Active substanceParacetamol + Pheniramine + Ascorbic acidParacetamol + Pheniramine + Ascorbic acid
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  • Dosage form: & nbsp

    powder for the preparation of solution for oral administration [lemon, raspberry, black currant]

    Composition:

    For one sachet:

    Active substances:

    Paracetamol 0.500 g

    Ascorbic acid 0,200 g

    Pheniramine maleate 0.025 g

    Excipients:

    saccharine races(sodium saccharinate dihydrate) - 0.020 g, citric acid (citric acidslots monohydrate) - 0,200 g; flavoring natural lemon - 0,600 g (lemon); or flavoring natural lemon - 0.1035 g, identical flavoring to natural raspberries - 0.215 g, food raspberry dye - 0.0015 g (raspberry); or - Flavor natural lemon - 0.1020 g, flavor identical to natural black currant - 0.215 g, food carmoazine dye - 0.00075 g, food color black shiny - 0.00025 g (black currant); sugar (sucrose) - up to 13.1 g.

    Description:

    Powder from white to white with a yellowish tinge of color with a characteristic smell. Presence of loosely adhering lumps (lemon) is allowed.

    Powder from white with a pinkish tinge to pink with a characteristic smell. Presence of loosely adhering lumps (raspberry) is allowed.

    Powder from white to white with a pinkish tint of color with a characteristic smell. Presence of loosely adhering lumps is permissible (black currant). An aqueous solution of the preparation obtained by dissolving the contents of the sachet in 200 ml of warm water, opalescent, from colorless to yellowish with a characteristic lemon scent (lemon). An aqueous solution of the preparation obtained by dissolving the contents of the sachet in 200 ml of warm water, opalescent, from light pink to reddish-pink with a characteristic smell of raspberries (raspberries).

    An aqueous solution of the preparation obtained by dissolving the contents of the sachet in 200 ml of warm water, opalescent, from lilac-red to violet with a characteristic smell of black currant (black currant).

    Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic means + H1-histamine receptor blocker + vitamin)
    ATX: & nbsp

    N.02.B.E   Anilides

    N.02.B.E.51   Paracetamol in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:
    Combined drug, the effect of which is due to the effects of its constituent components.

    Paracetamol has a pronounced analgesic and antipyretic effect by inhibiting cyclooxygenase in the central nervous system (CNS) and affecting pain centers and thermoregulation.

    Ascorbic acid (Vitamin C) participates in the regulation of oxidation-reduction processes, carbohydrate metabolism, blood coagulability, tissue regeneration, in the synthesis of steroid hormones, reduces the permeability of blood vessels and increases the body's resistance to various adverse environmental factors.

    Pheniramine maleate - inhibitor H1-gistaminovyh receptors, has an antiallergic effect, it can reduce the discharge from the nose, nasal congestion, lacrimation and eliminates sneezing.
    Pharmacokinetics:

    Paracetamol quickly and almost completely absorbed from the gastrointestinal tract, mainly the upper intestine. Maximum ConcentrationTrace in the plasma is achieved in 30-60 minutes.Poorly binds to blood plasma proteins - 15 - 25 %. Rapidly distributed in tissues, penetrates the placental barrier, a small part is excreted into breast milk (less than 1% of the dose taken). The half-life is 1 to 4 hours.

    Metabolised in the liver, entering into a conjugation reaction with glucuronic acid and sulfates with the formation of inactive metabolites. A small part of the drug (less than 4%) with the participation of cytochrome P450 turns into a metabolite and is inactivated by glutathione. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. Biotransformation products and unchanged drug (about 5% of the administered dose) are excreted by the kidneys.

    Ascorbic acid well absorbed in the small intestine. Bioavailability is approximately 70%. The level of binding to plasma proteins is low. Accumulates in the blood plasma and the cellthe maximum concentration is created in the glandular tissues. It is excreted mainly with urine, as well as with feces, then, breast milk in unchanged form and in the form of metabolites.

    Pheniramine maleate almost completely absorbed from the gastrointestinal tract (GIT). Has a great affinity for the tissues. Cmax in blood plasma is achieved after 1-2.5 h.Biotransformation occurs in the liver by oxidation with a system of cytochromes P450. It is allocated mainly with urine in the unchanged state or in the form of metabolites.

