Instructions Fervex for adults with raspberry flavor powder for oral solution sachet No. 8
Composition
active ingredients: paracetamol, ascorbic acid, pheniramine maleate;
1 sachet contains: paracetamol 500 mg, ascorbic acid 200 mg, pheniramine maleate 25 mg;
excipients: sucrose, anhydrous citric acid, acacia, sodium saccharin, raspberry flavor (containing sunset yellow FCF (E 110), special red AC (E 129), diamond blue FCF (E 133), starch sodium octenyl succinate (E 1450)).
Dosage form
Powder for oral solution.
Main physicochemical properties: granular powder from light pink to light beige.
Pharmacotherapeutic group
Other analgesics and antipyretics. Anilides. Paracetamol, combinations without psycholeptics.
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, which 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 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.
In case of severe renal failure (creatinine clearance less than 10 ml/min), the elimination of paracetamol and its metabolites is slowed.
In elderly patients, the conjugation capacity does not change.
Pheniramine maleate is well absorbed from the gastrointestinal tract. It is excreted mainly by the kidneys. The half-life in blood plasma is 60–90 min.
Ascorbic acid is well absorbed in the digestive tract. It is excreted mainly in the urine.
Indication
Colds, rhinitis, rhinopharyngitis and flu-like conditions in adults and children aged 15 years and over, accompanied by:
Contraindication
Hypersensitivity to the components of the drug or to other antihistamines, severe liver and/or kidney dysfunction, 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, risk of urinary retention in urethra and prostate diseases, bladder neck obstruction, pyloroduodenal obstruction, gastric and duodenal ulcer in the acute stage, angle-closure glaucoma, thrombosis, thrombophlebitis, diabetes mellitus, bronchial asthma, epilepsy, old age; fructose intolerance, glucose/galactose malabsorption syndrome or sucrase-isomaltase insufficiency due to the sucrose content.
Do not use with MAO inhibitors and within 2 weeks after discontinuation of MAO inhibitors. The drug is contraindicated in patients taking tricyclic antidepressants or β-blockers. Urolithiasis - provided that ascorbic acid enters the body in a dose of more than 1 g per day.
Do not use in children under 15 years of age.
Interaction with other medicinal products and other types of interactions
Undesirable combinations.
During treatment, you should avoid drinking alcoholic beverages and using medications containing ethyl alcohol, as ethanol increases the sedative effect of H1-blockers (pheniramine). Therefore, you should refrain from driving vehicles or operating other mechanisms.
Due to the presence of pheniramine, use with other sedatives may cause central nervous system depression, in particular with drugs 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, use with 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 to undesirable atropine-like effects, such as urinary retention, constipation, and dry mouth.
Combinations that should be used with caution.
When taken simultaneously with oral anticoagulants, there is a risk of increased effect and an increased risk of bleeding when taking paracetamol in maximum doses (4 g/day) for at least 4 days. INR (international normalized ratio) should be checked regularly. If necessary, the dose of the oral anticoagulant can be adjusted during paracetamol treatment and after stopping paracetamol treatment.
Taking paracetamol may affect the results of blood glucose determination using the glucose oxidase-peroxidase method with abnormally high concentrations.
Taking paracetamol may affect the results of blood urea determination using the phosphotungstic acid method.
The rate of absorption of paracetamol may be increased by concomitant use with metoclopramide and domperidone and decreased by co-administration with cholestyramine. 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.
Do not use simultaneously with alcohol.
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.
Application features
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.
Ascorbic acid may alter the results of laboratory tests (glucose, blood bilirubin, transaminase activity).
It is necessary to consult a doctor regarding the possibility of using the drug in patients with impaired renal and hepatic function. Before using the drug, it is necessary to consult a doctor if the patient uses warfarin or similar drugs that have an anticoagulant effect.
Patients with alcoholic liver disease are at increased risk of hepatotoxicity from paracetamol. The drug may affect laboratory tests for uric acid levels in the blood.
Do not exceed the indicated doses.
Do not take the drug with other products containing paracetamol.
If symptoms persist or the headache becomes persistent, you should see a doctor.
