Apap C Plus - instructions for use, dose, side effects, contraindications

Excipients: riboflavin sodium phosphate, citric acid anhydrous, sodium hydrogen carbonate, sodium carbonate anhydrous, povidone, macrogol 6000, flavoring lemon 84260-51, sodium saccharinate, aspartame, citrus flavor (lemon) 610049H, magnesium stearate.

Description:Ploskotsilindrichesky tablets of white with a yellowish or orangeish shade of color with a rough surface.

Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic remedy + vitamin)

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.51 Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Apap C plus a combined preparation. Paracetamol has analgesic and antipyretic effect. Due to the inhibition of cyclooxygenase, arachidonic acid prevents the formation of prostaglandins in the central nervous system (CNS). Reduction of the concentration of prostaglandins in the hypothalamus causes antipyretic effect. Ascorbic acid participates in the regulation of oxidation-reduction processes, carbohydrate metabolism, blood clotting, tissue regeneration, in the synthesis of steroid hormones; increases the body's resistance to infections, reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. It improves paracetamol tolerance and extends its action (slowing its excretion).

Indications:

Feverish syndrome on the background of "cold" diseases.

Pain syndrome (mild and moderate): arthralgia, myalgia, neuralgia, migraine, dental and headache, algodismenorea; pain with injuries, burns.

Contraindications:

Hypersensitivity; gastrointestinal bleeding; portal, hypertension; renal and / or liver failure; pregnancy (I and III trimesters); deficiency of glucose-6-phosphate dehydrogenase, children under 12 years.

Carefully:

With congenital hyperbilirubinemia (including Gilbert's syndrome), alcoholism, alcoholism, alcoholism, creatinine clearance less than 60 ml / min, lactation period, in old age, while taking oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (incl. acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation).

The drug should not be taken concurrently with other paracetamol-containing drugs.

Dosing and Administration:

Inside, adults and children over 12 years (with a body weight of more than 50 kg) 1 tablet every 4-6 hours. Do not take more than 3 tablets per day.Before taking the tablet should be dissolved in 100-200 ml of warm water.

The interval between individual methods of the drug should be at least 4 hours.

Duration of treatment without medical supervision should not exceed 3 days, with the appointment as an antipyretic agent, and 5 days as an analgesic.

Side effects:

From the skin: skin itching, rash on the skin and mucous membranes (usually erythematous or urticaria), Quincke's edema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's Syndrome).

From the gastrointestinal tract: nausea, pain in the epigastrium, increased activity of "liver" enzymes, usually without the development of jaundice.

From the endocrine system: hypoglycemia, up to hypoglycemic coma.

On the part of the organs of hematopoiesis: anemia (cyanosis), sulfogemaglobinemia, methemoglobinemia (dyspnea, heart pain), hemolytic anemia (especially for patients with deficiency of glucose-6-phosphate dehydrogenase). With prolonged use in large doses - aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.

From the urinary system: (when taking large doses) - nephrotoxicity (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis).

Overdose:

The clinical picture of acute overdose develops within 6-14 hours after taking the drug. Symptoms of chronic overdose appear after 2-4 days after increasing the dose of the drug.

Symptoms of acute overdose: gastrointestinal disorders (diarrhea, decreased appetite, nausea and vomiting, discomfort in the abdominal cavity and / or abdominal pain), increased sweating.

Symptoms of chronic overdose: a hepatotoxic effect develops, characterized by common symptoms (pain, weakness, adynamia, increased sweating) and specific, characterizing liver damage. As a result, hepatonecrosis can develop. Hepatotoxic effect of paracetamol can be complicated by the development of hepatic encephalopathy (disorders of thinking, suppression of higher nervous activity, agitation and stupor), convulsions, respiratory depression, coma, cerebral edema, bleeding disorders, development of DIC syndrome, hypoglycemia, metabolic acidosis, arrhythmia, collapse.Rarely, the dysfunction of the liver develops at a lightning speed and can be complicated by renal insufficiency (tubular necrosis).

Treatment: introduction of donators SH-groups and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N-acetylcysteine - after 12 hours The need to bring additional therapeutic measures (further introduction of methionine, iv administration N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:

Reduces the effectiveness of uricosuric drugs. The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a decrease in the synthesis of procoagulant factors in the liver). Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which allows the possibility of severe intoxication even with a slight overdose.

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

Ethanol promotes the development of acute pancreatitis.

Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects.

Long-term combined use of paracetamol and non-steroidal anti-inflammatory drugs increases the risk of developed analgesic neuropathy and renal papillary necrosis, the onset of the terminal stage of renal failure.

Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer. Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity. Reduces the effectiveness of uricosuric medicines.

With a decrease in the rate of gastric emptying (propanthelin), the action of the drug slows down, with acceleration (metoclopramide) starts to act faster.

Increases the toxicity of chloramphenicol.

Vitamin C increases the absorption of penicillin, iron, reduces the effect of heparin and indirect anticoagulants, increases the risk of crystalluria in the treatment of salicylates.Absorption of vitamin C decreases with simultaneous use with oral contraceptives.

Vitamin C slows the excretion of kidney acids, reduces the reabsorption of drugs that have an alkaline reaction (including alkaloids).

Vitamin C in combination with deferoxamine increases the toxic effect of iron on tissues (especially on the heart, causing the development of heart failure), administration of drugs containing ascorbic acid is carried out after determining the concentration of deferoxamine and determining the excretion of iron, no earlier than 1 to 2 hours after infusion of deferoxamine .

Special instructions:

With continued febrile syndrome with the use of the drug for more than 3 days, and pain syndrome - more than 5 days, you need a doctor's consultation. The risk of liver damage increases in patients with alcoholic hepatosis. Distorts the indicators of laboratory studies in quantitative determination of glucose and uric acid in the plasma. During long-term treatment, monitoring of the peripheral blood pattern and the functional state of the liver is necessary.

Persons prone to ethanol use should consult a doctor before starting treatment with the drug, since paracetamol can have a damaging effect on the liver.

In connection with the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, it is necessary to monitor the kidney function and arterial pressure. With prolonged use of large doses of vitamin C, oppression of the insular pancreas function may be possible. In patients with elevated the content of iron in the body should use ascorbic acid in minimal doses.

The administration of drugs containing ascorbic acid to patients with rapidly proliferating and intensely metastatic tumors can aggravate the course of the process.

Ascorbic acid, as a reducing agent, can distort the results of various laboratory tests (blood glucose, bilirubin, transaminase activity, LDH).

Form release / dosage:

Tablets effervescent 500mg + 300mg.

Packaging:

1. For 10 tablets in a polypropylene tube with a polyethylene cap containing a substance that absorbs moisture.

For 1 or 2 tubes in a cardboard box with instructions for use.

2. 1 tablet in the sachet paper / Al /LDPE / sirlin.

For 2, 6, 10 or 20 sachets in a cardboard box with instructions for use.

Storage conditions:

In a dry place at a temperature of 15 ° C to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the drug after the expiry date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-006782/09

Date of registration:25.08.2009

Expiration Date:Unlimited

The owner of the registration certificate: YuS Pharmacy LLC YuS Pharmacy LLC Poland

Manufacturer: & nbsp

SwissCo Servises, AG Switzerland

Information update date: & nbsp16.08.2017

Illustrated instructions

Instructions

Apap C Plus (Apap C Plus)