FluZiOZ (Powder) Instructions for Use

Marketing Authorization Holder

ZiO-Health CJSC (Russia)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Dosage Form

FluZiOZ

Powder for oral solution 500 mg+150 mg/5 g: sachet 5, 10, or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution blackberry, strawberry, cranberry, lemon, raspberry, peach, blueberry or currant flavored.

5 g – Sachets made of combined material (5) – cardboard packs.
5 g – Sachets made of combined material (10) – cardboard packs.
5 g – Sachets made of combined material (50) – cardboard packs.

Clinical-Pharmacological Group

Analgesic-antipyretic

Pharmacotherapeutic Group

Non-narcotic analgesic agent (non-narcotic analgesic + vitamin)

Pharmacological Action

Combined medicinal product.

Paracetamol is an analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory effects. The mechanism of action is associated with inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulation center in the hypothalamus.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and 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. Improves the tolerability of paracetamol and prolongs its action (associated with prolongation of T_1/2).

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. C_max in plasma is reached within 10-60 minutes after oral administration. It is distributed in most body tissues. It crosses the placental barrier and is excreted in breast milk. In therapeutic concentrations, binding to plasma proteins is insignificant but increases with increasing concentration. It undergoes primary metabolism in the liver. It is excreted mainly in the urine as glucuronides and sulfates. T_1/2 ranges from 1 to 3 hours.

Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Binding to plasma proteins is 25%. It is excreted in the urine as metabolites. Ascorbic acid taken in excessive amounts is rapidly excreted unchanged in the urine.

Indications

Febrile syndrome in colds.

Pain syndrome (mild to moderate): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algodysmenorrhea; pain in injuries, burns.

ICD codes

Dosage Regimen

Administer orally after preparing a solution. Dissolve the entire contents of one sachet in half a glass (approximately 100 ml) of warm or hot water. Stir thoroughly until the powder is completely dissolved. Consume the resulting solution immediately.

The single dose is determined by the patient’s age. For adults and adolescents aged 15 years and older, use one sachet (500 mg paracetamol + 150 mg ascorbic acid). Do not exceed this single dose.

Maintain an interval of at least 4 hours between doses. Do not administer more than 4 times within a 24-hour period. The maximum daily dose for adults and adolescents is 4 sachets (2000 mg of paracetamol).

The total duration of treatment for analgesia should not exceed 5 days. The duration for use as an antipyretic should not exceed 3 days. If symptoms persist beyond these durations, discontinue use and consult a physician.

For patients with hepatic impairment or chronic alcoholism, reduce the daily dose. Achieve this by either decreasing the single dose or increasing the interval between doses. Do not exceed 2-3 sachets per day in these populations. Avoid use in cases of severe hepatic insufficiency.

Do not use in children under 15 years of age, as this dosage form is intended for adults. Do not use concurrently with other medicinal products containing paracetamol or other analgesics/antipyretics.

Adverse Reactions

Allergic reactions skin itching, rash on the skin and mucous membranes (usually erythematous or urticarial), angioedema, multiform exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

From the central and peripheral nervous system usually when taken in high doses – dizziness, psychomotor agitation, disorientation.

From the digestive system nausea, epigastric pain, increased activity of hepatic transaminases, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).

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

From the hematopoietic system anemia (cyanosis), sulfhemoglobinemia, methemoglobinemia (shortness of breath, heart pain), hemolytic anemia (especially for patients with glucose-6-phosphate dehydrogenase deficiency); with long-term use in high doses – aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.

From the urinary system when taken in high doses – nephrotoxicity (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis).

Contraindications

Gastrointestinal bleeding; portal hypertension (increased blood pressure in the portal vein); severe liver and kidney dysfunction; blood system diseases (anemia, thrombocytopenia, leukopenia); childhood (for use of dosage forms intended for adults); hypersensitivity to paracetamol and/or ascorbic acid.

With caution

Renal and/or hepatic insufficiency, benign hyperbilirubinemia (Gilbert’s syndrome), viral hepatitis, alcoholic liver disease, chronic alcoholism, pregnancy, lactation (breastfeeding), in elderly patients.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is not recommended.

Use in Hepatic Impairment

With caution hepatic insufficiency.

In hepatic insufficiency, the daily dose is reduced by decreasing the single dose and/or frequency of administration.

Use in Renal Impairment

Contraindication — renal failure.

Pediatric Use

Do not use this product in children in dosage forms intended for adults.

Special Precautions

If hyperthermia persists for more than 3 days and pain syndrome for more than 5 days, a doctor’s consultation is required.

During long-term treatment, monitoring of peripheral blood picture and functional state of the liver is necessary.

Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, it is necessary to monitor kidney function and blood pressure.

With long-term use of ascorbic acid in high doses, suppression of the function of the insular apparatus of the pancreas is possible.

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

Do not use simultaneously with other drugs containing Paracetamol, as well as other non-narcotic analgesics, NSAIDs (for example, metamizole, acetylsalicylic acid, ibuprofen), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

Concomitant use with other medicinal products should be agreed with a doctor.

Persons prone to alcohol consumption should consult a doctor before starting treatment with this product, as Paracetamol may have a damaging effect on the liver.

Drug Interactions

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes possible the development of severe intoxications with small overdoses.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic action of paracetamol.

Ethanol contributes to the development of acute pancreatitis.

Reduces the effectiveness of uricosuric drugs .

When the rate of gastric emptying decreases (propantheline), the action of the combination slows down; when it accelerates (metoclopramide), it begins to act faster.

Increases the toxicity of chloramphenicol.

May enhance the effect of indirect anticoagulants.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.