Rinza^® (Tablets) 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)

Dosage Form

Rinza®

Tablets: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, flat, pink in color with dark pink and white specks, with beveled edges and a score line on one side.

Excipients: colloidal silicon dioxide – 7 mg, corn starch – 62.5 mg, corn starch (for 20% paste) – 20 mg, povidone (K30) – 4 mg, sodium methylparaben – 1 mg, magnesium stearate – 6 mg, talc – 7 mg, sodium carboxymethyl starch (type A) – 10 mg, Ponceau 4R dye – 0.5 mg.

4 pcs. – blisters (1) – cardboard packs.
4 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Remedy for the relief of acute respiratory disease and “common cold” symptoms (psychostimulant + non-narcotic analgesic + alpha-adrenergic agonist + H1-histamine receptor blocker)

Pharmacological Action

A combination drug.

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

Phenylephrine is an alpha₁-adrenergic agonist. It has a vasoconstrictive effect, reduces swelling and hyperemia of the mucous membranes of the upper respiratory tract and paranasal sinuses.

Chlorphenamine is a histamine H₁-receptor blocker, has an antiallergic effect, reduces swelling and hyperemia of the mucous membranes of the nasal cavity, nasopharynx and paranasal sinuses, relieves itching of the eyes, nose and throat, and reduces exudative manifestations.

Caffeine has a stimulating effect on the CNS, which leads to a reduction in fatigue and drowsiness, and an increase in mental and physical performance.

Indications

• Symptomatic treatment of infectious and inflammatory diseases: acute respiratory viral infections, including influenza and the “common cold”, which are accompanied by febrile syndrome, headache, muscle pain and aches, rhinorrhea, sore throat, sneezing and other symptoms.

ICD codes

Dosage Regimen

Administer orally.

For adults and children over 15 years, prescribe 1 tablet 3 to 4 times per day.

Maintain an interval of at least 4 hours between doses.

Do not exceed the maximum single dose of 1 tablet.

Do not exceed the maximum daily dose of 4 tablets.

Limit the course of treatment to no more than 5 days as symptomatic therapy.

Use the minimum effective dose for the shortest possible duration necessary to control symptoms.

Discontinue treatment if symptoms persist or worsen after 5 days and consult a physician.

Avoid concomitant use with other products containing paracetamol or caffeine.

Exercise caution in patients with hepatic or renal impairment; a dose reduction or increased dosing interval may be required.

Do not use in children under 15 years of age.

Adverse Reactions

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

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

Cardiovascular system disorders: increased blood pressure, tachycardia, palpitations.

Digestive system disorders: nausea, vomiting, epigastric pain, dyspepsia, diarrhea, hepatotoxic effect.

Sensory 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: dryness of the oral and nasal mucosa, pharyngitis, bronchospasm.

Skin and subcutaneous tissue disorders: serious skin reactions very rarely – acute generalized exanthematous pustulosis (AGEP; an acute condition with the development of pustular rashes; characterized by fever and diffuse erythema accompanied by burning and itching; swelling of the face, hands and mucous membranes 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, and 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 looks scalded).

Adverse reactions identified during post-marketing 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 rarely – anaphylactic reactions, hypersensitivity.

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

Nervous system disorders: very rarely – insomnia, feeling of anxiety, headache.

Cardiovascular system disorders: very rarely – palpitations, tachycardia.

Digestive system disorders: very rarely – abdominal pain, diarrhea, vomiting, increased transaminase levels*.

* A slight increase in transaminase levels may be observed in some patients taking 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 caffeine, chlorpheniramine, paracetamol, phenylephrine or other components of the drug;
• Severe coronary artery atherosclerosis;
• Arterial hypertension;
• Portal hypertension;
• Diabetes mellitus;
• Concomitant use of tricyclic antidepressants, MAO inhibitors, beta-blockers (including within 2 weeks after discontinuation of MAO inhibitors);
• Concomitant use of drugs containing substances that are part of the drug Rinza^®;
• Alcoholism;
• Pregnancy;
• Breastfeeding period;
• Children under 15 years of age.

With caution

In case of cardiac pathology, thyroid diseases, progressive malignant diseases, pheochromocytoma, bronchial asthma, chronic obstructive pulmonary disease, emphysema, chronic bronchitis, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, blood diseases, acute hepatitis, viral hepatitis, alcoholic hepatitis, congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson and Rotor syndromes), liver diseases, hepatic and/or renal failure, 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, glaucoma, epilepsy, difficulty urinating and/or prostatic hyperplasia, in case of dehydration, hypovolemia, anorexia, bulimia, cachexia (insufficient glutathione reserve in the liver), as well as in persons with a deficiency of calories consumed with food, the drug Rinza^® can 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

Should be used with caution in hepatic insufficiency.

