TheraFlu Extra Powder, packets, 10 pcs., 650 mg, for oral solution, lemon

Compound

Theraflu Extra Lemon

Registration number: LSR-007823/10. Trade name of the drug: TeraFlu Extra. International nonproprietary name: Paracetamol + Pheniramine + Phenylephrine. Dosage form: powder for the preparation of solution for oral administration (lemon).

COMPOSITION Active ingredients Paracetamol 650.0 mg Pheniramine maleate 20.0 mg Phenylephrine hydrochloride 10.0 mg

Auxiliary components Sucrose 12600.0 mg Acesulfame potassium 19.0 mg Quinoline yellow dye 0.147 mg Sunset yellow dye 0.035 mg Maltodextrin M100 26.0 mg Silicon dioxide 13.0 mg Natural lemon flavor WONF Durarome 860.098TD 300.0 mg Lemon flavor ny natural Durarome 860.202TD 09.91 35.0 mg Citric acid 1000.0 mg Sodium citrate dihydrate 180.0 mg Calcium phosphate 35.0 mg

DESCRIPTION Loose powder containing white and yellow granules with a specific odor. Soft lumps are allowed.

PHARMACOTHERAPEUTIC GROUP A remedy for eliminating the symptoms of acute respiratory infections and “colds” (analgesic non-narcotic drug + alpha-adrenergic agonist + H1-histamine receptor blocker).

ATX code: N02BE51.

PHARMACOLOGICAL PROPERTIES A combined drug, the effect of which is determined by its constituent components, has an antipyretic, analgesic, vasoconstrictor effect, and eliminates the symptoms of a “cold”. 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 homeostasis. The absence of suppression of peripheral prostaglandin synthesis gives the drug significant pharmacological properties, such as the preservation of protective prostaglandins in the gastrointestinal tract. Therefore, paracetamol is particularly suitable for patients with a history of diseases or concomitant medications in which suppression of peripheral prostaglandin synthesis would be undesirable (for example, patients with a history of gastrointestinal bleeding or elderly patients).

Pheniramine maleate Pheniramine maleate is an antiallergic agent - an antagonist of histamine H1 receptors. Leads to relief of common allergic symptoms associated with respiratory disorders. It has a moderate sedative effect and also exhibits antimuscarinic activity.

Phenylephrine hydrochloride Phenylephrine hydrochloride 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 Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. After taking the drug orally, the maximum plasma concentration of paracetamol is reached within 10–60 minutes. 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. It undergoes primary metabolism in the liver and is excreted mainly by the kidneys in the form of glucuronide and sulfate compounds. Less than 5% of the dose taken is excreted in the form of unchanged paracetamol. The half-life is 1–3 hours.

Pheniramine maleate The maximum concentration of pheniramine maleate in plasma is reached after approximately 1–2.5 hours. The half-life of pheniramine is 16–19 hours. Distribution and metabolism data are not available. 70–83% of the dose taken is excreted from the body in the urine in the form of metabolites or unchanged.

Phenylephrine hydrochloride Phenylephrine hydrochloride is unevenly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidases in the intestines and liver. Thus, phenylephrine hydrochloride when taken orally has reduced bioavailability. It is excreted almost completely by the kidneys in the form of sulfate compounds. Maximum plasma concentrations are achieved between 45 minutes and 2 hours. The half-life is 2–3 hours.

INDICATIONS FOR USE Symptomatic treatment of flu and cold symptoms, such as high fever accompanied by chills, body aches, headache, nasal congestion, sneezing and runny nose.

CONTRAINDICATIONS

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

CAREFULLY

• Severe atherosclerosis of the coronary arteries;
• cardiovascular diseases;
• acute hepatitis;
• hemolytic anemia;
• bronchial asthma;
• severe liver or kidney disease;
• prostatic hyperplasia;
• difficulty urinating due to prostate hypertrophy;
• blood diseases;
• deficiency of glucose-6-phosphate dehydrogenase;
• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);
• chronic malnutrition and dehydration;
• pyloroduodenal obstruction;
• stenosing ulcer of the stomach and/or duodenum;
• epilepsy;
• simultaneous use of digoxin and cardiac glycosides, ergot alkaloids (for example, ergotamine and methysergide), as well as drugs that can adversely affect the liver.

