Theraflu extra powder package lemon №1

COMPOSITION AND FORM OF ISSUE:

Theraflu EXTRA with lemon flavor

since then d / oral p-ra package, № 1, № 10

№ UA / 5797/01/01 from September 6, 2011 to September 6, 2016

THERAPY FROM FLU AND EXTRA PROCEDURES

since then d / oral r-ra, with taste yabl. and cinnamon, pack, No. 1, No. 10

№ UA / 5933/01/01 from 03/30/2010 to 03/30/2015

PHARMACOLOGICAL PROPERTIES:

combined preparation for the symptomatic treatment of cold and flu. It has antipyretic, decongestant, analgesic and anti-allergic effect.
Paracetamol has analgesic, antipyretic and minor anti-inflammatory action. The therapeutic effect is due to inhibition of COX enzymes. Phenylephrine hydrochloride is a sympathomimetic amine, acting primarily through a direct effect on α-adrenoreceptors. Causes vasoconstriction, reduces swelling and hyperemia of the mucous membrane of the nasal cavity and paranasal sinuses. Pheniramine maleate, blocker H₁-receptors, has anti-allergic effect, reduces the severity of local exudative manifestations, eliminates tearing, rhinorrhea.
After ingestion, paracetamol is rapidly absorbed in the gastrointestinal tract. WITH_max in blood plasma is reached in 30–60 min. When used in a therapeutic dose of T_½ is 1–4 hours. Paracetamol is metabolized in the liver mainly by the conjugation reaction. Depending on the concentration in the blood plasma, it is partially deacetylated or hydroxylated. The main route of excretion is with urine (90–100% for 24 hours), in the form of conjugates of glucuronides (60%), sulfates (35%) or cysteine ​​(3%).
WITH_max Pheniramine maleate in the blood plasma is achieved in 1–2.5 h; T_½makes 16–19 hours. 70–83% of the dose accepted inside are removed with urine in not changed look or in the form of metabolites.
Phenylephrine has a limited bioavailability due to insufficient absorption in the gastrointestinal tract and a presystemic effect in the intestine and liver, which are caused by the action of MAO.

INDICATIONS:

short-term symptomatic treatment of flu and colds, including fever and chills, headache, nasal congestion, sneezing and rhinorrhea, body pain.

APPLICATION:

adults and children over the age of 12 are prescribed 1 packet every 4–6 hours (as necessary to reduce symptoms), but not more than 3 packets per day. A single dose should not exceed 1 package. The drug is not recommended for more than 7 days. The contents of 1 package dissolve in a glass of hot water, take hot.

CONTRAINDICATIONS:

hypersensitivity to the drug. Severe cardiovascular, hepatic or renal failure, congenital hyperbilirubinemia,AH; pheochromocytoma, thyrotoxicosis, prostate adenoma with difficulty urinating; bladder neck obstruction, blood diseases, pyloroduodenal obstruction, stenosing gastric and duodenal ulcers, diabetes mellitus, lung diseases (including BA), angle-closure glaucoma, glucose-6-phosphate dehydrogenase deficiency, epilepsy, alcoholism, concomitant therapy, an inhibitor, antagonist, concomitant therapy with an inhibitor, antagonist, anesthesia weeks after stopping their use.

SIDE EFFECTS:

most often: dizziness, dry mouth or throat, fatigue, headache, anxiety, nervousness, tachycardia, palpitations. Rarely noted the excited state, sleep disturbance, edema.
Rarely can identify:
Allergic reactions: itching, rash, urticaria, in some cases - erythematous and other severe skin reactions, petechiae, angioedema, bronchospasm, reduction of blood pressure up to a shock, anaphylaxis;
from the gastrointestinal tract: digestive disorders, including constipation, nausea, vomiting, diarrhea or flatulence, epigastric pain, abnormal liver function;
from the endocrine system: fluctuations in blood glucose levels;
nervous system: confusion, vestibular disorders.
Related to the use of paracetamol: thrombocytopenia, leukopenia, hemolytic anemia, in some cases - agranulocytosis. In patients with intolerance to Acetylsalicylic acid (5–10%), reactions to paracetamol (for example, patients with asthma) are possible.
Related to the use of phenylephrine: increased blood pressure, pain in the heart, mydriasis, impaired vision and accommodation, increased intraocular pressure and potential effects on endocrine and other regulators of metabolic processes, impaired urination.
Related to the use of pheniramine: dryness of the mucous membrane of the eyes, insomnia, in some cases - coma, convulsions, dyskinesia, changes in behavior.
Unlike second-generation antihistamines, the use of pheniramine is not associated with prolongation of the intervalQ – Tc and cardiac arrhythmia.

