TheraFlu Extratab for colds and flu, tablets No. 10

Composition and release form

The drug is available as a topical spray and powder for oral administration. The latter has the smell of berries, a loose base of homogeneous granules of various colors. Packaged in cardboard packaging of 10 sachets with a volume of 11.5 g.

The spray is a clear solution with a mint smell. Sold in a spray bottle. The set includes instructions for use.

The active ingredients are paracetamol, pheniramine maleate, phenylephrine hydrochloride in the powder. And benzoxonium chloride, lidocoine hydrochloride in the aerosol base. Excipients: dyes, flavors, silicon dioxide, sucrose, citric acid, calcium phosphate, sodium dihydrate, acesulfame potassium, glycerin, menthol, peppermint, ethanol and pure water.

TheraFlu Extratab for colds and flu, tablets No. 10

A country

Turkey
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Paracetamol + Phenylephrine + Chlorphenamine

Description

THERAFLU EXTRATAB - the powerful power of Theraflu against the 7 main symptoms of flu and colds in a convenient tablet format!*.
It is used for the symptomatic treatment of infectious and inflammatory diseases: ARVI, including influenza and “colds”, the manifestations of which are: • Fever • Chills • Headache • Runny nose • Nasal congestion • Sneezing • Muscle pain*. Ready-made solution right on the go! * Instructions for medical use, RU P N015589/01 dated May 29, 2009

Compound

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.

Product description

Light yellow, oblong, biconvex, film-coated tablets with beveled edges. At the break the tablet is light yellow in color.

pharmachologic effect

The combined remedy 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 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 achieved 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.

Carefully

Diabetes mellitus, liver dysfunction, kidney 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 lactation

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 doses

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 Side effects Classification of the frequency of adverse reactions: very often (≥ 1/10); often (≥ 1/100, Overdose Overdose symptoms are caused mainly by 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 IV 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.

Interaction with other drugs

Paracetamol The anticoagulant effect of warfarin and other coumarins may be enhanced by 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 within 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 increase. Concomitant use of phenylephrine with digoxin and cardiac glycosides may increase the 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 liver damage, the drug should not be combined with the use of alcoholic beverages.

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 blister along with instructions for use is 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

Best before date

3 years. Do not use after expiration date.

pharmachologic effect

The drug belongs to combination drugs with a large list of pharmacological activities. It has an antihistamine, sedative, vasoconstrictor, and antitussive effect. It also lowers temperature and suppresses pain.

As a result of using the medicine, there is a decrease in the symptoms of acute respiratory infections and colds. Improves nasal breathing and overall well-being. The drug helps fight a runny nose, tonsillitis, swelling, and local allergic symptoms. Suppresses the development of the inflammatory process, pain and normalizes body temperature.

Due to the content of benzoxonium chloride in local form, the product has an antibacterial effect against gram-positive and gram-negative pathogens. In addition, it eliminates viruses and fungi, in particular helps in the treatment of influenza, parainfluenza and herpes infections.

The therapeutic effect of Theraflu occurs 15-20 minutes after administration and lasts up to 5 hours.

TheraFlu, 10 pcs., 11.5 g, powder for oral solution, wild berries

Symptoms (mainly caused by paracetamol, appear after taking more than 10–15 g): in severe cases of overdose, paracetamol has a hepatotoxic effect, including can cause liver necrosis. Also, an overdose can cause nephropathy with irreversible liver failure.

The severity of an overdose depends on the dose, so patients should be warned against simultaneous use of paracetamol-containing drugs. The risk of poisoning is pronounced especially in elderly patients, in children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition (calorie deficiency) and in patients taking inducers of microsomal oxidation in the liver.

An overdose of paracetamol can lead to liver failure, encephalopathy, coma and death.

Symptoms of paracetamol overdose

in the first 24 hours: pallor of the skin, nausea, vomiting, anorexia, convulsions. Abdominal pain may be the first sign of liver damage and usually does not appear for 24–48 hours and may sometimes appear later, after 4–6 days, with an average of 72–96 hours after taking the drug. Impaired glucose metabolism and metabolic acidosis may also occur. Even in the absence of liver damage, acute renal failure and acute tubular necrosis can develop. Cases of cardiac arrhythmia and pancreatitis have been reported.

