Instructions Renalgan tablets blister No. 20
Composition
active ingredients: metamizole sodium, fenpiverinium bromide, pitophenone hydrochloride;
1 tablet contains metamizole sodium 0.5 g (500 mg), pitofenone hydrochloride 0.005 g (5 mg), fenpiverinium bromide 0.0001 g (0.1 mg);
excipients: potato starch, calcium stearate.
Dosage form
Pills.
Main physicochemical properties: white or white with a yellowish tinge of color tablets with a flat surface, a score and a bevel.
Pharmacotherapeutic group
Antispasmodics in combination with analgesics. Synthetic anticholinergics in combination with analgesics. Pitofenone and analgesics. ATX code A03D A02.
Pharmacological properties
Pharmacodynamics.
Renalgan® combines analgesic, antispasmodic (papaverine-like), anticholinergic (atropine-like) and some anti-inflammatory activity.
Metamizole has a pronounced analgesic and antipyretic effect in combination with less pronounced anti-inflammatory and antispasmodic activity. Its effects are the result of inhibition of the synthesis of prostaglandins and endogenous algogens, an increase in the threshold of excitability in the thalamus and the conduction of pain extero- and interoceptive impulses in the central nervous system, and it also affects the hypothalamus and the formation of endogenous pyrogens.
Fenpiverinium has a moderate ganglioblocking and parasympathetic effect, reduces the tone and motility of the smooth muscles of the stomach, intestines, biliary and urinary tracts.
Pitofenone has a papaverine-like effect on vascular and extravascular smooth muscles with a pronounced antispasmodic character.
Pharmacokinetics.
Metamizole is characterized by rapid and complete resorption. 30 minutes after internal administration, amounts of 5% of the maximum serum concentration are detected in the blood serum. It is partially bound to blood plasma proteins. It undergoes intensive biotransformation in the body. At the same time, its main metabolites are pharmacologically active. It is eliminated in the urine in the form of metabolites. Only 3% of the amount excreted is unchanged metamizole. The degree of biotransformation is also influenced by the genetically determined type of acetylation. Individual components penetrate into breast milk.
Indication
Symptomatic treatment of mild to moderate pain syndrome in spasms of smooth muscles of internal organs:
- renal colic and inflammatory diseases of the urinary tract, which are accompanied by pain and dysuric disorders;
- stomach and intestinal spasms, hepatic colic, biliary dyskinesia;
- spastic dysmenorrhea.
Contraindication
Hypersensitivity to metamizole, to pyrazolone derivatives, to other nonsteroidal anti-inflammatory drugs (NSAIDs), and/or to any component of the drug. Gastrointestinal obstruction and megacolon; atony of the gallbladder or urinary bladder; severe renal and hepatic dysfunction; changes in the composition of peripheral blood (agranulocytosis, leukopenia); blood diseases (anemia of any etiology, cytostatic or infectious neutropenia); glucose-6-phosphate dehydrogenase deficiency; hepatic porphyria; angle-closure glaucoma; suspicion of acute surgical pathology; bronchial asthma; collaptoid conditions; tachyarrhythmia; prostatic hypertrophy with a tendency to urinary retention.
Interaction with other medicinal products and other types of interactions
Metamizole increases plasma concentrations of chloroquine, reduces plasma concentrations and effects of coumarin anticoagulants and cyclosporine.
Increases the hematotoxic effect of myelotoxic drugs, chloramphenicol.
Neuroleptics, sedatives and tranquilizers enhance the analgesic effect of metamizole.
Tempidone and tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole and increase its toxicity.
Barbiturates, phenylbutazone and other inducers of liver microsomal enzymes may reduce the effect of metamizole.
The simultaneous use of Renalgan® with other analgesics and nonsteroidal anti-inflammatory drugs increases the risk of developing toxic effects.
Metamizole reduces plasma concentrations of cyclosporine A, and its simultaneous use may be risky in case of existing tissue transplantation.
Combining Renalgan® with other medications requires special caution, given the content of metamizole, which is an enzyme inducer.
Metamizole can induce metabolic enzymes, including CYP2B6 and CYP3A4.
Concomitant use of metamizole with bupropion, efavirenz, methadone, valproate, tacrolimus or sertaline may result in decreased plasma concentrations of these drugs with potential for reduced clinical efficacy. Therefore, caution is recommended when using these drugs concomitantly with metamizole; monitoring of clinical response and/or drug levels may be necessary.
Application features
Use the drug with caution:
- with moderate renal and/or hepatic dysfunction;
- with a tendency to arterial hypotension and orthostatic reactions;
- in chronic bronchitis and bronchospasm (Renalgan® increases the viscosity of bronchial secretions);
- in the presence of hyperthyroidism;
- with cardiac rhythm disturbances (tachyarrhythmia - see the "Contraindications" section), ischemic heart disease (especially with acute myocardial infarction), chronic congestive heart failure;
- if there is evidence of hypersensitivity to non-narcotic analgesics or other manifestations of allergy (allergic rhinitis).
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), which can be life-threatening or fatal, have been reported with metamizole treatment.
Patients should be informed about the signs and symptoms of skin reactions and monitored closely.
If symptoms suggestive of these reactions appear, metamizole treatment should be discontinued and under no circumstances should it be restarted (see section "Contraindications").
