Theraflu ExtraTab
Registration number: P N 015589/01 Trade name: TeraFlu ExtraTab INN or group name: Paracetamol + Phenylephrine + Chlorphenamine Dosage form: coated tablets Description: light yellow oblong biconvex film-coated tablets with beveled edges. At the break the tablet is light yellow in color.
Composition Each tablet contains: Active ingredients: paracetamol 650.0 mg, chlorphenamine maleate 4.0 mg, phenylephrine hydrochloride 10.0 mg Excipients: colloidal silicon dioxide 0.40 mg, quinoline yellow dye-based varnish 0.85 mg, lactose monohydrate 3.10 mg, magnesium stearate 3.50 mg, hyprolose 17.00 mg, croscarmellose sodium 57.00 mg, corn starch 124.00 mg; film shell: varnish based on quinoline yellow dye 0.0331 mg, quinoline yellow dye 0.0392 mg, titanium dioxide 1.0882 mg, methyl parahydroxybenzoate 0.0889 mg, povidone K-30 0.4353 mg, colloidal silicon dioxide 0.6529 mg, macrogol-400 1.7412 mg, methylcellulose 3.9176 mg.
Pharmacotherapeutic group: Remedy for eliminating the symptoms of acute respiratory infections and “colds” (non-narcotic analgesic + alpha-adrenergic agonist + H1-histamine receptor blocker)
ATX code: [N02BE51]
Pharmacological action: A combined agent that has antipyretic, anti-inflammatory, decongestant, analgesic and antiallergic effects, eliminates the symptoms of “colds”. The effect of the drug is due to the components included in its composition. Paracetamol has an antipyretic effect by blocking cyclooxygenase mainly in the central nervous system, affecting the centers of pain and thermoregulation. It has virtually no anti-inflammatory effect. Paracetamol does not affect the synthesis of prostaglandins in peripheral tissues, thus not having a negative effect on water-salt metabolism (Na + and water retention) and the mucous membrane of the gastrointestinal tract. Phenylephrine is an alpha-adrenergic agonist, constricts blood vessels, eliminates swelling and hyperemia of the mucous membrane of the nasal cavity, nasopharynx and paranasal sinuses, reduces exudative manifestations (runny nose). Chlorphenamine is an H1-histamine receptor blocker that suppresses the symptoms of allergic rhinitis: sneezing, runny nose, itchy eyes, nose, and throat.
Pharmacokinetics of Paracetamol Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentrations are achieved 10-60 minutes after oral administration. Paracetamol is widely distributed in all tissues of the body. It crosses the placental barrier and is secreted into breast milk. Plasma protein binding is negligible at normal therapeutic concentrations, but increases with increasing concentrations. Paracetamol is metabolized in the liver primarily in two ways: glucuronidation and sulfation. It is excreted by the kidneys, mainly in the form of glucuronide and sulfate conjugates. The half-life is from 1 to 3 hours. In case of severe renal dysfunction (creatinine clearance less than 30 ml/min), the elimination of paracetamol and its metabolites is delayed.
Phenylephrine hydrochloride Phenylephrine hydrochloride is absorbed from the gastrointestinal tract and metabolized by monoamine oxidase during the initial passage through the intestinal wall and in the liver, therefore, when taken orally, phenylephrine hydrochloride has limited bioavailability. It is excreted almost entirely by the kidneys in the form of a sulfate conjugate. Maximum concentrations of the drug in plasma are achieved within 45 minutes - 2 hours, and the half-life of the drug from plasma is 2-3 hours.
Chlorphenamine maleate Chlorphenamine is absorbed relatively slowly from the gastrointestinal tract, maximum concentrations of chlorphenamine in the blood plasma are reached 2.5 - 6 hours after taking the drug. The substance has low bioavailability at the level of 25 – 50%. About 70% of chlorphenamine in the bloodstream is bound to plasma proteins. It is widely distributed in body tissues, including the central nervous system. Chlorphenamine undergoes significant first pass metabolism. The duration of action is 4-6 hours. In children, faster and more complete absorption, faster clearance, and a shorter half-life were observed. The half-life ranges from 2 to 43 hours, even with an average duration of action of 4-6 hours. Part of chlorphenamine unchanged with metabolites was excreted by the kidneys.
Indications for use: Symptomatic treatment of infectious and inflammatory diseases (ARVI, influenza), accompanied by high temperature, fever, headache, runny nose, nasal congestion, sneezing and muscle pain.
