Rinzasip^® for children (Powder) Instructions for Use

Marketing Authorization Holder

Johnson & Johnson, LLC (Russia)

Manufactured By

Unique Pharmaceutical Laboratories (India)

Company Division

J. B. Chemicals & Pharmaceuticals, Ltd. (India)

ATC Code

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

Active Substances

Paracetamol (Rec.INN registered by WHO)

Ascorbic acid (Rec.INN registered by WHO)

Pheniramine (Rec.INN registered by WHO)

Dosage Form

Rinzasip® for children

Powder for preparation of oral solution (raspberry) 280 mg+10 mg+100 mg: sachet 3 g 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution (raspberry) granulated, light pink to pink in color with white and dark pink inclusions.

Excipients: aspartame – 35 mg, acesulfame potassium – 23 mg, magnesium citrate – 105 mg, sucrose – 2361.7 mg, raspberry flavor Permasil 11036-31 – 71 mg, colorant azorubine – 4 mg.

3 g – multilayer sachets (5) – cardboard packs.
3 g – multilayer sachets (10) – cardboard packs.

Clinical-Pharmacological Group

Drug for the relief of symptoms of acute respiratory infections and colds

Pharmacotherapeutic Group

Remedy for the relief of symptoms of acute respiratory infections and the “common cold” (non-narcotic analgesic agent + H₁-histamine receptor blocker + vitamin)

Pharmacological Action

A combined drug, the pharmacological action of which is determined by its active components.

Paracetamol has analgesic and antipyretic action, reduces pain syndrome observed in colds – sore throat, headache, muscle and joint pain, reduces high temperature.

Pheniramine – has an anti-allergic action: relieves itching of the eyes, nose and throat, swelling and hyperemia of the mucous membranes of the nasal cavity, nasopharynx and paranasal sinuses, reduces exudative manifestations.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, in the synthesis of steroid hormones; reduces vascular permeability and increases the body’s resistance to the effects of various adverse environmental factors.

Pharmacokinetics

The action of the drug is due to the combined action of all active components included in its composition, therefore, conducting pharmacokinetic studies is not possible.

Indications

• Symptomatic treatment of colds, incl. influenza (febrile syndrome, pain syndrome), rhinitis and rhinopharyngitis of infectious-inflammatory and allergic nature.

ICD codes

Dosage Regimen

The contents of 1 sachet should be dissolved in a glass (200 ml) of warm water and drunk.

Depending on the child’s age, the drug is used in the following doses

• children from 6 to 10 years 1 sachet 2 times/day;
• children from 10 to 12 years 1 sachet 3 times/day;
• children from 12 to 15 years 1 sachet 4 times/day.

The interval between doses should be at least 4 hours. The duration of the treatment course is no more than 5 days.

Adverse Reactions

Allergic reactions skin rash, itching, urticaria, angioedema, anaphylactic shock.

Nervous system disorders headache, dizziness, drowsiness, sleep onset disorder, increased excitability.

Digestive system disorders nausea, vomiting, pain in the epigastric region, dyspepsia, diarrhea, hepatotoxic effect.

Sense organ disorders mydriasis, accommodation paresis, increased intraocular pressure.

Hematopoietic system disorders anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, leukopenia.

Urinary system disorders nephrotoxicity (renal colic, glucosuria, interstitial nephritis, papillary necrosis), difficulty urinating.

Other bronchospasm.

Skin and subcutaneous tissue disorders: serious skin reactions very rarely – acute generalized exanthematous pustulosis (AGEP; acute condition with the development of pustular eruptions; characterized by fever and diffuse erythema accompanied by burning and itching; facial, hand and mucous membrane swelling may occur), Stevens-Johnson syndrome (SJS; malignant exudative erythema; a severe form of erythema multiforme in which blisters appear on the mucous membrane of the mouth, throat, eyes, genitals, other areas of the skin and mucous membranes), toxic epidermal necrolysis (TEN, Lyell’s syndrome; the syndrome is a consequence of extensive apoptosis of keratinocytes, leading to detachment of large areas of skin at the dermo-epidermal junction; the affected skin has the appearance of being scalded by boiling water).