Treatment:

administration of acetylcysteine ​​intravenously or orally as an antidote, gastric lavage, and oral methionine may have a beneficial effect for at least 48 hours after an overdose.

It is recommended to take activated carbon and monitor breathing and circulation. If seizures develop, diazepam may be prescribed.

Pheniramine and phenylephrine

(symptoms of overdose are combined due to the risk of mutual potentiation of the parasympatholytic effect of pheniramine and the sympathomimetic effect of phenylephrine in case of drug overdose).

Symptoms of overdose include: drowsiness, followed by anxiety (especially in children), visual disturbances, rash, nausea, vomiting, headache, increased excitability, dizziness, insomnia, circulatory disorders, coma, convulsions, behavioral changes, increased or decreased blood pressure, bradycardia. Cases of atropine-like “psychosis” have been reported in cases of pheniramine overdose.

There is no specific antidote. The usual measures of assistance are necessary, including the administration of activated charcoal, saline laxatives, and measures to support cardiac and respiratory functions. Psychostimulants (methylphenidate) should not be prescribed due to the risk of seizures. For hypotension, vasopressor drugs may be used.

In case of increased blood pressure, intravenous administration of alpha-blockers is possible, because Phenylephrine is a selective alpha1-adrenergic receptor agonist; therefore, the hypertensive effect of phenylephrine overdose should be treated by blocking alpha-adrenergic receptors. If seizures develop, use diazepam.

What is Theraflu medicine for?

Indications for taking Theraflu are:

1. ARVI, ARZ.
2. Symptoms of influenza and colds include chills, high fever, headache, runny nose, impaired nasal breathing, fever, malaise and muscle aches.
3. Pharyngitis, laryngitis.
4. Stomatitis of various forms.
5. Sore throat, catarrhal and chronic.
6. Gingivitis.
7. Sinusitis.
8. Vasomotor and allergic rhinitis.
9. Rhinorrhea.
10. Hay fever.
11. Rhinosinusopathy.

Contraindications

Absolute contraindications to prescribing the drug are: hypersensitivity of the body to the components of the drug, children under 12 years of age, women during pregnancy and breastfeeding.

Antipyretic medication should be used with caution in the following cases:

1. Severe dysfunction of the liver and kidneys.
2. Glaucoma.
3. Bronchitis in the chronic stage.
4. Diabetes mellitus of any type.
5. Thyroid dysfunction.
6. Emphysema.
7. High blood pressure.
8. Diseases of the heart and vascular system.
9. Hyperbilirubinemia.

Theraflu Lemon

TheraFlu for colds and flu

Registration number: P N012063/01

Trade name: TheraFlu for colds and flu

Group name: Paracetamol + Phenylephrine + Pheniramine + Ascorbic acid

Dosage form: powder for oral solution [lemon].

Composition: One sachet contains: Active ingredients: paracetamol 325 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg, ascorbic acid 50 mg. Excipients: sodium citrate dihydrate 120.74 mg, malic acid 50.31 mg, sunset yellow dye 0.098 mg, quinoline yellow dye 0.094 mg, titanium dioxide 3.16 mg, lemon flavor 208.42 mg, tribasic calcium phosphate 82 mg , citric acid 1221.79 mg, sucrose 20000 mg.

Description: Free-flowing white granular powder with yellow inclusions without foreign particles with a citrus odor. Soft lumps are allowed.

Pharmacotherapeutic group: acute respiratory infections and “cold” symptoms remedy (non-narcotic analgesic + alpha-adrenergic agonist + H1-histamine receptor blocker + vitamin).

ATX code: N02BE51

Pharmacological properties The combined agent, the effect of which is determined by the components included in its composition, has an antipyretic, mild anti-inflammatory, anti-edematous, analgesic, anti-allergic, vasoconstrictor effect, and eliminates the symptoms of “colds”. Constricts the vessels of the nose, eliminates swelling of the mucous membrane of the nasal cavity and nasopharynx.

