Sedal-M

General characteristics. Structure:

Active agents: Paracetamol of 300 mg; Metamizol sodium of 150 mg; Caffeine of 50 mg; Phenobarbital of 15 mg;

Codeini phosphas of 10 mg.

Other ingredients: cellulose microcrystallic, starch wheat, K 25 povidone, кросповидон 50/50, magnesium stearate, talc, silicon dioxide colloid anhydrous.

Pharmacological properties:

The combined drug with anesthetic and febrifugal action and less expressed antiinflammatory and sedative action. These effects are inherent to the paracetamol and analginum (metamizol) which are generally a part of drug. By TsOG inhibition they break synthesis of prostaglandins.
Phenobarbital in low doses has sedative effect and exponentiates effect of components of analgetics.
Caffeine expands brain vessels, reduces the headache resulting from vasoconstriction. It stimulates psychomotor activity, increases intellectual and physical effeciency, interferes with development of sedative action of other components.
Codeini phosphas through opioid receptors has analgetic and sedative effect and exponentiates analgesic effect of paracetamol and analginum. The combination of several analgetics with other components, on the one hand, increases efficiency of an analgesia, and with another — reduces expressiveness of by-effects and reduces probability of development of accustoming.
Separate components of a combination are quickly enough soaked up in a GIT and rather quickly metabolized.
Are excreted generally with urine. T½ of codeine is 3–4 h, caffeine — 3–6 h, paracetamol — 1,5–3 h and analginum — 1–4 h.

Indications to use:

Symptomatic treatment of a pain syndrome at the following states: head and dentagra, migraine;
neuralgia and neuritis; pain after burns, injuries and surgical interventions; the rheumatic pain, respiratory diseases which are followed by pain and temperature increase; dysmenorrhea.

Route of administration and doses:

Apply inside during food, plentifully washing down with liquid.
Adults and children are aged more senior than 12 years: on 1 tablet 2–3 times a day. In the absence of satisfactory effect it is possible to accept on 1 tablet 4 times a day. The maximum single dose — 2 tablets, a daily dose — 6 tablets.
Duration of use should not exceed 3 days.

Features of use:

Treatment by drug needs to be stopped immediately at emergence of the first symptoms of hypersensitivity (skin rash, breath difficulty, cold sweat, decrease in the ABP, nausea, vomiting).
With extra care and only after consultation with the doctor drug is appointed to patients with allergic dermatitis and allergic rhinitis.
Drug is not appointed in the presence of active stomach ulcer or a duodenum. At use of drug in high doses, especially in an initiation of treatment, delay of psychomotor reactions is possible.
In view of decrease in tolerance to alcohol it is not necessary to use it during treatment by drug.
Wheat starch therefore drug is not recommended to be accepted the patient with a gluten enteropathy is a part of medicine.
Metabolites of metamizole sodium can cause coloring of urine in red color that has no clinical value.
Period of pregnancy and feeding by a breast. It is not recommended to use drug during pregnancy and feeding by a breast.
Children. To children aged up to 12 years drug use contraindicated due to the lack of clinical experience.
Ability to influence speed of response at control of vehicles or in operating time with other mechanisms. At use of drug it is necessary to avoid potentially dangerous types of activity requiring special attention (control of vehicles, work with other mechanisms, etc.).

Side effects:

Drug seldom causes allergic reactions (an itch, skin rash), seldom or never — a Lyell's disease and Stephens — Johnson, an acute anaphylaxis, a bronchospasm, gastrointestinal discomfort, dizziness, thrombocytopenia. Prolonged use can cause a renal failure and a liver. At sharp phase-out of drug after its long reception cancellation symptoms can appear (most often a headache).
At use of drug such side reactions can be noted:
from a nervous system: sleep disorder, easy tremor, lack of coordination, bystry fatigue, condition of concern, irritability, headache;
from cardiovascular system — hypotonia, a heart consciousness, arrhythmia (tachycardia, bradycardia, premature ventricular contraction);
from system of a hemopoiesis: very seldom — hemolitic anemia, a methemoglobinemia, a sulfhemoglobinemia, thrombocytopenia, in exclusively exceptional cases — an agranulocytosis;
from a GIT: dryness in a mouth, pain in epigastriums, anorexia (appetite loss), nausea, vomiting, diarrhea, a lock, an abnormal liver function and increase in level of transaminases;
from respiratory system: bronchospasm (provoking of an attack OH);
from urinogenital system: renal failure. At prolonged use — nephrotoxicity manifestations (intersticial effect).

Interaction with other medicines:

At treatment by the combined drug Sedal-M it is not necessary to apply other medicines containing paracetamol or metamizol.
Analgeziruyushchy and sedation of drug amplifies at simultaneous use with the means causing oppression of TsNS (somnolent, sedative, anxiolytic, antipsychotic means, narcotic analgetics).
The combined drug can strengthen or reduce therapeutic effect of peroral anticoagulants.
Use of drug along with NPVP can cause increase in risk of emergence of hematologic side effects or side effects from a GIT.
Toxic effect of metamizol on marrow can be strengthened at a concomitant use of the means suppressing function of marrow (chloramphenicol, cytostatics).
At the combined use with the drug Sedal-M concentration of cyclosporine in a blood plasma and its therapeutic effect can decrease.
Rifampicin and peroral contraceptive means can reduce the anesthetizing effect of the paracetamol which is a part of drug.
Simultaneous use of drug with alcohol and other hepatotoxic means can increase risk of emergence of side effects from a liver.

Contraindications:

Hypersensitivity to any component of drug, stomach ulcer and a duodenum, hemorrhagic diathesis, blood diseases (anemia, a leukopenia, thrombocytopenia, hemolitic anemia), the renal failure and a liver, OH, a bronchospasm, recently postponed craniocereberal injury, an acute myocardial infarction, disturbances of a cordial rhythm raised by the ABP, children aged up to 12 years, deficit glyukozo-6-fosfatdegidrogenazy, the period of pregnancy and feeding by a breast.

Overdose:

Symptoms: at overdose of drug there comes the oppression of TsNS which is expressed dizziness, drowsiness, delay of reflexes, dryness in a mouth, nausea, vomiting, respiratory depression, bradycardia, considerable weakness, and sometimes — a loss of consciousness.
Treatment: a gastric lavage water with absorbent carbon, an artificial diuresis, symptomatic therapy.

Storage conditions:

In original packaging (in the dry, protected from light place) at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

Tab., No. 10, No. 20.