Should be used with caution in elderly patients who are more susceptible to developing undesirable effects. Avoid use in elderly patients with confusion. 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.

USE DURING PREGNANCY AND BREASTFEEDING The use of the drug during pregnancy and breastfeeding is contraindicated.

METHOD OF APPLICATION AND DOSES : Orally. Do not exceed the recommended dose. The lowest dose required to achieve effect should be used for the shortest possible duration of treatment.

Adults (including older adults) and children 12 years of age and older: One sachet every 4–6 hours, as needed, but not more than 4 doses in 24 hours. One sachet is dissolved in a glass of hot, but not boiling water. Take it hot. TheraFlu Extra 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 Extra for more than 5 days.

Special groups of patients Renal failure Before using TheraFlu Extra, patients with impaired renal function should first consult a doctor. Limitations associated with the use of paracetamol-containing drugs in patients with impaired renal function are mainly related to the paracetamol content of the drug.

Liver failure: Before using TheraFlu Extra, patients with impaired liver function should first consult a doctor. Limitations associated with the use of paracetamol-containing drugs in patients with impaired liver function are mainly related to the paracetamol content of the drug.

Elderly patients No dose adjustment is necessary in elderly patients.

SIDE EFFECTS The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows:

very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1,000 and < 1/100), rare (≥ 1/10,000 and < 1/1,000) , very rare (< 1/10,000, including isolated cases).

Frequency categories were formed based on post-marketing surveillance.

Paracetamol Blood and lymphatic system disorders Very rare: thrombocytopenia.

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

Respiratory, thoracic and mediastinal disorders Very rare: bronchospasm in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

Liver and biliary tract disorders Very rare: liver dysfunction.

Pheniramine Blood and lymphatic system disorders Frequency unknown: leukopenia, thrombocytopenia, hemolytic anemia.

Immune system disorders Rare: anaphylactic shock, angioedema, hypersensitivity, urticaria.

Psychiatric disorders Frequency unknown: hallucinations, confusion, agitation effects (agitation, nervousness and insomnia).

Nervous system disorders Not known: anticholinergic symptoms, incoordination, tremor, loss of memory or concentration (more common in older patients), balance problems (more common in older patients), dizziness (more common in older patients), sedation ( more pronounced at the beginning of treatment), drowsiness (more pronounced at the beginning of treatment).

Violation of the organ of vision Frequency unknown: mydriasis, disturbance of accommodation.

Cardiac disorders Frequency unknown: palpitations.

Vascular disorders Frequency unknown: orthostatic hypotension.

Gastrointestinal disorders Frequency unknown: constipation.

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

Renal and urinary tract disorders Frequency unknown: urinary retention.

General disorders and disorders at the injection site Frequency unknown: dry mucous membrane.

Phenylephrine Immune system disorders Rare: hypersensitivity, allergic dermatitis, urticaria.

Mental disordersCommon: nervousness.

Nervous system disorders Common: dizziness, headache, insomnia.

Visual disorders Rare: mydriasis, acute attack of glaucoma in most cases in patients with angle-closure glaucoma.

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

Gastrointestinal disorders: Common: vomiting, nausea.

Skin and subcutaneous tissue disorders Common: rash.

Renal and urinary tract disorders Rare: difficulty urinating (most often occurs in patients with bladder outlet obstruction, for example due to prostatic hypertrophy), dysuria.

If any of the effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

OVERDOSE Symptoms 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, overdose can cause nephropathy with irreversible 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 and in patients taking enzyme activity inducers. Symptoms of paracetamol overdose in the first 24 hours: pale skin, nausea, vomiting, loss of appetite. Abdominal pain may be the first sign of liver damage and sometimes 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 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 immediate medical attention, even if you feel well, as there is a risk of delayed serious liver damage. Administration of N-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 caused by 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, which is subsequently accompanied by anxiety (especially in children), visual disturbances, rash, nausea, vomiting, headache, increased excitability, dizziness, insomnia, circulatory disorders, coma, convulsions (especially in children), changes behavior, increased 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. Stimulants should not be prescribed. For hypotension, vasopressor drugs may be used.

