Coldrex Junior Hot Drink, 10 pcs.

Combined drug for symptomatic treatment of acute respiratory diseases.

Paracetamol has antipyretic and analgesic effect.

Phenylephrine hydrochloride is a sympathomimetic, narrows the blood vessels of the nasal mucosa and paranasal sinuses, which reduces swelling and facilitates nasal breathing.

Ascorbic acid replenishes the increased need for vitamin C in colds and flu.

Indications

To eliminate symptoms of acute respiratory infections and flu in children aged 6-12 years, including:
— increased body temperature;
– headache;
– chills;
– pain in joints and muscles;
– feeling of nasal congestion;
– pain in the sinuses and throat.

Pharmacological effect

Combined drug for the symptomatic treatment of acute respiratory diseases.

Paracetamol has an antipyretic and analgesic effect.

Phenylephrine hydrochloride is a sympathomimetic, constricts the vessels of the nasal mucosa and paranasal sinuses, resulting in reduced swelling and easier nasal breathing.

Ascorbic acid replenishes the increased need for vitamin C during colds and flu.

Special instructions

The drug should not be taken simultaneously with other drugs containing paracetamol, as well as other non-narcotic analgesics (metamizole sodium), NSAIDs (acetylsalicylic acid, ibuprofen), with other drugs to relieve cold and flu symptoms, sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like psychostimulants), barbiturates, anticonvulsants, rifampicin and chloramphenicol.

When conducting tests to determine uric acid and blood glucose levels, you should inform your doctor about the use of Coldrex® Junior, because the drug may interfere with the results of laboratory tests assessing the concentration of glucose and uric acid.

Before taking the drug, you should consult a doctor in the following cases:

– taking metoclopramide, domperidone (used to relieve nausea and vomiting) or cholestyramine, used to lower blood cholesterol levels;
-taking medications to reduce blood clotting (for example, warfarin);
-following a low-sodium diet – each sachet contains 0.12 g of sodium.

To avoid toxic liver damage, paracetamol should not be combined with drugs containing ethanol.

Impact on the ability to drive vehicles and machinery

If dizziness occurs, the patient should refrain from driving vehicles or other potentially hazardous activities that require concentration and speed of psychomotor reactions.

Active ingredient

Paracetamol, Phenylephrine, [Ascorbic Acid]

Composition

Paracetamol 300 mg,

phenylephrine hydrochloride 5 mg,

ascorbic acid 20 mg.

Excipients:

sodium saccharinate,

sodium cyclamate,

citric acid,

sodium citrate,

corn starch,

sucrose,

lemon flavor (610399E),

curcumin dye (E100),

colloidal silicon dioxide.

Pregnancy

The drug is intended for teenagers

Contraindications

– hypersensitivity to the components of the drug;
– severe liver diseases;
– severe kidney disease;
— diseases of the hematopoietic system;
— thyrotoxicosis;
— arterial hypertension;
– heart disease (severe stenosis of the aortic mouth, acute myocardial infarction, tachyarrhythmias);
— prostatic hyperplasia;
— angle-closure glaucoma;
— diabetes mellitus;
– genetic absence of glucose-6-phosphate dehydrogenase;
– sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, because the drug contains sucrose;
– simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors and a period of up to 14 days after their withdrawal;
– children up to 6 years of age.
If your child has one of the following diseases/conditions/risk factors, be sure to consult your doctor before taking the drug:
Benign hyperbilirubinemia.
Mild to moderate liver and kidney dysfunction.
Prostate diseases and urinary problems.
Cardiovascular diseases, including high blood pressure, occlusive vascular disease (Raynaud’s syndrome).
Glaucoma (excluding angle-closure glaucoma).
Pheochromocytoma.
The presence of severe infections, including sepsis, because taking the drug may increase the risk of metabolic acidosis.
Patients with glutathione deficiency (in particular, extremely malnourished patients suffering from anorexia, chronic alcoholism or patients with a low body mass index).

Side Effects

Determination of the frequency of side effects: very often (≥1/10), often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rarely (≥1/10,000 and <1/1000), very rarely (≥1/100,000 and <1/10,000).
At recommended doses, the drug is usually well tolerated.

Paracetamol rarely has side effects.

With long-term use in excess of the recommended dose, hepatotoxic and nephrotoxic effects may occur.
From the hematopoietic system: very rarely – thrombocytopenia.

Allergic reactions: rarely – skin rash, urticaria, allergic dermatitis; very rarely – anaphylaxis, hypersensitivity reactions, incl. angioedema, Stevens-Johnson syndrome.

From the respiratory system: very rarely – bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.

From the digestive system: very rarely – nausea, vomiting, liver dysfunction.

