Description
Briefly about the product
TERAFLU EXTRA – powerful against 7 main symptoms of flu and colds! *. It is used for symptomatic treatment of infectious and inflammatory diseases: SARS, including influenza and the common cold, the manifestations of which are:
High fever
Chills
Headache
Runny nose
Nasal congestion
Sneezing
Muscle pain *.
* Instructions for medical use, RU LSR-007823/10 dated 08/10/2010
Description
Powder for the preparation of oral solution (lemon) loose, containing granules of white and yellow color, with a specific smell, soft lumps are allowed.
Latin name
TeraFlu Extra
Release form
15 g of powder in a multilayer bag. 10 sachets in a cardboard box.
Sachets can be placed individually or stapled in pairs.
Instructions for use are applied to the bag.
Pharmacological action
Combined drug whose action is due to its constituent components. It has an antipyretic, analgesic, vasoconstrictive effect, eliminates the symptoms of a cold. It constricts blood vessels and eliminates swelling of the mucous membrane of the nasal cavity and nasopharynx.
Paracetamol has an analgesic and antipyretic effect by inhibiting the synthesis of prostaglandins in the central nervous system. Does not affect platelet function and hemostasis.
Pheniramine is an antiallergic, histamine H1 receptor blocker. Eliminates allergic symptoms, to a moderate degree has a sedative effect, and also exhibits antimuscarinic activity.
Phenylephrine – alpha-1-adrenergic agonist, causes vasoconstriction, eliminates swelling and hyperemia of the nasal mucosa.
Indications
Symptomatic treatment of infectious and inflammatory diseases (SARS, including influenza), accompanied by fever, chills, headache, runny nose, nasal congestion, sneezing, muscle pain.
Contraindications
Hypersensitivity to the drug components severe cardiovascular disease arterial hypertension portal hypertension diabetes mellitus hyperthyroidism angle-closure glaucoma pheochromocytoma alcoholism sucrose / isomaltase deficiency, fructose intoxication, glucose, glucose, and 2 antidepressants, beta-blockers, other pregnancy sympathomimetics l period of breastfeeding for children under 12 years old.
Precautions: with severe atherosclerosis of the coronary arteries, 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’s syndrome, and Rotor), with depletion, dehydration, pyloroduodenal obstruction, stenotic gastric and / or duodenal ulcer, epilepsy, while taking pr drugs that can affect the liver (for example, inducers of microsomal liver enzymes.
Use during pregnancy and lactation
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.
Special instructions
To avoid toxic liver damage, the drug should not be combined with alcohol.
Patients should consult a doctor if:
– bronchial asthma is observed, emphysema or chronic bronchitis
– symptoms do not go away within 5 days, or are accompanied by severe fever lasting for 3 days, a rash or constant headache.
These may be signs of more serious violations.
Teraflu ® Extra contains: -sucrose 12.6 g per sachet. This should be taken into account in patients with diabetes. Patients with rare inherited problems such as fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency should not take Teraflu ® Extra
-sunset yellow stain (E110). May cause an allergic reaction
-sodium 42.2 mg per sachet. This should be taken but attention in patients on a sodium-restricted diet.
Do not use a drug from damaged sachets.
Influence on the ability to drive vehicles and mechanisms
Teraflu ® Extra can cause drowsiness, therefore, during treatment it is not recommended to drive vehicles or engage in other activities requiring concentration and high speed of psychomotor reactions.
Composition of
1 sachet of powder for oral solution contains:
Active ingredients
Paracetamol 650 mg.
Pheniramine maleate 20 mg.
Phenylephrine hydrochloride 10 mg.
Excipients:
sucrose,
acesulfame potassium,
quinoline yellow dye,
sunset yellow dye,
maltodextrin M100,
silicon dioxide,
natural lemon flavor WONrd Dldrd60 Lemon Drum Dlr.0, Dl.0, Dl.0, Dlrdm, Dl. 9, Dlrdm, Dlrdm, Dl. 9 Dlrdm, Dlrdm, Dlrdm, Dl. acid,
sodium citrate dihydrate,
calcium phosphate.
Dosage and Administration
Inside. The contents of one sachet are dissolved in 1 cup (250 ml) of hot but not boiling water. Accepted hot. A 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 is taking the drug before bedtime, at night. If symptom relief is not observed within 3 days after starting the drug, consult a doctor.
Do not use TeraFlu ® Extra 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.