Pharmacodynamics Paracetamol Paracetamol has an analgesic and antipyretic effect by suppressing the synthesis of prostaglandins in the central nervous system. Does not affect platelet function and hemostasis.

Pheniramine Pheniramine is an antiallergic drug - a blocker of H1-histamine receptors. Eliminates allergic symptoms, has a moderate sedative effect and also exhibits antimuscarinic activity.

Phenylephrine Phenylephrine is a sympathomimetic agent; when applied topically, it has a moderate vasoconstrictor effect (due to stimulation of alpha1-adrenergic receptors), reduces swelling and hyperemia of the nasal mucosa.

Pharmacokinetics of Paracetamol Absorption Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. After taking the drug orally, the maximum concentration of paracetamol in plasma is reached within 10-60 minutes.

Distribution Paracetamol is distributed in most body tissues, crosses the placenta and is present in breast milk. At therapeutic concentrations, binding to plasma proteins is insignificant and increases with increasing concentration.

Metabolism: It undergoes primary metabolism in the liver and is excreted mainly in the urine in the form of glucuronide and sulfate compounds. The half-life is 1-3 hours.

Elimination: Less than 5% of the dose taken is excreted in the form of unchanged paracetamol.

Pheniramine Absorption The maximum concentration of pheniramine in plasma is reached after approximately 1-2.5 hours. The half-life of pheniramine is 16-19 hours.

Excretion: 70-83% of the dose taken is excreted from the body in the urine in the form of metabolites or unchanged.

Phenylephrine Absorption Phenylephrine is unevenly absorbed from the gastrointestinal tract.

Metabolism: Subject to primary metabolism by monoamine oxidases in the intestine and liver. Phenylephrine when taken orally is characterized by reduced bioavailability.

Excretion: Excreted in urine almost entirely in the form of sulfate compounds. Maximum plasma concentrations are achieved in the range from 45 minutes to 2 hours. The half-life is 2-3 hours.

Ascorbic Acid Absorption

Ascorbic acid is quickly and completely absorbed from the gastrointestinal tract. Distribution

Plasma protein binding is 25%. Excretion In case of overdose, ascorbic acid is excreted in the form of metabolites in the urine.

Indications for use: Symptomatic treatment of infectious and inflammatory diseases (ARVI, including influenza), accompanied by high fever, chills, body aches, headache and muscle pain, runny nose, nasal congestion, sneezing.

Contraindications Hypersensitivity to individual components of the drug, simultaneous use of tricyclic antidepressants, beta-blockers or other sympathomimetic drugs, simultaneous or within the previous 2 weeks use of monoamine oxidase inhibitors (MAOIs), portal hypertension, alcoholism, diabetes mellitus, sucrase/isomaltase deficiency, fructose intolerance , glucose-galactose malabsorption, pregnancy, breastfeeding, children under 12 years of age, severe cardiovascular diseases, arterial hypertension, hyperthyroidism, angle-closure glaucoma, pheochromocytoma.

With caution In case of severe atherosclerosis of the coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma, severe liver or kidney diseases (concomitant liver disease increases the risk of paracetamol-related liver damage), hyperplasia and hypertrophy of the prostate gland, difficulty urinating due to hypertrophy prostate, blood diseases, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), vasospastic diseases (for example, Raynaud's disease), in patients suffering from malnutrition, dehydration, pyloroduodenal obstruction, stenosing gastric ulcer and /or duodenum, epilepsy, while taking drugs that can adversely affect the liver (for example, inducers of microsomal liver enzymes). Concomitant use with other drugs containing paracetamol may lead to an overdose. An overdose of paracetamol can cause liver failure, which can lead to liver transplantation or death. Cases of liver dysfunction/liver failure have been reported in patients with reduced glutathione levels, such as severely malnourished patients with anorexia, low body mass index, patients with severe chronic alcohol dependence or sepsis. In conditions accompanied by a decrease in glutathione levels, the use of paracetamol may increase the risk of metabolic acidosis. Concomitant use with other decongestants and antihistamines should be avoided. Caution should be exercised when treating patients with recurrent formation of urate kidney stones while using other antihypertensive drugs, digoxin and other cardiac glycosides, ergot alkaloids (ergotamine and methysergide). Should be used with caution in elderly patients who are more susceptible to developing undesirable effects. Avoid use in elderly patients with confusion.

