Active substanceMetamizol sodium + quinineMetamizol sodium + quinine
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  • Analgin-quinine
    pills inwards 
    Sopharma, AO     Bulgaria
  • Dosage form: & nbsptfilm-covered laths
    Composition:

    Active substance: metamizole sodium (as 100%) 200 mg, quinine hydrochloride 50 mg.

    Excipients: microcrystalline cellulose (Avicel PH 101) (75.00 mg), sodium carboxymethyl starch (primogel) (26.00 mg), kylidon-25 (povidone) (3.00 mg), talc (5.00 mg), magnesium stearate 1.00 mg).

    Shell composition: talc (4.10 mg), titanium dioxide (1,3005 mg), eudragid L 12.5 P (methacrylic acid and methyl methacrylate copolymer) (1.6832 mg), macrogol 400 (1.100 mg), glycerol (0.280 mg), castor oil (0.036 mg), pigment green pigment (quinoline yellow E 104 + blue patented V E 131) (0.0001 mg).

    Description:

    The tablets covered with a film cover of green color, round, biconcave.

    Pharmacotherapeutic group:Analgesic non-narcotic remedy
    ATX: & nbsp

    N.02.B   Analgesics and antipyretics

    Pharmacodynamics:

    Combined drug.

    Metamizol sodium is a derivative of pyrazolone and has analgesic, antipyretic and weak anti-inflammatory an action whose mechanism is associated with inhibition of the synthesis of prostaglandins by inhibition of COX.

    Quinine oppresses the center of thermoregulation, in high doses - the auditory and visual zones of the cerebral hemispheres.Also quinine inhibits the development of erythrocytic forms of schizonts and gamontes of malaria, suppressing DNA replication, has a locally irritating and local anesthetic effect.

    Pharmacokinetics:

    Pharmacological action develops in 20-40 minutes after taking the drug and reaches a maximum after 2 hours.

    Indications:

    - Pain syndrome of different etiology (including headache, neuralgia, arthralgia, myalgia, myositis, algodismenorea, postoperative pain);

    - renal and biliary colic (in combination with antispasmodics);

    - feverish conditions with infectious and inflammatory diseases.
    Contraindications:

    - Hypersensitivity to the components of the preparation, as well as to other pyrazolone derivatives;

    - severe violations of liver function;

    - severe renal dysfunction;

    - acute hepatic porphyria;

    - bronchial asthma;

    - complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in history);

    - diseases accompanied by bronchospasm;

    - hereditary hemolytic anemia caused by deficiency of glucose-6-phosphate dehydrogenase;

    - oppression hemopoiesis (agranulocytosis, neutropenia, leukopenia);

    - severe myasthenia gravis;

    - diseases of the middle and inner ear, hearing loss;

    - optic neuritis;

    - children under 12 years.

    Carefully:

    With food, medicinal or other forms of allergy, granulocytopenia (monitoring of hematological parameters is necessary.)

    Pregnancy and lactation:

    The drug is contraindicated in pregnancy and lactation (breastfeeding).

    If necessary, the appointment in the lactation period should resolve the issue of stopping breastfeeding.

    Dosing and Administration:

    Tablets should be taken without chewing, after eating, squeezed with enough liquid.

    Adults and children over 14 years of age: 1-2 tablets 1-3 times a day, depending on the severity of clinical symptoms.

    Children from 12 to 14 years old - 1 tablet 3 times a day, depending on the severity of clinical symptoms

    Duration of taking the drug (without consulting a doctor) as an antipyretic agent - no more than 3 days, as an analgesic - no more than 5 days.

    Patients over 65 years of age

    Usually, dose reduction is not required.In patients with age-related renal and hepatic impairment, treatment should be given using 1/2 the recommended adult dose for a short period of time.

    Application for violations of liver function

    In patients with impaired liver function, an increase in the half-life of metabolites of metamizole sodium is possible. In patients with moderate or severe liver damage, a recommended dose of 1/2 is recommended for adults.

    Application for violations of kidney function

    Metamizol sodium and its metabolites are excreted by the kidneys. In patients with impaired kidney function treatment should be carried out using 1/2 recommended dose for adults.

    Side effects:

    Side effects are listed below in the system-organ class and frequency.

    Frequencies are defined as: very frequent (≥1 / 10), frequent (≥1 / 100 to <1/10), infrequent (≥1 / 1,000 to <1/100), rare (≥1 / 10,000 to <1 / 1,000), very rare (<1/10 000), with an unknown frequency (based on existing data, it is impossible to make an estimate).

    From the digestive system:

    With unknown frequency: nausea, vomiting, pain and discomfort in the epigastric region and abdominal region, diarrhea;

    Rare: ulceration of the mucous membrane of the gastrointestinal tract, bleeding from the gastrointestinal tract.

    From the side of the central nervous system and peripheral nervous system:

    Headache, dizziness, fatigue, insomnia, limb tremor.

