COMPOSITION: Drugs in one tablet: Metamizole sodium 500.0 mg Pitofenon hydrochloride 5.0 mg Fenpiverine bromide 0.1 mg
Excipients: lactose monohydrate, wheat starch, gelatin, talc, magnesium stearate, sodium hydrogen carbonate.
PHARMACEUTICAL FORM AND PACKAGING:
Tablets of 10 pieces or 20 pieces in PVC blisters / para. foil
1 blister of 10 tablets in a cardboard box.
2 blisters of 10 tablets in a cardboard box. 1 blister of 20 tablets in a cardboard box.
ACTION: Spazmalgon® is a combined product that combines analgesic, smooth muscle relaxation, antipyretic and some anti-inflammatory action.
INDICATIONS: In mild or moderate pain syndrome due to spasms of the smooth muscles of the internal organs - kidney stones and inflammatory diseases of the urinary tract with pain and dysuric disorders, gastric and intestinal colic, gallstone disease, biliary dyskinesia painful menstruation.
INFORMATION REQUIRED BEFORE USING THE MEDICINAL PRODUCT:
• Allergy to the medicinal and / or excipients of the product;
• Gastrointestinal obstruction and megacolon;
• Atony of the gallbladder and bladder;
• Severe renal and hepatic failure;
• Hematological diseases (agranulocytosis and leukopenia);
• Pregnancy and lactation;
• Glucose-6-phosphate dehydrogenase deficiency;
• Closed-angle glaucoma.
SPECIAL PRECAUTIONS FOR USE: Prolonged use of the product (more than one week) requires monitoring of peripheral blood counts and liver function.
Metabolites of metamizole may turn urine red, which is of no clinical significance.
The product may affect the psychophysiological condition of patients when used concomitantly with alcohol and CNS depressants.
DRUG AND OTHER INTERACTIONS: Metamizole increases the blood chloroquine content, reduces the effects of coumarin anticoagulants (clotting agents) and the effects of cyclosporine.
Enhances the inhibitory effect on the hematopoietic function of myelotoxic drugs and chloramphenicol.
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 effects of metamizole.
Sedatives and tranquilizers enhance the analgesic effect of Spazmalgon®.
Concomitant use of Spazmalgon® with other analgesics and non-steroidal anti-inflammatory drugs increases the risk of hypersensitivity and other adverse reactions.
If it is necessary to simultaneously administer these or other drugs, a doctor's consultation is required!
WARNINGS FOR SPECIAL GROUPS OF PATIENTS: The product should be used with caution in patients with impaired renal and / or hepatic function, certain gastric diseases (achalasia, gastroesophageal reflux disease, pyloric stenosis), prostatic hypertrophy and hypertrophy. , tendency to low blood pressure (hypotension), severe arrhythmias, ischemic heart disease (especially recent myocardial infarction), advanced congestive heart failure, chronic bronchitis and bronchospasm (due to increased viscosity of bronchial secretions), in hypersensitivity products and non-narcotic analgesics or in other allergic manifestations (allergic rhinitis, bronchial asthma).
APPLICATION FOR PREGNANT WOMEN AND BREASTFEEDING: Do not use during pregnancy and lactation.
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES: Use with caution in patients who drive or operate machinery, as prolonged use of Spazmalgon® may cause dizziness and accommodation disturbances.
EXCIPIENT INFORMATION: The excipients include wheat starch, which poses a risk to people with gluten enteropathy (congenital small bowel disease manifested by diarrhea when using wheat products).
This medicinal product contains lactose (milk sugar) as an excipient, which makes it unsuitable for patients with lactose intolerance.
INFORMATION REGARDING THE CORRECT USE OF THE MEDICINAL PRODUCT:
DOSAGE AND METHOD OF ADMINISTRATION: It is taken orally. Recommended daily dose:
Adults and children over 15 years of age - 1-2 tablets 2-3 times a day. Maximum daily dose - 6 tablets.
- from 13 to 15 years - 1 table. 2-3 times a day. Maximum daily dose - 3 tablets.
- from 9 to 12 years - 1/2 tablet. 2-3 times a day. Maximum daily dose - 2 tablets.
The duration of treatment should not exceed 3 days. The tablets are taken with water after a meal.
OVERDOSAGE: In case of overdose, allergic manifestations are most often observed you, symptoms of impaired hematopoietic function, gastrointestinal disorders, in severe cases and symptoms of brain damage.
In case of overdose, the product should be stopped immediately and measures should be taken for its rapid elimination of the organism (vomiting, gastric lavage, increased urine output). Symptomatic agents are used. There is no specific antidote.
SIDE EFFECTS: In therapeutic doses the product is well tolerated. Allergic reactions are possible (skin rash, itching, rarely - bronchospasm, angioedema, anaphylactic shock and very rarely toxic epidermal necrolysis and Stevens Johnson syndrome), heaviness in the upper abdomen, dry mouth, constipation, exacerbation of gastritis and of the stomach, dizziness, visual disturbances, lowering of blood pressure, increased heart rate. With prolonged use of the product may be disorders of the peripheral blood picture (decrease in the number of platelets, leukocytes, to the absence of granulocytes). If you are prone to bronchospasm, the use of Spazmalgon® may provoke an attack. The product may in rare cases cause impaired renal function - urinary retention, development of acute renal failure and interstitial nephritis.
STORAGE: In a dry and protected from light place at a temperature below 25oС.
Keep out of reach of children!
SHELF LIFE: 3 (three) years from the date of manufacture.
Manufacturer: ACTAVIS OTC
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