Instructions Coldrex Max Flu wild berries powder for oral solution package No. 10
Composition
active ingredients: paracetamol, phenylephrine hydrochloride, ascorbic acid;
1 packet contains paracetamol 1000 mg, ascorbic acid 70 mg, phenylephrine hydrochloride 10 mg;
excipients: sucrose, tartaric acid, sodium citrate anhydrous, aspartame (E 951), fruit and berry flavoring, Black Currant Euromix.
Dosage form
Powder for oral solution.
Main physicochemical properties: light pink powder with a characteristic fruity-menthol odor.
Pharmacotherapeutic group
Analgesics and antipyretics. Paracetamol, combinations without psycholeptics.
ATX code N02B E51.
Pharmacological properties
Pharmacodynamics
Paracetamol is an analgesic and antipyretic. Its mechanism of action is explained by the inhibition of prostaglandin synthesis in the central nervous system.
Phenylephrine hydrochloride is a sympathomimetic. Its action is primarily associated with direct stimulation of adrenoreceptors, mainly alpha-adrenoreceptors. Phenylephrine hydrochloride reduces swelling of the nasal mucosa.
Ascorbic acid is a vital vitamin that is added to the preparation to compensate for the loss of vitamin C that may occur at the beginning of a viral infection.
Pharmacokinetics
Paracetamol is rapidly absorbed in the digestive tract, metabolized in the liver and excreted in the urine mainly in the form of glucuronide and sulfate conjugates. Ascorbic acid is rapidly absorbed in the digestive tract, 25% binds to blood proteins. The remainder of ascorbic acid, exceeding the body's needs, is excreted in the urine in the form of metabolites.
Phenylephrine hydrochloride is metabolized by monoamine oxidase in the intestine and liver. It is excreted in the urine in the form of sulfate conjugates.
Indication
Short-term relief of symptoms of colds and flu, such as headache, sore throat, nasal congestion, sinusitis and associated pain, muscle aches, fever.
Contraindication
Hypersensitivity to any of the components of the drug, severe cardiovascular insufficiency, severe liver and/or kidney dysfunction, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases (including severe anemia, leukopenia), thrombosis, thrombophlebitis, states of increased excitement, acute pancreatitis, prostatic hypertrophy with urinary retention, severe forms of diabetes mellitus, epilepsy, pheochromocytoma, hyperthyroidism, angle-closure glaucoma, severe forms of: arterial hypertension, atherosclerosis, ischemic heart disease; sleep disorders.
Do not use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuing their use, tricyclic antidepressants, beta-blockers or other antihypertensive drugs, other sympathomimetics (drugs to relieve mucosal edema).
Do not use in patients with phenylketonuria due to the presence of aspartame (E 951).
Interaction with other medicinal products and other types of interactions
The rate of absorption of paracetamol may increase with simultaneous use with metoclopramide and domperidone and decrease with cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced with an increased risk of bleeding with concomitant long-term daily use of paracetamol. With short-term use according to the recommended regimen, these interactions are not clinically significant.
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.
Simultaneous use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome. Paracetamol reduces the effectiveness of diuretics. Do not use simultaneously with alcohol.
If paracetamol is administered concomitantly with zidovudine, the toxicity of both drugs may increase (neutropenia and hepatotoxicity). When probenecid is administered concomitantly, the dose of paracetamol should be reduced, as probenecid reduces the clearance of paracetamol by almost half, acting by inhibiting its conjugation with glucuronic acid.
The interaction of phenylephrine with monoamine oxidase inhibitors causes a hypertensive effect, with tricyclic antidepressants (e.g. amitriptyline) and other sympathomimetics - increases the risk of cardiovascular side effects, with digoxin and cardiac glycosides - leads to heart rhythm disturbances or myocardial infarction.
Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive drugs (including debrisoquine, guanethidine, reserpine, methyldopa) with an increased risk of arterial hypertension and other adverse reactions from the cardiovascular system. Taking tricyclic antidepressants and phenylephrine may increase the risk of adverse reactions from the cardiovascular system.
Ascorbic acid when taken orally enhances the absorption of penicillin, iron, reduces the effectiveness of heparin and indirect anticoagulants, increases the risk of crystalluria during treatment with salicylates. Antidepressants, antiparkinsonian and antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation. Glucocorticosteroids increase the risk of glaucoma. Large doses of the drug reduce the effectiveness of tricyclic antidepressants.
Absorption of vitamin C is reduced by concomitant use of oral contraceptives, consumption of fruit or vegetable juices, alkaline drinks. Ascorbic acid can be taken only 2 hours after the injection of deferoxamine, since their simultaneous administration increases iron toxicity, especially in the myocardium. Long-term administration of large doses in persons treated with disulfiram inhibits the disulfiram-alcohol reaction.
Application features
Consult a doctor before using the drug. Contains paracetamol.
Concomitant use with other paracetamol-containing drugs may lead to overdose. Paracetamol overdose may cause liver failure, which may require liver transplantation or be fatal. The risk of overdose is higher in patients with non-cirrhotic alcoholic liver disease.
Cases of hepatic dysfunction/failure have been reported in patients with reduced glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, or suffer from chronic alcohol dependence.
Before using the drug, patients with arterial hypertension, cardiovascular diseases, diabetes, hyperthyroidism, angle-closure glaucoma, prostatic hypertrophy, Raynaud's disease, liver and kidney dysfunction should consult a doctor. Underlying liver disease increases the risk of liver damage associated with paracetamol. Patients with severe infections such as sepsis, which are accompanied by a decrease in glutathione levels, may be at increased risk of metabolic acidosis when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or difficult breathing, nausea, vomiting, loss of appetite. You should consult a doctor immediately if these symptoms occur.
The drug should not be used in patients taking other sympathomimetics (e.g. decongestants, cold and flu remedies, appetite suppressants and amphetamine-like psychostimulants). The drug contains phenylephrine, which may cause angina attacks.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine.
One sachet (1 dose) contains 5 g of sucrose. This should be taken into account by patients with diabetes. The preparation contains the dyes sunset yellow (E 110) and carmoisine (E 122) in the composition of the Black Currant Euromix, which may cause allergic reactions. Contains 117 mg of sodium per dose, which should be taken into account by patients on a hyposodium diet.
Contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Do not exceed recommended doses. If symptoms persist or worsen after more than 7 days of treatment with the drug, or are accompanied by high fever, rash, or persistent headache, you should consult a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
If dizziness occurs, it is not recommended to drive a vehicle or operate complex machinery.
Use during pregnancy or breastfeeding
The drug is not used during pregnancy, except in cases where the expected benefit to the woman justifies the potential risk to the fetus. It should be used in the lowest effective dose and for the shortest duration of treatment. Use only as directed by a doctor.
Paracetamol and phenylephrine may be excreted in breast milk. During breastfeeding, it should be used only as directed by a doctor.
Method of administration and doses
The drug is intended for oral administration.
Pour the contents of 1 packet into a glass and fill halfway with hot water. Stir until completely dissolved. Add cold water if necessary.
Adults and children over 12 years of age: 1 sachet every 4-6 hours as needed. Do not take more frequently than every 4 hours. Maximum daily dose is 4 sachets.
The course of treatment is no longer than 7 days. The duration of treatment should not be exceeded without medical advice. Do not exceed the indicated doses. If the patient's condition does not improve during treatment with the drug, a doctor should be consulted. The lowest dose necessary to achieve effectiveness should be taken.
The drug is not recommended for use in children under 12 years of age.
Overdose
The risk of overdose is increased in patients with liver disease.
