, p-hydroxy-benzylacetone, maltodextrin, E1450 modified corn starch, E129 dye enchanting red, E133 brilliant blue dye, dye E110 sunset yellow, permasteel 505528 RI, raspberry 054428 A, sodium chloride and/or sodium sulfate.

Pharmacological action

Combined drug.

Paracetamol has analgesic and antipyretic effects, which is associated with its effect on the thermoregulatory center in the hypothalamus; eliminates headaches and other types of pain, reduces fever.

Ascorbic acid (vitamin C) is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, synthesis of corticosteroids, collagen and procollagen; normalizes capillary permeability. Increases the body’s resistance, which is associated with the stimulation of the immune system.

Phenyramine-a blocker of_H1— histamine receptors-reduces rhinorrhea, nasal congestion, sneezing, lacrimation, itching and redness of the eyes.

Pharmacokinetics

Paracetamol. The absorption 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 through the BBB.

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 isoenzyme CYP2E1. T_1/2 — 1-4 hours is also involved in the metabolism of the drug. It is excreted by the kidneys in the form of metabolites, mainly conjugated. Less than 5%

of phenyramine maleate is excreted unchanged. It is well absorbed in the digestive tract. T_1/2 from the blood plasma is 1-1.5 hours. It is excreted from the body mainly through the kidneys.

Ascorbic acid. It is well absorbed in the digestive tract. T_max after oral use — 4 hours. 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

• erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);
• liver failure;
• angle-closure glaucoma;
• urinary retention associated with diseases of the prostate and urinary disorders;
• portal hypertension;
• alcoholism;
• phenylketonuria;
• glucose-galactose malabsorption, deficiency of sucrase/isomaltase, fructose intolerance;
• children’s age (under 15 years);
• pregnancy (safety have not been studied);
• lactation (safety have not been studied);
• increased sensitivity to paracetamol, ascorbic acid, Pheniramine or any other component of the drug.

With caution:  renal failure, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, old age, diabetes mellitus.

Use during pregnancy and lactation

The use of the drug is contraindicated in the first and third trimesters of pregnancy and during lactation (breastfeeding).

Use in children

Contraindication: children under 15 years of age.

Contraindications

• hypersensitivity to the components of the drug;
• erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase);
• renal failure;
• portal hypertension;
• chronic alcoholism;
• glucose-6-phosphate dehydrogenase deficiency;
• children under 15 years of age;
• I and III trimesters of pregnancy;
• lactation (breastfeeding).

The drug should be used with caution in patients with hepatic insufficiency, angle-closure glaucoma, prostatic hyperplasia, congenital hyperbilirubinemia (Gilbert’s, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, and elderly patients.

Side effects

The drug is well tolerated in the recommended doses. When using the drug, the following side effects were noted (frequency is not established).

From the hematopoietic system:  anemia, leukopenia, agranulocytosis, thrombocytopenia.

From the immune system:  allergic reactions (erythema, skin rash, pruritus, angioedema, anaphylactic shock).

Nervous system disorders:  drowsiness, confusion, hallucinations, impaired concentration (more often in elderly patients), agitation, nervousness, insomnia, coordination dysfunction, tremor.

From the side of the visual organ:  violation of accommodation.

From the cardiovascular system:  palpitations, orthostatic hypotension, dizziness.

From the digestive system:  dry mouth, nausea, vomiting, abdominal pain, constipation.

From the urinary system:  violation of urination.

If adverse reactions occur, the patient should stop taking the drug and consult a doctor.

Interaction

Ethanol increases the sedative effect of antihistamines (phenyramine), so it should be avoided during treatment with Fervex®. In addition, ethanol, when used concomitantly with phenyramine, contributes to the development of acute pancreatitis.

Feniramin enhances the action of sedatives: derivatives of morphine, barbiturates, benzodiazepine, and other tranquilizers, neuroleptics (meprobamate, phenothiazines), antidepressants (amitriptyline, mirtazapine, mianserin), antihypertensive medications Central action, sedatives, belonging to the group of histamine H₁-receptors, baclofen; this not only increases sedative effect, but also increases the risk of side effects (urinary retention, dry mouth, constipation).

Consideration should be given to the possibility of enhancing the central m-holinoblocking effects when used in combination with other drugs with m-holinoblocking activity (other histamine_H1-receptor blockers, tricyclic antidepressants, phenothiazine-type neuroleptics, antispasmodic and antiparkinsonian agents with m-holinoblocking activity, disopyramide).

When using the drug together with inducers of microsomal oxidation: 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.

CORTICOSTEROIDS, when used concomitantly, increase the risk of glaucoma.

Concomitant use with salicylates increases the risk of nephrotoxic effects.

When used concomitantly with chloramphenicol (levomycetin), the toxicity of the latter increases.

Paracetamol enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.

Ascorbic acid increases the concentration of benzylpenicillin and tetracyclines in the blood; at a dose of 1 g/day, it increases the bioavailability of ethinyl estradiol (including that included in oral contraceptives).

Ascorbic acid improves the absorption of iron preparations in the intestine (converts trivalent iron to divalent); it can increase the excretion of iron when used simultaneously with deferoxamine.

Ascorbic acid reduces the effectiveness of heparin and indirect anticoagulants.

