Expiration date: 09/2025

Form and composition:

Powder for oral solution (for children) heterogeneous, from white to pale yellow, with the smell of lemon dissolves in 125 ml of hot water to form a muddy solution from yellow to yellow-green, not having on the surface of the foam, with the smell of lemon may have a slight precipitate.

1 sachet contains:

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), silicon dioxide colloidal.

3 g-bags (10) - cardboard packs.

Pharmacological action:

Combined drug for symptomatic treatment of acute respiratory diseases.

Paracetamol has a antipyretic, analgesic effect.

Phenylephrine hydrochloride-sympathomimetic, narrows the vessels of the nasal mucosa and paranasal sinuses, thereby reducing swelling and facilitating nasal breathing.

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

Pharmacokinetics:

Data on the pharmacokinetics of Coldrex® Junior Hotdrink are not available.

Indications:

To eliminate the symptoms of ARI and influenza in children aged 6-12 years, including:

• elevated body temperature
  
• headache
  
• chill's
  
• joint and muscle pain
  
• feeling of nasal congestion
  
• pain in the sinuses and throat.
  

Dosage regimen:

Children aged 6 to 12 years appoint 1 paketiku every 4 h. do Not apply more than 4 sachets in 24 hours. do Not exceed stated dose. The maximum duration of application-no more than 5 days. If symptoms persist, a doctor's consultation is required. The need to continue treatment is determined by the doctor individually.

The contents of 1 bag pour into a mug, pour about 125 ml of hot water, stir until dissolved. If necessary, add cold water and sugar.

Side effect:

Allergic reactions: rarely - skin rash, urticaria, angioedema.

From the hematopoietic system: rarely-thrombocytopenia, leukopenia, agranulocytosis.

Other: with long-term use in doses exceeding the recommended, possible hepatotoxic and nephrotoxic action.

Phenylephrine, which is part of the drug, can cause nausea, headache, a slight increase in blood PRESSURE, in rare cases - heartbeat, which pass after the drug is canceled.

In recommended doses, the drug is usually well tolerated. If any adverse reactions occur, a doctor's consultation is necessary.

Contraindications:

• diseases of the blood system
  
• severe hepatic impairment
  
• severe renal impairment
  
• thyrotoxicosis
  
• diabetes
  
• arterial hypertension
  
• heart disease (severe aortic stenosis, acute myocardial infarction, tachyarrhythmia)
  
• glaucoma
  
• congenital deficiency of glucose-6-phosphate dehydrogenase
  
• children under 6 years
  
• along with other drugs containing paracetamol
  
• hypersensitivity to the drug components.
  

With caution, the drug should be used for benign hyperbilirubinemia.

Special instruction:

To avoid toxic liver damage Coldrex ® Junior hotdrink Should not be combined with ethanol-containing drugs.

The need for the use of the drug in patients on giponatriemii diet doctor determines individually, as each bag Coldrex® Junior Hotdrink contains 60 mg of sodium.

The drug should not be taken simultaneously with tricyclic antidepressants, beta-blockers, MAO inhibitors and within 14 days after their withdrawal.

Coldrex ® Junior Hotdrink active substances do not cause drowsiness.

Overdose:

Symptoms: nausea, vomiting, stomach pain, sweating, pale skin, arrhythmia. After 1-2 days, symptoms of liver damage may occur. In severe cases, develops liver failure and coma.

In case of overdose (even if the child feels well), the risk of delayed serious liver damage should be taken into account.

Treatment: in case of suspected poisoning, seek medical advice immediately. During the first 4 hours of poisoning, gastric lavage is indicated. The specific antidote for poisoning by paracetamol - acetylcysteine.

Drug interaction:

The risk of hepatotoxic effect is increased by concomitant administration of barbiturates, difenina, carbamazepine, rifampicin, zidovudine and other inductors of microsomal liver enzymes.

Metoclopramide and domperidone increase the rate of absorption of paracetamol, and colestyramine reduces (the need for joint use with Coldrex® Junior Hotdrink doctor determines individually).

Paracetamol reduces the effectiveness of diuretics. Paracetamol when taken for a long time increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding.

Phenylephrine reduce gipotenzivny effect guanetidina, guanetidin enhances alpha given effect fenilafrina.

While the use of Coldrex ® Junior Hotdrink should be taken into account that GCS increase the risk of glaucoma galotan increases the risk of ventricular arrhythmia.

Storage conditions and terms:

The drug should be stored out of reach of children at a temperature no higher than 25°C. shelf life – 3 years.