Fervex powder lemon flavor without sugar, No. 8

It is used for acute respiratory diseases, acute respiratory viral infections, rhinopharyngitis to relieve the following symptoms:

rhinorrhea,

nasal congestion;

headache;

increased body temperature;

lacrimation;

sneeze.

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

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

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

In patients with impaired renal function (creatinine clearance (CC) <10 ml / min), 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 malnourished patients and with dehydration, the daily dose of paracetamol should not exceed 3 g.

You should not take the drug for more than 3 days as an antipyretic agent and for more than 5 days as a pain reliever.

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

Powder for preparation of oral solution (lemon), light beige; blotches of brown are allowed; the prepared solution is opalescent, light yellow with a grayish tinge or yellowish-grayish color.

1 pack.

paracetamol 500 mg

pheniramine maleate 25 mg

ascorbic acid 200 mg

Excipients: mannitol - 3.515 g, citric acid - 0.05 g, povidone K30 - 0.01 g, magnesium citrate - 0.4 g, aspartame - 0.05 g, lemon-rum flavor * - 0.2 g.

• erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase);

• liver failure;

• angle-closure glaucoma;

• urinary retention associated with diseases of the prostate gland and urinary disorders;

• portal hypertension;

• alcoholism;

• phenylketonuria;

• deficiency of glucose-6-phosphate dehydrogenase;

• children's age (up to 15 years old);

• pregnancy (safety has not been studied);

• lactation period (safety has not been studied);

• hypersensitivity to paracetamol, ascorbic acid, feniramine or any other component of the drug.

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

pharmachologic effect

Combined preparation containing paracetamol, pheniramine and ascorbic acid.

Paracetamol is a non-narcotic analgesic that blocks cyclooxygenase, mainly in the central nervous system, affecting the centers of pain and thermoregulation; has an analgesic and antipyretic effect.

Pheniramine - a blocker of histamine H1-receptors, reduces rhinorrhea and lacrimation, eliminates spastic phenomena, swelling and hyperemia of the mucous membrane of the nasal cavity, nasopharynx and paranasal sinuses.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, in the synthesis of steroid hormones; reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. Improves the tolerance of paracetamol and lengthens its action (associated with lengthening T1 / 2).

Pharmacokinetics

Paracetamol

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Cmax of the drug in blood plasma is reached 10-60 minutes after administration. It is quickly distributed throughout the tissues of the body, penetrates the blood-brain barrier. Plasma protein binding is insignificant and has no therapeutic value, but increases with increasing dose.

Metabolism occurs in the liver, 80% of the dose taken enters into conjugation reactions 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. One of the hydroxylated metabolic intermediates exhibits a hepatotoxic effect. This metabolite is rendered harmless by conjugation with glutathione, but it can also accumulate in case of an overdose of paracetamol (150 mg of paracetamol / kg or 10 g of paracetamol orally) to cause necrosis of hepatocytes. It is excreted by the kidneys in the form of metabolites, mainly in the form of conjugates. Less than 5% of the dose taken is excreted unchanged. T1 / 2 is from 1 to 3 hours.

Pheniramine

It is well absorbed in the digestive tract. T1 / 2 from blood plasma ranges from 1 to 1.5 hours. It is excreted from the body mainly through the kidneys.

Vitamin C

Well absorbed in the digestive tract. The time to reach the maximum therapeutic concentration (TCmax) after oral administration is 4 hours. It is metabolized mainly in the liver. It is excreted by the kidneys, through the intestines, with sweat, unchanged and in the form of metabolites.

Side effect

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

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

From the immune system: allergic reactions (erythema, skin rash, itching, Quincke's edema, anaphylactic shock).

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

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

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

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

From the urinary system: urination disorder.

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

Application during pregnancy and lactation

Adequate and well-controlled studies of FervexЃ in pregnant women have not been carried out; therefore, the use of the drug in this group of patients is not recommended.

It is not known whether the active substances of the drug penetrate into breast milk. The drug should not be used during lactation.

Application for violations of liver function

The use of the drug is contraindicated in liver failure.

With care: congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis.

Application for impaired renal function

With caution: renal failure.

Application in children

Contraindication: children under 15 years of age.

Use in elderly patients

The drug should be used with caution in elderly patients.

special instructions

The drug does not contain sugar and can be used by patients with diabetes mellitus.

FervexЃ should not be used concurrently with other drugs containing paracetamol.

In order to avoid toxic damage to the liver, paracetamol should not be combined with the intake of alcoholic beverages, as well as taken by persons prone to chronic alcohol consumption.

The risk of developing liver damage increases in patients with alcoholic hepatosis.

It should not be used simultaneously with drugs that have hypnotic and anxiolytic effects, and in case of impaired renal function without consulting a doctor.