Contraindications Hypersensitivity to the components of the drug. Taking monoamine oxidase inhibitors (simultaneously or in the previous 14 days), tricyclic antidepressants, beta-blockers, and other sympathomimetics. Severe cardiovascular diseases, arterial hypertension, hyperthyroidism, angle-closure glaucoma, pheochromocytoma, lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Pregnancy, breastfeeding period. Children's age up to 12 years.
With caution Diabetes mellitus, liver dysfunction, renal dysfunction, prostatic hyperplasia, hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, bronchial asthma, chronic obstructive pulmonary disease (chronic bronchitis), pulmonary emphysema, acute hepatitis, chronic exhaustion or dehydration, pyloroduodenal stenosis, epilepsy, cardiovascular diseases. You should not simultaneously take other drugs containing paracetamol, as well as other drugs that affect liver function. Should be taken with caution in patients with alcohol dependence.
Use during pregnancy and breastfeeding The use of TheraFlu ExtraTab is not recommended during pregnancy and breastfeeding. The safety of TheraFlu ExtraTab when used during pregnancy and breastfeeding has not been specifically studied. Data on the potential effects of each individual ingredient on pregnancy and breastfeeding are presented below.
Pregnancy Epidemiological studies in pregnancy have shown no adverse effects when using oral paracetamol at the recommended dose. Reproductive studies evaluating the oral drug did not reveal signs of malformations or fetotoxicity. Under normal conditions of use, paracetamol can be used throughout pregnancy after assessing the benefit-risk ratio. There are limited data on the use of phenylephrine in pregnant women. Constriction of uterine vessels and decreased blood flow in the uterus when using phenylephrine can lead to fetal hypoxia. The use of phenylephrine should be avoided during pregnancy. Epidemiological data from human use have not revealed an association between chlorpheniramine and congenital malformations. However, due to the lack of controlled clinical studies, the use of chlorpheniramine maleate should be avoided during pregnancy.
Breastfeeding Paracetamol is excreted in breast milk, but in quantities that are not clinically significant. According to published data, the drug is not contraindicated during breastfeeding. There is no data on the excretion of phenylephrine in breast milk. You should avoid taking this drug during breastfeeding. There is no information on the use of chlorpheniramine during breastfeeding in humans. Its use should be avoided by women who are breastfeeding.
Directions for use and dosage : Inside. Adults: 1 tablet every 4-6 hours, but not more than 6 tablets per day. Children over 12 years old – 1 tablet every 4-6 hours, but no more than 4 tablets per day. It is recommended to swallow the tablet whole, without chewing, with water. The course of treatment should not exceed 5 days. If there is no relief of symptoms within 3 days after starting to take the drug, you should consult a doctor.
Doses for special categories of patients: Liver failure In patients with impaired liver function or Gilbert's syndrome, it is necessary to reduce the dose or increase the interval between doses.
Renal failure: In case of severe renal failure (creatinine clearance <10 ml/min), the interval between doses should be at least 8 hours.
Elderly patients No dosage adjustment is required for elderly patients
Side effect Classification of the frequency of occurrence of adverse reactions:
very often (≥ 1/10); often (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (<1/10000), including isolated reports, frequency unknown (it is not possible to determine the frequency of occurrence from available data).
From the blood and lymphatic system: Very rarely: thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.
From the immune system: rarely: hypersensitivity, angioedema. Not known: anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Mental disorders: Rarely: nervousness, insomnia.
From the nervous system: Often: drowsiness Rarely: dizziness, headache.
From the heart: Rarely: tachycardia, rapid heartbeat.
Vascular disorders: Rare: arterial hypertension
From the gastrointestinal tract: Often: nausea, vomiting Rarely: constipation, dry oral mucosa.
From the liver and biliary tract: Rarely: increased activity of hepatic transaminases.
From the skin and subcutaneous tissues: Rarely: skin rash, itching, erythema, urticaria.
