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Instructions for medical use of
Antiflu ®
Trade name
Antiflu ®
International nonproprietary name
No
Dosage form
Film-coated tablet
Composition
1 tablet includes:
active substance: acetaminophen 325 mg, phenylephrine hydrochloride 5 mg, Chlorpheniramine maleate 2 mg;
adjuvants: microcrystalline cellulose, cross-carmellose sodium, colloidal silicon dioxid, colourant D&C yellow No 10 varnish (Е104), stearic acid, magnesium stearate;
coating: hypromellose, mineral oil, polyethyleneglycol, magnesium silicate.
Description
Yellow film-coated tablets of capsule form with print AntiFlu on one side.
Pharmacotherapeutic group
Analgesic. Analgesic – alexipyretic, etc. Anilide. Paracetamol in combination with other drugs (except for neuroleptics)
Code АТХ N02BE51
Pharmacological properties
Pharmacokinetics
Acetaminophen (paracetamol) – effective half-life (Т ½) of acetaminophen is 2-2.5 hours. It extends after use of large dosages and in case of use by persons suffering hepatic disorders. Paracetamol is excreted with urine (85% of single dose of acetaminophen is excreted within 24 hours).
Excretion is significantly worse in case of failure of excretive function of kidney that can lead to accumulation of acetaminophen in body and products of its metabolism.
Chlorpheniramine maleate – elimination takes place in liver. Time of semielimination is 8 hours. Metabolism products andnon-metabolizing part of drug is excreted with urine.
Phenylephrine hydrochloride eliminates in liver by way of demethylation.
Pharmacodynamics
acetaminophen (paracetamol) has analgesic, antifebrile and slightly expressed antiphlogistic effect thanks to influence on heat regulating and inhibiting center of prostaglandin synthesis in central nervous system;
chlorpheniramine maleate – blocker of H1- histamine receptors, prevents fromactivity of one of main inflammatory mediators – histamine. It decreases penetrance of capillary wall, decreases intensity of local exudative occurrences: rhinorrhea, irritation in eyes and nose. Eliminates edema ofmucosae of nose, pharyngonasal cavity, upper respiratory tracts, thus it is easier to breath.
- symptomatic treatment of flue, virus infections and colds;
- relief of head, muscle and joint pain;
- edema of mucosae of respiratory tract.
Dosage and methods of use
1-2 tablets each 4 hours for adults. Tablets are taken with water.
Maximum daily dose shall not be more than 8 tablets per day.
Treatment period – not more than 7 days.
Adverse reaction
For most cases the drug is well tolerated.
In rear cases, the following adverse reactions can be observed after long use of doses exceeding recommended daily dosage.
Hematologic and lymphatic system disorders:
Anemias, sulfhemoglobinemia and methemoglobinemia (cyanosis, labored breathing, heartache), hemolytic anemia (if patient suffers glucose-6-phosphate dehydrogenase deficiency), thrombocytopenia.
gastroenteric upsets:
nausea, pain in pit of the stomach
hepatobiliary diseases:
High level of ferment of liver activity (usually, without symptoms of biliousness), hepatic necrosis (dose-dependent relationship).
Immune system:
Hypersensitivity
Nervous system disorder:
Sleepiness
Disorders of renal and urinary tracts:
Renal colic and interstitial nephritis.
Dermatopathy and areolar tissue:
Irritation, rash of skin and mucosae (erythematic, nettle rash), angioedema, erythema multiforme (including Stereos-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome).
Contraindications
- increased individual sensibility to drug components
- signified liver and/or kidney function abnormality
- deprivation of enzyme of glucose-6-phosphate dehydrogenase (signs of such blood disease like anemia)
- Gilbert's syndrome (secondary yellow innocent sickness as a result of deficit of glucuronil- transferase)
- hematopoietic dysfunction
- children under 18 years
- pregnancy and lactation period
Drug interaction
Not recommended to use together with sleeping aids, sedatives and drugs that include alcohol.
Hepato- and nephrotoxicity of acetaminophen strengthens during combination with barbiturates, alcohol.
Simultaneous use of sleeping aids and sedatives, neuroleptics, tranquilizing drug, alcohol significantly strengthens inhibiting effect of chlorpheniramine maleaten on central nervous system.
Acetaminophen slows down excretion of antibiotics from body. Tetracyclines increase risk of development of anemia and methemoglobinemia during application of acetaminophen.
Phenylephrine hydrochloride decreases hypotensive action of reserpine and octadinum. Joint application of inhibitors of monoamine oxidase and phenylephrine hydrochloride can lead to development of hypertensive crisis.
Special indications
Do not use together with sedative, slipping aids and alcoholic beverage.
The drug shall be taken in the following cases only after benefits/risks assessment by doctor:
Effects on ability to drive and use potentially dangerous machines
During treatment it is required to avoid driving vehicles and other potentially dangerous types of activity.
Overdosage
Symptoms: activation, dizziness, distribution of sleep, nausea, vomit. Symptomatic treatment. In case of overdosage of this or any other drug it is necessary to seek medical advice.
Form of output and packing
12 tablets in blister made of polyvinylchloride film and aluminium foil.
1 blister with use instruction in Kazakh and Russian is placed in carton package.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf life
3 years.
Do not use after the expiration date indicated on the package.
Conditions for drug supply
Over the counter.
Name and country of manufacturer
Contract Pharmacal Corporation, 150 and 160 Commerce Drive, Hauppauge, New-York, 11788, USA
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name and country of packer
Contract Pharmacal Corporation, 1324 Motor Parkway Hauppauge, New-York, 11788, USA
Address of the organization receiving claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and responsible for post-registration supervision over the drug safety:
«Bayer KAZ» LLP.
Timiryazev Street, 42, “Expo City” Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – round the clock
Tel.: +7 727 258 80 40 (106) – during working hours
Fax: +7 727 244 70 01
e-mail: kz.claims@bayer.com