Instructions Fervex for adults without sugar powder for oral solution sachet No. 8
Composition
active ingredients: paracetamol, ascorbic acid (vitamin C), pheniramine maleate;
1 sachet contains: paracetamol 500 mg, ascorbic acid (vitamin C) 200 mg, pheniramine maleate 25 mg;
excipients: mannitol (E 421), citric acid anhydrous, povidone, trimagnesium dicitrate anhydrous, aspartame (E 951), lemon flavoring: flavoring ingredients (about 5.5%): alpha-pinene, beta-pinene, sabinene, myrcene, limonene, gamma-terpine, paracymene, linalool, neral, geranial, geranyl acetate, geraniol; non-flavoring ingredients (about 94.5%): triacetin (E 1518), modified starch (E 1450), acacia gum (E 414), ethanol.
Dosage form
Powder for oral solution.
Main physicochemical properties: white or almost white granular powder.
Pharmacotherapeutic group
Analgesics and antipyretics. ATX code N02B E51.
Pharmacological properties
Pharmacodynamics.
Pharmacological effects caused by the components of the drug:
pheniramine maleate – a blocker of H1-histamine receptors, provides a desensitizing effect, which is manifested by a decrease in the inflammatory reaction of the mucous membranes of the upper respiratory tract (nasal breathing improves, rhinitis, sneezing and lacrimation decrease);
Paracetamol has antipyretic and analgesic effects that relieve pain and fever (headache, myalgia);
Ascorbic acid compensates for the body's needs for vitamin C.
Pharmacokinetics.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract after oral administration. The maximum concentration of paracetamol in blood plasma is reached 30-60 minutes after administration. Paracetamol is rapidly distributed in all tissues. Concentrations in blood, saliva and blood plasma are similar. Binding to plasma proteins is weak. Paracetamol is metabolized mainly in the liver with the formation of compounds with glucuronic acid and sulfates. A secondary metabolic pathway, catalyzed by cytochrome P 450, leads to the formation of an intermediate reagent (N-acetylbenzoquinoneimine), which under normal conditions of use is rapidly neutralized by reduced glutathione and excreted in the urine after conjugation with cysteine and mercapturic acid. However, in severe poisoning, the amount of this toxic metabolite increases.
Excreted in the urine, mainly as metabolites. 90% of the dose taken is excreted by the kidneys within 24 hours, mainly in the form of glucuronide conjugates (60-80%), sulfate conjugates (20-30%).
Approximately 5% of the dose is excreted unchanged. The half-life is approximately 2 hours.
Pheniramine maleate is well absorbed in the digestive tract. It is excreted mainly through the kidneys. Ascorbic acid is well absorbed in the digestive tract. It is excreted mainly with urine.
Indication
Symptomatic treatment of colds, allergic rhinitis, influenza, rhinopharyngitis, manifested by fever, headache, runny nose, sneezing and lacrimation.
Contraindication
Hypersensitivity to the components of the drug or to other antihistamines, severe liver and/or kidney dysfunction, phenylketonuria, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases, severe anemia, leukopenia, severe arterial hypertension, unstable angina; severe cardiac conduction disorders, acute myocardial infarction, severe atherosclerosis, uncompensated heart failure, hyperthyroidism, acute urinary retention in prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction, gastric and duodenal ulcer in the acute stage, angle-closure glaucoma, thrombosis, thrombophlebitis, severe forms of diabetes mellitus, epilepsy, old age. Do not use together with MAO inhibitors and within two weeks after stopping the use of MAO inhibitors. Contraindicated in patients taking tricyclic antidepressants or beta-blockers. Urolithiasis - provided that ascorbic acid enters the body in a dose of more than 1 g per day.
Special safety precautions
In case of high body temperature or prolonged fever that persists for 5 days while using the drug, or if signs of superinfection appear, you should consult a doctor to determine the appropriateness of further use of the drug.
Use with caution in patients with diabetes.
Alcohol enhances the sedative effect of pheniramine maleate and the hepatotoxicity of paracetamol.
Ascorbic acid may alter the results of laboratory tests (glucose, blood bilirubin, transaminase activity).
The risk of mainly psychological dependence appears when recommended doses are exceeded and with long-term treatment.
To prevent overdose, all medications containing paracetamol should be checked and excluded.
For adults weighing more than 50 kg, the total dose of paracetamol should not exceed 4 g per day.
Precautions.
Drinking alcoholic beverages or using sedatives (especially barbiturates) increases the sedative effect of pheniramine maleate, therefore, these substances should be avoided during treatment.
Interaction with other medicinal products and other types of interactions
Undesirable combinations.
Due to the presence of pheniramine, ethanol increases the sedative effect of H1-blockers, so you should refrain from driving vehicles or working with other mechanisms. During treatment, you should avoid drinking alcoholic beverages and using medications containing ethyl alcohol.
