Instructions for Vicks Anti-Flu Max powder for oral solution lemon No. 10
Composition
active ingredients: paracetamol, phenylephrine hydrochloride;
1 sachet contains paracetamol 1000 mg, phenylephrine hydrochloride 12.2 mg;
excipients: ascorbic acid, sucrose, anhydrous citric acid, acesulfame potassium, aspartame (E 951), sodium citrate, quinoline yellow (E 104), lemon flavor F/29088, lemon flavor F/29089, lemon flavor F/28151 (contains butylhydroxyanisole (E 320)), lemon flavor F/501.476/AP0504.
Dosage form
Lemon-flavored powder for oral solution.
Main physical and chemical properties: loose yellow powder, free from large lumps and foreign particles. Has a characteristic citrus odor.
Pharmacotherapeutic group
Analgesics and antipyretics. Paracetamol, combinations without psycholeptics. ATX code N02B E51.
Pharmacological properties
Pharmacodynamics.
Paracetamol has analgesic, weak anti-inflammatory and antipyretic effects, which occur mainly through inhibition of prostaglandin synthesis in the central nervous system.
Phenylephrine hydrochloride is a synthetic adrenomimetic agent with minimal central activity that stimulates postsynaptic α-adrenoceptors. It is a decongestant and acts by vasoconstriction, reducing edema, particularly edema of the nasal mucosa and paranasal sinuses, and thus reducing nasal congestion.
Pharmacokinetics.
Paracetamol is rapidly and completely absorbed mainly in the small intestine, peak plasma levels are reached 15–20 minutes after oral administration. Systemic bioavailability is due to presystemic metabolism and, depending on the dose, is from 70% to 90%. It is rapidly and widely distributed in the body, the half-life from blood plasma is about 2 hours. The main metabolites are glucuronide and sulfate conjugates (> 80%), which are excreted in the urine.
Phenylephrine hydrochloride is rapidly absorbed from the gastrointestinal tract. First-pass metabolism is high, about 60%, resulting in a systemic availability of about 40%. Peak plasma levels are achieved between 1 and 2 hours, with a plasma half-life of 2–3 hours. When administered orally for nasal decongestion, phenylephrine should usually be taken at intervals of 4–6 hours.
Indication
Symptomatic treatment of colds and flu (headache, body aches and pains, sore throat, nasal congestion and fever) in adults and children from 16 years of age.
Contraindication
Hypersensitivity to paracetamol, phenylephrine or any other component of the drug. Severe ischemic heart disease. Arterial hypertension. Diabetes mellitus. Angle-closure glaucoma. Severe hyperthyroidism. Prostatic hypertrophy. Urinary retention. Pheochromocytoma. Alcoholism. Acute hepatitis. Pancreatitis. Severe liver dysfunction. Renal dysfunction. Use simultaneously with monoamine oxidase inhibitors (or within two weeks after discontinuation of such treatment), tricyclic antidepressants, vasodilators, beta-blockers and other sympathomimetics. Phenylketonuria. Thrombosis, tendency to thrombosis, thrombophlebitis. Congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, blood diseases, severe anemia, leukopenia.
Children under 16 years of age.
Interaction with other medicinal products and other types of interactions
Metoclopramide or domperidone may increase the rate of absorption of paracetamol, and cholestyramine reduces the absorption of paracetamol.
Before using the drug, you should consult a doctor if the patient is taking warfarin or similar drugs that have an anticoagulant effect. With prolonged regular use of paracetamol, the anticoagulant effect of warfarin and other coumarins may increase, increasing the risk of bleeding; occasional use does not have a significant effect.
Paracetamol increases the plasma levels of acetylsalicylic acid and chloramphenicol. Due to the increased risk of renal impairment, similar to that resulting from the use of non-steroidal anti-inflammatory drugs, only short-term use with acetylsalicylic acid is possible.
Probenecid inhibits the conjugation of paracetamol with glucuronic acid and thus leads to a decrease in paracetamol clearance by almost half. When using probenecid simultaneously, the dose of paracetamol should be reduced.
Concomitant use of paracetamol and AZT (zidovudine) increases the risk of neutropenia. Therefore, concomitant use of paracetamol and AZT should be carried out under medical supervision.
Barbiturates reduce the antipyretic effect of paracetamol.
Concomitant use of high doses of paracetamol with isoniazid increases the risk of hepatotoxic syndrome. Paracetamol reduces the effectiveness of diuretics.
Phenylephrine may interact with other sympathomimetics, vasodilators, causing undesirable effects.
Phenylephrine may reduce the effectiveness of beta-blockers, methyldopa and reserpine. Simultaneous use of phenylephrine with these drugs may cause the development of hypertensive crisis. Diseases in which these drugs are used are a contraindication to the use of this drug.
MAO inhibitors enhance the effects of phenylephrine. Concomitant use of phenylephrine with MAO inhibitors and tricyclic antidepressants may cause hypertensive crisis. Phenylephrine may enhance the anticholinergic effects of tricyclic antidepressants.