Use during pregnancy and breastfeeding: It is not recommended to use the drug during pregnancy and breastfeeding.

Directions for use and dosage : Inside. The contents of one sachet are dissolved in 1 glass (250 ml) of hot but not boiling water. Take it hot. A repeat dose can be taken every 4-6 hours (no more than 3-4 doses within 24 hours). TheraFlu for colds and flu can be used at any time of the day, but the best effect comes from taking the drug before bed, at night. If there is no relief of symptoms within 3 days after starting to take the drug, you should consult a doctor. Patients should not take TheraFlu for colds and flu for more than 5 days. Do not exceed the indicated dose. The lowest dose necessary to achieve effect for the shortest possible duration of treatment should be used.

Special Populations: Hepatic Impairment: Patients with impaired liver function or Gilbert's syndrome should reduce the dose or increase the interval between doses of TheraFlu for colds and flu. Renal failure: in the presence of acute renal failure (creatinine clearance <10 ml/min), the interval between doses of TheraFlu for flu and colds should be at least 8 hours. Elderly patients: No dose adjustment is necessary in elderly patients.

Side effects 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 and reactions with unknown frequency (frequency cannot be estimated from available data).

Blood and lymphatic system disorders: Very rare: thrombocytopenia, agranulocytosis, pancytopenia. Unknown: leukopenia, hemolytic anemia.

Immune system disorders: Rare: anaphylactic reaction, angioedema, hypersensitivity, urticaria, allergic dermatitis. Very rare: cutaneous hypersensitivity reactions including, but not limited to, toxic epidermal necrolysis, Stevens-Johnson syndrome, and skin rash.

Mental disorders: Rare: increased excitability, sleep disturbance. Unknown: hallucinations, confusion.

Nervous system disorders: Common: drowsiness. Rarely: dizziness, headache. Not known: anticholinergic symptoms, incoordination, tremor, loss of memory or concentration, balance problems, sedation.

Visual disorders: Rare: angle-closure glaucoma, mydriasis, increased intraocular pressure. Unknown: accommodation paresis.

Cardiac disorders: Common: increased blood pressure. Rarely: tachycardia, palpitations.

Vascular disorders: Rare: increased blood pressure. Unknown: orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm in patients sensitive to aspirin and other NSAIDs.

Gastrointestinal disorders: Often: nausea, vomiting. Rarely: dry mouth, constipation, abdominal pain, diarrhea. Unknown: constipation.

Disorders of the liver and biliary tract: Rarely: increased activity of liver enzymes. Very rare: liver dysfunction

Skin and subcutaneous tissue disorders: Rare: rash, eczema, purpura, itching, erythema, urticaria.

Renal and urinary tract disorders: Rare: difficulty urinating.

General disorders and administration site disorders: Rare: malaise. Unknown: dry mucous membrane.

If any of the adverse reactions indicated in the instructions worsen, or you notice any other adverse reactions not listed in the instructions, tell your doctor.

Overdose of Paracetamol Symptoms and signsSymptoms (mainly caused by paracetamol, appear after taking more than 10-15 g): in severe cases of overdose, paracetamol has a hepatotoxic effect, including can cause liver necrosis. Also, an overdose can cause nephropathy and irreversible liver damage. The severity of an overdose depends on the dose, so patients should be warned against simultaneous use of paracetamol-containing drugs. The risk of poisoning is pronounced especially in elderly patients, in children, in patients with liver diseases, in cases of chronic alcoholism, in patients suffering from malnutrition and in patients taking inducers of microsomal liver enzymes. Overdose of paracetamol can lead to liver failure, encephalopathy, liver transplantation, coma and death. Symptoms of paracetamol overdose in the first 24 hours: pale skin, nausea, vomiting, anorexia, convulsions. Abdominal pain may be the first sign of liver damage and usually does not appear for 24-48 hours and can sometimes appear later, after 4-6 days. Liver damage occurs to its maximum extent on average 72-96 hours after taking the drug. Impaired glucose metabolism and metabolic acidosis may also occur. Even in the absence of liver damage, acute renal failure and acute tubular necrosis can develop. Cases of cardiac arrhythmia and acute pancreatitis have been reported, usually with liver dysfunction and liver toxicity.

