Rinsasip® for children (Rinzasip® for children)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspPowder for solution for oral administration
Composition:

Composition on 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, aromatic raspberry Permasil 11036-31 71.0 mg, dye azorubin 4.0 mg.

Description:

Granular powder from light pink to pink with white and dark pink impregnations.

Pharmacotherapeutic group:Means for elimination of symptoms of ARI and "colds" (analgesic non-narcotic means + H1-histamine receptor blocker + vitamin)
Pharmacodynamics:

Combined drug, the pharmacological effect of which is due to the active components that make up its composition.

Paracetamol has analgesic and antipyretic effect, reduces pain syndrome, which is observed in catarrhal diseases - sore throat, headache, muscle and joint pain, reduces heat.

Pheniramine - has an anti-allergic effect: it removes the itch 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 participates in the regulation of oxidation-reduction processes, carbohydrate metabolism, blood coagulability, tissue regeneration, in the synthesis of steroid hormones; reduces the permeability of blood vessels 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, therefore it is not possible to carry out pharmacokinetic studies.

Indications:

Symptomatic treatment of "colds", including influenza (febrile syndrome, pain syndrome), rhinitis and rhinopharyngitis infectious-inflammatory and allergic nature.

Contraindications:Hypersensitivity to paracetamol and other components that make up the drug; taking other drugs containing substances that are part of RINZASIP® FOR CHILDREN; deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption, portal hypertension, severe impairment of liver and kidney function; diseases blood, deficiency of the enzyme glucose-6-phosphate dehydrogenase, phenylketonuria, alcoholism, pregnancy, lactation, children under 6 years.

Carefully:In diabetes mellitus, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome and Rotor syndrome), simultaneous administration of drugs that can adversely affect the liver (barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes), pyloroduodenal obstruction, stenotic ulcer of the stomach and / or duodenum, emphysema, chronic bronchitis, bronchial asthma, simultaneous administration of monoamine oxidase inhibitors, tricyclic antidepressants, difficulty urinating, the drug can be used with caution after consulting a doctor.

Pregnancy and lactation:

Due to the lack of clinical data, the safety of the drug during pregnancy and during breastfeeding is not established, so the appointment of this medication is contraindicated.

Dosing and Administration:

Inside.

The contents of 1 sachet (sachet) dissolve 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 receptions should be at least 4 hours. The duration of the course of treatment is no more than 5 days.

Side effects:

Allergic reactions: skin rash, itching, urticaria, angioedema, anaphylactic shock.

From the nervous system: headache, dizziness, drowsiness, falling asleep, increased excitability.

From the digestive system: nausea, vomiting, pain in the epigastric region, dryness of the oral mucosa, hepatotoxic effect.

From the sense organs: mydriasis, paresis of accommodation, increased intraocular pressure.

From the hematopoiesis: anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia, and leukopenia.

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

Other: bronchospasm.

Serious skin reactions:

Rarely:

Acute generalized exanthematous pustulosis (OGEEP). Acute condition with 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 erythema multiforme form in which the bubbles emerge on the oral mucosa, throat, eyes, genital organs, other parts of the skin and mucous membranes.

- Toxic epidermal necrolysis (TEN, Lyell's syndrome). Syndrome is the result of extensive apoptosis of keratinocytes, which leads to the detachment of large areas of skin in places dermoepidermalnogo connection. The affected skin looks like scalded boiling water.

If you notice one of the side effects described above, stop taking the medication and consult a doctor immediately!

Overdose:

In case of overdose, immediately consult a doctor.

Rapid medical care is critical, even if you do not observe any signs or symptoms.

Pheniramine

Symptoms: convulsions, impaired consciousness, coma.

Paracetamol

Symptoms (due mainly to paracetamol), in adults and children older than 12 years, manifest after taking more than 7.5 - 10 g for 8 hours. Deaths are rare (less than in the 3- 4% untreated cases) and are observed with a dose of ≥ 15 g of paracetamol. In children younger than 12 years, acute overdose when taking ≤150 mg / kg of paracetamol is not associated with hepatotoxicity.

