Registration number: LSR-008564/10
Trade name of the drug: Migrenium®
International nonproprietary name or generic name: caffeine + paracetamol
Dosage form: film-coated tablets.
Composition per tablet:
active ingredients: paracetamol - 0.500 g; caffeine - 0.065 g
excipients: potato starch, microcrystalline cellulose, croscarmellose sodium, hyprolose (hydroxypropylcellulose), colloidal silicon dioxide (grade A-300), magnesium stearate
shell composition: hyprolose (hydroxypropylcellulose), copovidone, talc, titanium dioxide, silicone emulsion (50% solution).
Description: Oval, biconvex, film-coated tablets of white or almost white color with a score on one side. The cross section shows two layers. The color of the kernel without the shell is white or almost white.
Pharmacotherapeutic group: combined analgesic (non-narcotic analgesic + psychostimulant).
ATX code: [N02BE71].
Pharmacological properties
Migraine is a combination drug, the effect of which is determined by the components included in its composition.
Caffeine has a psychostimulant (stimulates the psychomotor centers of the brain), analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, and increases physical and mental performance. Paracetamol has an antipyretic and analgesic effect (due to inhibition of cyclooxygenase (COX) and inhibition of prostaglandin (Pg) synthesis, it affects the thermoregulation center in the hypothalamus and the conduction of pain impulses in the central nervous system (CNS)).
The drug blocks COX 1 and 2 mainly in the central nervous system, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on cyclooxygenase, which explains its almost complete lack of anti-inflammatory effect. The drug does not have a negative effect on water-salt metabolism (sodium and water retention) and the mucous membrane of the gastrointestinal tract (GIT) due to the lack of influence on the synthesis of prostaglandins in peripheral tissues. The possibility of methemoglobin formation is unlikely.
Pharmacokinetics
Caffeine is well absorbed in the intestines (including the colon). Time to reach maximum plasma concentration (TCmax) is 50-75 minutes after oral administration, maximum concentration (Cmax) is 1.58-1.76 mg/l. Quickly distributed in all organs and tissues of the body; easily penetrates the blood-brain barrier and placenta. Communication with blood proteins (albumin) - 25-36%. The half-life of the drug (T1/2) is about 5 hours, in some individuals it is up to 10 hours. The main part is demethylated and oxidized. About 10% is excreted unchanged by the kidneys.
Paracetamol is quickly and almost completely absorbed from the gastrointestinal tract. Plasma concentration reaches a maximum after 30-60 minutes. Cmax - 5-20 mcg/ml. Communication with plasma proteins - 15%. T1/2 of plasma - 1-4 hours. Metabolized in the liver. Excreted in the urine, mainly in the form of esters with glucuronic and sulfuric acids; less than 5% is excreted unchanged.
Indications for use
Pain syndrome (mild and moderate severity): headache, migraine, ossalgia, myalgia, neuralgia, arthralgia, algodismenorrhea, toothache; febrile syndrome, including colds, acute respiratory viral infections and influenza.
Contraindications
Hypersensitivity, severe hepatic and/or renal failure, epilepsy, glucose-6-phosphate dehydrogenase deficiency, old age, children (up to 12 years).
With caution: pregnancy, lactation, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes).
Directions for use and doses
Orally, adults and children over 12 years old - 1-2 tablets 4 times a day with an interval of at least 4 hours. The maximum daily dose is 8 tablets.
Duration of use - no more than 3 days (as an antipyretic) and no more than 5 days (as an analgesic).
Side effect
Allergic reactions (skin rash, angioedema, urticaria), dyspeptic disorders (including nausea, epigastric pain).
In rare cases - hemolytic anemia, thrombocytopenia, methemoglobinemia. With long-term use in large doses - hepatotoxicity, pancytopenia, nephrotoxicity (renal colic, pyuria, interstitial nephritis, papillary necrosis).
