Aflumed powder for oral solution (orange) №10

Name:
Aflumed por.d/prig.r-ra d/in.approx (orange) in pack. in pack. No. 10
Description:
Powder of white or almost white color with an orange smell. Soft lumps are allowed. AFLUMED (orange). The main active ingredient Paracetamol + phenylephrine + pheniramine + ascorbic acid Release form Powder Pharmacological properties Combined drug, has antipyretic, anti-inflammatory, decongestant, analgesic, anti-allergic effects. Pharmacodynamics Paracetamol It has an analgesic, antipyretic and weak anti-inflammatory effect, reduces pain associated with colds, sore throat, headache, muscle and joint pain, and reduces fever. The mechanism of action is associated with inhibition of prostaglandin synthesis, and a predominant effect on the thermoregulatory center in the hypothalamus. The analgesic mechanism of action due to inhibition of prostaglandin synthesis appears primarily in the central, but also in the peripheral nervous system. The antipyretic effect suppresses the effect of endogenous pyrogens in the temperature regulation center of the hypothalamus. Paracetamol does not have pronounced anti-inflammatory properties and does not affect hemostasis or the gastric mucosa. Pheniramine maleate is a blocker of H1 receptors, has an anti-allergic effect: it reduces the severity of exudative local manifestations of infection, stops lacrimation, reduces itching in the eyes and nose, and eliminates rhinorrhea. Phenylzphrine hydrochloride has a sympathomimetic effect: reduces hyperemia and swelling, causes vasoconstriction of the nasal mucosa and paranasal sinuses. Ascorbic acid helps to meet the need for ascorbic acid, which increases during fever and flu. Indications for use Short-term symptomatic treatment of infectious and inflammatory diseases (ARVI, influenza), accompanied by high fever, severe chills, body aches, headache and muscle pain, runny nose, nasal congestion, sneezing. Dosage and administration Dissolve the contents of 1 sachet in a glass of boiled hot water and drink hot. Adults and children over 12 years old: 1 sachet every 4-6 hours (as needed to relieve symptoms), not to exceed 3 sachets per day. A single dose should not exceed 1 packet. It is not recommended to use the drug for longer than 7 days. Aflumed can be used at any time of the day, but taking the drug before bedtime, at night, brings the best effect. If there is no relief of symptoms within 3 days after starting the drug, you should consult a doctor. Use during pregnancy and lactation The drug is contraindicated during pregnancy or lactation. Precautions Relative contraindications: renal or hepatic insufficiency, simultaneous use of drugs that are potentially toxic to the liver or induce liver enzymes. In order to avoid toxic damage to the liver, the drug should not be combined with the use of alcoholic beverages. Caution should be exercised when using the drug in elderly patients and patients with cardiovascular diseases due to the possible manifestation of the vasoconstrictive effect of phenylephrine, as well as when using the drug in patients with prostatic hyperplasia and thyroid diseases, bradycardia. Phenylephrine may contribute to false positive doping control results in athletes. Patients suffering from diabetes should take into account that one package contains about 5.0 g of sucrose. Patients with rare congenital fructose intolerance, glucose / galactose malabsorption or sucrase-isomaltase deficiency are not recommended to use the drug due to the presence of sucrose in the composition. Patients with phenylketonuria are not recommended to use the drug due to the presence of aspartame containing phenylalanine in its composition. Do not exceed the recommended dose or take the drug for more than 7 days in a row. Do not use the drug from damaged packages. A doctor should be consulted if symptoms: do not improve within 7 days; accompanied by a fever that lasts more than 3 days; include a sore throat that does not go away for more than 3 days, accompanied by fever, headache, rash, nausea or vomiting. The simultaneous use of other medicinal products containing paracetamol should be avoided. Interaction with other drugs It is recommended to refrain from taking the drug during treatment with monoamine oxidase inhibitors. The risk of hepatotoxic action of paracetamol increases with the simultaneous administration of barbiturates, diphenin, carbamaepin, rifampicin, zidovudine and other inducers of microsomal liver enzymes. Enhances the effect of sedatives, ethanol. Ethanol enhances the sedative effect of pheniramine. Antidepressants, antiparkinsonian and antipsychotic drugs, phenothiaine derivatives increase the risk of urinary retention, dry mouth, and constipation. Concomitant use of paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) can potentially increase the risk of NSAID-induced renal side effects. Phenylephrine may have adverse interactions with monoamine oxidase inhibitors, α and β blockers, phenothiazine antihistamines, bronchodilator adrenomimetics, tricyclic antidepressants, guanethidine or atropine, digitalis, rauwolfia alkaloids, indomethacin, methyldopa, central nervous system stimulants, and theophylline. There may be an increased pressor effect in combination with oxytoxic agents. When using some general anesthetics, arrhythmias are rarely possible. First-generation antihistamines such as pheniramine may increase the effect of central nervous