Spasmalgon solution for injections in ampoules 5ml №10×1

Name:
] Spazmalgon. [
Description:
] Spasmalgon is a combined drug that relieves spasms of smooth muscles of the gastrointestinal tract, biliary and urinary tract, reproductive organs and has a pronounced analgesic effect. Spasmalgon is used for short-term relief of acute, moderately severe to severe pain with spasms of smooth muscles of the gastrointestinal tract, biliary tract, kidneys and ureters, with nephrolithiasis, with painful menstruation (dysmenorrhea). [Precautions] You should not use the drug @ if you know that you have an allergy (hypersensitivity) to the active substances of the drug Spasmalgon; @ if you are allergic (hypersensitive) to pyrazolone derivatives or non-steroidal anti-inflammatory drugs; @ bronchial asthma; @ if you have severe liver and/or kidney disease; @ in cases of intestinal obstruction and megacolon (colon enlargement) @ if there is a hereditary disease of hepatic porphyria associated with dysfunction of red blood cells or insufficiency of the enzyme glucose-6-phosphate dehydrogenase; @ if there is impaired bone marrow function (after cytostatic therapy) or blood disorders such as aplastic anemia (a decrease in the number of blood cells with the appearance of weakness, bruising, or the possibility of infection), agranulocytosis (a sharp decrease in the number of white blood cells, which increases the likelihood of infections ) or leukopenia (a decrease in the total number of leukocytes); @ prostate adenoma (with a tendency to urinary retention); @ atony of the gallbladder and bladder; angle-closure glaucoma; @ if you have hypotension (low blood pressure) or unstable circulation; @ during pregnancy and breastfeeding. This drug should not be given to children under 15 years of age. [Special Instructions] Before starting treatment with Spasmalgon, inform your doctor if you have kidney or liver disease; diseases associated with obstruction of the intestinal tract or difficult passage of contents through the gastrointestinal tract (achalasia, stenosis between the pylorus and the duodenum); gastroesophageal reflux disease, intestinal atony, intestinal obstruction; glaucoma (increased intraocular pressure); myasthenia gravis (muscle weakness), heart disease (arrhythmias, coronary heart disease, congestive heart failure). During treatment with Spasmalgon, there is a risk of developing severe hypersensitivity reactions, including anaphylactic reactions. When the first symptoms of hypersensitivity appear, the administration of the drug should be stopped immediately and urgent measures should be taken to relieve the condition (adrenaline, glucocorticoids, antihistamines). The risk of possible severe hypersensitivity reactions to metamizole is significantly increased in the following cases: @ in patients with analgesic asthma; @ in patients with bronchial asthma, especially if there is rhinosinusitis (inflammation of the nose and nasal cavities) or nasal polyps; @ in patients with chronic urticaria; @ in patients with hypersensitivity to dyes (eg tartrazine) or preservatives (benzoates); @ in patients with alcohol intolerance. Such patients react even to small amounts of alcohol with the appearance of sneezing, tearing and severe reddening of the face. Such intolerance to alcohol may be a sign of an undiagnosed analgesic asthma syndrome. When treated with drugs containing metamizole, there is a risk of shock (circulatory collapse) and agranulocytosis (decrease in the number of white blood cells, which increases the likelihood of infections). They are dose-independent and cannot be predicted. When using the drug Spazmalgon in patients who have blood diseases or had such diseases in history, it is necessary to monitor the blood picture during treatment. Spasmalgon injection may cause a drop in blood pressure. The risk of such a reaction is especially increased in patients with low blood pressure or fluid loss, impaired circulation or initial circulatory collapse (eg in patients with a heart attack or severe wounds), in patients with high fever. In such patients, intramuscular administration of Spasmalgon should be done in a horizontal position (lying down) and under constant monitoring of blood pressure, heart rate and respiration. [Use of other medicines] Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Adverse interactions can be observed with the simultaneous use of the drug Spazmalgon with the following drugs: drugs that affect