Novalgin - instructions for use, dose, side effects, contraindications

Excipients: granulate for direct compression (croscarmellose sodium 1.1 mg, povidone 3.3 mg, pregelatinized starch 16.5 mg, stearic acid 1.1 mg) 22 mg, magnesium stearate 7 mg, pregelatinized starch 30 mg, lactose monohydrate 15 mg, cellulose microcrystalline 163 mg, croscarmellose sodium 5 mg, silicon dioxide colloidal 8 mg.

Description:

Tablets are white, round, with a biconvex surface, with a risk on one side.

Pharmacotherapeutic group:An analgesic agent combined (non-steroidal anti-inflammatory drug + analgesic non-narcotic agent + psychostimulating agent)

ATX: & nbsp

N.02.B.E Anilides

Pharmacodynamics:

Combined drug, the effect of which is determined by the components that make up its composition. Paracetamol and propiphenazone have an analgesic and antipyretic effect. Caffeine has psychostimulant (stimulates the psychomotor centers of the brain), an analeptic effect, eliminates drowsiness and a sense of fatigue, increases physical and mental performance.

The action begins 15-30 minutes after ingestion.

Pharmacokinetics:

Indications:

Treatment of pain syndrome of mild and moderate intensity with primary dysmenorrhea (painful menstruation in the absence of organic changes on the part of the genital organs).

Pain syndrome of mild and moderate intensity of various genesis: headache, migraine, toothache, arthralgia, myalgia;

Feverish syndrome (as an antipyretic agent).

Contraindications:

Hypersensitivity to the components of the drug severe hepatic and / or renal failure, deficiency of glucose-6-phosphate dehydrogenase, oppression of bone marrow hematopoiesis (leukopenia, anemia, including hemolytic), acute hematoporphyria, complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance of acetylsalicylic acid or other non-steroidalanti-inflammatory drugs (including history), conditions accompanied by respiratory depression, intracranial hypertension, acute myocardial infarction, arrhythmias, hypertension, alcoholic intoxication, glaucoma, pregnancy, lactation period, children's age (up to 12 years).

Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Carefully:

Peptic ulcer of the stomach and duodenum (in the stage of exacerbation), elderly age, moderate violations of the liver or kidney function, bronchial asthma.

Pregnancy and lactation:Application in pregnancy and lactation Contraindicated.

Dosing and Administration:

Inside, after eating, squeezed a small amount of liquid.

Adults take 1-2 tablets 1-4 times a day. The daily dose should not exceed 6 tablets.

Children from 12 to 18 years on 1/2 - 1 tablet up to three times a day.

Duration of reception no more than 3 days as an antipyretic agent and no more than 5 days as an anesthetic.

Side effects:

Dizziness, sleep disturbance, palpitations, nausea, vomiting severity and unpleasant sensations in the stomach, leukopenia, agranulocytosis, hemolytic anemia, methemoglobinemia, allergic reactions;

In case of adverse reactions, please consult with your doctor about the further administration of the drug.

Overdose:

For paracetamol.

Symptoms: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. Symptoms of the disorder, liver function may appear 12-48 hours after an overdose. In severe overdose, hepatic insufficiency with progressive encephalopathy, coma, is lethal (10 g when recalculated to paracetamol or 50 tablets of the drug); acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis.

Treatment: introduction of donators SH-groups and precursors of glutathione synthesis-methionine for 8-9 hours after overdose and acetylcysteine-for 8 hours. The need for additional therapeutic measures (further introduction of methionine, intravenous acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time that has elapsed since it was received.

For caffeine.

Symptoms: gastralgia, agitation, anxiety, motor anxiety, confusion; delirium, dehydration, tachycardia, arrhythmia; hyperthermia, frequent urination, headache, hypertension, tactile) or pain (sensitivity, tremor or muscle twitching, nausea and vomiting, sometimes with blood, ringing in the ears, convulsions (with acute overdose - tonic-clonic).