Concomitant use with ergot alkaloids (ergotamine, methysergide) increases the risk of ergotism.
Substances that induce liver microsomal enzymes, such as alcohol, barbiturates and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, especially after overdose. Should not be used in patients during treatment with monoamine oxidase inhibitors or within 14 days of stopping such treatment.
This drug increases the risk of arrhythmias in patients taking digitalis preparations. It may potentiate the cardiovascular effects of other sympathomimetic amines (decongestants).
Due to the presence of ascorbic acid, the drug reduces the toxicity of sulfonamide drugs, reduces the effect of heparin and indirect anticoagulants, promotes iron absorption, increases the absorption of penicillin and tetracycline, and enhances the side effects of salicylates (risk of crystalluria).
The use of oral contraceptives, drinking juices, and alkaline drinks reduces the level of vitamin C in the body.
Vitamin C in combination with deferoxamine increases tissue iron toxicity, especially in the heart muscle, which can lead to circulatory decompensation. Therefore, the drug can be taken only 2 hours after the deferoxamine injection.
Vitamin C increases the total clearance of ethyl alcohol.
If the recommended doses are significantly exceeded, the drug may reduce the effectiveness of tricyclic antidepressants, neuroleptics - phenothiazine derivatives, tubular reabsorption of amphetamine, disrupt the renal excretion of mexiletine, and inhibit the disulfiram-alcohol reaction in people treated with disulfiram.
Caution should be exercised when using paracetamol with flucloxacillin, as concomitant administration is associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section "Special warnings and precautions for use").
Application features
Do not use with other drugs containing paracetamol. Do not take with alcohol.
Paracetamol should be used with caution in patients taking hepatotoxic drugs, digitalis preparations, methyldopa or other antihypertensive drugs; in patients with chronic malnutrition (low hepatic glutathione levels), Raynaud's phenomenon, bronchial asthma, granulocytopenia, arrhythmias, chronic lung diseases.
It is necessary to consult a doctor regarding the possibility of using the drug in patients with impaired renal and hepatic function. The use of paracetamol in patients with impaired hepatic function and patients receiving long-term therapy with high doses of paracetamol requires monitoring of liver function.
It should be taken into account that patients with alcoholic liver damage have an increased risk of hepatotoxic effects of paracetamol.
Drugs containing sympathomimetics may act as cerebral stimulants, causing insomnia, nervousness, hyperpyrexia, tremors, and epileptiform convulsions.
Concomitant use with halogenated anesthetics such as chloroform, cyclopropane, halothane, enflurane, or isoflurane may cause or worsen ventricular arrhythmias.
If the headache becomes persistent, you should consult a doctor.
Do not exceed recommended doses, especially in patients with increased blood clotting.
Drugs containing sympathomimetics should not be used simultaneously by multiple routes, i.e. orally and topically (drugs for the nose, ears, and eyes).
Excipients
Ascorbic acid
1 sachet of the drug contains 100 mg of ascorbic acid.
Ascorbic acid as a reducing agent can affect the results of laboratory tests, for example, when determining the blood glucose content, bilirubin, transaminase activity, lactate dehydrogenase. Absorption of ascorbic acid can be impaired in intestinal dyskinesias, enteritis, and achilia.
Since ascorbic acid has a mild stimulating effect, it is not recommended to take the medicine at the end of the day.
Since ascorbic acid increases iron absorption, its use in high doses can be dangerous for patients with blood diseases. Patients with high iron levels in the body should use ascorbic acid in minimal doses.
The daily dose of the drug contains 7.75 g of sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine.
Aspartame
The medicinal product contains aspartame (E 951), a source of phenylalanine, 14 mg per dosage unit. May be harmful for patients with phenylketonuria.
Sodium
This medicinal product contains 118 mg sodium per dose. Caution should be exercised when used in patients on a controlled sodium diet.
Caution is advised when paracetamol is co-administered with flucloxacillin due to the increased risk of high anion gap metabolic acidosis, particularly in patients with severe renal insufficiency, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), and in those taking maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
Use during pregnancy or breastfeeding
There are no standard studies of reproductive and ontogenetic toxicity.
The results of epidemiological studies on the development of the nervous system of children exposed to paracetamol in utero are inconclusive.
Paracetamol crosses the placental barrier and enters breast milk.
The medicine should not be used during pregnancy or breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms
Does not affect.
Method of administration and doses
For oral use.
Dissolve the contents of 1 sachet in a standard cup of hot, but not boiling, water (approximately 250 ml). Consume warm. Given the presence of ascorbic acid in the composition of the medicinal product, it is not recommended to consume alkaline mineral water after its use.
Adults: 1 sachet per dose. Can be taken every 4–6 hours if necessary.
Children from 16 years: 1 sachet per dose. If necessary, can be taken every 6 hours.
Elderly patients: no special dose adjustment is required.
The maximum daily dose is 4 sachets.
The course of treatment should last no more than 3–5 days. If the symptoms of the disease do not disappear, you should consult a doctor.
