Instructions for Andipal-forte tablets strip No. 10
Composition
active ingredients: 1 tablet contains metamizole sodium 500 mg (0.5 g), bendazole hydrochloride 40 mg (0.04 g), papaverine hydrochloride 40 mg (0.04 g);
excipients: potato starch, calcium stearate, talc.
Dosage form
Pills.
Main physicochemical properties: tablets of white or white with a faint yellowish tint, with a flat surface, beveled edges and a score.
Pharmacotherapeutic group
Analgesics and antipyretics. Metamizole sodium, combinations without psycholeptics. ATX code N02B B52.
Pharmacological properties
Pharmacodynamics
A combined drug with analgesic, antispasmodic and vasodilator effects due to the specific action of its components. The drug also has antihypertensive and antipyretic effects.
Metamizole sodium is a nonsteroidal anti-inflammatory drug (NSAID) of the pyrazolone derivative group, which exhibits anti-inflammatory, analgesic, and antipyretic effects, the mechanism of action of which is due to inhibition of cyclooxygenase (COX) and blocking the synthesis of prostaglandins from arachidonic acid, as well as impaired conduction of pain extra- and proprioceptive impulses, increased threshold of excitability of thalamic centers of pain sensitivity, and increased heat dissipation.
Bendazole hydrochloride - has vasodilator, antispasmodic, hypotensive effects, and also has a stimulating effect on the functions of the spinal cord and helps restore the functions of peripheral nerves, and has a moderate immunostimulating effect.
Papaverine hydrochloride – has a myotropic, antispasmodic, hypotensive effect. Blocks phosphodiesterase, causes the accumulation of cyclic adenosine monophosphate (cAMP) and a decrease in calcium content in the cell, relaxes the smooth muscles of blood vessels and internal organs.
Pharmacokinetics
When taken orally, it is rapidly and completely absorbed. It is hydrolyzed in the intestinal walls to form an active metabolite. The effect develops after 20–40 minutes and reaches a maximum after 2 hours. It is metabolized in the liver. It is excreted by the kidneys.
Indication
Pain syndrome associated with spasm of blood vessels or smooth muscles of internal organs.
Contraindication
Known or suspected hypersensitivity to metamizole sodium salt, pyrazolone derivatives (butadione, tribuzone, antipyrine); suspected acute surgical pathology; anemia of any etiology, cytostatic or infectious neutropenia; leukopenia; agranulocytosis; thrombocytopenia; hepatoporphyria; glucose-b-phosphate dehydrogenase deficiency; bronchial asthma; respiratory depression; broncho-obstructive syndrome; diseases occurring with decreased muscle tone, convulsive syndrome; glaucoma.
Severe heart failure, atrioventricular (AV) block. Arterial hypotension. Severe liver and kidney dysfunction. Chronic nephritis with edema and impaired nitrogen-excreting kidney function. Gastric and duodenal ulcers accompanied by bleeding. Diabetes mellitus. Hypotonic colitis; habitual constipation; head injury; hypothyroidism; adrenal insufficiency; prostatic hypertrophy; simultaneous administration of monoamine oxidase inhibitors (MAO). Patient age over 75 years (risk of hyperthermia).
Interaction with other medicinal products and other types of interactions
Radiocontrast agents, colloidal blood substitutes, penicillin: should not be used during treatment with metamizole sodium.
Chlorpromazine or other phenothiazine derivatives: severe hypothermia may develop. Oral hypoglycemic drugs, indirect anticoagulants, phenytoin, glucocorticosteroids, indomethacin, ibuprofen: metamizole sodium salt increases the activity of these drugs by displacing them from protein binding.
Glutethimide: reduces the effectiveness of metamizole sodium salt.
Other nonsteroidal anti-inflammatory drugs: their analgesic and antipyretic effects are potentiated and the likelihood of additive undesirable side effects increases.
Sarcolysin, thiamazole (methimazole), drugs that suppress bone marrow activity, including gold preparations: the likelihood of hematotoxicity, including the development of leukopenia, increases.