From the side of the central nervous system: very rarely – dizziness, headache, insomnia.

From the sensory organs: rarely – mydriasis, acute attack of glaucoma in most cases in patients with angle-closure glaucoma.

From the cardiovascular system: rarely – tachycardia, palpitations, increased blood pressure.

From the urinary system: very rarely – dysuria, urinary retention in patients with obstruction of the bladder outlet due to prostatic hypertrophy.

If any adverse reactions occur, the patient should consult a doctor.

Interaction

Paracetamol, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Occasional administration of a single dose of the drug does not have a significant effect on the effect of indirect anticoagulants.

Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxicity in overdoses and concomitant use with paracetamol.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

Paracetamol reduces the effectiveness of diuretics.

Metoclopramide and domperidone increase, and cholestyramine reduces the rate of absorption of paracetamol.

Paracetamol enhances the effects of MAO inhibitors, sedatives, ethanol.

Phenylephrine when taken with MAO inhibitors can lead to an increase in blood pressure.

Phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs, increases the risk of developing arterial hypertension and disorders of the cardiovascular system.

Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine and may increase the risk of side effects from the cardiovascular system.

Concomitant use of halothane with phenylephrine increases the risk of developing ventricular arrhythmia.

Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenergic stimulating activity of phenylephrine.

Antidepressants, antiparkinsonian drugs, antipsychotic drugs, phenothiazine derivatives increase the risk of developing urinary retention, dry mouth, constipation.

Concomitant administration of GCS with phenylephrine increases the risk of developing glaucoma.

When used simultaneously with digoxin and cardiac glycosides, the risk of developing heart rhythm disturbances or a heart attack may increase.

Ascorbic acid, when used simultaneously with iron preparations, due to its restorative properties, converts ferric iron into divalent iron, which helps improve its absorption.

When used concomitantly, ascorbic acid increases iron excretion in patients receiving deferoxamine.

When used simultaneously with barbiturates and primidone, the excretion of ascorbic acid in the urine increases.

Ascorbic acid in high doses can reduce urine pH, which, when used simultaneously, reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.

When used simultaneously, acetylsalicylic acid reduces the absorption of ascorbic acid by about a third.

When used simultaneously with warfarin, the effects of warfarin may be reduced.

When used simultaneously with tetracycline, the excretion of ascorbic acid in the urine increases.

Overdose

In case of overdose of Coldrex® Junior (even if you feel well), the risk of delayed signs of serious liver damage should be taken into account.

Symptoms caused by paracetamol: within 24 hours – pale skin, loss of appetite, nausea, vomiting, abdominal pain. After 12-48 hours, signs of liver dysfunction, signs of impaired glucose metabolism and metabolic acidosis may appear.
In cases of severe poisoning, severe liver failure may occur, including hepatic encephalopathy, coma and death.

Clinical pharmacology

Suction and distribution

Paracetamol: absorption of paracetamol in the gastrointestinal tract is high. Time to reach maximum plasma concentration – 0.5 – 2 hours; maximum concentration in plasma is 5-20 mcg/ml. Connection with blood plasma proteins – 15%. Penetrates the blood-brain barrier.
Phenylephrine hydrochloride is unevenly absorbed from the gastrointestinal tract. The maximum plasma concentration is achieved in the range from 45 minutes to 2 hours.

Ascorbic acid is quickly absorbed in the gastrointestinal tract and distributed throughout the body. The connection with blood plasma proteins is 25%.

Metabolism

Paracetamol is metabolized predominantly in the liver (90–95%) in three main ways: 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergo hydroxylation to form 8 active metabolites, which conjugate with glutathione to form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme is also involved in the metabolism of the drug.

Phenylephrine hydrochloride undergoes primary metabolism by monoamine oxidases in the intestine and liver. Thus, when administered orally, the bioavailability of phenylephrine is reduced.

Removal

Paracetamol is excreted by the kidneys in the form of metabolites, mainly glucuronide and sulfate conjugates, about 3% is excreted unchanged. The half-life is 1-4 hours.

Phenylephrine hydrochloride is excreted almost entirely by the kidneys in the form of sulfate conjugates. The elimination period is 2-3 hours.

When used in doses exceeding the body’s needs for ascorbic acid, ascorbic acid is excreted by the kidneys in the form of metabolites.

Short product description

Coldrex Junior is a combination drug. Used in children 6-12 years old to eliminate symptoms of flu and colds, such as:
elevated temperature
headache
chills
joint and muscle pain
feeling of nasal congestion
pain in the sinuses and throat.*
* Instructions for medical use, RU P N015713/01

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf life

3 years. Do not use after the expiration date stated on the package

Manufacturer

SmithKline Beecham S.A., Spain