TeraFlu Extra for flu and cold, lemon flavored powder, 10 pcs.

A combination drug, the effect of which is due to its constituent components. It has antipyretic, analgesic, vasoconstrictor effect, eliminates the symptoms of “cold”. It narrows blood vessels and eliminates swelling of the nasal cavity mucosa and nasopharynx.

Indications

Anesthesia, Gum inflammation, Laryngitis, Sore throat, Nasal congestion, Angina, Headache, Chills, Inflammation in the mouth, runny nose (rhinitis) Symptomatic treatment of inflammatory diseases (SARS, including flu), accompanied by fever, chills, headache, runny nose, stuffy nose, sneezing, muscle pain.

Composition

One sachet of powder for oral solution contains:

The active ingredients

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

Excipients:

sucrose,

acesulfame potassium,

quinoline yellow dye,

sunset yellow dye,

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maltodextrin M100,

silicon dioxide,

Lemon natural flavoring WONF Durarome 860.098 TD,

Lemon natural flavoring Durarome 860.202 TD 09.91,

citric acid,

sodium citrate dihydrate,

calcium phosphate.

How to take, the dosage

Inside. The contents of one sachet dissolved in 1 cup (250 ml) of hot, but not boiling water. Take in hot water. The second dose may 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 is achieved by taking the drug at bedtime, at night. If there is no relief of symptoms within 3 days after the beginning of the drug, it is necessary to consult a physician.
Do not use TeraFlu® Extra more than 5 days.

In patients with impaired liver function or Gilbert syndrome it is necessary to reduce the dose or increase the interval between doses.

In severe renal failure (CK< 10 ml/min) the interval between doses should be at least 8 h.

In elderly patients no dose adjustment is required.

Interaction

Paracetamol
Increases the effects of MAO inhibitors, sedatives, 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.

Long-term regular use of paracetamol may increase anticoagulant effect of warfarin and other coumarins, with increased risk of bleeding. 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 plasma.

Paracetamol may increase the T1/2 of chloramphenicol.

Paracetamol may decrease the bioavailability of lamotrigine and the efficiency of lamotrigine may decrease due to induction of its metabolism in the liver.

Absorption of paracetamol may be decreased when concomitantly used with colestyramine, but the decrease in absorption is insignificant if colestyramine 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.
Hepatotoxicity of paracetamol is increased with prolonged excessive use of ethanol (alcohol).

Paracetamol may affect uric acid test results using a precipitating reagent phospho-tungstate.

Pheniramine
The effects of other substances on the CNS (e.g., MAO inhibitors, tricyclic antidepressants, alcohol, anti-Parkinsonian drugs, barbiturates, tranquilizers and narcotics) may be enhanced. Pheniramine may inhibit the effect of
anticoagulants.

Phenylephrine
Teraflu® Extra is contraindicated in patients who are receiving or have received MAO inhibitors within the last 2 weeks. Phenylephrine may potentiate the effects of MAO inhibitors and cause a hypertensive crisis.

Concomitant use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (such as amitriptyline) may increase the risk of adverse reactions from the cardiovascular system.

Phenylephrine may decrease the effectiveness of beta-adrenal blockers and other antihypertensive drugs (e.g., debrisochine, guanethidine, reserpine, methyldopa). There may be an increased risk of arterial hypertension and other cardiovascular side effects.

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

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

Special Instructions

In order to avoid toxic liver damage the drug should not be combined with the use of alcoholic beverages.

Patients should consult a physician if:
– Bronchial asthma, emphysema or chronic bronchitis are present;
-Symptoms do not resolve within 5 days or are accompanied by severe fever lasting for 3 days, rash or persistent headache.

These may be signs of more serious disorders.
Teraflu® Extra contains:

-saccharose 12.6 g per bag. This should be taken into account in patients with diabetes mellitus. Patients with such rare hereditary problems as fructose intolerance, glucose-galactose malabsorption or insufficiency of sucrose-isomaltase should not take Teraflu® Extra;
-dye sunset yellow (E110). May cause allergic reactions;
-Sodium 42.2 mg per sachet. It should be taken into account in patients on a sodium-restricted diet.