    Indications:

    - Symptomatic treatment of "catarrhal" diseases (influenza conditions, acute respiratory viral infections), accompanied by fever and runny nose,

    - Allergic rhinitis, rhinopharyngitis.

    Contraindications:
    Hypersensitivity to paracentesisTamol, ascorbic acid, fenirswell, or any other component of the drug; erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation); liver failure; angle-closure glaucoma; retention of urine, associated with prostatic hyperplasia glands; blood diseases (including sideroblastic anemia, thalassemia, leukopenia, thrombocytopenia); portal hypertension; diabetes mellitus, deficiency of glucose-6-phosphate dehydrogenase; hyperoxaluria; nephrolithiasis; pregnancy and the period of breastfeeding, deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption (because the dosage form contains sucrose), children under 18 years of age (t.the content of ascorbic acid in the daily dose of the drug (400 mg and 600 mg) exceeds the allowed maximum daily dose for children (300 mg)).
    Carefully:Renal failure, congenital hyperbilirubinemia (Gilbo syndromesRa, Dubin - Johnson and Rotor), viral hepatitis, alcoholic hepatitis, hemochromatosis, elderly age.

    If you have any of these diseases, consult a doctor before taking the drug.

    Pregnancy and lactation:The drug is not recommended for use in pregnancy and during breastfeeding.
    Dosing and Administration:

    Pour the contents of the sachet into a mug. Pour warm water. Stir until dissolved, use warmly.

    Adults and children over 18 years: 1 packet 2-3 times a day. The interval between the drug should not be less than 4 hours, and with severe renal failure (CC less than 10 ml / min), the interval between the first and second dose should be at least 8 hours.

    Do not take the drug for more than 3 days as an antipyretic agent and more than 5 days as an anesthetic.

    Side effects:

    Allergic reactions: a rash, redness of the skin, itching, hives, dermatitis, angioedema.

    From the digestive system: irritation of the mucous membrane of the gastrointestinal tract, nausea, pain in the stomach, dry mouth, with prolonged use in large doses - erosive and ulcerative lesions of the digestive tract, vomiting, diarrhea, hyperacid gastritis, bleeding in the gastrointestinal tract, impaired liver function.

    From the urinary system: dysuria, with prolonged use in large doses, there may be violations of the kidneys - hyperoxaluria (excessive excretion of urine in oxalic acid salts), nephrolithiasis (urolithiasis), damage to the glomerular apparatus, papillary necrosis.

    From the sense organs: disruption of accommodation (the ability of the eye to adapt to different distances), increased intraocular pressure.

    From the cardiovascular system: tachycardia (an increase in heart rate), with prolonged use in large doses - a decrease in the permeability of capillaries (possibly worsening tissue trophism, increased blood pressure and clotting, development of microangiopathies).

    From the central nervous system: drowsiness, a decrease in the rate of psychomotor reactions, in the elderly, confusion or excitement is possible, with prolonged intake of a dose of more than 5 packets - headache, increased excitability, insomnia.

    On the part of the hematopoiesis system: with prolonged use in large doses - anemia, methemoglobinemia (accompanied by weakness, shortness of breath with physical exertion, headaches, dizziness, palpitations), thrombocytopenia (decrease in platelet count in the blood, which can cause nasal bleeding, gum bleeding). In such cases, stop taking the drug immediately and consult a doctor.

    Laboratory indicators: hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia, glucosuria.

    Other: oppression of the function of the insulin pancreas apparatus, manifested in glucosuria, hyperglycemia (high blood glucose, accompanied by excessive thirst, frequent urination, weight loss, fatigue). If any of the side effects listed in the manual are aggravated, if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms caused by paracetamol: pallor of the skin, decreased appetite, nausea, vomiting, hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose). Toxic effect in adults is possible after taking more than 10-15 g of paracetamol (20 or more bags).

    A detailed clinical picture of liver damage manifests itself after 1-6 days. Rarely, liver failure develops at a lightning speed and can be complicated by renal insufficiency (tubular necrosis).

    Treatment: in the first 6 hours after an overdose - gastric lavage, reception of enterosorbents. Introduction of donors of SH-groups and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N-acetylcysteine ​​after 12 hours. The need for additional therapeutic measures (further introduction of methionine and N-acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as the time passed after its administration.