Treatment In case of overdose, immediate medical intervention is required even in the absence of overdose symptoms. Administration of acetylcysteine ​​intravenously or orally as an antidote, gastric lavage, and oral methionine may have a beneficial effect for at least 48 hours after an overdose. It is recommended to take activated carbon and monitor breathing and circulation. If seizures develop, diazepam may be prescribed.

Pheniramine and phenylephrine (overdose symptoms for pheniramine and phenylephrine are combined due to the risk of mutual potentiation of the parasympatholytic effect of pheniramine and the sympathomimetic effect of phenylephrine in case of drug overdose).

Symptoms and signs Drowsiness, which is later joined by anxiety (especially in children), visual disturbances, irritability, rash, nausea, vomiting, headache, increased excitability, dizziness, insomnia, circulatory disorders, coma, convulsions, behavioral changes, disturbances of consciousness, hallucinations, increased or decreased blood pressure, arrhythmia and bradycardia. Cases of atropine-like “psychosis” have been reported in cases of pheniramine overdose.

Treatment There is no specific antidote. The usual measures of assistance are necessary, including the administration of activated charcoal, saline laxatives, and measures to support cardiac and respiratory functions. Psychostimulants (methylphenidate) should not be prescribed due to the risk of seizures. For hypotension, vasopressor drugs may be used. In case of increased blood pressure, intravenous administration of alpha-blockers (for example, phentolamine) is possible, because Phenylephrine is a selective alpha1-adrenergic receptor agonist; therefore, the hypertensive effect of phenylephrine overdose should be treated by blocking alpha1-adrenergic receptors. If seizures develop, use diazepam.

Ascorbic acidHigh doses of ascorbic acid (> 3000 mg) may cause transient osmotic diarrhea and gastrointestinal disturbances such as nausea and abdominal discomfort. The effects of ascorbic acid overdose can be attributed to the serious hepatotoxicity caused by paracetamol overdose.

Interaction with other drugs Effect of paracetamol Enhances the effects of MAO inhibitors, sedatives, ethanol. The risk of hepatotoxic action of paracetamol increases with simultaneous use of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes. The anticoagulant properties of warfarin and other coumarins may be enhanced by long-term regular use of paracetamol, increasing the risk of bleeding. A single dose of paracetamol does not have this effect. When paracetamol is prescribed simultaneously with metoclopramide, the rate of absorption of paracetamol increases and, accordingly, its maximum concentration in plasma is reached faster. Likewise, domperidone may increase the rate of absorption of paracetamol. When chloramphenicol and paracetamol are used together, the half-life of chloramphenicol may increase. Paracetamol may reduce the bioavailability of lamotrigine, with a possible decrease in its effect due to induction of its hepatic metabolism. The absorption of paracetamol may be reduced when taken concomitantly with cholestyramine, but this can be avoided if cholestyramine is taken one hour after paracetamol. 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 taking probenecid concomitantly, the dose of paracetamol should be reduced. The hepatotoxicity of paracetamol may be increased by chronic or excessive alcohol consumption. Paracetamol may interfere with the results of the uric acid test using the phosphotungstate precipitating reagent.

Effect of pheniramine It is possible to enhance the effect of other substances on the central nervous system (for example, MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonian drugs, barbiturates, benzodiazepines, tranquilizers and narcotics). Pheniramine may inhibit the action of anticoagulants. Pheniramine has anticholinergic activity and may enhance the anticholinergic effects of other drugs (eg, other antihistamines, drugs for Parkinson's disease and phenothiazine antipsychotics).