When used concomitantly with acetylsalicylic acid (ASA), the urinary excretion of ascorbic acid increases and the excretion of ASA decreases. ASA reduces the absorption of ascorbic acid by about 30%. Increases the risk of crystalluria during treatment with short-acting salicylates and sulfonamides, slows down the excretion of acids by the kidneys, increases the excretion of drugs with an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood.

Ascorbic acid increases the total clearance of ethanol, which, in turn, reduces the concentration of ascorbic acid in the body.

Quinoline-type drugs, calcium chloride, salicylates, and corticosteroids deplete ascorbic acid reserves with prolonged use.

When used concomitantly, ascorbic acid reduces the chronotropic effect of isoprenaline.

When used for a long time or in high doses, ascorbic acid may interfere with the interaction of disulfiram and ethanol.

In high doses, ascorbic acid increases the excretion of mexiletin by the kidneys.

Barbiturates and primidone increase the excretion of ascorbic acid in the urine.

Ascorbic acid reduces the therapeutic effect of neuroleptics-phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

How to take it, course of use and dosage

Inside,1 sachet 2-3 times/day. Before use, the contents of the sachet should be dissolved in a glass (200 ml) of warm water.The maximum duration of treatment is 5 days.

The maximum daily dose of paracetamol for a body weight of more than 50 kg should not exceed 4 g (or 8 bags of Fervex®); in children or patients weighing 40-50 kg, the maximum daily dose of paracetamol should not exceed 3 g, for a body weight of less than 40 kg-no more than 2 g.

The interval between doses of the drug should be at least 4 hours.

In patients with impaired renal function (creatinine clearance (CC)) the interval between doses of the drug should be at least 8 hours.

In patients with chronic or decompensated liver diseases, in patients with hepatic insufficiency, chronic alcoholism, in emaciated patients and with dehydration, the daily dose of paracetamol should not exceed 3 g.

Do not take the drug for more than 3 days as an antipyretic and more than 5 days as an analgesic.

If there is no relief of symptoms within 5 days after starting the drug, if the body temperature remains elevated, or if it suddenly rises again after the initial decrease, the patient should consult a doctor.

Overdose

Paracetamol-related symptoms

Overdose can lead to intoxication, especially in elderly patients, children, patients with liver diseases (caused by chronic alcoholism), in patients with nutritional disorders, as well as in patients taking inducers of microsomal liver enzymes, which can develop lightning – fast hepatitis, liver failure, cholestatic hepatitis, in the above cases-sometimes with a fatal outcome. The overdose threshold may be lower in these categories of patients. The clinical picture of acute overdose develops within 24 hours after taking paracetamol.

Symptoms: gastrointestinal disorders (nausea, vomiting, decreased appetite, abdominal discomfort and / or abdominal pain), pallor of the skin. With simultaneous use of 7.5 g or more to adults or more than 140 mg/kg to children, cytolysis of hepatocytes occurs with complete irreversible liver necrosis, the development of liver failure, metabolic acidosis and encephalopathy, which can lead to coma and death. 12-48 hours after paracetamol use, there is an increase in the activity of microsomal liver enzymes, lactate dehydrogenase, bilirubin concentration, and a decrease in prothrombin concentration. Clinical symptoms of liver damage appear 2 days after an overdose of the drug and reach a maximum on day 4-6.

Treatment: immediate hospitalization. Determination of the quantitative content of paracetamol in blood plasma before starting treatment as early as possible after an overdose. use of SH-group donors and glutathione synthesis precursors-methionine and acetylcystine-is most effective in the first 8 hours. The need for additional therapeutic measures (further use of methionine, intravenous use of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its use. Symptomatic treatment. Laboratory tests of the activity of microsomal liver enzymes should be performed at the beginning of treatment and then every 24 hours. In most cases, the activity of microsomal liver enzymes normalizes within 1-2 weeks. In very severe cases, a liver transplant may be required.

Symptoms caused by the action of ascorbic acid

Symptoms: nausea, diarrhea, irritation of the gastrointestinal mucosa, flatulence, abdominal pain of a spastic nature, frequent urination, nephrolithiasis, insomnia, irritability, hypoglycemia.

Treatment: immediately stop using the drug and consult a doctor. Treatment is symptomatic, forced diuresis.

Phenyramine-related symptoms

Symptoms: convulsions, impaired consciousness, coma.

Treatment: immediately stop using the drug and consult a doctor. Gastric lavage, use of enterosorbents (activated carbon, hydrolytic lignin), intravenous or oral use of the antidote acetylcysteine (if possible, in the first 10 hours after overdose), and symptomatic treatment are recommended.

Special instructions

If you are taking metoclopramide, domperidone, or colestyramine, you should also consult your doctor.

It is possible to distort the indicators of laboratory tests when quantifying the concentration of uric acid and glucose in plasma. In order to avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, as well as taken by people who are prone to chronic alcohol consumption. The risk of developing liver damage increases in patients with alcoholic hepatosis.

In the case of taking the drug by patients suffering from diabetes mellitus or who are on a diet with a low sugar content, it should be borne in mind that each sachet contains 11.5 g of sugar, which corresponds to 0.9 XE.

Fervex Form of production. Powder for the preparation of a solution for oral use raspberry.

Storage conditions

In a dry place, at a temperature not exceeding 25 °C, out of the reach of children.

Shelf

life is 3 years.

Active ingredient

Paracetamol, Phenyramine, Ascorbic acid

Dosage form

powder for oral use

Purpose

For adults, Children over 15 years of age, Pregnant women only in the second trimester as prescribed by a doctor

Indications

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