TeraFlu® from the flu and colds Extra (TeraFlu® against cold and flu Extra)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceParacetamol + Phenylephrine + PheniramineParacetamol + Phenylephrine + Pheniramine
Dosage form: & nbspPpowder for preparation of solution for oral administration [apple-cinnamon].
Composition:

One packet contains:

Active components: paracetamol 650 mg, phenylramine maleate 20 mg, phenylephrine hydrochloride 10 mg.

Auxiliary components: ascorbic acid 50 mg, malic acid 50.25 mg, sodium citrate dihydrate 120 mg, ethylmaltol 12.5 mg, caramel 65 mg, titanium dioxide 3.158 mg, sucrose 19500 mg, calcium phosphate 82 mg, citric acid 750 mg, apple artificial flavoring 17,5 mg, flavored apple-cinnamon natural 450 mg.

Description:

A lightly flowing white powder with a grayish shade of color, containing granules of darker gray and light yellow color, with the smell of apple and cinnamon. Do not allow the presence of clots of coalesced powder mass.

Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic means + alpha-adrenomimetic + H1-histamine receptor blocker)
ATX: & nbsp

N.02.B.E   Anilides

N.02.B.E.51   Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Combined drug, the effect of which is due to its constituent components, has antipyretic, mild anti-inflammatory, anti-edematous, analgesic and antiallergic effect, eliminates the symptoms of "colds". Narrows the vessels of the nose, eliminates the swelling of the mucous membrane of the nasal cavity and nasopharynx.

Paracetamol

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

Pheniramine

Pheniramine is an antiallergic agent - blocker H1-gistaminovyh receptors. Eliminates allergic symptoms, has a moderate degree of sedation and also exhibits antimuscarinic activity.

Phenylephrine

Phenylephrine is a sympathomimetic agent, with local application has a moderate vasoconstrictive effect (due to stimulation of alpha1-adrenoreceptors), reduces edema and hyperemia of the mucous membrane of the nasal cavity.

Pharmacokinetics:

Paracetamol

Paracetamol is quickly and almost completely absorbed from the gastrointestinal tract. After taking the drug inside, the maximum concentration of paracetamol in the plasma is reached after 10-60 minutes. Paracetamol is distributed in most tissues of the body, penetrates the placenta and is present in breast milk. In therapeutic concentrations, binding to plasma proteins is insignificant, increasing with increasing concentration.

It is subjected to primary metabolism in the liver, is excreted mainly with urine in the form of glucuronide and sulfate compounds. The elimination half-life is 1-3 hours.

Pheniramine

The maximum concentration of Pheniramine in plasma is reached after approximately 1-2.5 hours. The half-life of phenyramine is 16-19 hours. 70-83% of the accepted dose is excreted from the body with urine in the form of metabolites or in unchanged form.

Phenylephry

Phenylephrine is absorbed from the gastrointestinal tract and is subjected to primary metabolism in the intestine and liver. It is excreted in the urine almost completely in the form of sulfate compounds.Maximum plasma concentrations are achieved in the range from 45 minutes to 2 hours. Half-life is 2-3 hours.

Indications:

Infectious and inflammatory diseases - influenza, acute respiratory infections ("colds"), accompanied by fever, chills and fever, headache, runny nose, stuffy nose, sneezing and muscle aches.

Contraindications:

Hypersensitivity to individual components of the drug, simultaneous administration of tricyclic antidepressants, beta-blockers or other sympathomimetic drugs, simultaneous or during the previous 2 weeks administration of monoamine oxidase inhibitors (MAO), portal hypertension, alcoholism, diabetes mellitus, sugarase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, pregnancy, the period of breastfeeding, children under 12 years, severe cardiovascular diseases, art Hyperthritis, hyperthyroidism, angle-closure glaucoma, pheochromocytoma.

Carefully:

At the expressed atherosclerosis of coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma,severe liver or kidney disease, prostatic hyperplasia, difficulty urinating due to prostatic hypertrophy, blood diseases, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), dehydrated patients, pyloroduodenal obstruction , stenotic ulcer of the stomach and / or duodenum, epilepsy, while taking drugs that can adversely affect the liver (eg, inducers rosomalnyh liver enzymes).

Care should be taken when treating patients with recurrent urate kidney stones.

Pregnancy and lactation:

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

Dosing and Administration:

Inside.