Adverse reactions identified during post-registration use of the drug were classified as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10000 and <1/1000), very rare (<1/10000); isolated reports of unspecified frequency (frequency cannot be estimated from the available data).

Immune system disorders: very rare – anaphylactic reactions, hypersensitivity.

Allergic reactions: very rare – skin rash, itching, urticaria.

Digestive system disorders: very rare – increased transaminase levels*.

Nervous system disorders: isolated reports of unspecified frequency – drowsiness.

* A slight elevation of transaminase levels may be observed in some patients taking Paracetamol at recommended doses; this elevation is not accompanied by liver failure and usually resolves with continued treatment or discontinuation of paracetamol.

If one of the above side effects occurs, the patient should stop taking the drug and immediately consult a doctor.

Contraindications

• Hypersensitivity to paracetamol, pheniramine, ascorbic acid or other components of the drug;
• Concomitant use of other drugs containing substances that are part of Rinzasip^® for children;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
• Portal hypertension;
• Severe liver and kidney dysfunction;
• Conditions associated with iron accumulation in the body, e.g., hemochromatosis, thalassemia, sideroblastic anemia;
• Severe renal failure or hemodialysis;
• Blood diseases;
• Glucose-6-phosphate dehydrogenase deficiency;
• Phenylketonuria;
• Alcoholism;
• Pregnancy;
• Lactation period (breastfeeding);
• Children under 6 years of age.

With caution

In diabetes mellitus, congenital hyperbilirubinemias (Gilbert, Dubin-Johnson and Rotor syndromes), concomitant use of drugs that can adversely affect the liver (barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of liver microsomal enzymes), pyloroduodenal obstruction, stenosing gastric and/or duodenal ulcer, emphysema, chronic bronchitis, bronchial asthma, urolithiasis, with kidney stone formation or glaucoma; concomitant use of MAO inhibitors, tricyclic antidepressants, difficulty urinating due to prostate enlargement, the drug should be used with caution after consultation with a doctor.

Use in Pregnancy and Lactation

Due to the lack of clinical data, the safety of the drug during pregnancy and breastfeeding has not been established, therefore the prescription of the drug to this category of patients is contraindicated.

Use in Hepatic Impairment

Contraindications: portal hypertension; severe liver dysfunction.

Use in Renal Impairment

Contraindications: severe kidney dysfunction; severe renal failure, hemodialysis.

Pediatric Use

Contraindication: children under 6 years of age.

Special Precautions

The drug should not be taken together with other medicines containing Paracetamol.

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

Paracetamol distorts the results of laboratory tests of plasma glucose and uric acid content.

Patients with liver diseases should consult a doctor before using the drug.

Consult a doctor before use if the patient is taking other drugs containing ascorbic acid.

Consult a doctor if the patient has had episodes of kidney stone formation.

If the symptoms of the disease worsen, persist or new symptoms appear after 5 days of using the drug, its use should be discontinued and a doctor should be consulted.

The drug may cause drowsiness.

The drug contains sucrose, which should be taken into account in children suffering from diabetes mellitus, as well as in children on a hypocaloric diet. 1 single dose of the drug contains 2361.7 mg of sucrose, which corresponds to 0.20 XE.

If the medicine is spoiled or the expiration date has expired – it should not be thrown into wastewater or onto the street. It is necessary to place the medicine in a bag and put it in a trash container. These measures will help protect the environment.

Effect on ability to drive vehicles and mechanisms

Rinzasip^® for children may cause drowsiness. During the treatment period, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

In case of overdose, you should immediately consult a doctor. Prompt medical attention is critical, even if no signs or symptoms are observed.

Ascorbic acid

Symptoms of acute overdose: diarrhea and other gastrointestinal disorders.

Symptoms of chronic intoxication with ascorbic acid: impaired renal excretory function, kidney stone formation, decreased capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies, iron metabolism disorder), tooth enamel erosion.