Overdose
Symptoms:
For paracetamol - pallor of the skin, loss of appetite, nausea, vomiting, sometimes with blood; hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose), gastralgia, agitation, anxiety, agitation, motor restlessness, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, frequent urination, headache, increased tactile or pain sensitivity, tremors or muscle twitching; ringing in the ears, epileptic seizures (in case of acute overdose - tonic-clonic), increased activity of “liver” transaminases, increased prothrombin time; a detailed clinical picture of liver damage appears after 1-6 days.
For caffeine - gastralgia, agitation, anxiety, agitation, motor restlessness, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, frequent urination, headache, increased tactile or pain sensitivity, tremor or muscle twitching; nausea and vomiting, sometimes with blood; ringing in the ears, epileptic seizures (in case of acute overdose - tonic-clonic). Caffeine in doses of more than 300 mg/day (including against the background of coffee abuse - more than 4 cups of natural coffee, 150 ml each) can cause anxiety, tremor, headache, confusion, extrasystole.
Treatment:
For paracetamol: administration of SH-group donors and precursors for the synthesis of glutathione - methionine within 8-9 hours after an overdose and acetylcysteine - within 12 hours. To prevent late hepatotoxicity, gastric lavage is performed.
For caffeine: gastric lavage if caffeine was taken in the last 4 hours at a dose of more than 15 mg/kg and there was no caffeine-induced vomiting; taking activated carbon, JIC laxatives; for hemorrhagic gastritis - administration of antacid JIC and gastric lavage with ice-cold 0.9% sodium chloride solution; maintaining pulmonary ventilation and oxygenation; for epileptic seizures, diazepam, phenobarbital or phenytoin is administered intravenously; maintaining fluid and salt balance.
Interaction with other drugs
Caffeine enhances the effect of monoamine oxidase inhibitors (MAO). Caffeine accelerates the absorption of ergotamine.
Mexiletine - reduces caffeine excretion by up to 50%; nicotine - increases the rate of caffeine elimination.
Caffeine reduces the absorption of calcium preparations in the gastrointestinal tract, reduces the effect of narcotic and sleeping pills, and increases the excretion of lithium preparations in the urine; accelerates absorption and enhances the effect of cardiac glycosides, increasing their toxicity. The combined use of caffeine with beta-blockers may lead to mutual suppression of therapeutic effects; with adrenergic bronchodilators JIC - to additional stimulation of the central nervous system and other additive toxic effects. Caffeine may decrease the clearance of theophylline and possibly other xanthines, increasing the potential for additive pharmacodynamic and toxic effects. With the combined use of caffeine and barbiturates, primidone, anticonvulsants (hydantoin derivatives, especially phenytoin), it is possible to enhance metabolism and increase the clearance of caffeine; cimetidine, oral contraceptives JIC, disulfiram, ciprofloxacin, norfloxacin - decreased metabolism of caffeine in the liver (slower its elimination and increased concentration in the blood). Paracetamol reduces the effectiveness of uricosuric drugs. Under the influence of paracetamol, the half-life of chloramphenicol increases 5 times.
With long-term use, paracetamol may enhance the effect of anticoagulants (dicoumarin derivatives).
The simultaneous use of paracetamol and ethanol increases the risk of developing hepatotoxic effects and acute pancreatitis. Barbiturates, phenytoin, ethanol, rifampicin, phenylbutazone, tricyclic antidepressants and other stimulants of microsomal oxidation increase the production of hydroxylated active metabolites, causing the possibility of severe intoxication with small overdoses. Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity. Metoclopramide and domperidone increase, and cholestyramine reduces absorption.
Long-term combined use of paracetamol increases the risk of developing “analgesic” nephropathy and renal papillary necrosis, and the onset of end-stage renal failure.
Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.
special instructions
Excessive consumption of caffeine-containing products (coffee, tea) during treatment may cause overdose symptoms.
With long-term (more than 1 week) treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary. Without consulting a doctor, take no more than 3 days for the treatment of fever and no more than 5 days for pain. May change the results of doping control tests for athletes. It makes it difficult to establish a diagnosis for an “acute abdomen.”
