Rinza^® kids (Powder) Instructions for Use

Marketing Authorization Holder

J&JTL, LLC (Russia)

Manufactured By

Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd.) (India)

Contact Information

J&JTL LLC (Russia)

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

Rinza® kids

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

Dosage Form, Packaging, and Composition

Powder for oral solution (raspberry) granulated, from 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 effects, reduces pain syndrome observed in colds – sore throat, headache, muscle and joint pain, reduces high temperature.

Pheniramine has an antiallergic effect: eliminates 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

• Used in children from 6 to 15 years of age for short-term symptomatic treatment of conditions accompanied by elevated temperature, runny nose, headache, sore throat, as well as pain and aches in muscles during acute respiratory viral infections, including colds and influenza, rhinitis and rhinopharyngitis of infectious-inflammatory and allergic nature.

ICD codes

Dosage Regimen

Orally.

Dissolve the contents of 1 sachet in a glass (200 ml) of warm water and drink.

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, angioneurotic edema, anaphylactic shock.

From the nervous system headache, dizziness, drowsiness, sleep onset disturbance, increased excitability.

From the digestive system nausea, vomiting, pain in the epigastric region, dryness of the oral mucosa, hepatotoxic effect.

From the sensory organs mydriasis, accommodation paresis, increased intraocular pressure.

From the hematopoietic organs anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, leukopenia.

From the urinary system nephrotoxicity (renal colic, glucosuria, interstitial nephritis, papillary necrosis), difficulty urinating.

Other bronchospasm.

From the skin: 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 occur 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 keratinocyte apoptosis, leading to detachment of large areas of skin at the dermo-epidermal junction; the affected skin looks scalded by boiling water); drug rash with eosinophilia and systemic symptoms (DRESS syndrome).

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 available data).

From the immune system: very rarely – anaphylactic reactions, hypersensitivity.

Allergic reactions: very rarely – skin rash, itching, urticaria, fixed erythema.

From the digestive system: very rarely – increased transaminase levels*.

From the nervous system: isolated reports of unspecified frequency – drowsiness.

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

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

Contraindications

• Hypersensitivity to paracetamol, pheniramine, ascorbic acid or other components included in the drug;
• Concomitant use of other drugs containing substances that are part of Rinza^® kids;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
• Portal hypertension;
• Severe liver function disorders;
• Severe renal function disorders;
• Conditions associated with iron accumulation in the body, for example, hemochromatosis, thalassemia, sideroblastic anemia;
• Severe renal failure or hemodialysis;
• Blood diseases;
• Glucose-6-phosphate dehydrogenase deficiency;
• Phenylketonuria;
• Alcoholism;
• Pregnancy;
• Breastfeeding period;
• Children under 6 years of age.

With caution

In diabetes mellitus, congenital hyperbilirubinemias (Gilbert’s, 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), as well as when taking flucloxacillin, pyloroduodenal obstruction, stenosing gastric and/or duodenal ulcer, emphysema, chronic bronchitis, bronchial asthma, urolithiasis, with formation of kidney stones 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 function disorders.

Use in Renal Impairment

Contraindications: severe renal function disorders; 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 glucose and uric acid content in blood plasma.

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 must 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 sewage 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 the ability to drive vehicles and mechanisms

The drug may cause drowsiness, accommodation disturbance. 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. Rapid 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 ascorbic acid intoxication: impaired excretory function of the kidneys, formation of kidney stones, 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 paracetamol concentration 4-6 hours after determining the initial plasma paracetamol concentration. Severe hepatotoxicity or fatal outcomes have been extremely rarely observed with 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, including 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 8-9 hours after overdose and acetylcysteine 12 hours later. 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 Rinza^® kids simultaneously with antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives), the risk of urinary retention, dryness of the oral mucosa, constipation increases, and the sedative effect also increases.

Simultaneous use of corticosteroids increases the risk of glaucoma.

Due to the pheniramine maleate included in the composition, Rinza^® kids enhances the effect of sedative drugs.

Paracetamol reduces the effectiveness of uricosuric drugs.

Paracetamol enhances the effects of MAO inhibitors, sedative drugs 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 used simultaneously with barbiturates, anticonvulsants (phenytoin), flumecinol, phenylbutazone, carbamazepine, rifampicin, isoniazid, zidovudine, anticoagulants, amoxicillin in combination with clavulanic acid, tricyclic antidepressants 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, and the toxicity of the latter increases.

When using therapeutic doses of paracetamol and flucloxacillin simultaneously, metabolic acidosis with a high anion gap caused by the accumulation of pyroglutamic acid (5-oxoprolinemia) has been reported. Elderly women with conditions such as sepsis, renal dysfunction and malnutrition are at greatest risk. Most patients showed improvement after discontinuation of one or both drugs.

Myelotoxic drugs enhance the manifestations of hematotoxicity of paracetamol, metoclopramide enhances its absorption.

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 when used in combination with other drugs with anticholinergic properties (other antihistamines, phenothiazine neuroleptics, imipramine-type antidepressants, anticholinergic antiparkinsonian drugs, atropine-like antispasmodic drugs, disopyramide) should be taken into account.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

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.