Overdose is usually caused by paracetamol and is manifested by pale skin, anorexia, nausea, vomiting, abdominal pain, hepatonecrosis, increased activity of hepatic transaminases, and an increase in the prothrombin index.
Symptoms of liver damage are observed 24-48 hours after overdose and may peak after 4-6 days. Glucose metabolism disorders and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy with impaired consciousness, hemorrhage, hypoglycemia, cerebral edema, in some cases - to the need for liver transplantation or to death.
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 have also been reported. Acute pancreatitis has been reported in patients with liver dysfunction and toxicity.
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 of paracetamol.
Taking 5 g or more of paracetamol can lead to liver damage in patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; regular intake of excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia).
Treatment: Paracetamol overdose requires immediate medical attention, even if no symptoms of overdose are present. 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 an overdose of paracetamol has been taken within 1 hour. Plasma paracetamol concentrations should be measured 4 hours or later after ingestion (earlier concentrations are unreliable).
Treatment with N-acetylcysteine can be used within 24 hours of paracetamol ingestion, 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. If necessary, the patient is given N-acetylcysteine intravenously according to the established dose list. In the absence of vomiting, oral methionine can be used as a suitable alternative in remote areas outside the hospital.
Overdose due to phenylephrine may lead to effects similar to those listed in the section "Adverse reactions". Other symptoms may include irritability, restlessness, hypertension and possibly reflex bradycardia. In severe cases, confusion, hallucinations, convulsions and arrhythmia may occur. However, the amount of the drug that can lead to serious phenylephrine toxicity is greater than the amount required to develop toxic effects on the liver of paracetamol.
Treatment: in case of overdose, gastric lavage, administration of activated charcoal, symptomatic therapy, use of alpha-blockers such as phentolamine, in case of severe hypertension are necessary.
Overdose due to the action of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disorders such as nausea and epigastric discomfort. The consequences of an overdose of ascorbic acid can be classified as those caused by severe liver damage as a result of an overdose of paracetamol.
Adverse reactions
Skin and subcutaneous tissue disorders: rash, urticaria, allergic dermatitis, Stevens-Johnson syndrome, pruritus, erythema multiforme, toxic epidermal necrolysis.
Immune system disorders: allergic reactions (including angioedema), anaphylactic shock, hypersensitivity reactions.
Mental disorders: psychomotor agitation and disorientation, anxiety, nervousness, feelings of fear, irritability, sleep disturbances, insomnia, confusion, depression, hallucinations.
From the nervous system: headache, dizziness, paresthesia.
From the side of the organs of hearing and vestibular apparatus: tinnitus.
On the part of the organs of vision: mydriasis, acute angle-closure glaucoma (more often in patients with glaucoma), visual impairment and accommodation.
Gastrointestinal: nausea, vomiting, dry mouth, hypersalivation, abdominal discomfort and pain, decreased appetite, heartburn, diarrhea.
On the part of the hepatobiliary system: impaired liver function, increased activity of liver enzymes, hepatonecrosis (dose-dependent effect), liver failure.
From the blood and lymphatic system: anemia (including hemolytic), sulfhemoglobinemia and methemoglobinemia, thrombocytopenia, leukopenia, agranulocytosis, pancytopenia, bruising or bleeding.
On the part of the cardiovascular system: increased blood pressure, tachycardia or reflex bradycardia, palpitations, shortness of breath, heart pain.
Respiratory, thoracic and mediastinal disorders: bronchospasm in patients sensitive to aspirin and other nonsteroidal anti-inflammatory drugs.
Others: general weakness, fever, hypoglycemia, glycosuria, zinc and copper metabolism disorders.
The drug may have a slight laxative effect.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 °C, out of the reach and sight of children.
Packaging
10 packages in a cardboard box.
Vacation category
Without a prescription.
Producer
SmithKline Beecham S.A., Spain.
Location of the manufacturer and its business address
Calle de Ayavir, km. 2.500, Alcala de Henares 28806 (Madrid), Spain.