Patients suffering from atopic bronchial asthma and hay fever have an increased risk of developing allergic reactions.
During treatment, you should stop drinking ethanol (increasing the risk of hepatotoxicity).
Release form
Film-coated tablets 65 mg + 500 mg. 10 tablets in a blister pack, 10 tablets in a BTS-type jar, or in a polymer jar. Each jar or 1 or 2 blisters is placed in a cardboard pack along with instructions for use.
Storage
In a dry place, protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Best before date
3 years. Do not use after the expiration date stated on the packaging.
Conditions for dispensing from pharmacies
Over the counter.
Registration Certificate Holder:
PROMOMED RUS LLC, Russia, 101000, Moscow, Arkhangelsky lane, 1, building 1.
Manufacturer/organization accepting claims:
PJSC Biokhimik, Russia
Legal address: Republic of Mordovia, 430030, Saransk, st. Vasenko, 15A.
Address of place of production: Republic of Mordovia, 430030, Saransk, st. Vasenko, 15A. Telephone.
E-mail, www.biohimic.ru
Address and telephone number of the authorized organization for contacts (forwarding claims and complaints):
Russia, 129090, Moscow, Mira Ave., 12, building 1
Tel. 8-495-640-25-28
Email address mail
Migraine
Allergic reactions (skin rash, angioedema, urticaria), dyspeptic disorders (including nausea, pain in the stomach).
In rare cases - hemolytic anemia, thrombocytopenia, methemoglobinemia.
With long-term use in large doses - hepatotoxicity, pancytopenia, nephrotoxicity (renal colic, pyuria, interstitial nephritis, papillary necrosis).
Symptoms of overdose can be caused by both of its components.
An overdose of paracetamol is characterized by pale skin, decreased appetite, nausea, vomiting, sometimes with blood; hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose), gastralgia, agitation, anxiety, agitation, restlessness, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, frequent urination, headache, increased tactile or pain sensitivity, tremor or muscle twitching; ringing in the ears, epileptic seizures (in case of acute overdose - tonic-clonic), increased activity of “liver” transaminases, increased prothrombin time; a detailed clinical picture of liver damage appears after 1-6 days.
For caffeine - gastralgia, agitation, anxiety, agitation, restlessness, confusion, delirium, dehydration, tachycardia, arrhythmia, hyperthermia, frequent urination, headache, increased tactile or pain sensitivity, tremor or muscle twitching; nausea and vomiting, sometimes with blood; ringing in the ears, epileptic seizures (in case of acute overdose - tonic-clonic). Caffeine in doses of more than 300 mg/day (including against the background of coffee abuse - more than 4 cups of natural coffee, 150 ml each) can cause anxiety, tremor, headache, confusion, and extrasystole.
To neutralize the effects of paracetamol, the administration of SH-group donors and precursors for the synthesis of glutathione - methionine within 8-9 hours after an overdose and acetylcysteine - within 12 hours is indicated. To prevent late hepatotoxicity, gastric lavage is performed.
To eliminate the effects of caffeine, gastric lavage is performed if caffeine was taken in the last 4 hours at a dose of more than 15 mg/kg and there was no vomiting caused by caffeine; taking activated carbon, laxatives; for hemorrhagic gastritis - administration of antacid drugs and gastric lavage with ice-cold 0.9% sodium chloride solution; maintaining pulmonary ventilation and oxygenation; for epileptic seizures, diazepam, phenobarbital or phenytoin is administered intravenously; maintaining fluid and salt balance.
Migraine tablet p o film 65 mg+500 mg x20
Migraine tablet p o film 65 mg+500 mg x20
ATX code: N02BE71 (Paracetamol in combination with psycholeptics) Active substances caffeine Ph.Eur. European Pharmacopoeia paracetamol Rec.INN registered by WHO
Dosage form MIGRENIUM tablet, coated. film-coated, 0.5 g+0.065 g: 10 or 20 pcs.
reg. No.: LSR-008564/10 dated 08.23.10 - Validity period of the reg. beat is not limited
Release form, composition and packaging Tablets, film-coated, white or almost white, oval, biconvex in shape, with a score on one side, two layers visible on the cross section, the color of the core without the shell is white or almost white.
