TheraFlu Extra for flu and cold, lemon flavoured powder, 10 sachets

Product description

Thera Flu EXTRA-Powerful power against 7 major flu and cold symptoms!*. It is used for the symptomatic treatment of infectious and inflammatory diseases: acute respiratory viral infections, including flu and “colds”, the manifestations of which are:

• High temperature
• Chills
• Headache
• Runny
• nose Stuffy nose
• Sneezing
• Muscle pain*.

* Instructions for medical use, RU LSR-007823/10 from 10.08.2010

Composition

In 1 sachet of powder for the preparation of a solution for oral use contains:

Active ingredients

• Paracetamol 650 mg
• . Phenyramine maleate 20 mg
• . Phenylephrine hydrochloride 10 mg.

Auxiliary substances:

sucrose,

acesulfame potassium,

quinoline yellow

dye, sunset yellow dye,

maltodextrin M 100,

silicon dioxide,

natural lemon flavor WONF Durarome 860.098 TD,

natural lemon flavor Durarome 860.202 TD 09.91,

citric acid,

sodium citrate dihydrate,

calcium phosphate.

Pharmacological action

A combined drug, the action of which is due to the components included in its composition. It has an antipyretic, analgesic, vasoconstrictor effect, eliminates the symptoms of a”cold”. Narrows blood vessels and eliminates swelling of the nasal and nasopharyngeal mucosa. Paracetamol has analgesic and antipyretic effects by suppressing the synthesis of prostaglandins in the central nervous system. It does not affect platelet function and hemostasis. Phenyramine is an anti-allergic agent, a histamine H1-receptor blocker. Eliminates allergic symptoms, has a moderate sedative effect, and also shows antimuscarinic activity. Phenylephrine-alpha 1-adrenomimetic, causes vasoconstriction, eliminates swelling and hyperemia of the nasal mucosa.

Clinical pharmacology

Paracetamol Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax in plasma is reached in 10-60 minutes after oral use. It is distributed in most body tissues. Penetrates the placental barrier, is excreted in breast milk. At therapeutic concentrations, binding to plasma proteins is insignificant, but increases with increasing concentration. It undergoes primary metabolism in the liver. It is mainly excreted in the urine in the form of glucuronides and sulfates. T1 / 2 is from 1 to 3 h. Phenyramine The maximum amount of phenyramine in plasma is reached in approximately 1-2.5 h. T1 / 2 of phenyramine is 16-19 h. 70-83% of the dose is excreted in the urine as metabolites or unchanged. Phenylephrine is absorbed from the gastrointestinal tract. It is metabolized during the” first pass” through the intestinal wall and in the liver, so when taken orally, phenylephrine hydrochloride is characterized by limited bioavailability. Cmax in plasma is reached in the range from 45 min to 2 h. It is excreted by the kidneys almost completely in the form of sulfate compounds. T1 / 2 is 2-3 hours.

Indications

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

Use during pregnancy and lactation

It is not recommended to use the drug during pregnancy and lactation due to the lack of data on the safe use of the drug in this category of patients.

Contraindications

Hypersensitivity to the components of the drug; severe cardiovascular diseases; arterial hypertension; portal hypertension; diabetes mellitus; hyperthyroidism; angle-closure glaucoma; pheochromocytoma; alcoholism; sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption; concomitant or within the previous 2 weeks taking MAO inhibitors; concomitant use of tricyclic antidepressants, beta-blockers, beta-blockers. adrenoblockers, other sympathomimetics; pregnancy; breast-feeding period; children under 12 years of age. With caution: with severe coronary artery atherosclerosis, 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 syndromes), exhaustion, dehydration, pyloroduodenal obstruction, stenotic gastric and/or duodenal ulcers, epilepsy, while taking medications that can negatively affect the liver (for example, inducers of microsomal liver enzymes.