During the first 24 hours after the reception - anorexia, nausea, vomiting, abdominal pain, increased sweating, pallor and general malaise.

Symptoms of liver dysfunction can appear in 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 at a lightning speed and can be complicated by renal insufficiency (tubular necrosis). In case of drug overdose paracetamol with delayed release, it is advisable to further determine the concentration of paracetamol in the plasma 4-6 hours after the initial concentration of paracetamol in the plasma is determined.Severe hepatotoxicity or deaths were 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 a fatal outcome due to fulminant hepatic insufficiency or its consequences. The following clinical consequences of acute liver failure caused by an overdose of paracetamol (in adults and adolescents over 12 years of age receiving> 7.5 g of paracetamol for 8 hours, in children <12 years of age, intake> 150 mg / kg paracetamol for 8 hours) are 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 gastrointestinal tract, acute renal failure (tubular necrosis), multiple organ failure.

The overdose threshold can be reduced in children, in patients taking certain medicines (eg, inductors of microsomal liver enzymes), alcohol or suffering from malnutrition.

Treatment: gastric lavage, the appointment of activated charcoal in the first 6 hours after an overdose, the introduction of donators SH-groups and precursors of the synthesis of glutathione-methionine after 8-9 hours after an overdose and acetylcysteine ​​through 12 h. The need for additional therapeutic measures (further introduction of methionine and acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as the time passed after its administration. Symptomatic therapy.

Interaction:With simultaneous reception of the drug RINSASIP® FOR CHILDREN from antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives) increase the risk of urinary retention, dryness of the oral mucosa, constipation, and also a sedative effect. Simultaneous reception of glucocorticosteroids increases the risk of developing glaucoma.

Paracetamol reduces the effectiveness of uricosuric medicines. Also paracetamol enhances the effects of monoamine oxidase inhibitors (MAO), sedatives and ethanol.

In the majority of patients with long-term warfarin, a rare use of paracetamol, as a rule, little or no effect on INR. However, with continued regular use paracetamol enhances the effect of indirect anticoagulants (warfarin and other coumarin derivatives), which increases the risk of bleeding.

When concomitantly with barbiturates, phenytoin, carbamazepine, rifampicin, isoniazid, zidovudine, and other inducers of microsomal liver enzymes, ethanol increases the risk of hepatotoxicity 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 may increase the risk of arrhythmia and myocardial infarction. Simultaneous reception with salicylates increases the risk of nephrotoxic action.

The possibility of strengthening central atropine-like effects when used in combination with other drugs with anticholinergic properties (other antihistamines, phenothiazine-type antipsychotics, atropine-like antispasmodics) should be considered.

Special instructions:

Do not take the drug with other medicines containing paracetamol. During the period of treatment, it is necessary to monitor the functional state of the liver, kidneys and peripheral blood picture. Paracetamol distorts the results of laboratory studies of glucose and uric acid in the blood plasma.

If the symptoms worsen or persist after 5 days of drug use, 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, as well as children on a hypocaloric diet. In 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 the expiration date has expired, do not throw it into sewage or into the street! Place the medicinalPut it in a bag and put it in the trash. These measures will help protect the environment!

Effect on the ability to drive transp. cf. and fur:

RINSASIP® FOR CHILDREN may cause drowsiness. During the treatment period it is necessary to refrain from driving motor vehicles and practicing other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Powder for solution for oral administration (crimson).

Packaging:

3 grams in a sachet of polyethylene / aluminum / polyester or polyethylene / aluminum / paper.

5 or 10 sachets together with instructions for use in a cardboard bundle.

Storage conditions:

Store at a temperature of no higher than 25 ° C in a dry place. Avoid damp conditions!

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe
Registration number:LP-001821
Date of registration:04.09.2012 / 25.04.2013
Expiration Date:Unlimited
The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia
Manufacturer: & nbsp
Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia
Information update date: & nbsp22.03.2017
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