In case of increased blood pressure, intravenous administration of alpha-blockers (for example, phentolamine) is possible. If seizures develop, use diazepam.

INTERACTION WITH OTHER MEDICINES The 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. Metoclopramide increases the rate of absorption of paracetamol and increases the plasma concentration of paracetamol to its maximum. Similarly, 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 phosphotungsten precipitating reagent.

Effect of pheniramine maleate 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 (other antihistamines, drugs for Parkinson's disease and phenothiazine antipsychotics).

Effect of phenylephrine hydrochloride TheraFlu Extra is contraindicated in patients who are taking or have taken MAO within the last two weeks. Phenylephrine hydrochloride may enhance the effect of MAO inhibitors and cause an increase in blood pressure. Concomitant use of phenylephrine with other sympathomimetic amines (e.g., decongestants, appetite suppressants, and amphetamine-like drugs) or tricyclic antidepressants (e.g., amitriptyline) may increase the risk of cardiovascular side effects. Phenylephrine may reduce the effectiveness of beta blockers and other antihypertensive drugs (eg, debrisoline, 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 heart attack. Concomitant use of phenylephrine with ergot alkaloids (ergotamine and methysergide) may increase the risk of ergotism.

SPECIAL INSTRUCTIONS To avoid toxic damage to the liver, the drug should not be combined with the use of alcoholic beverages. Do not use with any other medicines containing paracetamol. Combined use with other drugs containing paracetamol may lead to an overdose. An overdose of paracetamol may cause liver failure, which may lead to the need for a liver transplant or death. Cases of liver dysfunction/liver failure have been reported in patients with reduced glutathione levels, for example, in extremely malnourished patients suffering from anorexia, with a low body mass index, in patients with severe chronic alcohol dependence or sepsis. Concomitant use with decongestants and antihistamines should be avoided.

Patients with the following conditions should consult their doctor before taking this drug:

• Impaired liver or kidney function. Concomitant liver disease increases the risk of developing paracetamol-related liver injury.
• Conditions accompanied by a decrease in glutathione levels, such as the use of paracetamol, may increase the risk of metabolic acidosis.
• Angle-closure glaucoma.
• Prostate hypertrophy.
• Vascular occlusive disease (eg, Raynaud's phenomenon).

1 sachet of TheraFlu Extra contains:

• 12.6 g of sucrose, which should be taken into account by patients with diabetes.
• Sunset yellow dye (E110), which can cause allergic reactions.
• 42.2 mg sodium, which should be taken into account in patients on a sodium diet.

Do not use the drug from damaged sachets.

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND MECHANISMS TheraFlu Extra can cause drowsiness, dizziness, blurred vision, impaired cognitive function and coordination of movements, which can significantly affect the ability to drive vehicles and operate machinery. These undesirable effects may be further enhanced by the use of alcoholic beverages or other sedatives.

RELEASE FORM Powder for the preparation of solution for oral administration (lemon). For GSK Consumer Health, Inc., USA: 15 g of powder in a 6-layer bag (paper/low-density polyethylene/polyethylene/low-density polyethylene/aluminum foil/low-density polyethylene). 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 or 25 sachets 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 the Delpharm Orleans plant, France: 15 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/low-density polyethylene) ). 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 or 25 sachets 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.

EXPIRATION LIFE 2 years. Do not use after expiration date.

STORAGE CONDITIONS Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

VARIATION CONDITIONS Without a prescription.

MANUFACTURER GSK Consumer Health, Inc., USA / GSK Consumer Health, Inc., USA 10401 Highway 6, Lincoln, Nebraska 68517, USA or Delpharm Orleans, France / Delpharm Orleans, France 5 Avenue de Concyr F-45071 Orleans Cedex 02, France .

OWNER OF REGISTRATION CERTIFICATES / ORGANIZATION ACCEPTING CONSUMER CLAIMS GlaxoSmithKline Healthcare JSC. 123112, Russian Federation, Moscow, Presnenskaya embankment, 10, premises III, room 9, floor 6. Tel.; Fax.