system depressants (monoamine oxidase inhibitors, tricyclic antidepressants, alcohol, anti-Parkinson’s drugs, barbiturates, tranquilizers, and narcotics). pheniramine slows down the action of anticoagulants and interacts with progesterone, reserpine and thiazide diuretics. Oral contraceptives may reduce the effectiveness of antihistamines. Joint reception with glucocorticosteroids increases the risk of increased intraocular pressure. Agents that slow gastric emptying (eg, propaneline) reduce the rate of absorption. Agents that accelerate gastric emptying (eg, metoclopramide) increase the rate of absorption. Chloramphenicol: The half-life of chloramphenicol is increased by 5 times due to the action of paracetamol. Salicylamide: Salicylamide prolongs the half-life of paracetamol and increases the formation of liver-toxic metabolites. Chlorzoxazone: The simultaneous use of paracetamol and chlorzoxazone increases the hepatotoxicity of both substances. The simultaneous use of eidovudine and paracetamol leads to increased neutropenia. The action of coumarin derivatives may be enhanced. Contraindications Hypersensitivity to individual components of the drug, severe violations of the liver and kidneys, severe cardiovascular diseases, severe arterial hypertension, pheochromocytoma, thyrotoxicosis, prostate adenoma with accumulation of residual urine, hemolytic anemia, angle-closure glaucoma, simultaneous use of monoamine oxidase inhibitors (MAO) , alcoholism, epilepsy, diabetes mellitus, bronchial asthma, deficiency of the enzyme glucose-6-phosphate dehydrogenase, pregnancy, breastfeeding, children under 12 years of age. Composition 1 package contains: active substances: paracetamol – 325.0 mg, pheniramine maleate – 20.0 mg, phenylephrine hydrochloride – 10.0 mg, ascorbic acid – 50.0 mg. excipients: anhydrous citric acid, aspartame, sugar, orange flavor. Overdose Ingestion of 7.5-10 g of paracetamol in adults and 150-200 mg / kg of body weight in children causes an acute toxic effect on liver cells, causing necrosis. In susceptible patients, such as those with alcohol abuse or in patients with reduced glutathione levels, the toxic effects of paracetamol are possible even at low doses. Plasma concentrations > 200 µg/mL after 4 hours, > 100 µg/mL after 8 hours, > 50 µg/mL after 12 hours, and > 30 µg/mL after 15 hours result in fatal liver injury due to hepatic coma. Hepatotoxicity is directly related to plasma concentrations. Symptoms: First phase: nausea, vomiting, abdominal pain, anorexia, malaise. Second phase: subjective improvement, liver enlargement, increase in transaminases, increase in bilirubin level, increase in prothrombin time. The third phase: a significant increase in the content of transaminases, jaundice, hypoglycemia, hepatic coma. Symptoms due to the presence of pheniramine and phenylephrine: drowsiness, then agitation, especially in children, blurred vision, nausea, vomiting, headaches, circulatory disorders, coma, convulsions, arterial hypertension and bradycardia. Therapy: Effective therapy should be started promptly if poisoning is suspected. It is necessary to take the following measures: gastric lavage during the first hours of an overdose, followed by the introduction of activated charcoal. Oral administration of N-acetylcysteine. In situations where oral administration of an antidote is not possible or difficult (eg, due to severe vomiting, clouding of consciousness), it can be given intravenously. The concentration of paracetamol in plasma should be measured no earlier than 4 hours after taking the drug. Respiratory and circulatory control should be exercised (do not use adrenaline!). Diazepam can be used for convulsions. Side effects The most common side effects: dizziness, dry mouth or throat, fatigue, headache, anxiety, nervousness, tachycardia, palpitations, agitation, sleep disturbance, edema are rarely observed: Allergic reactions: itching, rash, urticaria, in isolated cases – erythematous and other skin reactions, petechiae, angioedema, bronchospasm, drop in blood pressure even to a state of shock, anaphylaxis; From the digestive tract: digestive disorders, including constipation, nausea, vomiting, diarrhea or flatulence, epigastric pain, abnormal liver function; From the endocrine system: fluctuations in blood sugar levels; From the nervous system: confusion, vestibular disorders. Adverse reactions caused by paracetamol: thrombocytopenia, leukopenia, hemolytic anemia, in isolated cases – agranulocytosis. Patients with intolerance to acetylsalicylic acid (5-10%) also react to paracetamol (for example, asthmatics). When taking paracetamol in high dosages and for a long time, it is possible to develop hepato- and nephrotoxic effects, hemolytic anemia, pancytopenia; Caused by phenylephrine: increased blood pressure, heart pain, mydriasis, impaired vision and accommodation, increased intraocular pressure and potential effects on endocrine and other metabolic regulators, impaired urination; Caused by pheniramine: dry eyes, insomnia, in some cases – coma, convulsions, dyskinesia, behavioral changes. Unlike second-generation antihistamines, pheniramine is not associated with QTc prolongation and arrhythmia. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children! Buy Aflumed powder for oral solution (orange) No. 10 Price for Aflumed powder for oral solution (orange) No. 10 Instructions for use for Aflumed powder for oral solution (orange) #10