Use in Renal Impairment

Should be used with caution in renal insufficiency.

Pediatric Use

The drug is contraindicated in children and adolescents under 15 years of age.

Special Precautions

During treatment, one should refrain from drinking alcohol, sleeping pills and anxiolytic (tranquilizer) drugs. Do not take together with other medicines containing Paracetamol, as well as with caffeine-containing drugs and products.

If the symptoms of the disease worsen, persist, or new symptoms appear after 5 days of using the drug, you should stop taking it and consult a doctor.

The drug may cause drowsiness.

The drug contains components that can cause allergic reactions (sodium methylparaben and Ponceau 4R dye), including delayed ones.

If the medicine is spoiled or the expiration date has expired, it should not be thrown into the sewage or on 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. 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, the patient should immediately consult a doctor. Prompt medical attention is critical, even if no signs or symptoms are observed.

Caffeine

Symptoms of acute overdose: abdominal pain, vomiting, facial flushing, fever, chills, agitation, insomnia, irritability, loss of appetite, weakness, tremor, increased muscle tone, altered state of consciousness, delirium, hallucinations, increased blood pressure followed by hypotension, tachycardia, tachypnea, increased diuresis, hypokalemia, hyponatremia, hyperglycemia, metabolic acidosis, convulsions, myoclonus and rhabdomyolysis, supraventricular and ventricular arrhythmias.

Symptoms of chronic caffeine intoxication “caffeinism”: irritability, insomnia, anxiety, emotional lability, chronic abdominal pain.

Chlorphenamine

Symptoms: CNS depression, hyperthermia, anticholinergic syndrome (mydriasis, facial flushing, fever, dry mouth, urinary retention, intestinal paresis), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, disorientation, hallucinations, psychosis, convulsions, arrhythmias. Rarely, patients with agitation, convulsions, or patients in a coma develop rhabdomyolysis and renal failure.

Phenylephrine

Symptoms: nausea, vomiting, irritability, agitation, insomnia, psychosis, convulsions, tremor, dizziness, headache, palpitations, tachycardia, increased blood pressure, reflex bradycardia, cerebral hemorrhage, paresthesia.

Paracetamol

Symptoms: appear after taking more than 7.5-10 g: within the first 24 hours after taking – pale skin, nausea, vomiting; anorexia, abdominal pain; increased prothrombin time, impaired glucose metabolism, metabolic acidosis (including lactic acidosis). Symptoms of impaired liver function may appear 12-48 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).

The overdose threshold may be reduced in elderly patients and 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 intake. Symptomatic therapy.

From the hematopoietic system: paracetamol overdose in people with glucose-6-phosphate dehydrogenase deficiency can cause hemolytic anemia.

Drug Interactions

Enhances the effects of MAO inhibitors, sedatives, ethanol.

Antidepressants, antiparkinsonian drugs, antipsychotics, phenothiazine derivatives – increase the risk of urinary retention, dry mouth, constipation.

Corticosteroids increase the risk of glaucoma.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects.

Metoclopramide and domperidone increase, and cholestyramine reduces the absorption rate of paracetamol.

Paracetamol reduces the effectiveness of uricosuric drugs.

When prescribed simultaneously with barbiturates, diphenylhydantoin, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of liver microsomal enzymes, the risk of hepatotoxic effects of paracetamol increases.

When chloramphenicol and paracetamol are used together, the T_1/2 of chloramphenicol may increase.

When therapeutic doses of paracetamol and flucloxacillin were used simultaneously, metabolic acidosis with a high anion gap caused by the accumulation of pyroglutamic acid (5-oxoprolinemia) was 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.

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.

A single large dose of caffeine promotes increased renal excretion of lithium. Abrupt discontinuation of caffeine can lead to an increase in serum lithium concentration.

Chlorphenamine simultaneously with MAO inhibitors, furazolidone can lead to hypertensive crisis, agitation, hyperpyrexia.

Concomitant use of phenylephrine with digoxin and other cardiac glycosides may increase the risk of arrhythmia and myocardial infarction.

Phenylephrine when taken with MAO inhibitors can lead to increased blood pressure. Phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs.

Tricyclic antidepressants enhance the adrenomimetic effect of phenylephrine, simultaneous administration of halothane increases the risk of ventricular arrhythmia. Reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenomimetic activity of phenylephrine.

Storage Conditions

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

Shelf Life

The shelf life is 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.