SPECIAL INSTRUCTIONS:

do not exceed the recommended dose or take the drug for more than 7 days in a row.
Consult a physician if symptoms:

• do not disappear within 7 days;
• accompanied by fever, which lasts more than 3 days;
• include sore throat that lasts more than 3 days, accompanied by fever, headache, rash, nausea or vomiting.

The simultaneous use of other medicines containing paracetamol should be avoided.
When using the drug is not recommended to consume alcoholic beverages, since ethyl alcohol, while taking it with paracetamol, can cause liver dysfunction.
The drug is used with caution in patients with prostate hypertrophy, thyroid disease, liver and kidney disease, bradycardia, acute pancreatitis, patients over 70 years old with cardiovascular diseases.
Without prescription, do not use the drug to patients who are undergoing treatment with other medicines.
Phenylephrine may contribute to a false-positive result in doping control in athletes.
Application in gestation period and breastfeeding. The drug is contraindicated during pregnancy and lactation.
Influence at ability to drive vehicles and work withmechanisms. During the use of the drug is not recommended to drive vehicles and work with mechanisms that require high concentration of attention and high speed psychomotor reactions. With the simultaneous use of sedatives, tranquilizers or alcohol may increase drowsiness.
Children. The drug is contraindicated in children under the age of 12 years.

INTERACTIONS:

drug interactions with paracetamol are usually negligible, but are enhanced when concomitant drugs such as anticoagulants (warfarin and coumarin) and anticonvulsant drugs have a low therapeutic index. The simultaneous use of paracetamol with NSAIDs can increase their nephrotoxicity. Pharmacodynamic interactions may occur with other painkillers, such as caffeine, opiates; barbiturates reduce the antipyretic effect. T_½ chloramphenicol increases. Probenecid, colestyramine (INN - colestyraminum) inhibits the metabolism of paracetamol.Treatment of tuberculosis with rifampicin and isoniazid increases the hepatotoxicity of paracetamol. Antiepileptic drugs (phenobarbital, phenytoin, carbazepine) do not increase the risk of a hepatotoxic effect.
Phenylephrine hydrochloride should not be used with MAO inhibitors , blockers of α- and β-adrenergic receptors, other antihypertensive drugs, phenothiazine derivatives (promethazine example), bronchodilatory sympathomimetic agents, tricyclic antidepressants, guanethidine or atropine, digitalis, Rauwolfia alkaloids, Indomethacin , methyldopa, SSC; drugs that affect the appetite, amphetamine-like psychostimulants, labor stimulants, anesthetics, ergot alkaloids.
Pheniramine maleate potentiates the action of drugs that depress the central nervous system (for example, anti-parkinsonian and antipsychotic drugs), as well as alcohol, inhibits the action of anticoagulants and interacts with Progesterone , reserpine, thiazide diuretics. Oral contraceptives may decrease the effectiveness of an antihistamine.

OVERDOSE:

symptoms of paracetamol overdose: hepatotoxic effect, in severe cases, liver necrosis develops. Accompanied by nausea, vomiting, abdominal pain, which can appear within 24–48 hours after an overdose. Violation of glucose metabolism and metabolic acidosis, ARF with tubular necrosis; arrhythmia, pancreatitis, sulfhemoglobinemia,methemoglobinemia, anemia.
Overdose symptoms associated with potentiation of the parasympatholytic effect of the antihistamine component andsympathomimetic action of phenylephrine: hemodynamic changes and cardiovascular insufficiency with respiratory depression, drowsiness, after which excitation is possible (especially in children); depression, ulcers of the mucous membrane of the mouth, blurred vision, headache; dizziness, insomnia, coma, convulsions; behavior changes; AH; bradycardia; atropin-like psychosis.
Treatment: gastric lavage, in / in or oral administration of N-acetylcysteine ​​as an antidote to paracetamol, taking Activated carbon , osmotic laxatives, monitoring breathing and blood circulation (use adrenaline (INN - epinephrinum)). Symptomatic treatment and maintenance therapy. In the case of convulsions, diazepam is prescribed.
In case of arterial hypotension, α-adrenoreceptor blockers or vasoconstrictor agents can be used.

STORAGE CONDITIONS:

at a temperature not higher than 25 ° C.