Rinzasip for children powder for the preparation of a solution for oral administration 3 g pack. No. 10 (raspberry)
Description:
A remedy for eliminating the symptoms of acute respiratory infections and colds.
Compound:
Ascorbic acid - 100 mg Paracetamol - 280 mg Pheniramine maleate - 10 mg Excipients: aspartame 35.0 mg, acesulfame potassium 23.0 mg, magnesium citrate 105.0 mg, sucrose 2361.7 mg, raspberry flavor Permasil, 0 mg, Azorubine dye 4.0 mg.
Indications for use:
Symptomatic treatment of colds, including influenza (fever, pain syndrome), rhinitis and nasopharyngitis of an infectious-inflammatory and allergic nature.
Contraindications:
Hypersensitivity to paracetamol and other components included in the drug; taking other medications containing substances included in Rinzasip for children; severe dysfunction of the liver and kidneys; blood diseases, deficiency of the enzyme glucose-6-phosphate dehydrogenase, phenylketonuria; children under 6 years of age.
Pharmacodynamics:
A combined drug, the pharmacological action of which is determined by the active components included in its composition. Paracetamol has an analgesic and antipyretic effect, reduces the pain syndrome observed with colds - sore throat, headache, muscle and joint pain, and reduces high fever.
Pharmacokinetics:
The effect of the drug is due to the combined effect of all the active components included in its composition, so pharmacokinetic studies are not possible.
Side effects:
Allergic reactions (skin rash, itching, urticaria, angioedema), nausea, dry mouth, epigastric pain, constipation; anemia, leukopenia, agranulocytosis, thrombocytopenia; accommodation paresis, urinary retention, drowsiness. With long-term use in large doses, hepatotoxic and nephrotoxic effects, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia are possible.
Method of preparation or use:
Inside. Dissolve the contents of 1 sachet (bag) in a glass (200 ml) of warm water and drink. Depending on the age of the child, the drug is used in the following doses: - children from 6 to 10 years old: 1 sachet 2 times a day; -children from 10 to 12 years old: 1 sachet 3 times a day. -children from 12 to 15 years old: 1 sachet 4 times a day. The interval between doses should be at least 4 hours. The duration of treatment is no more than 5 days.
Leave order:
No limits
Storage conditions:
Store in a dry place, at a temperature not exceeding 25°C. Keep out of the reach of children.
Rinzasip® for children
In case of overdose, consult a doctor immediately. Prompt medical attention is critical, even if you do not experience any signs or symptoms.
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.
Pheniramine
Symptoms
: convulsions, impaired consciousness, coma.
Paracetamol
Symptoms (caused mainly by paracetamol)
, in adults and children over 12 years of age, appear after taking more than 7.5-10 g within 8 hours. Deaths are rare (less than 3-4% of untreated cases) and occur with doses ≥ 15 g of paracetamol. In children under 12 years of age, acute overdose of ≤150 mg/kg paracetamol is not associated with hepatotoxicity.
During the first 24 hours after administration - anorexia, nausea, vomiting, abdominal pain, increased sweating, pallor and general malaise.
Symptoms of liver dysfunction may appear 12-48-72 hours after an overdose: increased activity of “liver” transaminases, hepatonecrosis. In severe cases - liver failure with progressive encephalopathy, coma. Rarely, liver failure develops rapidly and can be complicated by renal failure (tubular necrosis).
In case of overdose with a slow-release paracetamol preparation, it is advisable to additionally determine the concentration of paracetamol in plasma 4-6 hours after determining the initial concentration of paracetamol in plasma. Severe hepatotoxicity or death has been extremely rare during acute paracetamol overdose in young children, possibly due to differences in the metabolic pathways of paracetamol.
The following are clinical events associated with paracetamol overdose that, when considered in relation to overdose, are expected, including death due to fulminant liver failure or its sequelae.
The following clinical consequences of acute liver failure caused by an overdose of paracetamol (in adults and adolescents over 12 years of age, taking > 7.5 g paracetamol over 8 hours, in children under 12 years, taking > 150 mg/kg paracetamol over 8 hours) are expected: sepsis, fungal infection, bacterial infection, disseminated intravascular coagulation, coagulopathies, thrombocytopenia, hypoglycemia, metabolic acidosis, lactic acidosis, coma, encephalopathy, cerebral edema, cardiomyopathy, hypotension, respiratory failure, pancreatitis, gastrointestinal bleeding, acute renal failure ( tubular necrosis), multiple organ failure.
The threshold for overdose may be lowered in children, in patients taking certain medications (eg, liver microsomal enzyme inducers), alcohol, or who are malnourished.
Treatment
: gastric lavage, administration of activated charcoal in the first 6 hours after an overdose, administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8 - 9 hours after an overdose and acetylcysteine after 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 taking it. Symptomatic therapy.