Combinations to consider.
Due to the presence of pheniramine, other sedatives may cause central nervous system depression, such as: morphine derivatives (analgesics, cough suppressants and substitution therapy), neuroleptics, barbiturates, benzodiazepines; anxiolytics other than benzodiazepines (e.g. meprobamate); hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H1-blockers, centrally acting antihypertensives, baclofen and thalidomide.
Due to the presence of pheniramine, drugs that have atropine-like effects, such as: imipramine antidepressants, most atropine H1-blockers, anticholinergics, antiparkinsonian drugs, atropine antispasmodics, disopramide, phenothiazine neuroleptics and clozapine, may add undesirable atropine-like effects, such as urinary retention, constipation and dry mouth.
The rate of absorption of paracetamol may be increased by concomitant use with metoclopramide and domperidone and decreased by cholestyramine. The anticoagulant effect of warfarin and other coumarins with an increased risk of bleeding may be enhanced by concomitant long-term use of paracetamol. Intermittent administration has no significant effect.
Barbiturates reduce the antipyretic effect of paracetamol.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of liver microsomal enzymes, may enhance the toxic effect of paracetamol on the liver due to an increase in the degree of conversion of the drug to hepatotoxic metabolites. With simultaneous use of paracetamol with isoniazid, the risk of developing hepatotoxic syndrome increases. Paracetamol reduces the effectiveness of diuretics.
Ascorbic acid increases the absorption of iron in the intestine, increases the level of ethinylestradiol, penicillins, tetracyclines; reduces the level of antipsychotics, phenothiazine derivatives in the blood. Glucocorticosteroids reduce the reserves of ascorbic acid. Simultaneous administration of ascorbic acid and deferoxamine increases the tissue toxicity of iron, especially in the heart muscle, which can lead to decompensation of the circulatory system. It can be used only 2 hours after the injection of deferoxamine. Large doses of ascorbic acid reduce the effectiveness of tricyclic antidepressants. Absorption of ascorbic acid is reduced with simultaneous use of oral contraceptives, consumption of fruit or vegetable juices, alkaline drinks.
Caution should be exercised when using paracetamol and flucloxacillin simultaneously, as concomitant administration is associated with metabolic acidosis with a high anion gap, especially in patients at risk ("Special warnings and precautions for use").
Application features
In case of liver or kidney diseases, you should consult a doctor before using the drug. Before using the drug, you should consult a doctor if the patient is using warfarin or similar drugs that have an anticoagulant effect. It should be borne in mind that in patients with alcoholic necrotic liver lesions, the risk of hepatotoxic effects of paracetamol increases; the drug may affect the results of laboratory tests for blood glucose and uric acid. In patients with severe infections, such as sepsis, which are accompanied by a decrease in glutathione levels, the risk of metabolic acidosis increases when taking paracetamol. Symptoms of metabolic acidosis are deep, rapid or difficult breathing, nausea, vomiting, loss of appetite. You should immediately consult a doctor if these symptoms appear.
Do not exceed the indicated doses. If symptoms persist, consult a doctor.
It should be prescribed with extreme caution to patients with impaired iron metabolism (hemosiderosis, hemochromatosis, thalassemia).
Since ascorbic acid has a mild stimulating effect, it is not recommended to take this drug at the end of the day. Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, when using it in large doses, monitoring of kidney function and blood pressure is required.
The drug should be used with caution in cases of increased blood clotting.
It should be prescribed with extreme caution to patients with a history of nephrolithiasis (risk of hyperoxaluria and oxalate precipitation in the urinary tract after taking large doses of ascorbic acid).
Long-term use of large doses of ascorbic acid may accelerate its own metabolism, which may lead to paradoxical hypovitaminosis after discontinuation of treatment. The recommended dose should not be exceeded.
Should not be used simultaneously with other drugs containing vitamin C.
It should be noted that the use of vitamin C in high doses may alter some laboratory test results (uric acid, creatinine, inorganic phosphates). The result of the study for occult blood in the stool may be negative.
Caution is advised when paracetamol and flucloxacillin are used concomitantly due to the increased risk of developing metabolic acidosis with a high anion gap, especially in patients with severe renal insufficiency, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those taking maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
This medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose.
Use during pregnancy or breastfeeding
Since the effect of the drug on the course of pregnancy or breastfeeding has not been sufficiently studied, it should not be prescribed during these periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may cause drowsiness, so while taking the drug you should refrain from driving vehicles or operating other mechanisms.
Method of administration and doses
Internally, adults and children over 15 years of age should take 1 sachet 2-3 times a day. Dissolve the contents of the sachet in a glass of cold or warm water. Patients with symptoms of a cold should take a warm solution. The solution should be taken immediately after preparation. The interval between doses should be at least 4 hours. The maximum duration of treatment is 5 days.