Phenylbutazone, glutethimide, barbiturates and other inducers of liver microsomal enzymes: reduce the effectiveness of metamizole sodium.
Methotrexate: metamizole sodium salt in high doses may lead to an increase in the concentration of methotrexate in the blood plasma and an increase in its toxic effects (primarily on the digestive tract and the hematopoietic system).
Diuretics (furosemide): possible reduction of the diuretic effect.
Sulfonamide-type antidiabetic drugs: increased hypoglycemic effect.
Ethanol: metamizole sodium enhances its sedative effect.
Sedatives and tranquilizers (sibazon, diazepam, trimethoprim, trioxazine, valocardin, codeine, anaprilin, H2-receptor blockers and propranolol): enhance the analgesic effect of metamizole sodium salt.
Phentolamine, antihypertensive drugs (drugs that affect the renin-angiotensin system), antidepressants, sedatives, diuretics, saluretics, procainamide, reserpine, quinidine: when combined with bendazole, the hypotensive effect is enhanced.
Levodopa, methyldopa: reduction of the hypotensive effect of methyldopa and the antiparkinsonian effect of levodopa.
Cyclosporine: with simultaneous use, the concentration of cyclosporine in the blood decreases.
Nitrofurantoin: there is evidence of the development of hepatitis when used concomitantly with the drug.
Cardiac glycosides: pronounced increase in myocardial contractile function due to a decrease in total peripheral vascular resistance.
Adsorbents, astringents and enveloping agents: reduced absorption of the drug from the gastrointestinal tract.
Morphine: possible reduction of the antispasmodic activity of papaverine hydrochloride.
Phentolamine: potentiates the effect of papaverine on the corpora cavernosa of the penis when administered concomitantly.
There is evidence of the development of hepatitis when used concomitantly with furadonin.
The effectiveness of the drug is reduced by smoking.
Caution is required when using the drug simultaneously with salicylates.
Application features
Do not exceed the recommended doses of the drug.
Since metamizole sodium salt has anti-inflammatory and analgesic properties, it can mask signs of infection, symptoms of non-infectious diseases and complications with pain syndrome, which can make their diagnosis difficult. Do not use the drug to relieve acute abdominal pain until the cause is determined.
The drug should be used with caution in patients:
with existing allergic diseases (including hay fever) or with such diseases in history - the risk of allergic reactions increases; with inflammatory bowel diseases, including nonspecific ulcerative colitis and Crohn's disease; with cardiovascular insufficiency; with a tendency to arterial hypotension; with supraventricular tachycardia; with a history of kidney disease (pyelonephritis, glomerulonephritis); with impaired liver and/or kidney function; with simultaneous use of cytostatic drugs (only under the supervision of a doctor).
The drug should be used with caution in patients with a history of prolonged alcohol use, debilitated individuals; elderly individuals due to the risk of hyperthermia and an increased frequency of adverse reactions, especially from the digestive tract.
Patients should be warned before starting treatment that if chills of unknown cause appear, fever, sore throat, difficulty swallowing, bleeding gums, pale skin, asthenia, vaginitis or proctitis develop, the drug should be discontinued immediately. The drug should also be discontinued at the first rash on the skin and mucous membranes. If these symptoms appear, you should immediately consult a doctor.
The drug should not be used for longer than the prescribed period without consulting a doctor. Regular long-term use of the drug is not recommended due to the myelotoxicity of metamizole sodium salt; in case of prolonged use (more than 7 days), it is necessary to monitor the composition of peripheral blood, kidney and liver function.
During treatment, urine may turn red (due to metabolite excretion), which is of no clinical significance.
Use with caution in weakened patients, with reduced intestinal peristalsis. When taking the drug, the development of orthostatic hypotension is possible.
When using the drug, it is necessary to monitor the composition of peripheral blood (leukocyte formula).
If symptoms of liver dysfunction appear, including gastrointestinal disorders, jaundice, and elevated liver enzymes, the drug should be discontinued.