Side effects

Determining the frequency of side effects: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (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 disorders. From the side of the organ of vision: rarely-mydriasis, paresis of accommodation, increased intraocular pressure. From the cardiovascular system: rarely-tachycardia, palpitation, arterial hypertension. From the digestive system: often – nausea, vomiting; rarely-constipation, dryness of the oral mucosa, abdominal pain, diarrhea. From the liver and biliary tract: rarely-increased activity of hepatic transaminases. From the skin and subcutaneous tissues: rarely-skin rash, pruritus, 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, and ethanol. The risk of hepatotoxic effects of paracetamol increases with the simultaneous use of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes. With prolonged regular use of paracetamol, the anticoagulant effect of warfarin and other coumarins may increase, while the risk of bleeding increases. Single use of paracetamol has no significant effect. Metoclopramide increases the rate of absorption of paracetamol and reduces the time to reach its Cmax in blood plasma. Similarly, domperidone may increase the rate of absorption of paracetamol. Paracetamol can lead to an increase in the T1/2 of chloramphenicol. Paracetamol is able to reduce the bioavailability of lamotrigine, while it is possible to reduce the effectiveness of lamotrigine due to the induction of its metabolism in the liver. The absorption of paracetamol may be reduced when used concomitantly with colestyramine, but the decrease in absorption is insignificant if I take colestyramine an 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 taking probenecid concomitantly, the dose of paracetamol should be reduced. The hepatotoxicity of paracetamol increases with prolonged excessive use of ethanol (alcohol). Paracetamol may affect the results of a uric acid test using the precipitating reagent phosphoframate. Phenyramine may increase the effect of other substances on the central nervous system (for example, MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonian drugs, barbiturates, tranquilizers and narcotic drugs). Phenyramine may inhibit the action of anticoagulants. Phenylephrin Thera Flu® Extra is contraindicated in patients who receive or have received MAO inhibitors in 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 (for example, amitriptyline) may increase the risk of adverse reactions from the cardiovascular system. Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive drugs (for example, debrisoquine, guanethidine, reserpine, methyldopa). There may be an increased risk of hypertension and other side effects from the cardiovascular system. Concomitant use of phenylephrine with digoxin and cardiac glycosides may increase the risk of cardiac arrhythmia or myocardial infarction. Concomitant use of phenylephrine with ergot alkaloids (ergotamine and metisergide) may increase the risk of ergotism.

How to take it, course of use and dosage

Inside. The contents of one sachet are dissolved in 1 cup (250 ml) of hot, but not boiling water. Take it hot. A second dose can be taken every 4-6 hours (no more than 3-4 doses within 24 hours). Thera Flu® 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 there is no relief of symptoms within 3 days after starting the drug, you should consult a doctor. Do not use Thera Flu® Extra more than 5 days. In patients with impaired liver function or Gilbert’s syndrome, it is necessary to reduce the dose or increase the interval between doses.In severe renal insufficiency (CC

Overdose

Symptoms of overdose 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, including it can cause liver necrosis. Overdose can also 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 other drugs containing paracetamol. The risk of poisoning is expressed especially in elderly patients, in children, in patients with liver diseases, in cases of chronic alcoholism, in patients with exhaustion and in patients taking inducers of microsomal liver enzymes. 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 can be the first sign of liver damage and usually does not appear within 24-48 hours and can sometimes appear later, after 4-6 days. Liver damage is most pronounced after 72-96 hours after taking the drug. There may also 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 pancreatitis have been reported. Treatment: use of acetylcysteine intravenously or orally as an antidote, gastric lavage, oral methionine may have a positive effect for at least 48 hours after overdose. It is recommended to take activated charcoal, monitor respiration and blood circulation. In case of convulsions, diazepam may be prescribed. Phenyramine and phenylephrine 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 with phenyramine overdose. Treatment: there is no specific antidote. Routine care measures are needed, including the use of activated charcoal, saline laxatives, and cardiac and respiratory support measures. Psychostimulants (methylphenidate) should not be prescribed because of the risk of seizures. With arterial hypotension, vasopressors may be used. In case of increased blood pressure, intravenous use of alpha-blockers is possible, since phenylephrine is a selective agonist of α1-adrenergic receptors, therefore, the hypotensive effect of overdose should be treated by blocking α1-adrenergic receptors. With the development of seizures, enter diazepam.

Description

Powder for the preparation of a solution for oral use (lemon) is loose, containing granules of white and yellow color, with a specific smell, the presence of soft lumps is allowed.

Special instructions

To avoid toxic liver damage, the drug should not be combined with the use of alcoholic beverages. Patients should consult a doctor if: – bronchial asthma, emphysema, or chronic bronchitis occurs; – symptoms persist for 5 days or are accompanied by a severe fever lasting for 3 days, rash, or persistent headache. These may be signs of more serious disorders. Thera Flu® Extra contains:- sucrose 12.6 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 sucrose-isomaltase deficiency should not take Thera Flu®. Extra; – dye sunny sunset yellow (E 110). May cause allergic reactions; – sodium 42.2 mg per sachet. This should be taken into account in patients on a sodium-restricted diet. Do not use the drug from damaged sachets. Effects on the ability to drive vehicles and mechanismsi Thera Flu® Extra can cause drowsiness, so during treatment it is not recommended to drive vehicles or engage in other activities that require concentration of attention and a high rate of psychomotor reactions.

Form of production

15 g of powder in a multi-layer bag. 10 sachets in a cardboard box. The bags can be placed individually or held together in pairs. Instructions for use are applied to the sachet.

Storage conditions

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

Shelf

life is 2 years.

Active ingredient

Paracetamol, Phenylephrine, and Phenyramine

Dosage form

solution for oral use

Purpose

Children over 4 years old, For adults

Indications

Anesthesia, Tonsillitis, Laryngitis, Pharyngitis, Sore Throat, Gum Disease, Oral Inflammation, Stomatitis