Rinzasip with Vitamin C powder for oral administration sachet 5g No. 5 orange
Compound
Active ingredients:
- paracetamol - 750 mg;
- caffeine - 30 mg;
- pheniramine maleate - 20 mg;
- phenylephrine hydrochloride - 10 mg;
- ascorbic acid (vit. C) - 200 mg.
Excipients: citric acid - 200 mg, sodium saccharinate - 40 mg, sodium citrate - 500 mg, sucrose - 3062.5 mg, sunset yellow dye (E110) - 7.5 mg, orange flavor - 150 mg.
Pharmacokinetics
Data on the pharmacokinetics of the drug Rinzasip® with vitamin C are not provided.
Indications for use
Symptomatic treatment of colds, flu, acute respiratory viral infections (fever, pain, rhinorrhea).
Contraindications
- hypersensitivity to individual components of the drug, as well as to sympathomimetic drugs;
- simultaneous use of medications containing substances included in 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 discontinuation of their use less than 2 weeks ago;
- alcoholism;
- sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
- pregnancy;
- lactation period (breastfeeding);
- children under 15 years of age.
Carefully
For heart disease, arterial hypertension, bronchial asthma, chronic obstructive pulmonary disease, emphysema, chronic bronchitis, thyroid diseases, diabetes mellitus, pheochromocytoma, blood diseases, glucose-6-phosphate dehydrogenase deficiency, acute hepatitis, congenital hyperbilirubinemia (Gilbert, Dubin syndromes - Johnson and Rotor), liver and/or renal failure, concomitant use of drugs that can adversely affect the liver (for example, inducers of microsomal liver enzymes), pyloroduodenal obstruction, stenosing gastric and/or duodenal ulcer, angle-closure glaucoma, epilepsy, prostatic hyperplasia , urolithiasis, with the formation of kidney stones, as well as in patients suffering from exhaustion and/or dehydration, the drug can be used with caution after consultation with a doctor.
Directions for use and doses
Inside.
Pour the contents of 1 sachet (bag) into a glass, add hot water, stir until completely dissolved and drink (you can add sugar or honey if desired). Taking the drug is recommended 1-2 hours after eating.
Adults and children over 15 years of age: take 1 sachet 3-4 times a 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.
Storage conditions
The drug should be stored in a dry place, out of reach of children, at a temperature not exceeding 25°C.
Best before date
3 years. Do not use after expiration date.
special instructions
During the treatment period you should refrain from drinking alcohol.
If symptoms worsen or persist for more than 5 days, or if new symptoms appear, you should consult your doctor.
The drug may cause drowsiness.
The drug contains sucrose, which must be taken into account by patients suffering from diabetes mellitus, as well as those on a hypocaloric diet. 1 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 the drug is swallowed by a child, seek immediate medical attention.
If the medicine has become unusable or has expired, do not throw it into wastewater or onto the street! Place the medicine in a bag and place it in the trash. These measures will help protect the environment.
Description
A drug to eliminate the symptoms of acute respiratory infections and colds.
Dosage form
Powder for solution for oral administration (orange) from light orange to orange in color with white and orange inclusions.
Use in children
Contraindicated in children under 15 years of age.
Action
The combined drug has antipyretic, analgesic, alpha-adrenergic stimulating, vasoconstrictor and antihistamine effects, eliminating the symptoms of “colds”.
Paracetamol
- non-narcotic analgesic; blocks cyclooxygenase, mainly in the central nervous system, affecting the centers of pain and thermoregulation; has analgesic and antipyretic effects.
Phenylephrine
- alpha-adrenergic agonist with moderate vasoconstrictor effect. Reduces swelling and hyperemia of the mucous membranes of the upper respiratory tract and paranasal sinuses.
Pheniramine
- blocker of H1-histamine receptors. 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.
Caffeine
has a stimulating effect on the central nervous system, enhances the effect of analgesics, eliminates drowsiness and fatigue, increases physical and mental performance, reduces fatigue and drowsiness.
Ascorbic acid (vitamin C)
participates in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and the synthesis of steroid hormones; reduces vascular permeability and increases the body's resistance to various adverse environmental factors.
Side effects
Allergic reactions: skin rash, itching, urticaria, angioedema, anaphylactic shock.
From the nervous system: headache, dizziness, drowsiness, difficulty falling asleep, increased excitability.
From the cardiovascular system: increased blood pressure, tachycardia, palpitations.
From the digestive system: nausea, vomiting, pain in the epigastric region, dyspepsia, diarrhea, hepatotoxic effect.
From the senses: 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, glycosuria, interstitial nephritis, papillary necrosis), difficulty urinating.
Other: dryness of the oral and nasal mucosa, pharyngitis, bronchospasm.
