Rinsasip for children powder for oral solution Raspberry 3g sachet, 10pcs

Composition

For 1 sachet (3 g):

Active ingredients:

Ascorbic acid – 100 mg

Paracetamol-280 mg

Phenyramine maleate-10 mg

Auxiliary substances:

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.

Clinical Pharmacology

Pharmacodynamics : A combined drug, the pharmacological action of which is determined by the active components included in its composition. Paracetamol has analgesic and antipyretic effects, reduces the pain syndrome observed in colds – sore throat, headache, muscle and joint pain, reduces high fever. Phenyramine-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, and the synthesis of steroid hormones; it reduces vascular permeability and increases the body’s resistance to various adverse environmental factors. Pharmacokinetics: The effect of the drug is due to the combined effect of all the active components that make up its composition, so it is not possible to conduct pharmacokinetic studies.

Indications

Symptomatic treatment of “colds”, including flu (fever syndrome, pain syndrome), rhinitis and rhinopharyngitis of infectious-inflammatory and allergic nature.

Use during pregnancy and lactation

Due to the lack of clinical data, the safety of using the drug during pregnancy and lactation has not been established, so the use of the drug in this category of patients is contraindicated.

Contraindications

Side effects

Allergic reactions: skin rash, pruritus, urticaria, angioedema, anaphylactic shock. From the nervous system: headache, dizziness, drowsiness, sleep disturbance, increased excitability. From the digestive system: nausea, vomiting, epigastric pain, dryness of the oral mucosa, hepatotoxic effect. From the sensory organs: mydriasis, paresis of accommodation, increased intraocular pressure. Hematopoietic disorders: anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, leukopenia. From the urinary system: nephrotoxicity (renal colic, glucosuria, interstitial nephritis, papillary necrosis), difficulty urinating. Other: bronchospasm. Serious skin reactions: Very rare: – Acute generalized exanthematous pustulosis (OGEP). Acute condition with the development of pustular rashes. It is characterized by fever and diffuse erythema accompanied by burning and itching. There may be swelling of the face, hands and mucous membranes; – Stevens-Johnson syndrome (SSD) (malignant exudative erythema). 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, which leads to the detachment of large areas of the skin at the sites of the dermoepidermal junction. The affected skin has the appearance of scalded with boiling water. If you notice any of the side effects described above, you should stop taking the drug and immediately consult a doctor!

Interaction

Concomitant use of RINZASIP® FOR CHILDREN with antidepressants, antiparkinsonian, antipsychotic medications (phenothiazine derivatives) increases the risk of urinary retention, dry oral mucosa, constipation, and increases the sedative effect. Concomitant use of glucocorticosteroids increases the risk of glaucoma. Paracetamol reduces the effectiveness of uricosuric drugs. Paracetamol also enhances the effects of monoamine oxidase (MAO) inhibitors, sedatives, and ethanol. In most patients taking warfarin for a long time, infrequent use of paracetamol usually has little or no effect on INR. However, with prolonged regular use, paracetamol increases the effect of indirect anticoagulants (warfarin and other coumarin derivatives), which increases the risk of bleeding. When taken concomitantly with barbiturates, phenytoin, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes, ethanol increases the risk of developing hepatotoxic effects of paracetamol. Microsomal oxidation inhibitors (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 arrhythmia and myocardial infarction may increase. Concomitant use with salicylates increases the risk of nephrotoxic effects. Consideration should be given to the possibility of enhancing central atropine-like effects when used in combination with other drugs with anticholinergic properties (other antihistamines, phenothiazine-type neuroleptics, atropine-like antispasmodics).

How to take, course of use and dosage

Inside. Dissolve the contents of 1 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: : – children from 6 to 10 years: 1 sachet 2 times a day; – children from 10 to 12 years: 1 sachet 3 times a day. – children from 12 to 15 years: 1 sachet 4 times a day. The interval between sessions should be at least 4 hours. The duration of the course of treatment is no more than 5 days.

Overdose

In case of overdose, you should immediately consult a doctor. Getting medical attention quickly is critical, even if you don’t see any signs or symptoms. Phenyramine symptoms: convulsions, impaired consciousness, coma. Paracetamol Symptoms (mainly caused by paracetamol), in adults and children over 12 years of age, appear after taking more than 7.5-10 g for 8 hours. Fatal outcomes are rare (less than 3-4% of untreated cases) and are observed when taking a dose of ≥ 15 g of paracetamol. In children under 12 years of age, acute overdose with less than 150 mg/kg of paracetamol is not associated with hepatotoxicity. During the first 24 hours after ingestion – anorexia, nausea, vomiting, abdominal pain, increased sweating, pallor and general malaise. Symptoms of impaired liver function 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 delayed-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 fatal outcomes have been extremely rare in acute paracetamol overdose in young children, possibly due to differences in the metabolic pathways of paracetamol. The following are clinical events associated with an overdose of paracetamol that, if considered in connection with an overdose, are considered expected, including death due to lightning-fast 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 for 8 hours, in children under 12 years of age, taking > > 150 mg / kg of paracetamol for 8 hours) considered 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 insufficiency. The overdose threshold may be lowered in children, in patients taking certain medications (for example, inducers of microsomal liver enzymes), alcohol, or those suffering from exhaustion. Treatment: gastric lavage, use of activated charcoal in the first 6 hours after overdose, use of SH-group donors and glutathione – methionine synthesis precursors in 8-9 hours after overdose and acetylcysteine in 12 hours. The need for additional therapeutic measures (further use 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.

Description

Granulated powder of light pink to pink color with white and dark pink flecks.

Special instructions

Do not take the drug together with other medicines containing paracetamol. During treatment, it is necessary to monitor the functional state of the liver, kidneys and peripheral blood picture. Paracetamol distorts the results of laboratory tests of glucose and uric acid in blood plasma. If the symptoms of the disease 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 should be taken into account by children suffering from diabetes, as well as children who are on a hypocaloric diet. A single dose of the drug contains 2361.7 mg of sucrose, which corresponds to 0.20 XE. If the medicine has fallen into disrepair or the expiration date has expired, do not throw it into the sewer or on the street! Place the medicine in a plastic bag and put it in the trash can. These measures will help protect the environment!

Form of production

Rinzasip. Powder for preparation of an oral solution

Storage conditions

Store at a temperature not exceeding 25 °C in a dry place. Avoid wet conditions!Keep out of reach of children.

Active ingredient

Paracetamol, Phenylephrine, Ascorbic acid

Dosage form

oral solution