TeraFlu for flu and cold, 4 pcs.

Combined drug, the action of which is due to its constituent components.

Indications

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.

Pharmacological effect

A combined drug whose effect is determined by its constituent components.

Special instructions

To avoid toxic liver damage, the drug should not be combined with alcoholic beverages.

Patients should consult a doctor if:

– bronchial asthma, emphysema or chronic bronchitis is observed;
-symptoms do not resolve within 5 days or are accompanied by severe fever lasting 3 days, rash, or persistent headache.
These may be signs of more serious problems.
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 with caution in patients on a sodium-restricted diet.

Do not use the drug from damaged sachets.

Impact on the ability to drive vehicles and machinery

Theraflu® for colds and flu may cause drowsiness, so during treatment it is not recommended to drive vehicles or engage in other activities that require concentration and high speed of psychomotor reactions.

Active ingredient

Paracetamol, Phenylephrine, Pheniramine, Ascorbic acid

Composition

Paracetamol;

Pregnancy

It is not recommended to use TheraFlu® against flu and colds during pregnancy and lactation (breastfeeding).

Contraindications

Hypersensitivity to the components of the drug;
– severe cardiovascular diseases;
— arterial hypertension;
— portal hypertension;
— diabetes mellitus;
— hyperthyroidism;
— angle-closure glaucoma;
— pheochromocytoma;
— alcoholism;
– sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
– simultaneous use of MAO inhibitors or within the previous 2 weeks;
– simultaneous use of tricyclic antidepressants, beta-blockers, other sympathomimetics;
— pregnancy;
– period of breastfeeding;
— children’s age up to 12 years.

With caution:

with severe atherosclerosis of the coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma, severe liver or kidney diseases, prostatic hyperplasia, difficulty urinating due to prostatic hypertrophy, blood diseases, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor), with exhaustion, dehydration, pyloroduodenal obstruction, stenotic ulcer of the stomach and/or duodenum, epilepsy, while taking drugs that can negatively affect the liver (for example, inducers of microsomal liver enzymes); in patients with recurrent formation of urate kidney stones.

Side Effects

Determination of the frequency of side effects: very often (≥1/10), often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rarely (≥1/10,000 and <1/1000), very rarely (<1/10,000), including individual reports, frequency unknown (it is impossible to determine the frequency based on available data).From the hematopoietic system: very rarely – thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.
Allergic reactions: rarely – hypersensitivity (rash, shortness of breath, anaphylactic shock), urticaria, angioedema; frequency unknown – anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the nervous system: often – drowsiness; rarely – dizziness, headache.
Mental disorders: rarely – increased excitability, sleep disturbance.

From the organ of vision: rarely – mydriasis, accommodation paresis, increased intraocular pressure.

From the cardiovascular system: rarely – tachycardia, palpitations, arterial hypertension.

From the digestive system: often – nausea, vomiting; rarely – constipation, dry oral mucosa, abdominal pain, diarrhea.

From the liver and biliary tract: rarely – increased activity of liver transaminases.

From the skin and subcutaneous tissues: rarely – skin rash, itching, erythema.

From the urinary system: rarely – difficulty urinating.

General reactions: rarely – malaise.

If any of the above side effects worsen and any other side effects occur, the patient should consult a doctor.

Interaction

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.

With long-term regular use of paracetamol, the anticoagulant effect of warfarin and other coumarins may be enhanced, and the risk of bleeding increases. A single use of paracetamol does not have a significant effect.

Metoclopramide increases the rate of absorption of paracetamol and reduces the time to reach its Cmax in the blood plasma. Likewise, domperidone may increase the rate of absorption of paracetamol.

Paracetamol may lead to an increase in T1/2 of chloramphenicol.

Paracetamol can reduce the bioavailability of lamotrigine, which may reduce the effectiveness of lamotrigine due to the induction of its metabolism in the liver.

Absorption of paracetamol may be reduced when used concomitantly with cholestyramine, but the reduction in absorption is not significant if cholestyramine is taken 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 the results of the uric acid test using the phosphotungstate precipitating reagent.

