Composition, form of production and packaging
? The tablets covered with a cover round, biconcave; on the fracture - a white core with a fine-grained structure, surrounded by a continuous green layer of the film shell.
1 tab.
metamizole sodium 500 mg
triacetonamide 4-toluenesulfonate 20 mg
[PRING] wheat starch, microcrystalline cellulose, povidone, talc, magnesium stearate, ethanol, purified water.
Sheath composition: eudrazhit L, talc, titanium dioxide, macrogol 400, glycerol, castor oil, polysorbate 80, dyes (Eurocert Quinoline Yellow 70 (E104), Spectracol Patent blue V (E131)), purified water, acetone, isopropanol.
10 pieces. - blisters (1) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
The instruction is approved by the Pharmacological Committee of the Ministry of Health of Russia on September 27, 2001.
Tempanginol is a combined preparation that includes a non-narcotic analgesic metamizole (analgin) and a triacylation triacetonamine 4-toluenesulfonate. It has analgesic, antipyretic, weak anti-inflammatory and soothing effect.
INDICATIONS
- Moderately or poorly expressed pain syndrome, especially in patients with increased nervous excitability: headache, dental, migraine pain, neuralgia, radicular syndrome, myalgia, dysmenorrhea;
- with mild pains of visceral origin (renal, hepatic, intestinal colic) in combination with antispasmodics;
- as an adjuvant can be used to reduce pain after surgical and diagnostic interventions;
- fever with colds and other infectious and inflammatory diseases.
DOSING MODE
Tablets are taken orally, without chewing, with a sufficient amount of liquid, during or after a meal. Usual dose for adults - 1 tab. 1-3 times / day. The maximum single dose of 2 tablets, the maximum daily - 6 tablets. Duration of reception no more than 5 days. An increase in the daily dose of the drug or the duration of treatment is possible only under the supervision of a physician. At long (more than a week) application of a preparation control of a picture of peripheric blood and a functional status of a liver is necessary
SIDE EFFECT
In some cases, a burning sensation in the epigastric region, dry mouth, headache.
Allergic reactions with hypersensitivity to some components (skin rash, itching, Quincke's edema), rarely - anaphylactic shock.
From the nervous system: dizziness, extremely rarely hallucinations.
From the cardiovascular system: lowering of blood pressure, tachycardia, cyanosis.
On the part of the hematopoiesis system: agranulocytosis, leukopenia, thrombocytopenia.
From the respiratory system: with a tendency to bronchospasm may provoke an attack.
From the digestive system: cholestasis, jaundice, increased levels of transaminases, hyperbilirubinemia.
From the genitourinary system: a violation of kidney function (in high doses).
In connection with the tranquilizing effect of triacetonamide 4-toluenesulfonate, the drug should not be used when driving transport and other activities requiring increased attention.
CONTRAINDICATIONS
- hypersensitivity to analgin (metamizol sodium), derivatives of pyrazolone or triacetone-4-toluenesulfonate;
- marked violations of the liver and kidneys;
- heart failure;
- arterial hypotension;
- oppression of hematopoiesis (agranulocytosis);
- hereditary hemolytic anemia associated with a deficiency of glucose-6-phosphate dehydrogenase;
- Pregnancy;
- the period of breastfeeding;
- Children's age (up to 14 years).
PREGNANCY AND LACTATION
Contraindicated in pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated: severe renal dysfunction.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated: marked violations of the liver.
APPLICATION FOR CHILDREN
Contraindicated: children's age (up to 14 years).
Adolescents under 18 years of age should be used only as directed by a doctor.
SPECIAL INSTRUCTIONS
With caution apply in patients with impaired liver or kidney function, with a tendency to arterial hypotension, patients with allergies.
If the drug is used for a long time (more than a week), it is necessary to monitor the blood picture and the functional state of the liver.
During the intake of the drug is not recommended the use of alcohol.
Adolescents under 18 years of age should be used only as directed by a doctor.
OVERDOSE
Nausea, vomiting, pain in the epigastric region. The victim should immediately consult a doctor.
First aid: gastric lavage, the appointment of activated charcoal
DRUG INTERACTION
Simultaneous application of Tempanginol with other non-narcotic analgesics can lead to mutual enhancement of toxic effects. Tricyclic antidepressants, oral contraceptives and allopurinol also increase its toxicity. Barbiturates and phenylbutazone weaken the action of analgin.
Simultaneous use of Tempanginol with cyclosporine reduces the level of the latter in the blood.
Sedatives and anxiolytics strengthen the analgesic effect of the drug.
With the joint use of Tempanginol with oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and indomethacin, the action of the latter is enhanced.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
List B. In a dry, sheltered from light, out of reach of children, at a temperature of 15-25 В° C.
Shelf life - 4 years. Do not use after the expiration date printed on the package.