Effect of phenylephrineTheraFlu for colds and flu is contraindicated in patients who are taking or have taken MAO inhibitors within the past two weeks. Phenylephrine can enhance the effect of MAO inhibitors and cause a hypertensive crisis. Concomitant use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (eg, amitriptyline) may increase the risk of cardiovascular side effects.

Phenylephrine may reduce the effectiveness of beta blockers and other antihypertensive drugs (eg, debrisoquine, guanethidine, reserpine, methyldopa). The risk of increased blood pressure and other cardiovascular side effects may be increased. Concomitant use of phenylephrine with digoxin and other cardiac glycosides may increase the risk of arrhythmia or myocardial infarction. Concomitant use of phenylephrine with ergot alkaloids (ergotamine and methysergide) may increase the risk of ergotism.

The effect of the medicinal product for medical use on the ability to drive vehicles and machinery TheraFlu for flu and colds may cause drowsiness, therefore, during treatment it is not recommended to drive a car or engage in other activities that require concentration and high speed of psychomotor reactions. In some patients, pheniramine may also cause dizziness, blurred vision, impaired cognitive function and motor coordination, which can significantly affect the ability to drive vehicles and operate machines. These undesirable effects may be further enhanced by the use of alcoholic beverages or other sedatives.

Special instructions To avoid toxic damage to the liver, the drug should not be combined with the use of alcoholic beverages. TheraFlu for colds and flu contains:

• sucrose 20 g per sachet. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems such as fructose intolerance, glucose-galactose malabsorption or sucrase/isomaltase deficiency should not take TheraFlu for colds and flu.
• Sunset yellow dye (E110). May cause allergic reactions.
• sodium 28.3 mg per sachet. This should be taken into account in patients on a sodium-low diet.

Do not use the drug from damaged sachets. Patients should consult a doctor if:

• Bronchial asthma, emphysema or chronic bronchitis is observed;
• Symptoms do not go away within 5 days or are accompanied by severe fever lasting 3 days, rash, or persistent headache.

These may be signs of more serious problems.

Release form: Powder for the preparation of a solution for oral administration (lemon). For the Delpharm Orleans plant, France: 22.1 g of powder in a 4-layer bag (polyethylene / low-density polyethylene / aluminum foil / low-density polyethylene) or 5-layer bag (paper / polyethylene / low-density polyethylene / aluminum foil / polyethylene low density). Sachets in quantities of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 , 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 pieces in a cardboard box, placed individually or in pairs, fastened through perforations, along with instructions for use. Secondary packaging is allowed to have a first-opening control. For GSK Consumer Health, Inc., USA: 22.1 g of powder in a 6-layer bag (paper / low-density polyethylene / polyethylene / low-density polyethylene / aluminum foil / low-density polyethylene). Sachets in quantities of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 , 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 pieces in a cardboard box, placed individually or in pairs, fastened through perforations, along with instructions for use. Secondary packaging is allowed to have a first-opening control.

Storage conditions: At a temperature not exceeding 25 °C. Keep out of the reach of children.

Shelf life: 2 years. The drug should not be used after the expiration date.

Conditions for dispensing from pharmacies: Without a prescription.

Manufacturer Delpharm Orleans, France / DELPHARM ORLEANS, 5 avenue de Concyr, ORLEANS CEDEX 2, 45071, France.

Or

GSK Consumer Health, Inc., USA/GSK Consumer Health, Inc., 10401 Highway 6, Lincoln, Nebraska, 68517, USA.

Legal entity in whose name the registration certificate was issued and the organization accepting claims on the territory of the Russian Federation: GlaxoSmithKline Healthcare JSC.

123112, Russian Federation, Moscow, Presnenskaya embankment, 10, premises III, room 9, floor 6. Tel.; Fax

Toll-free hotline number 8

Email

The trademark is owned or used by the GlaxoSmithKline Group of Companies. DN504906/RU-110

Side effects

Theraflu in certain situations can provoke the development of side effects. More often occur:

1. Dyspeptic disorders - vomiting, nausea, pain in the epigastric region, dry mouth.
2. Dizziness.
3. Insomnia, drowsiness.
4. Increased intraocular pressure.
5. Urinary dysfunction.
6. Decreased platelet levels in the blood.
7. Allergic manifestations - skin rashes, itching, hyperemia, swelling, urticaria.
8. Paresis.
9. Bronchospasm.

