Rinzasip^® with vitamin C (Powder) Instructions for Use

ATC Code

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

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 (non-narcotic analgesic + psychostimulant + H₁-histamine receptor blocker + alpha-adrenergic agonist + vitamin)

Pharmacological Action

A combined drug that has antipyretic, analgesic, alpha-adrenergic stimulating, vasoconstrictive, and antihistamine effects, and relieves the symptoms of the “common cold”.

Paracetamol – a non-narcotic analgesic; it blocks cyclooxygenase (COX), predominantly in the CNS, affecting the centers of pain and thermoregulation; it has an analgesic and antipyretic effect.

Phenylephrine – an alpha-adrenergic agonist with a moderate vasoconstrictive effect. It reduces edema and hyperemia of the mucous membranes of the upper respiratory tract and paranasal sinuses.

Pheniramine – an H₁-histamine receptor blocker. It has an antiallergic effect: it relieves itching of the eyes, nose, and throat, swelling and hyperemia of the mucous membranes of the nasal cavity, nasopharynx, and paranasal sinuses, and reduces exudative manifestations.

Caffeine has a stimulating effect on the CNS, enhances the effect of analgesics, eliminates drowsiness and fatigue, increases physical and mental performance, and reduces fatigue and sleepiness.

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

Pharmacokinetics

Data on the pharmacokinetics of the drug Rinzasip^® with vitamin C are not provided.

Indications

• symptomatic treatment of infectious and inflammatory diseases (ARVI, including the “common cold” and influenza), accompanied by high fever, chills, body aches, headache and muscle pain, runny nose, nasal congestion, sore throat, sneezing.

ICD codes

Dosage Regimen

Powder

Orally.

Pour the contents of 1 sachet into a glass, add hot water, stir until completely dissolved and drink (sugar or honey can be added if desired). It is recommended to take the drug 1-2 hours after a meal.

Adults and children over 15 years of age should take 1 sachet 3-4 times/day with intervals between doses of 4-6 hours.

The maximum daily dose is 4 sachets.

The course of treatment without consulting a doctor is no more than 5 days.

Adverse Reactions

Allergic reactions skin rash, itching, urticaria, angioedema, hypersensitivity reaction, anaphylactic reaction.

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

From the cardiovascular system increased blood pressure, tachycardia, palpitations.

From the digestive system nausea, vomiting, pain in the epigastric region, dry oral mucosa, increased activity of liver enzymes, 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.

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

Other bronchospasm, dryness of the nasal mucosa.

From the skin: serious skin reactions very rarely – acute generalized exanthematous pustulosis (AGEP; an acute condition with the development of pustular eruptions; 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 oral cavity, 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-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).

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

From the nervous system: very rarely – insomnia, feeling of anxiety, headache.

From the cardiovascular system: very rarely – palpitations, tachycardia.

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

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

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

* 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.

Contraindications

• hypersensitivity to individual components of the drug, as well as to sympathomimetic drugs;
• Simultaneous use of medicinal products containing substances that are part of the drug;
• Severe atherosclerosis of the coronary arteries;
• Portal hypertension;
• Conditions associated with the accumulation of iron in the body, such as hemochromatosis;
• Severe renal failure or hemodialysis;
• Simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors and their discontinuation less than 2 weeks ago;
• Alcoholism;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
• Pregnancy;
• Lactation period (breastfeeding);
• Children under 15 years of age.

With caution

In case of heart disease, arterial hypertension, bronchial asthma, COPD, emphysema, chronic bronchitis, thyroid diseases, diabetes mellitus, pheochromocytoma, blood diseases, glucose-6-phosphate dehydrogenase deficiency, acute hepatitis, congenital hyperbilirubinemias (Gilbert, Dubin-Johnson and Rotor syndromes), hepatic and/or renal failure, simultaneous use of drugs that can adversely affect the liver (e.g., inducers of liver microsomal enzymes), as well as when taking flucloxacillin, with pyloroduodenal obstruction, stenosing gastric and/or duodenal ulcer, closed-angle glaucoma, epilepsy, prostatic hyperplasia, urolithiasis, with the formation of kidney stones, as well as in the case of recurrent urate stone formation, in patients with impaired consciousness, as well as in patients suffering from exhaustion and/or dehydration, the drug 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 using 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

The drug should be used with caution in hepatic insufficiency.

Use in Renal Impairment

The drug should be used with caution in renal insufficiency.

Pediatric Use

Contraindicated in children under 15 years of age.

Special Precautions

During treatment, alcohol consumption should be avoided.

If the symptoms of the disease worsen or persist for 5 days, or if new symptoms appear, you should consult a doctor.

The drug may cause drowsiness.

The drug contains sucrose, which must be taken into account in patients suffering from diabetes mellitus, as well as in persons on a low-calorie diet. One single dose of the drug contains from 2915 to 3136 mg of sucrose, which corresponds to 0.24-0.26 XE.

Keep out of the reach of children. If a child swallows the drug, seek medical attention immediately.

If the medicine is unusable 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, 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 excretory function of the kidneys, formation of kidney stones, decreased capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies, impaired iron metabolism), erosion of tooth enamel.

Caffeine

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

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

Pheniramine

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

Phenylephrine

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

Paracetamol

Symptoms appear after taking more than 7.5-10 g: within the first 24 hours after ingestion – pallor of the skin, nausea, vomiting, anorexia, abdominal pain, increased prothrombin time, impaired glucose metabolism, hypokalemia, 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 rapidly 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 glutathione synthesis precursors – methionine 8-9 hours after overdose and acetylcysteine – after 12 hours. The need for additional therapeutic measures (further administration of methionine and acetylcysteine) depends on the concentration of paracetamol in the blood, as well as on the time elapsed after its intake. Symptomatic therapy.

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

Drug Interactions

Oral contraceptives and hormone replacement therapy. Ascorbic acid acts as a competitive inhibitor for sulfated ethinylestradiol. It has been noted that Ascorbic acid at a dose of 1 g increases the bioavailability of ethinylestradiol by 60-70% in women receiving a single oral dose, by 47% with long-term use of contraceptives, and by 21% in postmenopausal women receiving transdermal estradiol.

Iron. The use of ascorbic acid may increase the absorption of iron. Ascorbic acid enhances iron absorption due to the formation of a chelate with oxidized iron at an acidic pH, which remains soluble at the alkaline pH of the duodenum.

Deferoxamine. Concomitant use of ascorbic acid and deferoxamine in severe chronic iron intoxication may lead to impaired cardiac function. Presumably, the effect is a result of deferoxamine increasing the amount of iron available for chelation with ascorbic acid.

MAO inhibitors. Enhances the effects of MAO inhibitors, sedatives, ethanol.

There is a risk of serotonin syndrome when using phenylephrine concomitantly with MAO inhibitors.

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

Flucloxacillin

When therapeutic doses of paracetamol and flucloxacillin were used concomitantly, 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.

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 diuretic and uricosuric drugs.

When prescribed concomitantly with barbiturates, diphenin, carbamazepine, rifampicin and other inducers of liver microsomal enzymes, the risk of developing the hepatotoxic effect of paracetamol increases.

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.

When taken concomitantly with MAO inhibitors, furazolidone, pheniramine can lead to hypertensive crisis, agitation, hyperpyrexia.

When taken with MAO inhibitors, phenylephrine can lead to increased blood pressure. Phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs, and also reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenergic activity of phenylephrine.

Tricyclic antidepressants enhance the adrenomimetic effect of phenylephrine, simultaneous administration of halothane increases the risk of ventricular arrhythmia.

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.