The risk of mainly psychological dependence appears when recommended doses are exceeded and with long-term treatment.
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, the use of these substances should be avoided during treatment.
Each sachet contains 11.5 g of sucrose, which should be taken into account by patients on a low-sugar diet.
Very rare cases of serious skin reactions have been reported. Patients should be informed of the possibility of early signs of these serious skin reactions, such as rash or other signs of hypersensitivity. If these occur, the medicinal product should be discontinued.
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 is 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.
Absorption of ascorbic acid may be impaired in cases of impaired intestinal motility, enteritis, or achilli (inhibition of gastric secretion).
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.
The medicine contains sunset yellow FCF (E 110), which may cause allergic reactions.
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
There may be a significant impact on the reaction rate when driving or using other mechanisms. The drug may cause drowsiness, especially at the beginning of its administration. Therefore, you should refrain from driving or using other mechanisms while taking the drug.
The use of the drug with alcoholic beverages, drugs containing ethyl alcohol, or other sedatives increases these risks.
Method of administration and doses
Use as an oral solution.
The contents of the sachet should be taken by dissolving in a sufficient amount of hot or cold water.
Dosage.
This medicine is only for use in adults and children aged 15 years and over.
The dose is 1 sachet 2 or 3 times a day.
An interval of 4 hours should always be observed between doses.
When treating flu-like conditions, it is recommended to take this medication with hot water in the evening.
Duration of treatment.
The maximum duration of treatment is 5 days.
If the patient has severe renal insufficiency (creatinine clearance below 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 stopping the intake of ascorbic acid.
Related to pheniramine.
Overdose with pheniramine can cause convulsions (especially in children), impaired consciousness, 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 occur quite often). Paracetamol overdose can be fatal. Symptoms of overdose in the first 24 hours: pallor, nausea, vomiting, anorexia and abdominal pain.
Liver damage may become apparent 12–48 hours after overdose. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure may progress to hemorrhage and hypoglycemia. 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.
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; regular use of excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia), the use of 5 g or more of paracetamol can lead to liver damage. With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic organs. When taking large doses, from the CNS - dizziness, psychomotor agitation and disorientation; from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).
Emergency measures.
– Immediate hospitalization;
– determination of the initial level of paracetamol in blood plasma;
– immediate removal of the administered drug by gastric lavage;
– The usual treatment for overdose includes the administration of the antidote N-acetylcysteine intravenously or orally. The antidote should be administered as soon as possible, preferably within 10 hours of the overdose;
– symptomatic therapy.
Adverse reactions
From the blood and lymphatic system: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia; thrombosis, hyperprothrombinemia, erythrocytopenia, thrombocytopenia, neutrophilic leukocytosis, agranulocytosis, purpura, leukopenia, neutropenia, bruising or bleeding.
Immune system disorders: anaphylaxis, anaphylactic shock, cutaneous hypersensitivity reactions including pruritus, rash on the skin and mucous membranes (usually erythematous, urticaria, purpura), 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 tract: 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.
Nervous system: rarely - headache, dizziness, sleep disturbances, insomnia, sedation or drowsiness, confusion, hallucinations, nervousness, impaired coordination of movements, tremor; in some cases - coma, convulsions, dyskinesia, behavioral changes, increased excitability; impaired balance and memory, inattention, dizziness, especially in elderly patients. Anticholinergic effects, such as dryness of the mucous membranes, constipation, accommodation disorders, mydriasis, palpitations, risk of urinary retention. Orthostatic hypotension.
On the part of the cardiovascular system: in rare cases - tachycardia, myocardial dystrophy (dose-dependent effect with prolonged use), orthostatic hypotension.
Metabolic disorders: zinc and copper metabolism disorders.
From the urinary system: urinary retention and difficulty urinating, aseptic pyuria.
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.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
8 sachets in a cardboard box.
Vacation category
Without a prescription.
Producer
UPSA SAS, France.
Location of the manufacturer and address of its place of business.
304, Avenue Dr. Jean Bru, 47000 Agen, France.
979, Avenue de Pyrenees, 47520 Le Passage, France.