From the skin: serious skin reactions very rarely - acute generalized exanthematous pustulosis (AGEP; 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 (SS; malignant exudative erythema; 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, which leads to the detachment of large areas of skin at the dermoepidermal 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 often (≥1/10), often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rare (1/10,000 and <1/1000), very rare (<1/10,000).
Isolated reports of unspecified frequency (frequency of occurrence cannot be estimated from available data)
From the immune system: very rarely - anaphylactic reactions, hypersensitivity.
Allergic reactions: very rarely - skin rash, itching, urticaria.
From the nervous system: very rarely - insomnia, anxiety, headache.
From the cardiovascular system: very rarely - palpitations, tachycardia.
From the digestive system: very rarely - increased levels of transaminases*.
* A slight increase in transaminase levels may be observed in some patients using paracetamol in recommended doses; this elevation is not associated with liver failure and usually resolves with continued treatment or discontinuation of paracetamol.
If one of the side effects described above develops, the patient should stop taking the drug and consult a doctor immediately.
Use during pregnancy and breastfeeding
Due to the lack of clinical data, the safety of the drug during pregnancy and breastfeeding has not been established, therefore the use of the drug in this category of patients is contraindicated.
Interaction
- Oral contraceptives and hormone replacement therapy. Ascorbic acid acts as a competitive inhibitor for sulfated ethinyl estradiol. It was noted that ascorbic acid at a dose of 1 g increases the bioavailability of ethinyl estradiol 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 iron absorption. Ascorbic acid enhances iron absorption due to the formation of a chelate with oxidized iron at acidic pH, which remains soluble at alkaline duodenal pH.
- Deferoxamine. The combined use of ascorbic acid and deferoxamine in severe chronic iron intoxication can lead to impaired cardiac function. Presumably, the effect results from deferoxamine increasing the amount of iron available to chelate with ascorbic acid.
- MAO inhibitors. Enhances the effects of MAO inhibitors, sedatives, ethanol.
- When taken with digoxin or other cardiac glycosides, the risk of arrhythmia and myocardial infarction may increase.
- Antidepressants, antiparkinsonian drugs, antipsychotic drugs, phenothiazine derivatives increase the risk of developing urinary retention, dry mouth, and constipation.
- GCS increase the risk of developing glaucoma.
- Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.
- Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol.
- Paracetamol reduces the effectiveness of diuretic and uricosuric drugs.
- When administered simultaneously with barbiturates, diphenin, carbamazepine, rifampicin and other inducers of microsomal liver enzymes, the risk of developing the hepatotoxic effect of paracetamol increases.
- In most patients taking warfarin long-term, infrequent use of paracetamol usually has little or no effect on the 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 dose of caffeine increases lithium excretion by the kidneys. Abrupt cessation of caffeine may result in increased serum lithium concentrations.
- When taken simultaneously with MAO inhibitors, furazolidone, pheniramine can lead to hypertensive crisis, agitation, and hyperpyrexia. When taken with MAO inhibitors, phenylephrine can lead to an increase in 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-adrenomimetic activity of phenylephrine.
- Tricyclic antidepressants enhance the adrenomimetic effect of phenylephrine; simultaneous administration of halothane increases the risk of developing ventricular arrhythmia.
Overdose
In case of overdose, consult a doctor immediately. 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, state of altered 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 (“caffeineism”): irritability, insomnia, anxiety, emotional lability, chronic abdominal pain.
- Pheniramine
Symptoms: central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, intestinal paresis), tachycardia, hypotension, hypertension, nausea, vomiting, psychomotor agitation, disorientation, hallucinations, psychosis, convulsions , arrhythmias. Rarely, patients with agitation, seizures, or comatose patients develop rhabdomyolysis and renal failure.
- Phenylephrine
Symptoms: headache, nausea, vomiting, irritability, agitation, insomnia, psychosis, convulsions, palpitations, tachycardia, increased blood pressure, reflex bradycardia.
- Paracetamol
Symptoms appear after taking more than 7.5-10 g: during 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 liver dysfunction may appear 12-48 hours after an overdose: increased activity of liver transaminases, hepatonecrosis. In severe cases - liver failure with progressive encephalopathy, coma. Rarely, liver failure develops rapidly and can be complicated by renal failure (tubular necrosis).
The threshold for overdose may be lowered in elderly patients and children, in patients taking certain medications (eg, liver microsomal enzyme inducers), alcohol, or who are malnourished.
From the circulatory system: an overdose of paracetamol in people with glucose-6-phosphate dehydrogenase deficiency can cause hemolytic anemia.
Treatment: gastric lavage, administration of activated carbon in the first 6 hours after an overdose, administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after an 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 administration. Symptomatic therapy.
Impact on the ability to drive vehicles and operate machinery
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.
