Teraflu extratab tablets, No. 10

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

It is taken internally. It is recommended to swallow the tablet whole without chewing with water.

Adults - 1 tablet every 4-6 hours, but not more than 6 tablets per day.

Children over 12 years old - 1 tablet every 4-6 hours, but not more than 4 tablets per day.

The course of treatment is no more than 5 days.

If there is no relief of symptoms within 3 days after starting the drug, you should see your doctor.

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.

No dose adjustment is required in elderly patients.

Active ingredient: paracetamol 650 mg; chlorphenamine maleate 4 mg; phenylephrine hydrochloride 10 mg;
Excipients: colloidal silicon dioxide - 0.4 mg, quinoline yellow dye-based varnish - 0.85 mg, lactose - 3.1 mg, magnesium stearate - 3.5 mg, hyprolose - 17 mg, croscarmellose sodium - 57 mg, corn starch - 124 mg.
The composition of the film shell: varnish based on quinoline yellow dye - 0.0331 mg, quinoline yellow dye - 0.0392 mg, titanium dioxide - 1.0882 mg, methyl parahydroxybenzoate - 0.0889 mg, povidone - 0.4353 mg, colloidal silicon dioxide - 0.6529 mg, macrogol 400 - 1.7412 mg, methylcellulose - 3.9176 mg.

• Hypersensitivity to the components of the drug;

• severe cardiovascular disease;

• arterial hypertension;

• hyperthyroidism;

• angle-closure glaucoma;

• pheochromocytoma;

• lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

• taking MAO inhibitors (simultaneously or in the previous 14 days), tricyclic antidepressants, beta-blockers, and other sympathomimetics;

• pregnancy;

• breastfeeding period;

• children under 12 years of age.

Precautions: diabetes mellitus, liver dysfunction, renal dysfunction, prostatic hyperplasia, hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, bronchial asthma, chronic obstructive pulmonary disease (chronic bronchitis), pulmonary emphysema, acute hepatitis, chronic exhaustion or dehydration , pyloroduodenal stenosis, epilepsy, cardiovascular diseases; alcohol addiction.

You should not take other paracetamol-containing drugs at the same time, as well as other drugs that affect liver function.

TERAFLU EXTRATAB - the powerful power of Theraflu against the 7 main symptoms of flu and colds in a convenient pill format!.

It is used for the symptomatic treatment of infectious and inflammatory diseases: ARVI, including flu and 'cold', the manifestations of which are:
Х High fever
Х Chills
Х Headache
Х Runny nose
Х Nasal congestion
Х Sneezing
Х Muscle pain.
Turnkey solution on the go!

Side effect

From the hematopoietic system: very rarely - thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.

From the immune system: rarely - hypersensitivity, urticaria, angioedema; frequency unknown - anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the nervous system: often - drowsiness; rarely - dizziness, headache.

Mental disorders: rarely - nervousness, insomnia.

From the side of the cardiovascular system: rarely - tachycardia, heart palpitations, arterial hypertension.

From the digestive system: often - nausea, vomiting; rarely - constipation, dryness of the oral mucosa.

From the liver and biliary tract: rarely - an increase in the activity of hepatic transaminases.

Skin and subcutaneous tissue disorders: rarely - skin rash, itching, erythema.

Application during pregnancy and lactation

The use of the drug during pregnancy and lactation (breastfeeding) is contraindicated.

The safety of TeraFluЃ ExtraTab when used during pregnancy and during breastfeeding has not been specifically studied.

Pregnancy

Epidemiological studies during pregnancy have shown no adverse effect when using paracetamol orally at the recommended dose. In studies of the reproductive toxicity of paracetamol with oral administration, there were no signs of malformations or fetotoxicity. Paracetamol can be used in therapeutic doses throughout pregnancy after evaluating the benefit / risk ratio of therapy.

There are limited data on the use of phenylephrine in pregnant women. The narrowing of the vessels of the uterus and a decrease in blood flow in the uterus with the use of phenylephrine can lead to fetal hypoxia. The use of phenylephrine during pregnancy should be avoided.

Epidemiological data on the use in humans have not revealed an association between chlorphenamine and congenital malformations. However, controlled clinical trials are not enough, therefore, the use of chlorphenamine maleate during pregnancy should be avoided.

Breast-feeding

Paracetamol is excreted in breast milk, but in amounts that are not clinically significant. According to published data, paracetamol is not contraindicated during breastfeeding.

There are no data on the excretion of phenylephrine in breast milk. Phenylephrine should be avoided during breastfeeding.

There are no data on the excretion of chlorphenamine in breast milk. Chlorphenamine should be avoided during breastfeeding.

Application for violations of liver function

With care: severe liver disease.

Application for impaired renal function

With care: severe kidney disease.

special instructions

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

Influence on the ability to drive vehicles and mechanisms

During treatment, it is not recommended to drive vehicles or other mechanisms that require concentration of attention and a high speed of psychomotor reactions.

Overdose

Paracetamol

Symptoms: due mainly to the presence of paracetamol. In acute overdose, paracetamol can have a hepatotoxic effect and even cause liver necrosis. Paracetamol overdose, including the general high dose level after a long period of therapy, can lead to nephropathy caused by analgesics, with irreversible liver failure. Patients should be warned about the inadmissibility of the simultaneous administration of other drugs containing paracetamol. There is a risk of poisoning, especially in elderly patients and young children, those with liver disease, in the case of chronic alcoholism, patients with chronic malnutrition and patients receiving microsomal enzyme inducers.

