Terraflue® Extra (TheraFlu® 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: & nbsppowder for solution for ingestion (lemon)
Composition:

One packet contains:

Active substances - paracetamol 650 mg, phenylramine maleate 20 mg, phenylephrine hydrochloride 10 mg.

Excipients - sucrose 12600 mg, acesulfame potassium 19 mg, dye quinoline yellow 0.147 mg, dye sunset yellow 0.035 mg, maltodextrin M 100 26 mg, silicon dioxide 13 mg, natural lemon flavor WONF Durarome 860.098 TD 300 mg, natural lemon flavor Durarome860.202 TD 09.91 35 mg, citric acid 1000 mg, sodium citrate dihydrate 180 mg, calcium phosphate 35 mg.

Description:

Loose powder containing granules of white and yellow color, with a specific odor. Presence of soft lumps.

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, analgesic, vasoconstrictive action, eliminates the symptoms of "colds". Narrows the vessels of the nose, eliminates the 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 the function of platelets and hemostasis.

Pheniramine maleate

Phenyromia is an antiallergic antagonist of histamine H1receptors. Eliminates allergic symptoms, moderately renders sedative effect and also exhibits antimuscarinic activity.

Phenylephrine hydrochloride

Phenylephrine hydrochloride is a sympathomimetic agent, with local application has a moderate vasoconstrictive effect (due to stimulation of alpha1-adrenoreceptors), reduces edema and flushing 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, it is excreted mainly with urine of glucuronide and sulfate compounds. The half-life period is 1-3 hours.

Pheniramine maleate

The maximum concentration of phenyramine maleate in plasma is reached after about 1-2.5 hours. The half-period of the peniramine maleate is 16-19 hours. 70-83% the accepted dose is excreted from the body with urine in the form of metabolites or in unchanged form.
Phenylephrine hydrochloride
Phenylephrine hydrochloride 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. Peak concentrations in plasma are achieved in the range from 45 minutes to 2 hours.Half-life is 2-3 hours.
Indications:Symptomatic therapy of infectious and inflammatory diseases: ARVI, including influenza and "cold", accompanied by fever, chills, headache, runny nose, stuffy nose, sneezing and muscle pain.
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-galactosia malabsorption, pregnancy, the period of breastfeeding, children under 12 years of age, severe cardiovascular diseases, art Hyperthritis, hyperthyroidism, angle-closure glaucoma, pheochromocytoma.
Carefully:

With 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 prostatic hypertrophy, blood diseases, deficiency of glucose-6-phosphate dehydrohease, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), chronic malnutrition and dehydration, pyloroduodenal obstruction, stenotic gastric ulcer and / or duodenal ulcer, epilepsy simultaneous administration of drugs that can adversely affect the liver.

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.

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). Teraflu ® Extra can be used at any time of the day, but the best effect comes from taking the drug before going to bed, at night.If no symptoms are observed within 3 days after the start of the drug, you should consult a doctor. Patients should not take Teraflu ® 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® Extra.

Renal insufficiency: In the presence of acute renal failure (creatinine clearance <10 ml / min), the interval between TeraFlu® Extra 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.

Violations from the blood and lymphatic system:

Rarely: thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.
Immune system disorders:
Rarely: increased sensitivity, angioedema.
Unknown: anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Disorders of the psyche:
Rarely: increased excitability, sleep disturbance.
Impaired nervous system:
Often: drowsiness.
Rarely: dizziness, headache.
Disorders from the side of the organ of vision:
Rarely: mydriasis, accommodation paresis, increased intraocular pressure.
Heart Disease:
Rarely: tachycardia, sensation palpitation.
Vascular disorders:
Rarely: increased blood pressure.
Disorders from the gastro-intestinal tract:
Often: nausea, vomiting.
Rarely: dry mouth, constipation, discomfort in the stomach, diarrhea.
Violations with hand 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 irreversible nephropathy with hepatic insufficiency. Patients should be warned about the prohibition of 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 with chronic malnutrition and in patients receiving enzyme inducers.
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. Pain in the stomach may be the first sign of liver damage and usually does not appear within 24-48 hours and sometimes may appear later, after 4-6 days, 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 N-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 maleate and phenylephrine hydrochloride
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 and bradycardia. When an overdose of phenyramine was reported cases of atropine-like "psychosis". There is no specific antidote. The usual measures of assistance are needed. including the appointment of activated carbon, salt laxatives, measures to support cardiac and respiratory functions. Do not prescribe stimulants. With hypotension, the use of vasopressor drugs is possible.
AT In case of an increase in blood pressure, intravenous administration of alpha-blockers is possible. When developing seizures, use diazepam.
Interaction:Effect of paracetamol
Strengthens the effects of MAO inhibitors, sedatives, ethanol. The risk of hepatotoxic action of paracetamol increases with simultaneous administration of barbiturates, 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 the uric acid test using the precipitating reagent phosphotungstate.
Influence of phenyramine maleate
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). Pheniramip maleate can inhibit the action of anticoagulants. Effect of phenylephrine hydrochloride
TerraFlu® Extra is contraindicated in patients who have been taking or taking to MAO for the past two weeks. Phenylephrine hydrochloride 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 (eg, debrisoquine, guanethidine, reserpine, methyldopa). The risk of increased blood pressure and other cardiovascular side effects may be increased. The simultaneous use of phenylephrine with digoxin and cardiac glycosides may increase the risk of arrhythmia or heart attack. The 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® Extract contains:

- Sucrose 12.6 g per bag. The ego should be taken into account in patients with diabetes mellitus.Patients with such rare hereditary problems as fructose intolerance, glucose-galactose malabsorption or sugar-isomaltose deficiency should not take Teraflu® Extra.

- dye sunset sunset yellow

- (E110). May cause allergic reactions.

- Sodium 180 mg per bag. This should be taken into account in patients who follow a diet but sodium content.

Do not use the drug from damaged pouches.

Effect on the ability to drive transp. cf. and fur:TerraFlu® Extra can cause drowsiness, so during treatment, it is recommended to drive the car and engage in other activities that require concentration and high speed of psychomotor reactions.
Form release / dosage:

Powder for the preparation of a solution for reception inside (lemon).

Packaging:

For Novartis Consumer Helms Inc., USA:

For 15 g of powder in a 6-layer sachet (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 bags in a cardboard box, placed individually or in pairs fastened through perforations, together with instructions for use.

For the factory of Famap Orleans, France:

For 15 grams of powder in a 4-layer sachet (polyethylene / low density polyethylene / aluminum foil / low density polyethylene) or a 5-layer sachet (paper / polyethylene / polyethylene low density / aluminum foil / low density polyethylene). 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 or 25 bags in a cardboard box, placed individually or in pairs fastened through perforations, along with instructions for use.

Storage conditions:

At 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 printed on the package.
Terms of leave from pharmacies:Without recipe
Registration number:LSR-007823/10
Date of registration:10.08.2010
The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland
Manufacturer: & nbsp
Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland
Information update date: & nbsp09.09.2015
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