1 tab. paracetamol 0.5 g caffeine 0.065 g
Excipients: potato starch, microcrystalline cellulose, croscarmellose sodium, hyprolose, colloidal silicon dioxide, magnesium stearate.
Shell composition: hyprolose, copovidone, talc, titanium dioxide, silicone emulsion (50% solution).
10 pieces. — cellular contour packages (1) — cardboard packs. 10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — cans (1) type BTS — cardboard packs. 10 pieces. — polymer jars (1) — cardboard packs.
Clinical and pharmacological group: Analgesic-antipyretic
Pharmacotherapeutic group: Analgesic non-narcotic drug (psychostimulant + non-narcotic analgesic)
Indications
Pain syndrome (mild and moderate severity): - headache, - migraine, - ossalgia, - myalgia, - neuralgia, - arthralgia, - algomenorrhea, - toothache. Feverish syndrome, colds, flu.
ICD-10 codes
Dosage regimen
Orally for adults - 2 tablets. 4 times a day with an interval of at least 4 hours. The maximum daily dose is 8 tablets. Duration of use - no more than 10 days.
Side effects Allergic reactions (skin rash, angioedema, urticaria), dyspeptic disorders (including nausea, epigastric pain).
In rare cases - hemolytic anemia, thrombocytopenia. With long-term use in large doses - hepatotoxicity, nephrotoxicity, pancytopenia.
Contraindications for use: hypersensitivity, severe liver and/or renal failure, epilepsy, glucose-6-phosphate dehydrogenase deficiency.
With caution: pregnancy, lactation, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), children (up to 12 years).
Use during pregnancy and lactation With caution: pregnancy, lactation. Use for liver dysfunction Contraindicated in severe liver failure. Use for renal impairment
Contraindicated in severe renal failure.
Use in children With caution: children's age (up to 12 years).
special instructions
Excessive consumption of caffeine-containing products (coffee, tea) during treatment may cause overdose symptoms.
With long-term (more than 1 week) treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary. Without consulting a doctor, take no more than 3 days for the treatment of fever and no more than 5 days for pain.
May change the results of doping control tests for athletes.
It makes it difficult to make a diagnosis with the “acute abdomen” symptom complex.
Patients suffering from atopic bronchial asthma and hay fever have an increased risk of developing allergic reactions.
During treatment, you should stop drinking ethanol (increasing the risk of hepatotoxicity).
Overdose
Symptoms: pale skin, decreased appetite, nausea, vomiting, hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose), increased activity of “liver” transaminases, increased prothrombin time, a detailed clinical picture of liver damage appears after 1-6 days.
Treatment: administration of SH-group donors and precursors for the synthesis of glutathione-methionine 8-9 hours after an overdose and N-acetylcysteine - after 12 hours.
To prevent late hepatotoxicity, gastric lavage is performed.
Drug interactions
Enhances the effect of MAO inhibitors.
Reduces the effectiveness of uricosuric drugs.
Caffeine accelerates the absorption of ergotamine.
Under the influence of paracetamol, the elimination time of chloramphenicol increases 5 times.
With long-term use, paracetamol may enhance the effect of anticoagulants (dicoumarin derivatives).
The simultaneous use of paracetamol and ethanol increases the risk of developing hepatotoxic effects and acute pancreatitis.
Barbiturates, phenytoin, ethanol, rifampicin, phenylbutazone, tricyclic antidepressants and other stimulants of microsomal oxidation increase the production of hydroxylated active metabolites, causing the possibility of severe intoxication with small overdoses.
Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.
Metoclopramide and domperidone increase, and cholestyramine reduces absorption.
Storage conditions: In a dry place, protected from light, at a temperature not exceeding 25 C. Out of reach of children.
Dispensing conditions Without a prescription