Children
Do not use in children under 16 years of age.
Overdose
Paracetamol.
Liver damage is possible in adults who have taken 10 g or more of paracetamol, and in children who have taken more than 150 mg/kg of body weight. The use of 5 g of paracetamol or more can lead to liver damage if the patient is on long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; constantly drinks alcohol or there is suspicion of glutathione depletion, for example, in case of dietary disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms of paracetamol overdose within the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may occur 12–48 hours after ingestion. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, indicated by low back pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have 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 high doses, from the central nervous system - dizziness, psychomotor agitation and disorientation; from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).
Other symptoms may include depression, cardiovascular disorders, and kidney damage.
Treatment.
In case of overdose, urgent medical attention is required. The patient should be taken to hospital immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage. Treatment with activated charcoal should be considered if the overdose of paracetamol has been taken within 1 hour. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). If necessary, the patient should be given intravenous N-acetylcysteine at the recommended doses. Treatment with N-acetylcysteine can be used for up to 24 hours after ingestion of paracetamol, but the maximum protective effect occurs when it is used within 8 hours of ingestion. The effectiveness of the antidote decreases sharply after this time. In the absence of vomiting, oral methionine can be used as a suitable alternative in remote areas outside the hospital.
Treatment of patients with severe hepatic impairment within 24 hours of ingestion should be under the supervision of a specialist in poison control or liver disease.
Phenylephrine hydrochloride.
Symptoms: headache (may be a symptom of arterial hypertension), convulsions, palpitations, feeling of increased heartbeat, vomiting. Signs of severe phenylephrine overdose include hemodynamic changes and cardiovascular failure with respiratory depression.
Treatment includes early gastric lavage, and symptomatic and supportive measures. Hypertensive effects may be treated with alpha-blockers.
Symptoms of ascorbic acid overdose include: nausea, vomiting, bloating and abdominal pain, itching, skin rash, increased excitability and increased adverse reactions described in the section "Adverse reactions that may be due to the presence of ascorbic acid in the composition of the medicinal product."
With prolonged use in high doses, inhibition of the insular apparatus of the pancreas (hyperglycemia, glucosuria) is possible, therefore its function must be monitored; development of cystitis; acceleration of the formation of stones (urates, oxalates).
When using ascorbic acid in a dose of more than 1 g per day, irritation of the digestive tract mucosa and exacerbation of urolithiasis are possible, therefore it is contraindicated to exceed the recommended doses of the drug. Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, when using it in high doses, it is necessary to monitor kidney function and blood pressure.
Treatment: gastric lavage, alkaline drinking, taking activated charcoal or other sorbents, symptomatic therapy.
Side effects
If adverse reactions occur, discontinue use of the drug and consult a doctor immediately.
From the side of the circulatory and lymphatic system: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia. With prolonged use in doses exceeding therapeutic doses, aplastic anemia, pancytopenia, thrombocytopenia, which can cause nosebleeds and/or bleeding gums, bruising, leukopenia, neutropenia, agranulocytosis have been observed.
On the part of the immune system: anaphylaxis, hypersensitivity reactions, including skin itching, rashes on the skin and mucous membranes (usually generalized, erythematous rashes, urticaria), Quincke's edema, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock.
Nervous system: dizziness, irritability, headache, psychomotor agitation, disorientation, insomnia, restlessness, impaired consciousness, nervousness, tremor and anxiety (usually develop when taking high doses), increased excitability.
On the part of the organs of vision: eye pain, burning sensation in the eyes, blurred vision, photophobia, acute angle-closure glaucoma.
Cardiovascular system: tachycardia, bradycardia, heart pain, shortness of breath, feeling of increased heartbeat, increased blood pressure, arrhythmia.
On the part of the digestive system: heartburn, nausea, vomiting, diarrhea, loss of appetite, epigastric pain.
On the part of the hepatobiliary system: impaired liver function, increased activity of liver enzymes in the blood serum, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).
On the part of the endocrine system: hypoglycemia, development of hypoglycemic coma.
From the urinary system: urinary retention, difficulty urinating.
Respiratory system: bronchospasm in patients sensitive to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs).
Adverse reactions that may be due to the presence of ascorbic acid in the medicinal product
From the urinary system: damage to the glomerular apparatus of the kidneys, crystalluria, renal failure.
Skin: eczema.
On the part of the endocrine system: impaired glycogen synthesis up to the appearance of diabetes mellitus.
From the cardiovascular system: myocardial dystrophy.
From the side of the hematopoietic system: thrombocytosis, hyperprothrombinemia, thrombocytopenia, erythrocytopenia, neutrophilic leukocytosis.
From the nervous system: sleep disturbances, feeling of heat, increased fatigue.
Metabolic disorders: zinc and copper metabolism disorders.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
5 or 10 sachets in a box.
Vacation category
Without a prescription.
Producer
Rafton Laboratories Limited.
Location of the manufacturer and its business address
Exeter Road, Rafton, Braunton, EX33 2DL, United Kingdom.