Overdose
Overdose symptoms are mainly due to the presence of paracetamol. In acute overdose, paracetamol can have a hepatotoxic effect and even cause liver necrosis. Overdose of paracetamol, including a general high dose level after a long period of therapy, can lead to analgesic-induced nephropathy with irreversible liver failure. Patients should be warned not to take other drugs containing paracetamol at the same time. There is a risk of poisoning, especially in elderly patients and young children, persons with liver disease, in cases of chronic alcoholism, patients with chronic malnutrition and patients receiving microsomal enzyme inducers. An overdose of paracetamol can lead to liver failure, encephalopathy, coma and death. Symptoms of paracetamol overdose on the first day include pallor, nausea, vomiting and anorexia. Abdominal pain may be the first sign of liver damage, and it may appear only 24-48 hours, and sometimes 4-6 days after taking the drug. Most often, signs of liver damage occur 72-96 hours after taking the drug. Impaired glucose metabolism and metabolic acidosis are possible. Acute renal failure and acute renal tubular necrosis can develop even in the absence of severe liver damage. Cases of cardiac arrhythmia and pancreatitis have been reported. To treat an overdose of paracetamol, treatment must be started immediately. During the first 48 hours after an overdose, it is advisable to use N-acetylcysteine intravenously or orally as an antidote to paracetamol, possibly gastric lavage and/or the use of methionine orally. It is advisable to use activated carbon and control breathing and circulation. In case of seizures, diazepam may be used. Symptoms of the sympathomimetic effect of phenylephrine include hemodynamic changes and cardiovascular collapse with respiratory depression, such as drowsiness, which may be followed by agitation (especially in children), blurred vision, skin rash, nausea, vomiting, persistent headaches, nervousness , dizziness, insomnia, circulatory disorders (thrombocytopenia, agranulocytosis, leukopenia, pancytopenia), coma, convulsions, arterial hypertension and bradycardia. Treatment includes surgical gastric lavage, symptomatic and supportive therapy. The hypertensive effect can be reversed with an intravenous alpha-receptor blocker. In case of seizures, diazepam may be used. Symptoms of chlorphenamine maleate overdose include drowsiness, respiratory arrest, seizures, anticholinergic effects, dystonic reactions, and cardiovascular collapse including arrhythmia. In children, symptoms of overdose may include incoordination, agitation, tremors, behavioral changes, hallucinations, seizures, and anticholinergic effects. Treatment includes gastric lavage in case of massive overdose or induction of vomiting. After this, activated charcoal and a laxative may be prescribed to slow down absorption. In case of seizures, sedation should be performed with intravenous diazepam or phenytoin. In severe cases, hemoperfusion may be performed.
Interactions with other medicinal products Paracetamol The anticoagulant effect of warfarin and other coumarins can be enhanced with long-term regular use of paracetamol, and the risk of bleeding increases. Occasional use of paracetamol has no significant effect. Hepatotoxic substances can lead to accumulation of paracetamol and overdose. The risk of paracetamol hepatotoxicity is increased by the use of drugs that induce liver microsomal enzymes, such as barbiturates, antiepileptic drugs (eg, phenytoin, phenobarbital, carbamazepine) and drugs for the treatment of tuberculosis, such as rifampicin and isoniazid. Metoclopramide increases the rate of absorption of paracetamol and increases its maximum concentration in blood plasma. Likewise, domperidone may increase the rate of absorption of paracetamol. Paracetamol may increase the half-life of chloramphenicol. Paracetamol may lead to a decrease in the bioavailability of lamotrigine, with a possible decrease in the effect of the latter, which may lead to a possible induction of hepatic metabolism. Absorption of paracetamol may be reduced when administered concomitantly with cholestyramine, but the reduction in absorption is not significant if cholestyramine is administered one hour later. Regular use of paracetamol concomitantly with zidovudine may cause neutropenia and increase the risk of liver damage. Probenecid affects the metabolism of paracetamol. In patients concomitantly using probenecid, the dose of paracetamol should be reduced. The hepatotoxicity of paracetamol increases with prolonged excessive consumption of ethanol (alcohol). Paracetamol may interfere with phosphotungstic uric acid test results.
Phenylephrine hydrochloride This drug is contraindicated in patients taking or who have taken monoamine oxidase inhibitors in the past two weeks. Phenylephrine may potentiate the effect of monoamine oxidase inhibitors and induce a hypertensive crisis. Concomitant use of phenylephrine with other sympathometic drugs or tricyclic antidepressants (for example, amitriptyline) may lead to an increased risk of adverse reactions from the cardiovascular system. The use of phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive agents (for example, debrisoquine, guanethidine, reserpine, methyldopa). The risk of hypertension and other cardiovascular adverse reactions may be increased. Concomitant use of phenylephrine with digoxin and cardiac glycosides may result in an increased risk of cardiac arrhythmias or heart attack. Concomitant use of ergot alkaloids (ergotamine) may increase the risk of ergotism.
