Composition, form of production and packaging
? Tablets 1 tab.
metamizole sodium 500 mg
pituophenone hydrochloride 5 mg
fenpiverinia bromide 100 Ојg
10 pieces. - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
Renalgan is a combined preparation with analgesic and antispasmodic action. Reduces tone and eliminates spasms of smooth muscles of internal organs.
Metamizole sodium has analgesic, antipyretic and weak anti-inflammatory effect.
Pitophenone hydrochloride has a myotropic antispasmodic effect.
Fenpiverinia bromide due to anticholinergic action has an additional relaxing effect on smooth muscles.
The combination of the three components of the drug leads to mutual potentiation of their pharmacological effects.
Metamizol sodium is well and quickly absorbed into the digestive tract. In the intestinal wall it hydrolyzes with the formation of an active metabolite - there is no unchanged metamizole of sodium in the blood. The association of the active metabolite with proteins is 50-60%. Metabolized in the liver, excreted by the kidneys. In therapeutic doses penetrates into the mother's milk.
Renalgan is used as an analgesic and antispastic agent with:
- mild or moderate pain syndrome;
- spasms of muscles of internal organs, including those with renal colic;
- spasms of the ureter and bladder;
- biliary and intestinal colic;
- chronic colitis;
As an adjuvant can be used to reduce pain after surgical and diagnostic interventions.
Can be used as an analgesic for short-term symptomatic treatment with:
- myalgia (muscle strain).
The drug is taken orally, after eating, with water.
Adults and children over the age of 15 years are prescribed 1-2 tablets 2-3 times / day. The daily dose should not exceed 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.
Dosage for children. Children should be given the drug only as prescribed by the doctor. Dosage for children 5-7 years - half the tablet, 8-12 years - 3/4 tablets, 13-15 years - one tablet 2-3 times a day. Other dosage regimens are possible only after consultation with a physician.
In therapeutic doses, the drug is usually well tolerated.
Sometimes allergic reactions are possible (skin rash, itching, very rarely anaphylactic shock), burning sensation in the epigastric region, dry mouth, headache, dizziness, lowering blood pressure, tachycardia, decreased sweating. With propensity to bronchospasm may provoke an attack.
With prolonged admission, it is possible to develop thrombocytopenia, leukopenia, agranulocytosis, which can be manifested by an unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, and the development of vaginitis or proctitis.
- diseases of the blood system;
- oppression of bone marrow hematopoiesis;
Decompensated heart failure;
- Ischemic heart disease (CHD);
- Decompensated violations of the liver and kidneys;
- hepatic porphyria;
- an angle-closure glaucoma;
- hypertrophy of the prostate;
- intestinal obstruction;
- deficiency of glucose-6-phosphate dehydrogenase;
- period of pregnancy;
- lactation period;
- age up to 5 years;
- Hypersensitivity to the components of the drug.
With caution: renal / hepatic insufficiency, bronchial asthma, a tendency to arterial hypotension, hypersensitivity to other NSAIDs, bronchial asthma, urticaria or acute rhinitis triggered by the use of acetylsalicylic acid or other NSAIDs.
PREGNANCY AND LACTATION
Contraindicated during pregnancy. Use in nursing mothers requires the cessation of breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in decompensated violations of kidney function.
Use with caution in renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in decompensated violations of liver function, with hepatic porphyria.
Use with caution in case of liver failure. With prolonged (more than a week) treatment requires monitoring of the functional state of the liver.
APPLICATION FOR CHILDREN
Contraindicated for children under 5 years. Children older than 6 years of age should be given the drug only as prescribed by the doctor.
During the treatment with the drug, ethanol is not recommended.
With prolonged (more than a week) treatment requires monitoring of the functional state of the liver.
If suspected of agranulocytosis or in the presence of thrombocytopenia should stop taking the drug.
It is not allowed to use acute pains in the abdomen for relief (until the cause is clarified).
It is possible to stain urine in red by the release of a metabolite (it has no clinical significance).
Impact on the ability to drive vehicles and manage mechanisms
Care should be taken during the treatment of drivers of vehicles and persons engaged in potentially hazardous activities requiring quick physical and mental reactions.
Exceeding the dose can cause nausea, vomiting, lowering blood pressure, drowsiness, confusion, pain in the epigastric region, impaired liver and kidney function, convulsions.
Treatment: gastric lavage, the appointment of activated charcoal, symptomatic therapy.
The drug can affect the psychomotor ability of the patient with simultaneous reception with alcohol and drugs that depress the central nervous system, in view of increased sedative activity of alcohol-containing drugs.
The simultaneous use of Renalgan with non-narcotic analgesics can lead to a mutual enhancement of toxic effects.
Toxic effects of metamizole sodium are enhanced by the simultaneous administration of tricyclic antidepressants, oral contraceptives, allopurinol.
Antagonists of H 2 -receptor histamine, barbiturates, and codeine, when used simultaneously, enhance the effect of metamizole sodium.
When co-administered with H 1 -gistaminoblockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine and quinidine, m-choline blocking effect may be enhanced.
Simultaneous use with chlorpromazine or other derivatives of phenothiazine may lead to the development of severe hyperthermia.
Phenylbutazone and other hepatoinductors with simultaneous administration decrease the effectiveness of metamizole sodium.
Sedative and anxiolytic drugs (tranquilizers) increase the analgesic effect of metamizole sodium.
Radiopaque drugs, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizole sodium. With the simultaneous administration of cyclosporine, the concentration of the latter in the blood decreases.
Metamizole sodium, displacing from the bond with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticoid agents and indomethacin, may increase the severity of their action.
Thiamazole and cytostatics increase the risk of developing leukopenia.
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
Store in a dry, dark place at a temperature of +8 В° C to + 15 В° C. Keep out of the reach of children. Shelf life - 2 years.