Do not use the drug from the damaged bags.

Effect on the ability to drive vehicles and mechanisms

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

Synopsis

Powder for oral solution (lemon) is loose, containing white and yellow granules, with a specific smell, soft lumps are allowed.

Contraindications

Hypersensitivity to the drug components; severe cardiovascular disease; arterial hypertension; portal hypertension; diabetes mellitus; hyperthyroidism; closed-angle glaucoma; pheochromocytoma; alcoholism; sugar/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption; concomitant or during the preceding 2 weeks taking MAO inhibitors; concomitant use of tricyclic antidepressants, beta-adrenoblockers, other sympathomimetics; pregnancy; breastfeeding; children under 12 years of age.

With caution: In marked coronary atherosclerosis, cardiovascular disease, 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, Dubin-Johnson, and Rotor syndromes), in emaciation, dehydration, pyloroduodenal obstruction, stenotic gastric and/or duodenal ulcer, epilepsy, in concurrent use of drugs that may adversely affect the liver (such as inducers of microsomal liver enzymes.

Side effects

Determination of the frequency of side effects: very frequently (≥1/10), frequently (≥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 is unknown (according to available data the frequency cannot be determined).

Blood system: very rare – thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.

Allergic reactions: rare – hypersensitivity (rash, shortness of breath, anaphylactic shock), urticaria, angioedema; frequency is unknown – anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Nervous system: often – drowsiness, rarely – dizziness, headache.
Mental disorders: rarely – increased excitability, sleep disturbance.

Visually: rare – mydriasis, accommodation paresis, increased intraocular pressure.

Cardiovascular system: rare – tachycardia, palpitations, arterial hypertension.

The digestive system: frequently – nausea, vomiting, rarely – constipation, dry mouth, abdominal pain and diarrhea.

The liver and biliary tract: rare – increased liver transaminase activity.

Skin and subcutaneous tissue: rare – skin rash, itching, erythema.

The urinary system: rare – difficulty urinating.

General reactions: rarely – malaise.
If any of the above side effects worsen and any other side effects appear, the patient should consult a physician.

Overdose

Symptoms of overdose are mainly caused by paracetamol.

Paracetamol
Symptoms: mainly occur after taking 10-15 g of paracetamol. In severe cases of overdose, paracetamol has hepatotoxic effects, including can cause liver necrosis. Also overdose may cause irreversible nephropathy and irreversible liver damage. The severity of overdose depends on the dose, therefore patients should be warned against concomitant use of other drugs containing paracetamol. The risk of poisoning is especially high in elderly patients, children, patients with liver diseases, in cases of chronic alcoholism, in patients with emaciation and in patients taking inducers of liver microsomal enzymes.

Paracetamol overdose can lead to liver failure, encephalopathy, coma and death.

Symptoms of paracetamol overdose in the first 24 h: pale skin, nausea, vomiting, anorexia, seizures. Abdominal pain may be the first sign of liver damage and usually does not manifest itself within 24-48 h and sometimes may appear later, after 4-6 days.

Liver damage is at its maximum extent after 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 may develop. Cases of cardiac arrhythmias and development of pancreatitis have been reported.

Treatment: administration of acetylcysteine v/v or orally as an antidote, gastric lavage, oral methionine administration may have a positive effect for at least 48 h after overdose. Administration of activated charcoal and monitoring of respiration and circulation are recommended. If seizures develop, diazepam may be prescribed.

Pheniramine 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, seizures, behavioral changes, increased BP and bradycardia. Cases of atropine-like “psychosis” have been reported in cases of pheniramine overdose.

Treatment: there is no specific antidote. Routine relief measures are necessary, including administration of activated charcoal, saline laxatives, and measures to support cardiac and respiratory function. Psychostimulants (methylphenidate) should not be administered because of the risk of seizures. In case of arterial hypotension vasopressor drugs may be used.

In case of BP increase IV administration of alpha-adrenoblockers is possible since phenylephrine is a selective agonist of α1-adrenoreceptors, hence the hypotensive effect in overdose should be treated by blocking α1-adrenoreceptors. If seizures develop, diazepam should be administered.

Pregnancy use

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