Composition, form of production and packaging
? Powder for preparation of solution for ingestion (lemon) white with yellow impregnations, loose, granular, free of foreign particles, with citrus smell; the presence of soft lumps is allowed.
1 pack.
paracetamol 325 mg
Pheniramine maleate 20 mg
phenylephrine hydrochloride 10 mg
ascorbic acid 50 mg
[PRING] sodium citrate dihydrate - 120.74 mg, malic acid - 50.31 mg, dye sunset yellow - 0.098 mg, dye quinoline yellow - 0.094 mg, titanium dioxide 3.16 mg, lemon flavor 208.42 mg, calcium phosphate tribasic 82 mg, citric acid - 1221.79 mg, sucrose - 20 000 mg.
22.1 g - multi-layer sachets (4) - cardboard packs.
22.1 g - multi-layer sachets (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Combined drug, the effect of which is due to its constituent components. It has antipyretic, analgesic, vasoconstrictive action, eliminates the symptoms of "colds".Narrows the vessels and eliminates the swelling of the mucous membrane of the nasal cavity and nasopharynx.
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.
Phenyramin is an antiallergic agent, a blocker of histamine H 1 -receptors. Eliminates allergic symptoms, has a moderate degree of sedation, and also exhibits antimuscarinic activity.
Phenylephrine - alpha 1- adrenomimetic, causes vasoconstriction, eliminates edema and flushing of the mucous membrane of the nasal cavity.
PHARMACOKINETICS
Paracetamol
Paracetamol is rapidly and almost completely absorbed from the digestive tract. C max in plasma is achieved after 10-60 min after ingestion. It is distributed in most body tissues. Penetrates through the placental barrier, excreted in breast milk. In therapeutic concentrations, binding to plasma proteins is negligible, but increases with increasing concentration. It is subjected to primary metabolism in the liver. It is excreted mainly with urine in the form of glucuronides and sulfates. T 1/2 is from 1 to 3 hours.
Pheniramine
C max of the phenyramine in plasma is reached after approximately 1-2.5 hours. T 1/2 of the phenyramine - 16-19 hours. 70-83% of the dose is excreted in the urine in the form of metabolites or unchanged.
Phenylephrine
Phenylephrine is absorbed from the digestive tract. Metabolized at the "first passage" through the intestinal wall and in the liver, therefore when administered phenylephrine hydrochloride is characterized by limited bioavailability. C max in plasma is achieved in the range from 45 minutes to 2 hours. It is excreted by the kidneys almost completely in the form of sulfate compounds. T 1/2 is 2-3 hours.
Ascorbic acid
Quickly and completely absorbed from the digestive tract. Binding to plasma proteins - 25%. It is excreted in the form of metabolites with urine. Ascorbic acid, taken in excessive amounts, is quickly excreted unchanged in urine.
INDICATIONS
- symptomatic treatment of infectious and inflammatory diseases (ARVI, including influenza), accompanied by fever, chills, body aches, headaches and muscle pain, runny nose, nasal congestion, sneezing.
DOSING MODE
Inside. The contents of one sachet are dissolved in 1 glass 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 В® from the flu and cold 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 see a doctor.
Do not use TeraFlu В® against flu and cold for 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.
For renal insufficiency of severe degree (CC <10 ml / min), the interval between doses should be at least 8 hours.
In elderly patients, dose adjustment is not required.
SIDE EFFECT
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 messages, the frequency is unknown (it is impossible to determine the frequency from the available data).
From the hemopoietic system: very rarely - thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.
Allergic reactions: rarely - hypersensitivity (rash, dyspnea, anaphylactic shock), urticaria, angioedema; frequency unknown - anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the nervous system: often - drowsiness; rarely - dizziness, headache.
Disorders of the psyche: rarely - increased excitability, sleep disturbance.
From the side of the organ of vision: rarely - mydriasis, paresis of accommodation, increased intraocular pressure.
From the cardiovascular system: rarely - tachycardia, palpitations, arterial hypertension.
On the part of the digestive system: often - nausea, vomiting; rarely - constipation, dryness of the oral mucosa, abdominal pain, diarrhea.
From the liver and bile ducts: 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 are aggravated and any other side effects occur, the patient should consult a doctor.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
- severe cardiovascular diseases;
- arterial hypertension;
- portal hypertension;
- diabetes;
- hyperthyroidism;
- an angle-closure glaucoma;
- pheochromocytoma;
- Alcoholism;
- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption;
- simultaneous or during the previous 2 weeks of taking MAO inhibitors;
- simultaneous reception of tricyclic antidepressants, beta-adrenoblockers, other sympathomimetics;
- Pregnancy;
- the period of breastfeeding;
- Children under 12 years old.