For patients with severe renal impairment (creatinine clearance less than 10 ml/min), the interval between doses should be at least 8 hours.
Children.
Do not use in children under 15 years of age.
Overdose
Related to ascorbic acid.
Ascorbic acid is well tolerated. It is a water-soluble vitamin, its excess is excreted in the urine. However, with prolonged use of vitamin C in large doses, inhibition of the function of the insular apparatus of the pancreas is possible, which requires monitoring of the condition of the latter. Overdose can lead to changes in the renal excretion of ascorbic and uric acids during urine acetylation with the risk of precipitation of oxalate stones. The use of large doses of ascorbic acid can lead to vomiting, nausea or diarrhea, which disappear after its withdrawal.
Related to pheniramine.
Overdose with pheniramine can cause convulsions (especially in children), impaired consciousness, and coma.
In case of an overdose of pheniramine, atropine-like symptoms occur: mydriasis, photophobia, dryness of the skin and mucous membranes, hyperthermia, intestinal atony. Central nervous system depression leads to disruption of the respiratory and cardiovascular systems (bradycardia, arterial hypotension, collapse).
Related to paracetamol.
There is a risk of intoxication in the elderly and especially in young children (cases of therapeutic overdose and accidental poisoning are quite common).
An overdose of paracetamol can be fatal.
Symptoms
Nausea, vomiting, anorexia, pallor, increased sweating, abdominal pain, which usually appear within the first 24 hours.
Acute renal failure with acute tubular necrosis may present with severe back pain, hematuria, and proteinuria, and may occur even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have also been reported.
With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic system. When taking large doses, from the central nervous system - dizziness, psychomotor agitation and disorientation; from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis); from the digestive system - hepatonecrosis.
Overdose of more than 10 g of paracetamol per dose in adults and 150 mg/kg body weight per dose in children causes hepatic cytolysis, which can lead to complete and irreversible necrosis, leading to hepatocellular failure, metabolic acidosis, encephalopathy, which in turn can lead to coma and death.
At the same time, elevated levels of hepatic transaminases, lactate dehydrogenase, and bilirubin are observed against the background of elevated prothrombin levels, which may appear 12-48 hours after administration.
In patients with risk factors (long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; alcohol abuse; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia) the use of 5 g or more of paracetamol can lead to liver damage.
Emergency measures
Immediate hospitalization;
determination of the initial level of paracetamol in blood plasma;
The usual treatment for overdose includes the administration of the antidote N-acetylcysteine, either intravenously or orally. The antidote should be administered as soon as possible, preferably within 10 hours of the overdose;
methionine as symptomatic therapy.
Side effects
From the blood and lymphatic system: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia; thrombosis, hyperprothrombinemia, erythrocytopenia, thrombocytopenia, agranulocytosis, neutrophilic leukocytosis, purpura, leukopenia, neutropenia, bruising or bleeding.
On the part of the immune system: anaphylaxis, anaphylactic shock, skin hypersensitivity reactions, including itching, rash on the skin and mucous membranes (usually erythematous, urticaria), angioedema, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
Respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.
On the part of the digestive system: dry mouth, nausea, heartburn, vomiting, constipation, epigastric pain, diarrhea, impaired liver function, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).
From the endocrine system: hypoglycemia up to hypoglycemic coma.
From the nervous system: rarely - headache, dizziness, sleep disturbances, insomnia, drowsiness, confusion, hallucinations, nervousness, tremor; in some cases - coma, convulsions, dyskinesia, behavioral changes, increased excitability; impaired balance and memory, inattention, especially in elderly patients.
Cardiovascular system: in rare cases - tachycardia, myocardial dystrophy (dose-dependent effect with prolonged use), orthostatic hypotension.
Metabolic disorders: zinc and copper metabolism disorders.
On the part of the urinary system: urinary retention and difficulty urinating, aseptic pyuria, renal colic.
Skin: eczema.
From the organs of vision: dry eyes, mydriasis, accommodation disorders.
With prolonged use in large doses: damage to the glomerular apparatus of the kidneys, crystalluria, formation of urate, cystine and/or oxalate stones in the kidneys and urinary tract; damage to the insular apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the development of diabetes mellitus.
Adverse reactions to ascorbic acid: when used in doses exceeding 1 g per day - irritation of the mucous membrane of the digestive tract, renal failure, arterial hypertension.
Expiration date
3 years.
Storage conditions
Store at a temperature of 15–25 °C in a dry place, out of the reach of children.
Packaging
8 sachets in a cardboard box.
Vacation category
Without a prescription.
Producer
UPSA SAS, France.
Address
979, avenue des Pyrenees, 47520 Le Passage, France/979, avenue des Pyrenees, 47520 Le Passage, France;
or
304, avenue du Docteur Jean Bru, 47000 Agen, France/304, avenue du Docteur Jean Bru, 47000 Agen, France.