Chlorphenamine maleate Antihistamines such as chlorphenamine may enhance the effects of opioid analgesics, anticonvulsants, antidepressants (tricyclics and monoamine oxidase inhibitors), other antihistamines, antiemetics and antipsychotics, anxiolytics, hypnotics, ethanol (alcohol) and other central nervous system depressants. Because chlorphenamine has some anticholinergic activity, the effects of anticholinergic drugs (eg, some psychotropic drugs, atropine, and urinary incontinence drugs) may be increased by this drug. This can lead to tachycardia, dry mouth, gastrointestinal disorders (eg colic), urinary retention and headache. The metabolism of phenytoin may be inhibited by chlorphenamine and phenytoin toxicity may develop.
Special instructions: To avoid toxic damage to the liver, the drug should not be combined with the use of alcoholic beverages.
Impact on the ability to drive a vehicle and operate machinery During treatment, it is not recommended to drive a vehicle or other mechanisms that require concentration and high speed of psychomotor reactions.
Release form: Film-coated tablets, 650.0 mg + 10.0 mg + 4.0 mg. 10 film-coated tablets are placed in a blister made of PVC/PVDC and aluminum foil. 1 or 2 blisters along with instructions for use are placed in a cardboard box. Secondary packaging is allowed to have a first-opening control.
Storage conditions: At a temperature not exceeding 25°C, out of the reach of children.
Shelf life: 3 years. Do not use after expiration date.
Conditions for dispensing from pharmacies: Without a prescription
Manufacturer: Novartis Saglik Gida ve Tarim Urunleri San. Ve Tik. A.S., Yenisehir Mahallesi, Ilhara Vadisi Sokak No.2, Pendik, Istanbul, TR 34912, Turkey. Novartis Saglik Gida ve Tarim Urunleri San ve Tic. AS, Yenisehir Mahallesi, Ihlara Vadisi Sokak, No:2 Pendik, Istanbul, TR 34912, Turkey.
Legal entity in whose name the registration certificate was issued and the organization accepting claims from consumers: JSC GlaxoSmithKline Healthcare 123112, Moscow, Presnenskaya embankment, 10, premises III, room 9, floor. 6. Tel.; Fax
Toll-free hotline number8 800 333 46 94
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The trademark is owned or used by the Group of Companies
Contraindications to the use of the drug Theraflu extratab
Hypersensitivity to the components of the drug; severe cardiovascular diseases; severe liver or kidney disease; AH (arterial hypertension); prostate adenoma with difficulty urinating; bladder neck obstruction; pyloroduodenal obstruction; stenosing ulcer of the stomach and duodenum; diabetes; lung disease (including asthma); angle-closure glaucoma; deficiency of glucose-6-phosphate dehydrogenase; epilepsy; During pregnancy and breastfeeding; age up to 12 years.
Overdose of the drug Theraflu extratab, symptoms and treatment
Symptoms of paracetamol overdose: hepatotoxic effect, in severe cases liver necrosis develops. The first symptoms may appear 24–48 hours or later after overdose and include nausea, vomiting and epigastric pain. Symptoms of phenylephrine overdose: drowsiness, which may be followed by agitation (especially in children); visual impairment; nausea; vomit; headache; blood flow disturbance; coma; convulsions; behavior changes; AH (arterial hypertension); bradycardia. Treatment: timely intravenous or oral administration of N-acetylcysteine as an antidote to paracetamol, gastric lavage, administration of activated charcoal, monitoring the state of the respiratory and circulatory systems (epinephrine should not be used). In case of seizures, diazepam is prescribed.
Special instructions for the use of the drug Theraflu extratab
Do not exceed the recommended dose or take the drug for more than 5 days in a row. Long-term use of high dose paracetamol, including general high dose levels, may cause nephropathy or irreversible liver failure. The simultaneous use of other drugs containing paracetamol is contraindicated. To prevent toxic liver damage, you should not drink alcohol while taking the drug. The drug is prescribed with caution for cardiovascular diseases, hypertension (arterial hypertension), thyroid diseases, diabetes mellitus, prostate hyperplasia, psychosis, moderate and severe liver and kidney failure, increased intraocular pressure, as well as liver and kidney diseases. In case of expected surgery, it is recommended to stop taking the drug several days before surgery (the risk of allergic reactions increases when used simultaneously with halogen anesthetics). Phenylephrine may cause a false positive result in doping tests in athletes taking part in competitions. The drug may cause drowsiness, so during treatment it is not recommended to drive vehicles or operate complex mechanisms that require increased concentration and high speed of psychomotor reactions. Drowsiness may increase when used simultaneously with sedatives, tranquilizers or alcoholic beverages. Since clinical experience with use during pregnancy and lactation is limited, the drug should be used only when the expected benefit of use outweighs the potential risk to the fetus/child.