Toll free hotline:8 800 333 46 94

Email:

The trademark is owned or used by the GlaxoSmithKline Group of Companies.

DN500804/RU-48

Interaction

Enhances the effects of MAO inhibitors, sedatives, ethanol.

The risk of hepatotoxicity from paracetamol increases with concomitant use of barbiturates, phenytoin, carbamazepine, rifampicin, zidovudine and other inducers of microsomal liver enzymes.

Antidepressants, antiparkinsonian and antipsychotic drugs, incl. phenothiazine derivatives increase the risk of developing urinary retention, dry mouth, and constipation.

Glucocorticoids increase the risk of increased IOP.

Paracetamol reduces the effectiveness of uricosuric drugs and increases the effectiveness of indirect anticoagulants.

Tricyclic antidepressants enhance their sympathomimetic effect.

Co-administration of halothane increases the risk of developing ventricular arrhythmia.

Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenomimetic effect of phenylephrine.

Ethanol may enhance the sedative effect of the drug.

Pharmacological properties

Combined drug for the symptomatic treatment of influenza and colds.
has antipyretic, decongestive, analgesic and antiallergic effects. Paracetamol has analgesic, antipyretic and minor anti-inflammatory properties. The therapeutic effect is due to inhibition of COX enzymes. Phenylephrine hydrochloride is a sympathomimetic amine, acting primarily through a direct effect on α-adrenergic receptors. Causes vasoconstriction, reduces swelling and hyperemia of the mucous membrane of the nasal cavity and paranasal sinuses. Pheniramine maleate, an H1 receptor blocker, has an antiallergic effect, reduces the severity of local exudative manifestations, eliminates lacrimation and rhinorrhea.

After oral administration, paracetamol is quickly absorbed into the gastrointestinal tract. Cmax in blood plasma is reached within 30–60 minutes. When used in a therapeutic dose, T½ is 1–4 hours. Paracetamol is metabolized in the liver mainly through the conjugation reaction. Depending on the concentration in the blood plasma, it is partially amenable to deacetylation or hydroxylation. The main route of elimination is in the urine (90–100% over 24 hours), in the form of glucuronide conjugates (60%), sulfates (35%) or cysteine ​​(3%).

Cmax of pheniramine maleate in blood plasma is achieved after 1–2.5 hours; T½ is 16–19 hours. 70–83% of the dose taken orally is excreted in the urine unchanged or in the form of metabolites.

Phenylephrine has limited bioavailability due to insufficient absorption in the gastrointestinal tract and presystemic effects in the intestines and liver, which are caused by the action of MAO.

Overdose

Symptoms (due to paracetamol, appear after taking more than 10-15 g): pallor of the skin, loss of appetite, nausea, vomiting, pain in the epigastric region, in severe cases - liver failure, hepatonecrosis, increased activity of liver transaminases, increased PT, encephalopathy and coma.

Treatment: gastric lavage in the first 6 hours, administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an overdose and acetylcysteine ​​- after 12 hours.

Contraindications

Hypersensitivity to the components of the drug. severe cardiovascular, hepatic or renal failure, congenital hyperbilirubinemia, hypertension; pheochromocytoma, thyrotoxicosis, prostate adenoma with difficulty urinating; obstruction of the bladder neck, hemolytic anemia, pyloroduodenal obstruction, stenosing gastric and duodenal ulcers, diabetes mellitus, lung diseases (including asthma), closed-angle glaucoma, glucose-6-phosphate dehydrogenase deficiency, epilepsy, alcoholism, concomitant therapy with MAO inhibitors and for 2 weeks after stopping their use.

Release form

Powder for preparing a solution for oral administration (lemon).

For Novartis Consumer Health Inc., USA: 15 g of powder in a 6-layer bag (paper/LDPE/PE/LDPE/aluminum foil/LDPE). 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 or 25 packs. in a cardboard box, placed individually or in pairs, fastened through perforations. The instructions for use are printed on the bag.