Paracetamol overdose can lead to liver failure, encephalopathy, coma, and death. Symptoms of a paracetamol overdose on the first day include pallor, nausea, vomiting, and anorexia. Abdominal pain can be the first sign of liver damage, and it can appear only after 24-48 hours, sometimes 4-6 days after taking the drug. Most often, signs of liver damage occur 72-96 hours after taking the drug. Possible impairment of glucose metabolism and metabolic acidosis. Acute renal failure and acute renal tubular necrosis may develop even in the absence of severe liver damage. Cases of cardiac arrhythmias and pancreatitis have been reported.

Treatment: Treatment of paracetamol overdose should be started immediately. During the first 48 hours after an overdose, it is advisable to use N-acetylcysteine ??intravenously or orally as an antidote to paracetamol, possibly gastric lavage and / or the use of methionine orally. It is advisable to use activated carbon. Control of breathing and circulation is necessary. Diazepam can be used in case of seizures.

Phenylephrine

Symptoms: sympathomimetic effect, which causes hemodynamic changes and cardiovascular collapse with respiratory depression, manifested as, for example, drowsiness, followed by agitation (especially in children), visual impairment, skin rash, nausea, vomiting, persistent headaches, nervousness, dizziness, insomnia, hematopoietic disorders (thrombocytopenia, agranulocytosis, leukopenia, pancytopenia), coma, convulsions, arterial hypertension and bradycardia.

Treatment: immediate gastric lavage, symptomatic and supportive therapy. The hypertensive effect can be stopped by intravenous administration of an alpha-blocker. In case of seizures, diazepam may be used.

Chlorphenamine

Symptoms: drowsiness, respiratory arrest, seizures, anticholinergic effects, dystonic reactions, and cardiovascular collapse, including arrhythmia. In children, overdose symptoms may include impaired coordination, agitation, tremors, behavior changes, hallucinations, seizures, and anticholinergic effects.

Treatment: gastric lavage in case of massive overdose, or stimulation of vomiting. After that, it is possible to prescribe activated carbon and a laxative to slow down absorption. In case of seizures, intravenous diazepam or phenytoin should be given. In severe cases, hemoperfusion may be performed.

Drug interactions

Paracetamol

With prolonged regular use of paracetamol, the anticoagulant effect of warfarin and other coumarins may increase, while the risk of bleeding increases. Intermittent use of paracetamol has no significant effect.

Hepatotoxic substances can lead to paracetamol accumulation and overdose. The risk of paracetamol hepatotoxicity is increased with drugs that induce microsomal liver enzymes, such as barbiturates, antiepileptic drugs (eg phenytoin, phenobarbital, carbamazepine), and drugs for the treatment of tuberculosis such as rifampicin and isoniazid.

Metoclopramide increases the rate of absorption of paracetamol and increases its Cmax in blood plasma. Likewise, domperidone may increase the rate of absorption of paracetamol.

Paracetamol can lead to an increase in T1 / 2 of chloramphenicol.

Paracetamol can reduce the bioavailability of lamotrigine, while the effectiveness of lamotrigine may decrease due to the induction of its metabolism in the liver.

The absorption of paracetamol can be reduced when used simultaneously with cholestyramine, but the decrease in absorption is insignificant if cholestyramine is taken an hour later.

Regular use of paracetamol along with zidovudine can 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.

The hepatotoxicity of paracetamol increases with prolonged excessive use of ethanol (alcohol).

Paracetamol may interfere with the uric acid test using the phosphotungstate precipitating reagent.

Phenylephrine

Contraindicated in patients receiving or receiving MAO inhibitors within the past 2 weeks. Phenylephrine can potentiate the action of MAO inhibitors and induce a hypertensive crisis.

The simultaneous use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (for example, amitriptyline) may increase the risk of adverse reactions from the cardiovascular system.

The use of phenylephrine can lead to a decrease in the effectiveness of beta-blockers and other antihypertensive drugs (for example, debrisoquine, guanethidine, reserpine, methyldopa). The risk of arterial hypertension and other adverse reactions from the cardiovascular system may increase.

The simultaneous use of phenylephrine with digoxin and cardiac glycosides may increase the risk of heart rhythm disturbances or heart attack.

Concomitant use of ergot alkaloids (ergotamine) may increase the risk of ergotism.

Chlorphenamine

Chlorphenamine, like other antihistamines, can enhance the effect of opioid analgesics, anticonvulsants, antidepressants (tricyclics and MAO inhibitors), other antihistamines, antiemetics and antipsychotics, anxiolytics, hypnotics, ethanol (alcohol) and drugs that have an effect on the central nervous system ...

Because chlorphenamine has some anticholinergic activity, the effects of anticholinergic drugs (eg, some psychotropic drugs, atropine, and urinary incontinence drugs) may be enhanced with this drug. This can lead to tachycardia, dryness of the oral mucosa, digestive disorders (such as colic), urinary retention, and headache.

Chlorphenamine can inhibit phenytoin metabolism, and phenytoin toxicity may develop.