Pheniramine
The effect of other substances on the central nervous system (for example, MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonian drugs, barbiturates, tranquilizers and narcotic drugs) may be enhanced. Pheniramine may inhibit the action of anticoagulants.

Phenylephrine
Theraflu® for colds and flu is contraindicated in patients who are receiving or have received MAO inhibitors within the last 2 weeks. Phenylephrine can potentiate the effect of MAO inhibitors and cause a hypertensive crisis.

Concomitant use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (eg, amitriptyline) may lead to an increased risk of adverse cardiovascular reactions.

Phenylephrine may reduce the effectiveness of beta blockers and other antihypertensive drugs (eg, debrisoquine, guanethidine, reserpine, methyldopa). Possible increased risk of hypertension and other cardiovascular side effects.

Concomitant use of phenylephrine with digoxin and cardiac glycosides may increase the risk of cardiac arrhythmias or myocardial infarction.

Concomitant use of phenylephrine with ergot alkaloids (ergotamine and methysergide) may increase the risk of ergotism

Overdose

Overdose symptoms are mainly caused by paracetamol.

Paracetamol
Symptoms: mainly appear after taking 10-15 g of paracetamol. In severe cases of overdose, paracetamol has a hepatotoxic effect, incl. may cause liver necrosis. Also, an overdose can cause irreversible nephropathy and irreversible liver damage. The severity of overdose depends on the dose, so patients should be warned about the prohibition of 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 with malnutrition and in patients taking inducers of microsomal liver enzymes.
Overdose of paracetamol can lead to liver failure, encephalopathy, 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 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 positive 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: drowsiness, which is later joined by anxiety (especially in children), visual disturbances, rash, nausea, vomiting, headache, increased excitability. dizziness, insomnia, circulatory disorders, coma, convulsions, behavioral changes, increased blood pressure 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 arterial hypotension, vasopressor drugs may be used.

In case of increased blood pressure, intravenous administration of alpha-blockers is possible, because Phenylephrine is a selective α1-adrenergic receptor agonist; therefore, the hypotensive effect in overdose should be treated by blocking α1-adrenergic receptors. If seizures develop, administer diazepam.

Clinical pharmacology

Paracetamol
Paracetamol is quickly and almost completely absorbed from the gastrointestinal tract. Cmax in plasma is achieved 10-60 minutes after oral administration. Distributed in most tissues of the body. Penetrates the placental barrier and is excreted in breast milk. At therapeutic concentrations, binding to plasma proteins is negligible, but increases with increasing concentration. Subjects to primary metabolism in the liver. It is excreted mainly in the urine in the form of glucuronides and sulfates. T1/2 ranges from 1 to 3 hours.

Pheniramine
Cmax of pheniramine in plasma is achieved after approximately 1-2.5 hours. T1/2 of pheniramine is 16-19 hours. 70-83% of the dose is excreted from the body in the urine in the form of metabolites or unchanged.

Phenylephrine
Phenylephrine is absorbed from the gastrointestinal tract. It is metabolized during the “first pass” through the intestinal wall and in the liver, therefore, when taken orally, phenylephrine hydrochloride is characterized by limited bioavailability. Cmax in plasma is achieved in the range from 45 minutes to 2 hours. It is excreted almost entirely by the kidneys in the form of sulfate compounds. T1/2 is 2-3 hours.

Ascorbic acid
Quickly and completely absorbed from the gastrointestinal tract. Plasma protein binding – 25%. Excreted in the form of metabolites in the urine. Ascorbic acid, taken in excessive quantities, is quickly excreted unchanged in the urine.

Short product description

THERAFLUE WITH LEMON FLAVOR for flu and colds is your compact assistant. Intended for the symptomatic treatment of infectious and inflammatory diseases (ARVI, including influenza), the manifestations of which are:
High temperature
Chills
Body aches
Headache and muscle pain
Runny nose
Nasal congestion
Sneezing*.
* Instructions for medical use, RU P N012063/01 dated 05/31/2011

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf life

2 years

Manufacturer

Delpharm Orleans, France