With prolonged use, it is necessary to control the picture of peripheral blood, the concentration of glucose in the blood and urine, bilirubin, uric acid in plasma, the activity of hepatic transaminases and lactate dehydrogenase.

If the recommended doses are exceeded and with prolonged use, mental dependence on the drug may appear.

To avoid an overdose of paracetamol, you should make sure that the total daily dose of paracetamol contained in all drugs taken by the patient does not exceed 4 g.

The preparation contains mannitol and aspartame (a source of phenylalanine); the flavor contains dextrose.

Influence on the ability to drive vehicles and use mechanisms

Given the possibility of the development of such undesirable effects as drowsiness and dizziness, during the period of drug treatment, it is recommended to refrain from driving and machinery.

Overdose

Symptoms due to the action of paracetamol

In case of an overdose, intoxication is possible, especially in elderly patients, children, patients with liver diseases (caused by chronic alcoholism), in patients with malnutrition, as well as in patients taking inducers of microsomal liver enzymes, in which fulminant hepatitis, liver failure, cholestatic hepatitis, in the above cases - sometimes fatal. The overdose threshold in these categories of patients may be lower. The clinical picture of an acute overdose develops within 24 hours after taking paracetamol.

Symptoms: gastrointestinal disorders (nausea, vomiting, loss of appetite, discomfort in the abdominal cavity and / or abdominal pain), pallor of the skin. When administered simultaneously to adults 7.5 g and more or children more than 140 mg / kg, 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 the introduction of paracetamol, there is an increase in the activity of liver microsomal enzymes, lactate dehydrogenase, bilirubin concentration and a decrease in prothrombin concentration. Clinical symptoms of liver damage appear 12-48 hours after drug overdose and reach a maximum on day 4-6.

Treatment: immediate hospitalization. Gastric lavage during the first hours of poisoning, intake of enterosorbents (activated carbon, hydrolytic lignin). Determination of the quantitative content of paracetamol in blood plasma before starting treatment as early as possible after an overdose. Administration of SH-group donors and precursors of glutathione synthesis - methionine and acetylcysteine ??- is most effective in the first 8 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as passed after its introduction. Symptomatic treatment. Laboratory studies of the activity of liver microsomal enzymes should be carried out at the beginning of treatment and then every 24 hours.In most cases, the activity of liver microsomal enzymes is normalized within 1-2 weeks. In very severe cases, a liver transplant may be required.

Symptoms due to the action of pheniramine

Signs of feniramine poisoning are convulsions, impaired consciousness, coma. If symptoms of poisoning appear, you should immediately stop using the drug and consult a doctor. Recommended gastric lavage, intake of enterosorbents (activated carbon, hydrolytic lignin), intravenous or oral administration of the antidote acetylcysteine ??(if possible, in the first 10 hours after an overdose), symptomatic treatment.

Drug interactions

Ethanol enhances the sedative effect of antihistamines (pheniramine); therefore, it should be avoided during treatment with FervexЃ. In addition, ethanol, when used simultaneously with feniramine, contributes to the development of acute pancreatitis.

Pheniramine in the composition of FervexЃ enhances the effect of sedatives: morphine derivatives, barbiturates, benzodiazepine and other tranquilizers, neuroleptics (meprobamate, phenothiazine derivatives), antidepressants (amitriptyline, mirtazapine, mianserin), antihypertensive drugs of the central action group histamine H1 receptors, baclofen; this not only increases the sedative effect, but also increases the risk of side effects of the drug (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, antidepressants of the imipramine group, antipsychotics of the phenothiazine series, m-anticholinergic antiparkinsonian drugs, atropine-like antispasmodics, disopyramide).

When the drug is used together with inducers of microsomal oxidation (barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol), the risk of hepatotoxic action is significantly increased (due to the paracetamol included in the composition).

GCS with simultaneous use increase the risk of developing glaucoma.

Reception simultaneously with salicylates increases the risk of nephrotoxic effects.

With simultaneous use with chloramphenicol (chloramphenicol), the toxicity of the latter increases.

Paracetamol contained in the drug 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 increases the bioavailability of ethinylestradiol (including that which is part of oral contraceptives). Improves the absorption of iron preparations in the intestine (converts ferric iron to bivalent); can increase the excretion of iron when used concomitantly with deferoxamine. Reduces the effectiveness of heparin and indirect anticoagulants.

With simultaneous use with acetylsalicylic acid (ASA), the excretion of ascorbic acid in the urine 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), and reduces the concentration of oral contraceptives in the blood.

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

Medicines of the quinoline series, calcium chloride, salicylates, GCS, with prolonged use, deplete the reserves of ascorbic acid.

With the simultaneous use of ascorbic acid reduces the chronotropic effect of isoprenaline.

With long-term use or use in high doses, it can interfere with the interaction of disulfiram and ethanol.

In high doses, it increases the excretion of mexiletine by the kidneys.

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

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