Caffeine in doses of more than 300 mg / day (including against the background of the abuse of coffee - more than 4 cups of natural coffee of 150 ml) can cause anxiety, tremor, headache, confusion, extrasystole.

Treatment: gastric lavage, if caffeine was taken in the last 4 hours at a dose of more than 15 mg / kg and there was no vomiting caused by caffeine; reception of activated carbon, laxatives; with hemorrhagic gastritis - the introduction of antacids, washing 'zheludka', ice 0.9% solution of sodium, chloride; maintenance of ventilation and oxygenation; with convulsions - intravenously diazepam, phenobarbital or phenytoin; maintaining the balance of liquid and salts.

Interaction:

Paracetamol reduces the effectiveness of uricosuric agents.

Simultaneous use of paracetamol in high doses increases the effect of anticoagulants (a decrease in the synthesis of procoagulant factors in the liver).

Inductors of microsomal enzymes of the liver, ethanol and hepatotoxic agents increase production: hydroxylated. metabolites of paracetamol, which allows the development of severe intoxication, even with a small overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

When used simultaneously with ethanol, it will break down. risk of acute pancreatitis.

Myelotoxic agents increase the manifestation of hematotoxicity of paracetamol.

Caffeine is an adenosine antagonist (large doses of adenosine may be required).

With simultaneous application; caffeine and inductors of microsomal liver enzymes may enhance metabolism and increase caffeine clearance; inhibitors, microsomal enzymes of the liver - a decrease in the metabolism of caffeine in the liver.

Mexiletine reduces caffeine withdrawal to 50 %; nicotine increases speed excretion of caffeine.

Monoamine oxidase inhibitors; furazolidone, procarbazine and soylegiline - large doses of caffeine can cause the development of dangerous cardiac arrhythmias or severe, high blood pressure.

Caffeine reduces absorption of drugs calcium from the gastrointestinal tract; reduces the effect of narcotic and hypnotics; increases the excretion of lithium drugs with urine; accelerates absorption and enhances the action of cardiac glycosides, increases their toxicity.

The simultaneous use of caffeine with p- adrenoblockers can lead to mutual suppression of therapeutic effects; with P-adrenomimetics - to additional stimulation of central CNS and other additive toxic effects.

Caffeine can reduce the clearance of theophylline and, possibly, other xanthines, increasing the possibility of additive pharmacodynamic and toxic effects.

Propifenazone-can increase the effect of oral hypoglycemic agents sulfanilamide preparations anticoagulants ulcerogenic effect of glucocorticosteroids, reduces the effectiveness of potassium-sparing diuretics.

Absorption of the components of the drug may decrease with simultaneous application with colestyramine; m-holinoblokatorami, antidepressants.

Special instructions:

Excessive use of caffeinated products on the background of treatment - can cause symptoms of an overdose of caffeine.

For the duration of treatment it is necessary to refrain from drinking alcohol.

Effect on the ability to drive transp. cf. and fur:During the period of taking the drug, care should be taken when driving vehicles and engaging in other activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Pills.

6 tablets per blister. One blister, together with a pocket for wearing a blister or without it, and the instructions for use are placed in a cardboard pack.

12 tablets per blister. One or two blisters together with a pocket for wearing a blister or without it and the instructions for use are placed in a cardboard pack.

30 tablets per container-polymer for medicines. Free space in containers is filled with cotton wool. On. container paste a self-adhesive label. One container together with the instruction for use is placed in a cardboard pack.

Packaging:

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. After expiration date the drug should not be used.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001021

Date of registration:18.10.2011

The owner of the registration certificate:ALVILS Patent, Open CompanyALVILS Patent, Open Company

Manufacturer: & nbsp

STIROLBIOFARM, LLC Ukraine

Representation: & nbspALVILS Patent, Open CompanyALVILS Patent, Open Company

Information update date: & nbsp12.02.2014

Illustrated instructions

Instructions

Новалгин (Novalgin)