Rinzasip for children powder d / prig.r-ra d / pr. Inside raspberry 3g, No. 10
Expiration Date: 05/2027
Russian Pharmacy name:
Ринзасип для детей порошок д/приг.р-ра д/пр.внутрь малина 3г, №10
Inside.
Dissolve the contents of 1 sachet (sachet) 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: - for 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 the course of treatment is no more than 5 days.
Composition for 1 sachet (3 g):
Active substances:
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 11036-31 71.0 mg, dye azorubin 4.0 mg.
Hypersensitivity to paracetamol, pheniramine, ascorbic acid or other components that make up the drug; taking other drugs containing substances that make up RINZASIPЃ FOR CHILDREN;
deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption,
portal hypertension,
severe impairment of liver and kidney function;
conditions associated with the accumulation of iron in the body, for example, hemochromatosis, thalassemia, sideroblastic anemia;
severe renal failure or hemodialysis;
blood diseases,
deficiency of the enzyme glucose-6-phosphate dehydrogenase,
phenylketonuria,
alcoholism,
pregnancy, lactation period,
children under 6 years of age.
Pharmacological properties
Pharmacodynamics
Combined drug, the pharmacological action of which is due to its constituent active components. Paracetamol has analgesic and antipyretic effects, reduces pain associated with colds - sore throat, headache, muscle and joint pain, and reduces fever. Pheniramine - has an anti-allergic 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 effect of the drug is due to the combined effect of all active components that make up its composition, therefore, pharmacokinetic studies are not possible.
Carefully
With diabetes mellitus, congenital hyperbilirubinemia (Gilbert, 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) , stenosing ulcer of the stomach and / or duodenum, emphysema, chronic bronchitis, bronchial asthma, urolithiasis, with the formation of kidney stones or glaucoma; while taking monoamine oxidase inhibitors, tricyclic antidepressants, difficulty urinating due to an enlarged prostate gland, the drug can be used with caution after consulting a doctor.
Application during pregnancy and during breastfeeding
Due to the lack of clinical data, the safety of using the drug during pregnancy and during breastfeeding has not been established, therefore, the appointment of the drug in this category of patients is contraindicated.
Side effect
Allergic reactions: skin rash, itching, urticaria, angioedema, anaphylactic shock.
From the nervous system: headache, dizziness, drowsiness, sleep disturbance, irritability.
From the digestive system: nausea, vomiting, pain in the epigastric region, dryness of the oral mucosa, hepatotoxic effect.
From the senses: mydriasis, accommodation paresis, increased intraocular pressure.
From the side of 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.
Others: bronchospasm. Serious skin reactions: Very rare: - Acute generalized exanthematous pustulosis (OGEP). Acute condition with the development of pustular eruptions. It is 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, 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 sites of the dermoepidermal junction.
From the immune system. Very rare: anaphylactic reactions, hypersensitivity.
Allergic reactions: Very rare: skin rash, itching, urticaria.
From the digestive system. Very rare: an increase in the level of transaminases *.
* a low rise in the level of transaminases can be observed in some patients using paracetamol at the doses indicated in the instructions; this rise is not accompanied by liver failure and is usually resolved by continued treatment or discontinuation of paracetamol.
From the nervous system. Separate messages of unspecified frequency: drowsiness. If you notice one of the side effects described above, you should stop taking the drug and immediately consult a doctor!
Overdose
In case of overdose, consult a doctor immediately. Prompt medical attention is critical, even if you don't see any signs or symptoms.
Vitamin C
Symptoms of acute overdose: diarrhea and other gastrointestinal disorders. Symptoms of chronic intoxication with ascorbic acid: impaired renal excretory function, 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 (mainly due to paracetamol), in adults and children over 12 years of age, appear after taking more than 7.5 - 10 g for 8 hours. Fatalities are rare (less than 3-4% of untreated cases) and are observed with doses> 15 g of paracetamol. In children under 12 years of age, acute overdose when taking <150 mg / kg of 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 'hepatic' transaminases, hepatonecrosis. In severe cases - liver failure with progressive encephalopathy, coma. Rarely, liver failure develops lightning fast and can be complicated by renal failure (tubular necrosis). In case of an overdose with a sustained-release paracetamol drug, 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 deaths have been extremely rare in acute paracetamol overdose in young children, possibly due to differences in the pathways of paracetamol metabolism. Below are the clinical phenomena,associated with an overdose of paracetamol, which, if considered in connection with an overdose, are considered expected, including death 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 to be expected: sepsis, fungal infection, bacterial infection, disseminated intravascular coagulation, coagulopathy, thrombocytopenia, hypoglycemia, metabolic acidosis, lactic acidosis, coma, encephalopathy, cerebral edema, cardiomyopathy, hypotension, respiratory failure, pancreatitis, bleeding from the tractacute renal failure (tubular necrosis), multiple organ failure. The overdose threshold can be lowered in children, in patients taking certain medications (for example, inducers of liver microsomal enzymes), alcohol, or wasting.
Treatment: gastric lavage, the appointment of activated carbon in the first 6 hours after the overdose, the introduction of SH-group donors and precursors of the synthesis of glutathione - methionine 8-9 hours after the 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.
Interaction with other medicinal products
With the simultaneous administration of RINZASIPЃ FOR CHILDREN 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. Concomitant use of glucocorticosteroids increases the risk of developing glaucoma. Paracetamol reduces the effectiveness of uricosuric drugs.
Paracetamol also enhances the effects of monoamine oxidase (MAO) inhibitors, sedatives and ethanol. In most patients on long-term warfarin, infrequent use of paracetamol tends to have 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 taken simultaneously with barbiturates, phenytoin, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of liver microsomal enzymes, ethanol increases the risk of developing the hepatotoxic effect of paracetamol. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects.
With the combined use of chloramphenicol and paracetamol, the half-life of chloramphenicol may increase.
When taken with digoxin or other cardiac glycosides, the risk of arrhythmias and myocardial infarction may increase. Concomitant use with salicylates increases the risk of nephrotoxic effects. Consideration should be given to the possibility of enhancing the central atropine-like effects when used in combination with other drugs with anticholinergic properties (other antihistamines, phenothiazine neuroleptics, atropine-like antispasmodics).
special instructions
The drug should not be taken together with other medicines containing paracetamol. During the period of treatment, it is necessary to monitor the functional state of the liver, kidneys and the picture of peripheral blood. Paracetamol distorts the results of laboratory studies of the content of glucose and uric acid in the blood plasma. Patients with liver disease should consult a doctor before using the drug. Consult your doctor before use if you are taking other preparations containing ascorbic acid. Talk to your doctor if you have had episodes of kidney stones. 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 your doctor. The drug may cause drowsiness. The drug contains sucrose,what should be taken into account for children with diabetes mellitus, as well as for children on a low-calorie diet. 1 single dose of the drug contains 2361.7 mg of sucrose, which corresponds to 0.20 XE. If a medicinal product has become unusable or the expiration date has expired, do not throw it into wastewater or outside! Place the medicine in a bag and put it in the trash can. These measures will help protect the environment!These measures will help protect the environment!These measures will help protect the environment!
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