Theraflu: how to take it

The product in powder form is intended for oral administration. The contents of the sachet are dissolved in 180 ml of hot water and drunk immediately. Sugar can be added if necessary. It is permissible to use no more than 3 sachets per day.

Taking the medicine does not depend on food or time. For the best pharmacological effect, it is advisable to take Theraflu before going to bed.

The duration of therapy is 3 days. If symptoms of the disease persist, it is important to consult a specialist.

The medicine in aerosol form is used for up to 5 days according to the traditional scheme: no more than 6 times a day, 4 sprays.

TeraFlu

Symptoms caused by paracetamol

(appears after taking more than 10-15 g)

In severe cases of overdose, paracetamol has a hepatotoxic effect, including causing liver necrosis. Overdose can also cause liver failure, which can lead to liver transplantation or death. Clinical signs of liver damage develop mainly after 24-48 hours and reach a maximum after 4-6 days. Acute pancreatitis has been observed, usually with liver dysfunction and liver toxicity.

The severity of an overdose depends on the dose, so simultaneous use of paracetamol-containing drugs is prohibited. The risk of poisoning is pronounced especially in elderly patients, in children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition (calorie deficiency) and in patients taking inducers of microsomal oxidation in the liver.

Symptoms of paracetamol overdose in the first 24 hours: pale skin, nausea, vomiting, loss of appetite, convulsions. Abdominal pain may be the first sign of liver damage and sometimes does not appear for 24-48 hours and can sometimes appear later, after 4-6 days, on average 72-96 hours after taking the drug. Impaired glucose metabolism and metabolic acidosis may also occur. Even in the absence of liver damage, acute liver failure and acute tubular necrosis can develop. Cases of cardiac arrhythmia and pancreatitis have been reported.

Treatment

If you exceed the recommended dose, seek medical attention immediately, even if you feel well, as there is a risk of delayed serious liver damage.

Administration of acetylcysteine ​​intravenously or orally as an antidote, gastric lavage, and oral methionine may have a beneficial effect for at least 48 hours after an overdose.

It is recommended to take activated carbon and monitor breathing and circulation. If seizures develop, diazepam may be prescribed.

Symptoms associated with pheniramine and phenylephrine

(combined due to the mutual potentiation of the parasympatholytic effect of pheniramine and the sympathomimetic effect of phenylephrine in case of drug overdose)

Symptoms of overdose include drowsiness, followed by restlessness (especially in children), visual disturbances, rash, nausea, vomiting, headache, increased excitability, dizziness, insomnia, circulatory disorders, coma, convulsions (especially in children), changes in behavior , increased or decreased blood pressure, bradycardia.

Cases of atropine-like "psychosis" have been reported in cases of pheniramine overdose. In severe cases, confusion, hallucinations, seizures and arrhythmias may develop.

There is no specific antidote. The usual measures of assistance are necessary, including the administration of activated charcoal, saline laxatives, and measures to support cardiac and respiratory functions. Psychostimulants (methylphenidate) should not be prescribed due to the risk of seizures. For hypotension, vasopressor drugs may be used.

In case of increased blood pressure, intravenous administration of alpha-blockers (for example, phentolamine) is possible, since phenylephrine is a selective alpha1-adrenergic agonist, therefore, the hypertensive effect of phenylephrine overdose should be treated by blocking alpha-adrenergic receptors.

If seizures develop, use diazepam.

Drug interactions

When Theraflu interacts with MAO inhibitors, sedatives and ethyl alcohol, the effect of the latter is enhanced.

Combining medications with hormones can lead to the development of glaucoma.

The use of tricyclic antidepressants increases the symptomatic effect of Theraflu.

Phenothiazine group drugs, antipsychotics and antiparkinsonian drugs increase the risk of adverse reactions such as bowel problems, urinary problems and dry mouth.