You should inform your doctor about the following symptoms: hot flashes, sweating, headache, fatigue, jaundice, skin rash, nausea, stomach discomfort, constipation.
When used in children, constant medical supervision is required.
Smoking impairs the effectiveness of the drug.
While taking the drug, you should refrain from drinking alcohol and drugs that depress the central nervous system.
If the signs of the disease do not disappear or, on the contrary, the state of health worsens, or undesirable phenomena appear, it is necessary to stop using the drug and consult a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment with the drug, driving and working with complex mechanisms should be avoided.
Use during pregnancy or breastfeeding
Not recommended for use during pregnancy or breastfeeding.
Method of administration and doses
Take orally after meals, with a small amount of water.
Adults are prescribed 1 tablet 1–2 times a day.
The maximum daily dose is 2 tablets.
The course of treatment depends on the nature and course of the disease, the achieved effect, the nature of the complex pharmacotherapy used, but the duration of treatment should not exceed 3 days.
Children
In this dosage, the drug is not used in children.
Overdose
Symptoms: hypothermia, pronounced decrease in blood pressure, arrhythmia, tachycardia, partial or complete atrioventricular block, acute agranulocytosis, increased sweating, headache, feeling of heat, dizziness, dysphagia, delirium, possible development of acute agranulocytosis, acute renal or hepatic failure, paralysis of the respiratory muscles, decreased tissue perfusion, anxiety, lethargy, visual impairment, ataxia, nystagmus, diplopia, central nervous system depression, convulsive syndrome, collapse, coma, cyanosis, metabolic acidosis, hyperventilation, hyperglycemia, hyperkalemia, oliguria, anuria, constipation, gastrointestinal disorders, gastralgia, gastritis, nausea, vomiting, diarrhea, skin rash, shortness of breath, moderate shortness of breath, tinnitus, drowsiness, skin redness, general weakness, palpitations. With prolonged use in high doses: impaired liver function, neutropenia, hemorrhagic syndrome, possible convulsions and impaired consciousness.
Treatment: drug withdrawal, induction of vomiting, gastric lavage, maintenance of blood pressure, administration of enterosorbents, saline laxatives, forced diuresis, symptomatic therapy aimed at maintaining vital functions. In severe cases, hemodialysis, hemoperfusion, peritoneal dialysis are possible. If convulsions occur, consult a doctor.
At the first symptoms of overdose, you should seek medical help immediately.
Adverse reactions
Gastrointestinal: nausea, constipation, increased activity of hepatic transaminases, jaundice, hepatitis, discomfort in the stomach area, dry mouth;
On the part of the immune system: possible manifestations of hypersensitivity reactions, including rashes on the skin and mucous membranes, skin hyperemia, conjunctivitis, itching, urticaria, dry cough, runny nose, difficulty breathing, burning in the throat, facial flushing, angioedema, bronchospastic syndrome, anaphylactic shock, Stevens-Johnson syndrome, Lyell syndrome;
from the blood and lymphatic system: with prolonged use, leukopenia, thrombocytopenia, granulocytopenia, anemia, eosinophilia, agranulocytosis are possible;
From the urinary system: usually in patients with impaired renal function and/or when using excessive doses - transient oliguria, anuria, proteinuria, interstitial nephritis, red urine color.
from the cardiovascular system: AV block, ventricular extrasystole, decreased cardiac output, decreased blood pressure, weakness, numbness, tremor, loss of consciousness, palpitations, arrhythmias, pain in the heart area, with prolonged use - deterioration of ECG indicators, orthostatic hypotension, ventricular fibrillation, asystole, ventricular flutter, collapse, apnea;
from the side of the central nervous system: drowsiness, increased sweating, dizziness, headache, feeling of heat, hot flashes, anorexia;
Hepatobiliary system: hepatitis.
If any adverse reactions occur, the patient should consult a doctor.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in strips per pack.
Vacation category
Without a prescription.
Producer
PJSC "Monpharm".
Location of the manufacturer and its business address
Ukraine, 19100, Cherkasy region, Monastyryshche, Zavodska st., 8.