blood clotting (acenocoumarol and warfarin); drugs for the treatment of psychosis (chlorpromazine and other phenothiazine derivatives); depressing the immune system (cyclosporine); chloramphenicol and other drugs that depress the bone marrow; drugs to treat depression; sleeping pills; oral contraceptives; drugs for the treatment of gout (allopurinol); other pain and anti-inflammatory drugs such as piroxicam, aspirin, ibuprofen, indomethacin. Spasmalgon can interact with captopril (for the treatment of heart disease and hypertension), with lithium (for the treatment of mental illness), with methotrexate (for the treatment of rheumatic and neoplastic diseases) and triamterene (diuretic), and also change the effect of antihypertensive (lowering blood pressure) drugs and diuretics (diuretics). [Use of Spazmalgon with food and drink] Drinking alcohol is not recommended during treatment with Spazmalgon due to the possibility of increasing the side effects of the drug. [Pregnancy and breast-feeding] Talk to your doctor or pharmacist before taking any medicine. Spasmalgon should not be used during pregnancy. If it is necessary to treat breastfeeding mothers with the drug, breastfeeding should be discontinued. [Driving and operating machines] The drug Spasmalgon can cause dizziness, blurred vision, as well as adversely affect attention and impair reactions in unexpected situations. Therefore, driving and operating machinery should be avoided while taking this drug. [Method of application] Spasmalgon injection is administered intramuscularly. Used only for short-term treatment! It is administered under the supervision of a physician and when ready to provide emergency assistance due to the risk of anaphylactic shock in patients with hypersensitivity. Adults and adolescents over 15 years of age The usual dose for adults and adolescents over 15 years of age (> 53 kg) is 2-5 ml intramuscularly, once. If necessary, the dose is repeated after 6-8 hours. The maximum daily dose should not exceed 6 ml of solution for injection (equivalent to 3 g of metamizole sodium monohydrate). The duration of treatment is 2-3 days. After achieving a therapeutic effect, you can proceed to treatment with oral painkillers and antispasmodics. Patients over 65 years of age Usually no dose reduction is required. In patients with impaired liver and kidney function associated with age, it is necessary to reduce the dose of the drug. The dose is determined by the attending physician. Patients with impaired renal function If you have kidney disease, use 1/2 of the prescribed adult dose, as the rate of excretion of the substance in kidney disorders slows down. Patients with impaired liver function If you have impaired liver function, high doses should be avoided. With short-term use, there is no need to lower the dose. The duration of treatment is 2-3 days. After achieving a therapeutic effect, you can proceed to treatment with oral painkillers and antispasmodics. If you have any further questions on the use of this medicine, please ask your doctor or pharmacist. If Spasmalgon is used in a dose exceeding the required dose. Overdose may cause nausea, vomiting, dizziness, tinnitus, shock, acute renal and hepatic failure, convulsions. Symptomatic treatment is carried out in a medical institution. If symptoms such as cold sweat, dizziness, nausea, discoloration of the skin and suffocation appear, you should immediately seek medical help. If the administration of the required dose is missed Spasmalgon Do not use a double dose to compensate for the missed one. [Side Effects] Like all medicines, Spasmalgon can cause side effects, although not everybody gets them. Side effects are classified by frequency as follows: very common (≥ 1/10), frequent (≥ 1/100 and < 1/10), infrequent (≥ 1/1000 and < 1/100), rare (≥ 1/10 000 and < 1/1000), very rare (< 1/10 000), with unknown frequency (no estimate can be made from existing data). The adverse reactions listed below are mainly caused by metamizole, which is part of the medicinal product. Uncommon (affects less than 1 in 100 people) Skin rash (exanthema) - oval, plate-shaped, purple to dark red blisters. During or after administration - a decrease in blood pressure, which is not accompanied by other signs of hypersensitivity reactions, increased heart rate. Rare (may occur less than 1 in 1,000 people) Leukopenia (a decrease in the number of white blood cells, which increases the likelihood of infection), maculopapular rash (formation of skin plates and nodes), anaphylactic or anaphylactoid reactions, especially after parenteral use. Such reactions may appear during the administration of the drug or immediately after the cessation of administration, but may also appear after a few hours. Most often they appear within the first hour after the injection. Milder reactions appear as typical skin and mucosal reactions (eg, itching, burning, redness, rash, urticaria, edema), dyspnea and, in rare cases, gastrointestinal complaints. These milder reactions can progress to more severe forms with generalized urticaria, severe swelling of the face and throat, severe bronchospasm, cardiac arrhythmias, low blood pressure (sometimes preceded by high blood pressure), kidney problems, such as protein in the urine , decreased or increased amount of urine, inflammation of the kidneys. During treatment with Spasmalgon, urine may turn red. After the treatment is stopped, the color returns to normal. Very rare (affects less than 1 in 10,000 people) Agranulocytosis (a dramatic decrease in the number of white blood cells that increases the chance of infections). Agranulocytosis can also occur in patients who have been treated with metamizole in the past without the appearance of side effects. The risk of agranulocytosis increases with prolonged use (more than 1 week) of metamizole. Characteristic signs of agranulocytosis include inflammatory changes in the skin and mucous membranes of the mouth, throat, genitals, sore throat and fever. In case of a sudden deterioration in the general condition, in the absence of a decrease in temperature or its repeated increase, with the appearance of painful changes in the mucous membrane and skin, it is necessary to stop treatment with Spasmalgon and consult a doctor. In very rare cases, thrombocytopenia (a decrease in the number of platelets, which increases the risk of bleeding or bruising), hemolytic anemia (a decrease in the number of red blood cells, which can lead to pale or yellow skin, weakness or shortness of breath), aplastic anemia (acute a decrease in the number of blood cells, which causes weakness, bruising, or infection). In patients with analgesic asthma, hypersensitivity reactions usually manifest as an asthmatic attack; Stevens-Johnson syndrome (malignant exudative erythema) or Lyell's syndrome (toxic epidermal necrolysis); circulatory shock. With an unknown frequency: dry mouth, nausea, vomiting, abdominal pain and discomfort, constipation, exacerbation of gastritis and gastric ulcer, in rare cases, ulceration and bleeding, dizziness, headache, visual disturbances, disturbance of accommodation, difficulty urinating. With parenteral use, pain at the injection site and local reactions may appear, extremely rarely even phlebitis. With the appearance of hypersensitivity, data on violations of the renal or hematopoietic function, the use of the drug Spasmalgon is stopped. If any of the side effects become serious or if you notice other side effects not listed in this package insert, please tell your doctor. [Storage conditions] In the original packaging, in a place protected from light at a temperature not exceeding 25°C. Do not freeze! Keep out of the reach of children. Shelf life - 4 years. Do not use Spasmalgon after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month. Medicines should not be disposed of in the sewer or in the household waste container. Ask your pharmacist how to dispose of unwanted medicines. These measures will contribute to the protection of the environment. [Composition] @ Active substances: metamizole sodium monohydrate 1,000 mg, pitofenone hydrochloride 4 mg, fenpiverinium bromide 0.04 mg in 2 ml injection solution; metamizole sodium monohydrate 2500 mg, pitofenone hydrochloride 10 mg, fenpiverinium bromide 0.1 mg in 5 ml injection solution. @ Excipients: water for injection. [Packaging] Clear liquid, practically free of particles, yellow-green or yellow-brown. Brown glass ampoules of the 1st hydrolytic class with a marking for opening at the top of the ampoule with a colored dot. Ampoules of 2 ml solution for injections 5 or 10 ampoules in a blister made of PVC film, 1 blister in a carton box with a leaflet. Ampoules of 5 ml solution for injections 5 or 10 ampoules in a PVC film blister, 1 blister in a carton box with a leaflet. Not all types of packages may be put on sale. [Dispensing conditions] Available by prescription. 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