For the Famar Orleans plant, France: 15 g of powder in a 4-layer bag (PE/LDPE/aluminum foil/LDPE) or 5-layer bag (paper/PE/LDPE/aluminum foil/LDPE). 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 or 25 packs. in a cardboard box, placed individually or in pairs, fastened through perforations. The instructions for use are printed on the bag.

Side effects

Most often: dizziness, dry mouth or throat, increased fatigue, headache, anxiety, nervousness, tachycardia. An excited state and sleep disturbance are rarely noted, especially in children.

Rarely can detect:

allergic reactions: itching, rash, urticaria, in some cases - erythematous and other severe skin reactions, petechiae, angioedema, bronchospasm, decreased blood pressure to the point of shock, anaphylaxis;

from the gastrointestinal tract: digestive disorders, including constipation, nausea, vomiting, diarrhea or flatulence, epigastric pain, liver dysfunction;

from the endocrine system: fluctuations in blood glucose levels;

from the nervous system: confusion, vestibular disorders.

Associated with the use of paracetamol: rarely - urticaria, in isolated cases, erythematous and other severe skin reactions, thrombocytopenia, leukopenia, hemolytic anemia, in isolated cases - agranulocytosis. Patients with intolerance to acetylsalicylic acid (5–10%) also react to paracetamol (for example, patients with asthma).

Associated with the use of phenylephrine: increased blood pressure (especially in patients with hypertension), cardiac arrhythmias, mydriasis, blurred vision and accommodation, increased intraocular pressure and potential effects on endocrine and other regulators of metabolic processes, urinary disturbances, stranguria.

Associated with the use of pheniramine: dryness of the mucous membrane of the eyes, insomnia, in some cases - coma, convulsions, dyskinesia, behavioral changes.

Unlike second-generation antihistamines, the use of pheniramine is not associated with prolongation of the QTc interval and cardiac arrhythmia.

Manufacturer

Novartis Consumer Health SA, Switzerland.

Manufactured by: 1. Novartis Consumer Health Inc., USA. 10401 Highway 6, Lincoln, NE, USA 68501.

2. Famar Orleans, France. 5, Avenue de Consir F-45071 Orléans Sede 02, France.

Marketing authorization holder: Novartis Consumer Health SA. Rue de Letraz, 1260, Nyon, Switzerland.

Consumer complaints should be directed to Novartis Consumer Health LLC

Legal address: 123317, Moscow, Presnenskaya embankment, 10.

Actual and postal address: 125315, Moscow, Leningradsky Prospekt, 72, bldg. 3.

Tel.; Fax.

e-mail

special instructions

Do not exceed the recommended dose or take the drug for more than 5-7 days in a row.

Consult a doctor if symptoms:

• do not disappear within 7 days;
• accompanied by fever that lasts more than 3 days;
• include a sore throat that lasts more than 3 days, accompanied by fever, headache, rash, nausea or vomiting.

The simultaneous use of other medicinal products containing paracetamol should be avoided.

When using the drug, it is not recommended to drink alcoholic beverages, since ethyl alcohol, when taken simultaneously with paracetamol, can cause liver dysfunction.

The drug should be used with caution in patients with prostatic hypertrophy, diseases of the thyroid gland, liver and kidneys, bradycardia, acute pancreatitis, and patients over 70 years of age with cardiovascular diseases.

The drug should not be used by patients undergoing treatment with other medications without a doctor's prescription.

Phenylephrine may contribute to false-positive drug testing results in athletes.

The drug contains sucrose. Patients with rare hereditary diseases, fructose intolerance or sucrase-isomaltase deficiency should not use the drug.

Use during pregnancy and lactation. The drug is contraindicated during pregnancy and breastfeeding.

Impact on the ability to drive vehicles and operate machinery. While using the drug, it is not recommended to drive vehicles or operate machinery that requires increased concentration and high speed of psychomotor reactions. With the simultaneous use of sedatives, tranquilizers or alcohol, drowsiness may increase.

Children. The drug is contraindicated in children under 12 years of age.

Note!

Description of the drug TheraFlu Extra pores. d/oral. Lemon solution package No. 10 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.