GSK

COLDREX JUNIOR 16 FILM-COATED TABLETS

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Composition. Each film-coated tablet contains paracetamol 250 mg, guaifenesin 100 mg, phenylephrine hydrochloride 5 mg. The other components are: Core: Povidone K30, Microcrystalline cellulose, Stearic acid; Film: Hypromellose, Macrogol 3350.

Therapeutic indications.

Symptomatic treatment of mild to moderate pain from colds and flu (e.g., headache, sore throat), feverish conditions, nasal mucosal congestion, nasal hypersecretion, and productive cough.

Dosage and administration.

Adults (including the elderly) and adolescents aged 12 years and over: The recommended dose is 2 Coldrex Junior film-coated tablets. The dose can be repeated every 4 hours, if necessary. The maximum dose is 8 Coldrex Junior film-coated tablets (2000 mg paracetamol, 800 mg guaifenesin, 40 mg phenylephrine hydrochloride) in 24 hours. Do not continue treatment for more than 7 days without a doctor's recommendation.

Children between 6 and 12 years: The recommended dose is 1 Coldrex Junior film-coated tablet. The dose can be repeated every 4 hours, if necessary. The maximum dose is 4 Coldrex Junior film-coated tablets (1000 mg paracetamol, 400 mg guaifenesin, 20 mg phenylephrine hydrochloride) in 24 hours. Do not continue treatment for more than 3 days without a doctor's recommendation.

Children under 6 years of age

Coldrex Junior should not be administered to children under 6 years of age.

The recommended doses should not be exceeded. The minimum interval between administrations is 4 hours.

The lowest effective dose necessary should be used

Precautions.

Should not be used concomitantly with other medicines containing paracetamol, decongestants, or cold and flu combinations.

Concomitant use with other medicines containing paracetamol can lead to overdose.

Paracetamol overdose can cause liver failure which can lead to liver transplant or death. Cases of liver dysfunction/failure have been reported in patients with low glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, or are chronic alcohol consumers.

Special warnings.

Pregnancy and breastfeeding

Coldrex Junior should not be used during pregnancy or breastfeeding without a doctor's recommendation.

Driving vehicles and operating machinery

This medicine may cause dizziness. Patients should be warned not to drive vehicles or operate machinery if they experience dizziness during treatment with this medicine.

Packaging. Box with 2 PVC-paper/Al blisters, each containing 8 film-coated tablets.

Page updated on: 13.04.2022