The contents of one sachet are dissolved in 1 glass (250 ml) of hot but not boiling water. Take in hot. Repeated dose can be taken every 4-6 hours (no more than 3-4 doses within 24 hours).

TerraFlu® from flu and cold The extra can be used at any time of the day, but the best effect is taken by taking the drug before going to bed, at night.

If there is no relief of symptoms within 3 days after starting the drug, you should see a doctor.

Patients should not take TeraFlu ® from flu and colds Extra for more than 5 days.

Special Populations:

Liver failure: patients with impaired liver function or Gilbert's syndrome should reduce the dose or increase the interval between TeraFlu® from influenza and colds Extra.

Renal insufficiency: In the presence of acute renal failure (creatinine clearance <10 ml / min), the interval between TeraFlu® from influenza and cold should be at least 8 hours.

Elderly patients: there is no need to adjust the dose in elderly patients.

Side effects:

Classification of incidence of adverse reactions: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000); including individual messages and reactions with an unknown frequency (the frequency can not be estimated from available data).

Violations of the blood and lymphatic system:

Very rarely: thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.

Immune system disorders:

Rarely: hypersensitivity reactions (rash, dyspnea, anaphylactic shock), angioedema.

The frequency is unknown: anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Disorders of the psyche:

Rarely: increased excitability, sleep disturbance.

Disturbances from the nervous system:

Often: drowsiness.

Rarely: dizziness, headache.

Disturbances on the part of the organ of sight:

Rarely: mydriasis, paresis of accommodation, increased intraocular pressure.

Heart Disease:

Rarely: tachycardia, palpitation.

Vascular disorders:

Rarely: increased blood pressure.

Disorders from the gastrointestinal tract:

Often: nausea, vomiting.

Rarely: dry mouth, constipation, abdominal pain, diarrhea.

Disturbances from the liver and bile ducts:

Rarely: increased activity of hepatic enzymes.

Disturbances from the skin and subcutaneous tissues:

Rare: rash, itching, erythema, urticaria.

Disorders from the kidneys and urinary tract:

Rarely: difficulty urinating.

General disorders and disorders at the site of administration:

Rarely: malaise.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms (mainly due to 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 the overdose depends on the dose, so patients should be warned against the simultaneous use of paracetamol-containing drugs.

There is a risk of poisoning 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 inductors of microsomal liver enzymes.

An overdose of paracetamol can lead to hepatic insufficiency, encephalopathy, coma and death.

Symptoms of an overdose of paracetamol in the first 24 hours: pallor of the skin, nausea, vomiting, anorexia, convulsions. Abdominal pain can be the first sign of liver damage and usually does not appear within 24-48 hours and can sometimes manifest later, after 4-6 days. Damage to the liver is manifested to the maximum extent on average after 72-96 hours after taking the drug. Also, there may be a violation of glucose metabolism and metabolic acidosis.Even in the absence of liver damage, acute renal failure and acute tubular necrosis may develop. Cases of cardiac arrhythmia and development of pancreatitis have been reported.

Treatment: the administration of acetylcysteine ​​intravenously or orally as an antidote, gastric lavage, intake of methionine may have a positive effect for at least 48 hours after an overdose.

Recommended reception of activated charcoal, monitoring of breathing and circulation. In the case of seizures, diazepam may be prescribed.

Pheniramine and phenylephrine (symptoms of an overdose for phenyramine and phenylephrine are combined because of the risk of mutual potentiation of the parasympatolytic effect of phenyramine and the sympathomimetic effect of phenylephrine in case of drug overdose)

Symptoms of overdose include: drowsiness, which is followed by anxiety (especially in children), visual disturbances, rash, nausea, vomiting, headache, increased excitability, dizziness, insomnia, circulatory disorders, coma, convulsions, behavioral changes, increased blood pressure, hypotension, bradycardia.When an overdose of phenyramine was reported cases of atropine-like "psychosis".

There is no specific antidote.

The usual measures of care, including the appointment of activated carbon, salt laxatives, measures to support cardiac and respiratory functions are necessary. Do not prescribe psychostimulant (methylphenidate) because of the risk of seizures.

With hypotension, the use of vasopressor drugs is possible.

In case of high blood pressure, intravenous administration of alpha-blockers is possible, because phenylephrine is a selective alpha agonist1adrenoreceptors, therefore, the hypertensive effect in case of an overdose of phenylephrine should be treated by blocking the alpha-adrenergic receptors.

