Description
Briefly about the product
TERAFLU WITH A TASTE OF LEMON from influenza and the common cold – your compact assistant. It is intended for the symptomatic treatment of infectious and inflammatory diseases (SARS, including influenza), the manifestations of which are:
High fever
Chills
Body aches
Head and muscle pain
Runny nose
Nasal congestion
Sneezing *.
* Instructions for medical use, RU Ñ N012063 / 01 of 05/31/2011
Description
Powder for the preparation of oral solution (lemon) white with yellow spots, granular, granular, without foreign particles, with a citrus smell, soft lumps are allowed.
Latin name
TeraFlu
Release form
22.1 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 (acute respiratory viral infections, including flu), accompanied by fever, chills, body aches, headache and muscle pain, runny nose, stuffy nose, sneezing.
Contraindications
Hypersensitivity to the components of the drug
– severe cardiovascular disease
– arterial hypertension
– portal hypertension
– diabetes mellitus
oltosis , glucose-galactose malabsorption
– simultaneous or within the previous 2 weeks intake of MAO inhibitors
– simultaneous administration of tricyclic antidepressants ntov, beta-blockers, other sympathomimetics
– pregnancy
– breastfeeding
– children under 12 years old.
Precautions: with severe atherosclerosis of the coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma, serious 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 Roto syndromes) depletion, dehydration, pyloroduodenal obstruction, stenotic gastric and / or duodenal ulcer, epilepsy, while taking drugs that can negatively pour on the liver (for example, inducers of microsomal liver enzymes) in patients with recurrent formation of urate stones in the kidneys.
Use during pregnancy and lactation
It is not recommended to use TeraFlu® against flu and colds during pregnancy and during lactation (breastfeeding).
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 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, rash or persistent headache.
These may be signs of more serious violations.
Teraflu ® against influenza and the common cold contains: -sucrose 20 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 ® for influenza and colds
-dye sun sunset yellow (E110). May cause allergic reactions
-sodium 28.3 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 ® against influenza and the common cold can cause drowsiness, so during treatment it is not recommended to drive vehicles or engage in other activities requiring concentration and high speed of psychomotor reactions.
Composition
1 sachet contains:
active ingredients:
paracetamol 325 mg
phenylephrine hydrochloride 10 mg
phenyramine maleate 20 mg
ascorbic acid 50 mg.
excipients:
sodium citrate dihydrate
malic acid
dye sunny sunset yellow
dye quinoline yellow
titanium dioxide
flavor lemon
calcium phosphate tribasic
citric acid
.
Dosage and Administration
Inside. The contents of one sachet are dissolved in 1 cup 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 ® against influenza and the common cold can be used at any time of the day, but taking the drug at bedtime brings the best effect. If symptom relief is not observed within 3 days after starting the drug, consult a doctor.
TheraFlu ® should not be used for flu and colds 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 the effects of MAO inhibitors, sedatives, ethanol. 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 may be reduced when used with cholestyramine, but the absorption is negligible if cholestyramine is taken 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 ® for influenza and cold 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 use of phenylephrine with ergot alkaloids (ergotamine and metisergide) may increase the risk of ergotism Overdose Overdose symptoms 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 administration of paracetamol-containing drugs. 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, convulsions. 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. Liver damage manifests itself 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 (overdose symptoms are combined due to the risk of mutual potentiation of the parasympatolytic effect of pheniramine and the sympathomimetic effect of phenylephrine in case of drug overdose) Symptoms: drowsiness, which later becomes an anxiety (especially in children), visual disturbances, rash, nausea vomiting, headache, irritability. dizziness, insomnia, circulatory disorders, coma, convulsions, behavioral 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. Conditions of supply of pharmacies Conditions of supply of pharmacies without prescription Famard Orleans, Switzerland
