special instructions
The drug should not be taken together with other medicines containing paracetamol. During the treatment period, 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 in blood plasma.
If symptoms worsen or persist after 5 days of using the drug, you should stop taking it and consult your doctor.
The drug may cause drowsiness.
The drug contains sucrose, which must be taken into account for children suffering from diabetes mellitus, as well as 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 has become unusable or has expired, do not throw it into wastewater or onto the street! Place the medication in a bag and place it in the trash. These measures will help protect the environment!
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.
Rinzasip for children por d/r-ra vn prim raspberry 3 g pack of cards x10
ATX code: N02BE51 (Paracetamol in combination with other drugs (excluding psycholeptics)) Active substances ascorbic acid Rec.INN WHO registered paracetamol Rec.INN WHO registered pheniramine Rec.INN WHO registered Dosage form RINZASIP ® FOR CHILDREN powder for preparation. solution for oral administration (raspberry) 3 g: sachet 5 or 10 pcs. reg. No.: LP-001821 dated 09/04/12 - Validity period of reg. beat not limited Release form, composition and packaging Powder for the preparation of a solution for oral administration, granular, from light pink to pink, with white and dark pink inclusions.
1 sachet ascorbic acid 100 mg paracetamol 280 mg pheniramine maleate 10 mg
Excipients: aspartame 35 mg, acesulfame potassium 23 mg, magnesium citrate 105 mg, sucrose 2361.7 mg, raspberry flavor Permasil mg, azorubine dye 4 mg.
3 g - sachet (5) - cardboard packs. 3 g - sachet (10) - cardboard packs.
Clinical-pharmacological group: Drug for symptomatic treatment of acute respiratory diseases Pharmaco-therapeutic group: Drug for eliminating the symptoms of acute respiratory infections and “colds” (non-narcotic analgesic + vasoconstrictor + vitamin)
Indications: ARVI (symptomatic therapy),
- allergic rhinitis,
- nasopharyngitis,
- pain syndrome (mild and moderate severity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algodismenorrhea,
- pain from injuries, burns.
ICD-10 codes ICD-10 code Indication G43 Migraine J00 Acute nasopharyngitis J02 Acute pharyngitis J06.9 Acute upper respiratory tract infection, unspecified J10 Influenza caused by an identified influenza virus J30.1 Allergic rhinitis caused by pollen J30.3 Other allergic rhinitis ( year-round allergic rhinitis) K08.8 Other specified changes in the teeth and their supporting apparatus (including toothache) M25.5 Joint pain M79.1 Myalgia M79.2 Neuralgia and neuritis, unspecified N94.4 Primary dysmenorrhea N94.5 Secondary dysmenorrhea R50 Fever of unknown origin R51 Headache R52.0 Acute pain R52.2 Other persistent pain (chronic)
Dosage regimen: Orally, adults (dosage form intended for adults) - 1 pack. 2-3 times/day.
Children (children's dosage form) 6-10 years old - 1 pack. 2 times/day, 10-12 years - 1 pack. 3 times/day, 12-15 years - 1 pack. 4 times/day. The interval between doses is at least 4 hours.
For chronic renal failure (creatinine clearance 10 ml/min), the interval between doses is 8 hours.
Side effects Allergic reactions (skin rash, itching, urticaria, angioedema), nausea, epigastric pain, anemia, thrombocytopenia, dry mouth, accommodation paresis, urinary retention, drowsiness.
With long-term use in large doses - hepatotoxic effect, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, erosive and ulcerative lesions of the gastrointestinal tract, bleeding in the gastrointestinal tract, nephrotoxicity (papillary necrosis).
Contraindications for use: hypersensitivity,
- portal hypertension,
- alcoholism,
— pregnancy (I and III trimesters),
- lactation period.
With caution: congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), children's age (up to 15 years - for the dosage form intended for adults), children's age (up to 6 years - for the pediatric dosage form), angle-closure glaucoma, prostatic hyperplasia , renal failure, glucose-6-phosphate dehydrogenase deficiency.
Use during pregnancy and breastfeeding Contraindications: pregnancy (I and III trimesters), lactation period.
Use for impaired renal function Caution: renal failure.
For chronic renal failure (creatinine clearance 10 ml/min), the interval between doses is 8 hours.
Use in children With caution: children's age (up to 15 years - for the dosage form intended for adults), children's age (up to 6 years - for the children's dosage form).
Children (children's dosage form) 6-10 years old - 1 pack. 2 times/day, 10-12 years - 1 pack. 3 times/day, 12-15 years - 1 pack. 4 times/day. The interval between doses is at least 4 hours.
Special instructions For hyperthermia lasting more than 3 days and pain lasting more than 5 days, consult a doctor.
Distorts laboratory test results in the quantitative determination of glucose and uric acid in plasma.
During treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.
During the treatment period, it is necessary to refrain from drinking ethanol (hepatotoxic effects may develop).
Impact on the ability to drive vehicles and operate machinery
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 Symptoms (caused by paracetamol): pallor of the skin, loss of appetite, nausea, vomiting, hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose). Toxic effects in adults are possible after taking more than 10-15 g of paracetamol: increased activity of liver transaminases, increased prothrombin time (12-48 hours after administration), a detailed clinical picture of liver damage appears after 1-6 days. Rarely, liver failure develops rapidly and can be complicated by renal failure (tubular necrosis).
Treatment: in the first 6 hours after an overdose - gastric lavage, administration of SH-group donors and precursors for the synthesis of glutathione - methionine 8-9 hours after the overdose and N-acetylcysteine after 12 hours.
The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as the time elapsed after its administration.
Drug interactions Ethanol enhances the sedative effect of antihistamines.
Antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives) increase the risk of side effects (urinary retention, dry mouth, constipation).
GCS increase the risk of developing glaucoma.
Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication with small overdoses.
Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.
Paracetamol reduces the effectiveness of uricosuric drugs.
Conditions for dispensing from pharmacies The drug is approved for use as an over-the-counter product. Conditions and periods of storage Store in a dry place, out of reach of children, at a temperature not exceeding 25°C.
Directions for use and doses
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.
pharmachologic effect
A combined drug used for colds.
- 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.
- 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, and in the synthesis of steroid hormones; reduces vascular permeability and increases the body's resistance to various adverse factors
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.
Contraindications
- Hypersensitivity to paracetamol and other components included in the drug;
- taking other medications containing substances included in RINZASIP® FOR CHILDREN;
- sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption,
- portal hypertension,
- severe dysfunction of the liver and kidneys;
- blood diseases, deficiency of the enzyme glucose-6-phosphate dehydrogenase,
- phenylketonuria,
- alcoholism,
- pregnancy, lactation period,
- children under 6 years of age.