In severe renal failure (CC <10 ml / min), the interval between doses should be at least 8 hours. In elderly patients, dose adjustment is not required. Side effects Determination of frequency of side effects: very common ( 1/10), often ( 1/100 and <1/10), infrequent ( 1/1000 and <1/100), rare ( 1 / 10,000 and <1/1000), very rare (<1 / 10,000), including individual messages, the frequency is unknown (according to available data it is impossible to determine the frequency). From the hematopoietic system: very rarely – thrombocytopenia, agranulocytosis, leukopenia, pancytopenia. Allergic reactions: rarely – hypersensitivity (rash, shortness of breath, anaphylactic shock), urticaria, angioneurotic edema frequency unknown – anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis. From the nervous system: often – drowsiness is rare – dizziness, headache. Mental disorders: rarely – increased arousal, sleep disturbance. From the organ of vision: rarely – mydriasis, paresis of accommodation, increased intraocular pressure. From the cardiovascular system: rarely – tachycardia, palpitations, hypertension. From the digestive system: often – nausea, vomiting rarely – constipation, dryness of the oral mucosa, abdominal pain, diarrhea. From the side of the liver and biliary tract: rarely – increased activity of hepatic transaminases. Skin and subcutaneous tissue: rarely – skin rash, itching, erythema. On the part of the urinary system: rarely – difficulty in urinating. General reactions: rarely – malaise. If any of the above side effects are exacerbated and any other side effects occur, the patient should consult a doctor. Drug Interaction Paracetamol Enhances Effects of Inhibitors, MA The risk of hepatotoxic action of paracetamol increases with the concomitant use of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of liver microsomal enzymes. With long-term regular use of paracetamol, the anticoagulant effect of warfarin and other coumarins may be increased, with the risk of bleeding increasing. Single administration 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 can increase the rate of absorption of paracetamol. Paracetamol may increase T1 / 2 chloramphenicol. Paracetamol is able to reduce the bioavailability of lamotrigine, while reducing the effectiveness of lamotrigine due to the induction of its metabolism in the liver. The absorption of paracetamol can be reduced when used with cholestyramine, but the decrease in absorption is negligible if I take cholestyramine an hour later. Regular administration of paracetamol with zidovudine can cause neutropenia and increase the risk of liver damage. Probenecid affects the metabolism of paracetamol. In patients receiving concomitant probenecid, the dose of paracetamol should be reduced. The hepatotoxicity of paracetamol is exacerbated by prolonged excessive use of ethanol (alcohol). Paracetamol can affect the results of a uric acid test using a phosphovalframate precipitating reagent. Pheniramine The effects of other substances on the CNS (eg MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonian drugs, barbiturates, tranquilizers and narcotics) may be increased. Pheniramine can inhibit the action of anticoagulants. Phenylephrine Teraflu ® Extra is contraindicated in patients receiving or receiving MAO inhibitors within the last 2 weeks. Phenylephrine can potentiate the effects of MAO inhibitors and cause hypertensive crises. Concomitant administration of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (eg, amitriptyline) may increase the risk of adverse reactions by the cardiovascular system. Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive drugs (eg, debrizochina, guanethidine, reserpine, methyldopa). It is possible to increase the risk of hypertension and other side effects from the cardiovascular system. Co-administration of phenylephrine with digoxin and cardiac glycosides may increase the risk of heart rhythm disturbance or myocardial infarction. Concomitant administration of phenylephrine with ergot alkaloids (ergotamine and metisergide) may increase the risk of ergotism. Overdose Symptoms of overdose are mainly due to paracetamol. Paracetamol Symptoms: mainly appear after taking 10-15 g of paracetamol. In severe cases of an overdose, paracetamol has a hepatotoxic effect, including may cause liver necrosis. Also, an overdose can cause irreversible nephropathy and irreversible liver damage. The severity of an overdose depends on the dose, so patients should be warned about the prohibition of the simultaneous use of other drugs containing paracetamol. The risk of poisoning is especially pronounced 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 an overdose of paracetamol in the first 24 hours: pallor of the skin, nausea, vomiting, anorexia, cramps. Abdominal pain can be the first sign of liver damage and usually does not appear within 24-48 hours and can sometimes occur later, after 4-6 days. Damage to the liver appears to the 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 can develop. Cases of cardiac arrhythmia and the development of pancreatitis have been reported. Treatment: the introduction of acetylcysteine iv or orally as an antidote, gastric lavage, ingestion of methionine can have a positive effect for at least 48 hours after an overdose. Recommended intake of activated carbon, monitoring of respiration and blood circulation. In the case of seizures, diazepam may be prescribed. Pheniramine and phenylephrine Symptoms: drowsiness, to which anxiety subsequently joins (especially in children), visual disturbances, rash, nausea, vomiting, headache, irritability. dizziness, insomnia, circulatory disorders, coma, convulsions, behavior changes, increased blood pressure and bradycardia. With an overdose of feniramine, cases of atropine-like psychosis have been reported. Treatment: no specific antidote. Conventional care measures are needed, including the use of activated charcoal, saline laxatives, measures to support cardiac and respiratory functions. Psychostimulating agents (methylphenidate) should not be prescribed because of the risk of seizures. With arterial hypotension, the use of vasopressor drugs is possible. In the case of an increase in blood pressure, the introduction of alpha-blockers is possible. phenylephrine is a selective? 1-adrenergic receptor agonist, therefore, the hypotensive effect of an overdose should be treated by blocking? 1-adrenergic receptors. With the development of seizures, enter diazepam. Storage conditions The product should be stored out of the reach of children at a temperature not exceeding 25 ° C. Expiration 2 years. active substance Paracetamol Phenylephrine, pheniramine Famar Orleans, Switzerland