    From the sense organs:

    Noise in the ears and hearing loss, impaired vision (blurred vision, scotoma, photophobia, diplopia, decreased visual fields, impaired color vision).

    From the side of the cardiovascular system:

    Infrequent: angina, palpitations, lowering blood pressure, fainting.

    On the part of the hematopoiesis system:

    Rare: leukopenia;

    Very rare: agranulocytosis and thrombocytopenia. Hemolytic anemia, aplastic anemia.

    From the urinary system:

    Rare: impaired renal function (including oliguria, anuria, proteinuria), water retention and electrolytes.

    From the immune system:

    Infrequent: itching, eczema, enanthema, urticaria, angioedema;

    Rarely: anaphylactic shock or anaphylactoid reactions;

    Very rare: malignant exudative erythema (Stevens-Johnson), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome.

    All side effects (including those not mentioned above) should be reported to the doctor in charge and stop taking the drug.

    Overdose:

    Symptoms: nausea, vomiting (including bloody), melena, epigastric pain, agranulocytosis, aplastic anemia, hemorrhagic diathesis, dizziness, tinnitus, clonic and tonic convulsions, cardiotoxic effect, skin rash (bullous, petechial, kore- or typhoid-like), anaphylactic shock, coma is possible.

    Treatment: gastric lavage, the appointment of salt laxatives, activated charcoal and gastroprotective drugs, forcing diuresis, respiratory recovery, anti-shock measures, recovery of bcc; if necessary - symptomatic therapy, with the development of seizures - to introduce intravenous barbiturates and diazepam. There is no specific antidote.
    Interaction:

    The simultaneous use of metamizole sodium with other analgesics-antipyretics may lead to a mutual enhancement of toxic effects.

    Tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

    Barbiturates and phenylbutazone weaken the action of metamizole sodium.

    Sedatives and tranquilizers increase the analgesic effect of metamizole sodium.

    Metamizole sodium enhances the effect of ethanol-containing beverages.

    Metamizole sodium, displacing from the bond with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, enhances their action.

    With the simultaneous use of metamizole sodium with chlorpromazine may occur hypothermia.

    Chloramphenicol and other myelotoxic drugs increase the myelotoxic effect of metamizole sodium.

    Quinine can potentiate the action of drugs that block neuromuscular transmission.

    Quinine increases the concentration of digoxin in the blood plasma and enhances its effect.

    Cimetidine reduces clearance and increases T1/2 quinine.

    Simultaneous use of Analgin-Quinine with cyclosporine reduces the level of the latter in the blood.

    Inductors of microsomal oxidation accelerate metabolism and reduce the effectiveness of the drug, inhibitors of microsomal oxidation increase the effectiveness and risk of side effects.

    With simultaneous use with thiamazole and sarcolysin, the risk of developing leukopenia increases.

    Codeine, propranolol strengthen the action of Analgin-Khinin.

    Against the background of the drug should not use radiocontrast agents and colloidal blood substitutes.

    Analgin-Quinine can be used simultaneously with antibiotics, chemotherapeutic agents and vitamins.

    Special instructions:

    Metamizole sodium can cause agranulocytosis and thrombocytopenia. The development of agranulocytosis does not depend on the dose and it can not be envisaged. May occur after the first use or after repeated use. Typical signs of agranulocytosis are fever, sore throat, painful swallowing, inflammation of the mucous membrane of the mouth, nose, throat, anorectal and genital area. With a sudden deterioration in the general condition and the appearance of signs of agranulocytosis, stop using metamizole sodium and examine the blood picture.

    Metamizole sodium can provoke hypotensive reactions. These reactions are dose-dependent and are observed mainly with parenteral application.

    Despite this, treatment with metamizole sodium in the form of tablets should be carried out with extreme caution in patients with hypotension, body fluid deficiency or dehydration, unstable blood circulation. Do not use the drug for acute pain in the abdomen (until finding out the cause).

    In case of side effects (including those not mentioned above), the patient should stop taking the drug and consult a doctor.

    In patients suffering from bronchial asthma and pollinosis, it is possible to develop reactions of hypersensitivity.

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

    In the period of taking the drug should not be engaged in driving vehicles and work with mechanisms, tk. there is a risk of a decrease in the ability to concentrate attention and speed of psychomotor reactions.

    Form release / dosage:Film-coated tablets.
    Packaging:

    For 10 tablets in a blister of PVC film and aluminum foil.

    2 blisters in a cardboard box with instructions for use.

    35 blisters in a cardboard box with instructions for use (for hospitals).

    Storage conditions:

    The drug should be stored out of the reach of children, dry, protected from light,at a temperature of no higher than 25 ° C.

    Shelf life:

    5 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N008778
    Date of registration:31.08.2007 / 26.05.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria
    Manufacturer: & nbsp
    Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria
    Information update date: & nbsp27.08.2017
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