With caution: 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
glucose-6-phosphate dehydrogenase, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome and
Rotor), with exhaustion, dehydration, pyloroduodenal obstruction, stenotic ulcer of the stomach and / or duodenum, epilepsy, while taking drugs that can adversely affect the liver (for example, inducers of microsomal liver enzymes); in patients with recurrent urate kidney stones.
PREGNANCY AND LACTATION
It is not recommended to use Teraflu В® against influenza and colds during pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution in severe kidney disease.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution in severe liver disease.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
SPECIAL INSTRUCTIONS
To avoid toxic damage to the liver, the drug should not be combined with the use of alcoholic beverages.
Patients should consult a doctor if:
- observed 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.
Teraflu В® from influenza and cold contains:
-Sucrose 20 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 isomaltase sucrose should not take Teraflu В® from the flu and colds;
Dye sunset sunset yellow (E110). May cause allergic reactions;
-Sodium 28.3 mg per bag. This should be taken into account in patients observing a diet with sodium restriction.
Do not use the drug from damaged pouches.
Impact on the ability to drive vehicles and mechanisms
Teraflu В® from influenza and cold can cause drowsiness, so during treatment it is not recommended to drive vehicles or engage in other activities requiring concentration of attention and high speed of psychomotor reactions.
OVERDOSE
Symptoms of overdose are mainly due to paracetamol.
Paracetamol
Symptoms: mainly manifested after taking 10-15 g of paracetamol. In severe cases of overdose, paracetamol has a hepatotoxic effect, incl. can cause liver necrosis.Also, an overdose can cause irreversible nephropathy and irreversible liver damage. The severity of the overdose depends on the dose, so 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 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. Pain in the abdomen may 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 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 ​​IV 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 (overdose symptoms 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: 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".
Treatment: there is no specific antidote. Normal relief measures, including appointment, are required.
activated charcoal, saline laxatives, measures to support cardiac and respiratory functions. Do not prescribe psychostimulant (methylphenidate) because of the danger of seizures. With arterial hypotension, the use of vasopressor drugs is possible.
In the case of increased blood pressure, iv administration of alpha-blockers is possible, Phenylephrine is a selective agonist? 1- adrenoreceptor, so the hypotensive effect of overdose should be treated by blocking? 1- adrenoreceptors. When developing seizures, administer diazepam.
DRUG INTERACTION
Paracetamol
Strengthens 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.
With prolonged regular use of paracetamol, an increase in the anticoagulant effect of warfarin and other coumarins is possible, and the risk of bleeding increases.Single application of paracetamol has no significant effect.
Metoclopramide increases the rate of absorption of paracetamol and reduces the time it reaches its C max in blood plasma. Similarly, domperidone may increase the rate of absorption of paracetamol.
Paracetamol can lead to an increase in T 1/2 chloramphenicol.
Paracetamol is able to reduce the bioavailability of lamotrigine, with the possible decrease in the effectiveness of lamotrigine due to the induction of its metabolism in the liver.
Absorption of paracetamol can be reduced with simultaneous application with colestyramine, but a decrease in absorption is insignificant if colestyramine is taken an hour later.
Regular use of paracetamol simultaneously with zidovudine can cause neutropenia and increase the risk of liver damage.
Probenecid affects the metabolism of paracetamol. In patients who simultaneously use probenecid, the dose of paracetamol should be reduced.
Hepatotoxicity of paracetamol is enhanced by prolonged excessive use of ethanol (alcohol).
Paracetamol can affect the results of a uric acid test using the precipitating reagent phosphotungstate.
Pheniramine
It is possible to increase the influence of other substances on the CNS (for example, MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonics, barbiturates, tranquilizers and narcotics). Pheniramine can inhibit the action of anticoagulants.
Phenylephrine
Teraflu В® against influenza and colds is contraindicated in patients who receive or have received MAO inhibitors within the past 2 weeks. Phenylephrine can potentiate the effect of MAO inhibitors and cause hypertensive crisis.
The simultaneous use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (for example, amitriptyline) may lead to an increased risk of unwanted reactions from the cardiovascular system.
Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive drugs (for example, debrisoquine, guanethidine, reserpine, methyldopa).Perhaps increased risk of hypertension and other side effects from the cardiovascular system.
The simultaneous use of phenylephrine with digoxin and cardiac glycosides may increase the risk of heart rhythm or myocardial infarction.
The simultaneous use of phenylephrine with ergot alkaloids (ergotamine and metisergid) may increase the risk of ergotism.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.