Drug-induced liver injury
Cases of hepatitis, mainly hepatocellular in nature, have been reported in patients taking metamizole, occurring within a few days to several months after initiation of treatment. Signs and symptoms include elevated serum liver enzymes, with or without jaundice, often in the setting of hypersensitivity reactions to other drugs (e.g. skin rash, blood dyscrasias, fever and eosinophilia) or accompanied by signs of autoimmune hepatitis. In most patients, the condition normalized after discontinuation of metamizole; however, isolated cases of progression to acute liver failure requiring liver transplantation have been reported.
The mechanism of liver damage caused by metamizole is not clearly understood, although available data suggest an immunoallergic mechanism.
Patients should be advised to seek medical advice if symptoms suggestive of liver damage occur. In such cases, metamizole should be discontinued and liver function should be assessed.
If symptoms such as feeling sick (nausea and vomiting), fever, feeling tired, loss of appetite, dark urine, light stool, yellowing of the skin or whites of the eyes, itching, rash, or upper abdominal pain occur, Renalgan® should be discontinued and a doctor should be consulted.
If the patient has previously had liver problems while taking any medication containing metamizole, the use of Renalgan® is not recommended.
With prolonged use of Renalgan®, it is necessary to check the condition of peripheral blood and liver function.
The drug may affect the psychophysical state of patients when used simultaneously with alcohol and medications that depress the central nervous system.
The drug contains the active substance metamizole sodium. Metamizole sodium can cause agranulocytosis and thrombocytopenia. The development of agranulocytosis is not dose-dependent and cannot be predicted; it can occur after the first dose or after repeated use. Typical signs of agranulocytosis are fever, sore throat, painful swallowing, inflammation of the mucous membranes of the mouth, nose, pharynx, anorectal and genital areas. In case of sudden deterioration of the general condition and the appearance of signs of agranulocytosis, treatment with metamizole should be stopped and a complete blood count should be performed.
It is not recommended to use other medicines containing metamizole simultaneously with Renalgan®.
Metabolites of metamizole sodium can change the color of urine to red, which is of no clinical significance.
Headache may occur or worsen after prolonged analgesic treatment (>3 months) when analgesics are used every other day or more frequently. Headache caused by excessive use of analgesics should not be treated by increasing their dose. In such cases, analgesic treatment should be discontinued after consultation with a doctor.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using Renalgan®, caution should be exercised when driving or operating other mechanisms, as due to the anticholinergic effect, prolonged use of the drug may lead to dizziness and accommodation disorders.
Method of administration and doses
Renalgan® tablets should be taken orally after meals, with water.
The recommended daily dose for adults and children over 15 years of age is 1-2 tablets per day, the maximum daily dose is 2 tablets.
The duration of use of Renalgan® is no longer than 3 days.
Children.
The drug should not be prescribed to children under 15 years of age.
Overdose
Symptoms. In case of overdose, symptoms of metamizole intoxication in combination with anticholinergic effects, impaired liver and kidney function, respiratory paralysis predominate. Most often, toxic-allergic syndrome, symptoms of impaired hematopoietic functions, gastrointestinal disorders, and in severe cases, symptoms of brain damage are observed.
Treatment. If an overdose is suspected, the drug should be discontinued immediately and measures should be taken to rapidly eliminate it from the body (induce vomiting, perform gastric lavage, increase urine output). Use symptomatic agents. There is no specific antidote.
Adverse reactions
On the part of the immune system: allergic reactions (or hypersensitivity reactions), including urticaria, skin rashes, itching, bronchospasm, conjunctivitis, angioedema, anaphylactic shock, toxic epidermal necrolysis, Stevens-Johnson syndrome.
On the part of the digestive tract: discomfort, dry mouth, constipation, exacerbation of gastritis and gastric and duodenal ulcers.
From the cardiovascular system: palpitations, decreased blood pressure, tachycardia, heart rhythm disturbances.
From the hematopoietic system: granulocytopenia, anemia, agranulocytosis, thrombocytopenia, leukopenia.
On the part of the urinary system: oliguria, anuria, proteinuria, red urine color, development of acute renal failure and interstitial nephritis.
Skin and subcutaneous tissue disorders: drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome.
Hepatobiliary: drug-induced liver damage, including hepatitis, jaundice, increased liver enzymes. Symptoms of liver damage: feeling sick (nausea and vomiting), fever, feeling tired, loss of appetite, dark urine, light stools, yellowing of the skin or whites of the eyes, itching, rash, or upper abdominal pain.
Others: visual disturbances, decreased sweating, dizziness.
With prolonged use of large doses, a decrease in kidney function is possible (especially in patients with a history of kidney disease, in some cases - papillary necrosis).
Reporting of suspected adverse reactions.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua/.
Expiration date
2 years.
Storage conditions
Store out of the reach of children in the original packaging at a temperature not exceeding 25 °C.
Packaging
10 tablets in a blister; 1 or 2 blisters in a pack.
Vacation category
Without a prescription.
Producer
Private Joint-Stock Company "Lekhim-Kharkiv". PrJSC "Technolog".
Location of the manufacturer and address of its place of business.
Ukraine, 61115, Kharkiv region, Kharkiv city, Severyna Pototskoho street, building 36.
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