Pheniramine

Symptoms: convulsions, impaired consciousness, coma.

Paracetamol

Symptoms (mainly due to paracetamol), in adults and children over 12 years of age, appear after taking more than 7.5-10 g within 8 hours. Fatal outcomes are rare (less than 3-4% of untreated cases) and are observed when taking a dose of >15 g of paracetamol. In children under 12 years of age, acute overdose with <150 mg/kg of paracetamol is not associated with hepatotoxicity.

Within the first 24 hours after ingestion – anorexia, nausea, vomiting, abdominal pain, increased sweating, pallor and general malaise.

Symptoms of liver dysfunction may appear 12-48-72 hours after overdose: increased activity of liver transaminases, hepatonecrosis. In severe cases – liver failure with progressive encephalopathy, coma. Rarely – liver failure develops fulminantly and may be complicated by renal failure (tubular necrosis). In case of overdose with a sustained-release paracetamol preparation, it is advisable to additionally determine the plasma concentration of paracetamol 4-6 hours after determining the initial plasma concentration of paracetamol. Severe hepatotoxicity or fatal outcomes were extremely rarely observed in acute paracetamol overdose in young children, possibly due to differences in paracetamol metabolism pathways.

The following are clinical phenomena associated with paracetamol overdose, which, when considered in connection with overdose, are considered expected, incl. fatal outcome due to fulminant liver failure or its consequences.

The following clinical consequences of acute liver failure caused by paracetamol overdose (in adults and adolescents over 12 years of age taking >7.5 g of paracetamol within 8 hours, in children under 12 years of age taking >150 mg/kg of paracetamol within 8 hours) are considered expected: sepsis, fungal infection, bacterial infection, disseminated intravascular coagulation, coagulopathies, thrombocytopenia, hypoglycemia, metabolic acidosis, lactic acidosis, coma, encephalopathy, cerebral edema, cardiomyopathy, arterial hypotension, respiratory failure, pancreatitis, gastrointestinal bleeding, acute renal failure (tubular necrosis), multiple organ failure.

The overdose threshold may be reduced in children, in patients taking certain medications (e.g., inducers of liver microsomal enzymes), alcohol or suffering from exhaustion.

Treatment: gastric lavage, administration of activated charcoal within the first 6 hours after overdose, administration of SH-group donors and precursors of glutathione synthesis – methionine within 8-9 hours after overdose and acetylcysteine within 12 hours. The need for additional therapeutic measures (further administration of methionine and acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as the time elapsed after its ingestion. Symptomatic therapy.

Drug Interactions

When taking Rinzasip^® for children simultaneously with antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives), the risk of urinary retention, dry mouth, constipation increases, and the sedative effect also increases.

Simultaneous use of corticosteroids increases the risk of glaucoma.

Paracetamol reduces the effectiveness of uricosuric drugs.

Paracetamol enhances the effects of MAO inhibitors, sedatives and ethanol.

In most patients taking warfarin long-term, occasional use of paracetamol generally has little or no effect on INR. However, with prolonged regular use, Paracetamol enhances the effect of indirect anticoagulants (warfarin and other coumarin derivatives), which increases the risk of bleeding.

When taken simultaneously with barbiturates, phenytoin, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of liver microsomal enzymes, ethanol, the risk of hepatotoxic action of paracetamol increases.

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

With simultaneous use of chloramphenicol and paracetamol, the T_1/2 of chloramphenicol may increase.

When taken with digoxin or other cardiac glycosides, the risk of arrhythmia and myocardial infarction may increase.

Simultaneous use with salicylates increases the risk of nephrotoxic action.

The possibility of enhancement of central atropine-like effects should be taken into account when used in combination with other drugs that have anticholinergic properties (other antihistamines, phenothiazine antipsychotics, atropine-like antispasmodic agents).

Storage Conditions

The drug should be stored out of the reach of children, in a dry place, protected from moisture at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is available without a prescription.

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.