Rinzasip for children Raspberry, 10 pcs.

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

Indications

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

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!

Active ingredient

Paracetamol, Phenylephrine, [Ascorbic Acid]

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,

Azorubine dye 4.0 mg.

Pregnancy

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.

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 liver and kidney dysfunction;
blood diseases, deficiency of the enzyme glucose-6-phosphate dehydrogenase, phenylketonuria, alcoholism, pregnancy, lactation, children under 6 years of age.

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 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 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: bronchospasm.

Serious skin reactions:

Very rare:

– Acute generalized exanthematous pustulosis (AGEP). Acute condition with the development of pustular rashes. 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, 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 detachment of large areas of skin at the dermoepidermal junction. The affected skin looks like it has been scalded by boiling water.

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

Interaction

When taking the drug RINZASIP® FOR CHILDREN simultaneously with antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives), the risk of developing urinary retention, dry 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 inhibitors (MAOIs), sedatives and ethanol.

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.

When taken simultaneously with barbiturates, phenytoin, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of microsomal liver enzymes, ethanol, the risk of developing the hepatotoxic effect of paracetamol increases. Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

When chloramphenicol and paracetamol are used together, 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 nephrotoxicity.

The possibility of increased central atropine-like effects should be taken into account when used in combination with other drugs that have anticholinergic properties (other antihistamines, phenothiazine neuroleptics, atropine-like antispasmodics).

Overdose

In case of overdose, consult a doctor immediately. Prompt medical attention is critical, even if you do not experience any signs or symptoms.

Pheniramine

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 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 suddenly 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 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.

The overdose threshold 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 it reception.

Symptomatic therapy.

Clinical pharmacology

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.

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 environmental factors.

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.

Storage conditions

Store at a temperature not exceeding 25 °C in a dry place.

Avoid wet conditions!

Keep out of the reach of children.

Manufacturer

Unique Pharmaceutical Laboratories, India