    Symptoms caused by a penis enlargement: convulsions, impaired consciousness, coma.

    Symptoms caused by ascorbic acid: diarrhea, nausea, flatulence, pain in the stomach,frequent urination, urolithiasis, insomnia, irritability, hypoglycemia (low blood glucose, accompanied by excitation, muscle tremor, sweating, pallor, dilated pupil, vomiting, tachycardia, increased blood pressure).

    Treatment: symptomatic, forced diuresis.

    Interaction:

    Ethanol strengthens the sedative effect, promotes the development of acute pancreatitis. Antidepressants, antiparkinsonics, antipsychotics (phenothiazine derivatives) increase the risk of side effects (urinary retention, dry mouth, constipation).

    Glucocorticosteroids increase the risk of developing glaucoma, with prolonged use depletes the stores of ascorbic acid.

    Inducers of microsomal liver enzymes (barbiturates, phenytoin, phenylbutazone, rifampicin, zidovudine, carbamazepine, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication with small overdoses.

    Barbiturates and primidon increase the excretion of ascorbic acid in the urine.

    Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects. With long-term joint use with other non-steroidal anti-inflammatory drugs, the risk of developing an "analgesic" nephropathy and renal papillary necrosis increases, and the terminal stage of renal failure sets in. Diflunisal increases the plasma concentration of paracetamol by 50%, increasing hepatotoxicity.

    Long-term use in high doses concurrently with salicylates increases the risk of developing kidney or bladder cancer. With simultaneous use with acetylsalicylic acid (ASA), absorption of ascorbic acid decreases (by approximately 30%) and its excretion in urine increases, and the excretion of ASA decreases. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Quinoline drugs, calcium chloride with long-term use exhaust the stores of ascorbic acid, oral contraceptives, fresh juices and alkaline drink reduce its absorption and absorption.

    Included in the preparation paracetamol reduces the effectiveness of uricosuric drugs, when taken in high doses increases the effect of anticoagulant drugs. Ascorbic acid increases the concentration in the blood of benzylpenicillin and tetracyclines, in a dose of 5 bags per day increases the bioavailability of ethinyl estradiol; improves the absorption of iron in the intestine, may increase the excretion of iron with simultaneous use with deferoxamine; reduces the effectiveness of heparin and indirect anticoagulants; increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids and increases the excretion of drugs that have an alkaline reaction (including alkaloids); reduces the concentration of oral contraceptives in the blood; increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body; reduces the therapeutic effect of antipsychotic drugs - phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants; with simultaneous use reduces the chronotropic effect of isoprenaline; with long-term use or use in high doses can interfere with the interaction of disulfiram and ethanol; in high doses increases the excretion of mexiletine by the kidneys.

    Special instructions:

    With continued febrile syndrome for more than 3 days and pain syndrome for more than 5 days need medical advice.

    Distorts the results of some laboratory tests (quantitative determination in blood and urine of glucose, bilirubin, uric acid in plasma, activity of "liver" transaminases and lactate dehydrogenase). During treatment, it is necessary to monitor the picture of peripheral blood, blood pressure, functional state of the liver, insulin apparatus of the pancreas, adrenals.

    Do not exceed the recommended dose. Do not use with other drugs (in particular, with sedatives) and with kidney dysfunction without consulting a doctor.

    Patients suffering from diabetes or on a diet with a low sugar content should take into account that each packet contains 1 1.555 g of sucrose, which corresponds to 1.16 XE (taste: lemon) or 1 1.835 g of sucrose, which corresponds to 1.18 XE (taste: raspberry) or 11.837 g of sucrose, which corresponds to 1.18 XE (taste: black currant).

    Effect on the ability to drive transp. cf. and fur:

    To drivers of vehicles and whethermachines working on machines / mechanisms when using the drug should pay attention to the risk of drowsiness.

    During the period of treatment, it is necessary to refrain from drinking alcoholic beverages (possibly developing hepatotoxic action), driving vehicles and other potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Powder for the preparation of solution for ingestion [lemon, raspberry, scooping currant].

    Packaging:

    For 13,1 g in heat-sealing bags of 6, 9, 12 pieces together with instructions for use in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:2 years.
    Terms of leave from pharmacies:Without recipe
    Registration number:P N001440 / 01
    Date of registration:24.12.2008 / 15.01.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.09.2017
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