Universal reference book for medicines
Product name: SEDALGIN ® PLUS (SEDALGIN PLUS)

Active substance: caffeine, metamizole sodium, thiamine

Type: Analgesic-antipyretics of combined composition

Manufacturer: BALKANPHARMA-DUPNITSA (Bulgaria)
Composition, form of production and packaging
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Tablets from white to almost white, round, flat, with a double-faced facet and a risk on one side.
1 tab.

metamizole sodium 500 mg

caffeine 50 mg

thiamine hydrochloride 38.75 mg

[PRING] microcrystalline cellulose - 45.75 mg, wheat starch - 11 mg, gelatin - 4 mg, silicon dioxide colloid - 2.5 mg, talc - 12 mg, magnesium stearate - 6 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Combined drug, has analgesic, antipyretic and anti-inflammatory effect.

Metamizole sodium is a derivative of pyrazolone and has an analgesic, antipyretic and weak anti-inflammatory effect, the mechanism of which is associated with the inhibition of prostaglandin synthesis by inhibition of COX.

Caffeine has a stimulating effect on the central nervous system, mainly on the cerebral cortex, respiratory and vasomotor centers.
Increases mental and physical performance, reduces drowsiness, a sense of fatigue. Caffeine increases the permeability of histohematological barriers and increases the bioavailability of non-narcotic analgesics, thereby enhancing the therapeutic effect.
Thiamine (vitamin B 1 ) is involved in the metabolism, contributes to the improvement of neural-reflex conductivity.

PHARMACOKINETICS

The pharmacokinetic properties of Sedalgin® Plus are dependent on the pharmacokinetics of the components that make up the formulation.

Metamizol sodium

After intake of metamizole sodium quickly and completely absorbed from the digestive tract.
C max in plasma is achieved on average 60-90 minutes after administration. It binds to plasma proteins and undergoes metabolism in the liver. Along the path of nonenzymatic hydrolysis, it is cleaved to 4-methylaminoantipyrine with further metabolism through active 4-aminoantipyrine to 4-acetylaminoantipyrine, the main metabolite, 90% of which is excreted by the kidneys and 10% by bile.T 1/2 is about 10 hours.
Caffeine

Caffeine, which is part of the drug, is almost completely absorbed from the digestive tract.
C max in plasma is determined after 30-40 minutes. Quickly passes through the BBB and the placental barrier. Penetrates into breast milk. It is excreted mainly by the kidneys in unchanged form and in the form of metabolites.
Thiamine

After ingestion, thiamine absorption is high and occurs throughout the small intestine.
Before sucking thiamine hydrochloride is released from the bound state by digestive enzymes. In the blood, the thiamine hydrochloride concentration is relatively low. In plasma, mainly free thiamine is found, in erythrocytes and leukocytes - its phosphoric esters. Half of the total is contained in the striated muscles (including the myocardium) and about 40% in the internal organs. Phosphorylation occurs in the liver. The most active phosphoric ester is thiamine diphosphate, which has coenzyme activity. It accumulates mainly in the liver, heart, brain, kidneys, spleen. It is excreted through the intestines and kidneys.
INDICATIONS

Moderately or mildly expressed pain syndrome of different genesis:

- headache (including migraine);

- toothache;

- neuralgia;

- pain in the muscles (myalgia);

- joint pain (arthralgia);

- radicular syndrome;

- menstrual pain (algodismenorea).

Feverish syndrome with "colds" and other infectious-inflammatory diseases (with established diagnosis).

DOSING MODE

The drug is taken orally after a meal of 1 tab.
2-3 times in the morning.
Adults and adolescents aged 16 years and older: the maximum single dose is 2 tablets, the maximum daily dose is 6 tablets.
within no more than 1-2 days.
Children aged 12 to 16 years: 1/2 tab.
or 1 tab. 2-3 times / day. The maximum daily dose is 4 tablets.
Duration of admission - no more than 5 days with the appointment as an anesthetic and 3 days as an antipyretic.

If symptoms persist or worsen, you should consult your doctor.

An increase in the daily dose of the drug or the duration of treatment is possible only under the supervision of a physician.

SIDE EFFECT

From the digestive system: loss of appetite, nausea, vomiting, cholestasis, jaundice.

On the part of the hemopoietic system: thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, purpura.

From the nervous system: insomnia, dizziness, increased excitability.

From the cardiovascular system: a feeling of palpitation, arrhythmia.

Allergic reactions: skin rash, itching, redness, Quincke's edema, anaphylactic shock;
bronchospasm.
The patient should inform the attending physician of any side effects that occur when the drug is used.

CONTRAINDICATIONS

- severe renal failure;

severe hepatic impairment;

- bronchospasm;

- diseases of the blood system;

- Insomnia;

uncontrolled arterial hypertension;

- severe atherosclerosis;

- increased intraocular pressure;

- deficiency of glucose-6-phosphate dehydrogenase (syndrome of congenital insufficiency of the enzyme glucose-6-phosphate dehydrogenase);

- Pregnancy;

- the period of lactation (breastfeeding);

- children's age till 12 years;

- hypersensitivity to the components of the drug;

- hypersensitivity to other pyrazolone derivatives (including phenylbutazone).

With caution: impaired liver function and / or kidney function.

PREGNANCY AND LACTATION

Contraindicated use of the drug Sedalgin ® Plus during pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindication: severe renal failure.

With caution: impaired liver function and / or kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindication: severe hepatic failure.

With caution: impaired liver function and / or kidney function.

APPLICATION FOR CHILDREN

Contraindication: children under 12 years.

SPECIAL INSTRUCTIONS

Excessive consumption of caffeinated products (tea, coffee) on the background of treatment can cause symptoms of an overdose.

With caution and under medical supervision apply in patients with impaired liver or kidney function.

In patients with atopic bronchial asthma, pollinosis, there is an increased risk of developing hypersensitivity reactions.

Simultaneous use of the drug with alcohol-containing beverages is not recommended.

Impact on the ability to drive vehicles and manage mechanisms

Patients should be careful when driving vehicles, working with mechanisms and in other activities that require increased concentration and speed of psychomotor reactions, since dizziness may develop when taking the drug.

OVERDOSE

Symptoms: nausea and vomiting sometimes with blood, stomach pain, mental and motor agitation, tachycardia, cardiac arrhythmias, possibly a decrease or increase in diuresis, convulsions, anxiety, confusion, delirium, dehydration, hyperthermia, headache, increased tactile or pain sensitivity, tremor or muscle twitching;
ringing in the ears, epileptic seizures (with acute overdose - tonic-clonic).
Treatment: gastric lavage, prescribe adsorbents (for example, activated charcoal), laxative medicines.
If necessary, conduct symptomatic therapy. With hemorrhagic gastritis - the introduction of antacid preparations and gastric lavage with ice 0.9% solution of sodium chloride; maintenance of ventilation and oxygenation; with epileptic seizures - in / in diazepam, phenobarbital or phenytoin; maintaining the balance of liquid and salts.
DRUG INTERACTION

With the simultaneous use of metamizole sodium with other non-narcotic analgesics, NSAIDs can lead to a mutual enhancement of toxic effects.

Tricyclic antidepressants, oral contraceptives, allopurinol disrupt metamizole sodium metabolism in the liver and increase its toxicity.

Barbiturates, phenylbutazone (butadione) and other inducers of microsomal liver enzymes weaken the effect of metamizole sodium.

Simultaneous use of metamizole sodium with cyclosporine reduces the concentration of the latter in the blood.

Sedatives and tranquilizers increase the analgesic effect of metamizole sodium.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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