When developing seizures, use diazepam.

Interaction:

Effect of paracetamol

Strengthens the effects of MAO inhibitors, sedatives, ethanol.

The risk of hepatotoxic effects of paracetamol increases with the simultaneous administration of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes.

The properties of warfarin as an anticoagulant and other coumarins can be strengthened against the background of prolonged regular use of paracetamol, increasing the risk of bleeding. A single dose of paracetamol does not have such an effect.

Metoclopramide increases the rate of absorption of paracetamol, and raises the level of paracetamol concentration in the plasma to the maximum.

The same way domperidone can increase the rate of absorption of paracetamol.

With the combined use of chloramphenicol and paracetamol, the half-life of chloramphenicol may increase.

Paracetamol may reduce the bioavailability of lamotrigine, with a possible decrease in its effect due to the induction of its hepatic metabolism.

Absorption of paracetamol can be reduced by simultaneous administration with colestyramine, but this can be avoided if taken colestramine an hour later than paracetamol.

Regular use of paracetamol concurrently with zidovudine may cause neutropenia and increase the risk of liver damage.

Probenecid affects the metabolism of paracetamol. In patients taking probenecid simultaneously, the dose of paracetamol should be reduced.

Hepatotoxicity of paracetamol can increase with chronic or excessive alcohol consumption.

Paracetamol can affect the results of a uric acid test using a precipitating reagent of phosphotungstate.

Effect of Pheniramine

It is possible to increase the influence of other substances on the central nervous system (for example, MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonics, barbiturates, tranquilizers and narcotics). Pheniramine can inhibit the action of anticoagulants.

Effect of phenylephrine

TeraFlu® against influenza and colds Extra is contraindicated in patients who have taken or taken MAO inhibitors within the past two weeks.

Phenylephrine can enhance the action of MAO inhibitors and cause a hypertensive crisis.

The simultaneous use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (eg, amitriptyline) may increase the risk of cardiovascular side effects.

Phenylephrine can reduce the effectiveness of beta-blockers and other antihypertensive drugs (for example, debrisoquine, guanethidine, reserpine,methyldopy). The risk of increased blood pressure and other cardiovascular side effects may be increased.

The simultaneous use of phenylephrine with digoxin and other cardiac glycosides may increase the risk of arrhythmia or myocardial infarction.

Simultaneous use of phenylephrine with ergot alkaloids (ergotamine and metisergide) 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.

TeraFlu® against influenza and colds Extra contains:

- sucrose 19.5 g per bag. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems such as fructose intolerance, glucose-galactose malabsorption or lack of sucrase / isomaltase should not take TeraFlyu® from the flu and colds Extra;

- sodium 28.1 mg per bag. This should be taken into account in patients who follow a diet for sodium content.

Do not use the drug from damaged pouches.

Patients should consult a doctor if:

- There is bronchial asthma, emphysema or chronic bronchitis;

- Symptoms do not go away for 5 days or are accompanied by severe fever lasting for 3 days, a rash or a constant headache.

These may be signs of more serious violations.

Effect on the ability to drive transp. cf. and fur:

TeraFlu® from flu and colds Extra can cause drowsiness, so during treatment it is not recommended to drive and engage in other activities requiring concentration of attention and high speed of psychomotor reactions.

Form release / dosage:

Powder for solution for oral administration (apple-cinnamon).

Packaging:

By 21.78 grams of powder in a four-layer (paper / low density polyethylene / aluminum foil / low density polyethylene) or five-layer sachet (paper / polyethylene / low density polyethylene / aluminum foil / low density polyethylene).

Sachets in quantity from 1 to 25 pieces in a cardboard bundle, placed individually or in pairs fastened through perforations, together with instructions for use.

Storage conditions:PAt a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:
2 years.
Do not use after the expiry date,
indicated on the package.
Terms of leave from pharmacies:Without recipe
Registration number:П N014315 / 01
Date of registration:23.03.2009 / 16.09.2016
Expiration Date:Unlimited
The owner of the registration certificate: GlaxoSmithClean Consumer Helscher GlaxoSmithClean Consumer Helscher United Kingdom
Manufacturer: & nbsp
Representation: & nbspNovartis Consumer Helms Ltd.Novartis Consumer Helms Ltd.
Information update date: & nbsp29.12.2016
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