Antigripal

Paracetamolum/Pseudoephedrinum/Chlorphenaminum

Each sachet (20 g) of powder for oral solution contains paracetamol 500 mg, pseudoephedrine hydrochloride 60 mg and chlorphenamine maleate 4 mg. Excipients with known effect: sodium (150.64 mg per dose) and sucrose (17508.5 mg). White to slightly yellowish powder with an orange flavour.

Indication: Indicated for the symptomatic treatment of colds, flu and other upper respiratory tract infections (fatigue, fever, headache, runny nose, nasal congestion, sneezing, pain) in adults and children over 12 years of age.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substances: paracetamol, pseudoephedrine, chlorphenamine, or to any of the excipients listed in section 6.1. − Severe or uncontrolled arterial hypertension − Tachycardia − Severe coronary artery disease − Diagnosed congenital long QT syndrome or Torsades de Pointes − Severe acute or chronic renal disease / renal impairment − Severe hepatic impairment − Bladder neck obstruction − Pyloroduodenal obstruction − Stenosing peptic ulcer − Pulmonary disease (including asthma) − Epilepsy and history of convulsions − Angle-closure glaucoma − Diabetes mellitus − Phaeochromocytoma − Hyperthyroidism − Pregnancy and breast-feeding − Concomitant administration of other medicinal products containing active substances similar to those in Antigripal − Use together with sympathomimetic medicinal products (decongestants, tricyclic antidepressants, appetite suppressants or amphetamine-like psychostimulants) and beta-blockers. − Patients using or who have used monoamine oxidase inhibitors (MAOIs) (including furazolidone) within the last two weeks (see section 4.5); concomitant use of pseudoephedrine with this class of medicinal products may cause an increase in blood pressure.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use If high fever (39°C) persists for more than 3 days, signs of superinfection appear, or symptoms persist beyond 4 days, treatment should be reassessed. Do not use together with other products containing paracetamol, decongestants or other cold and flu medicines. Consumption of alcoholic beverages / alcohol-based medicines, and of hypnotic and anxiolytic (tranquillising) remedies, should be avoided during treatment. Special warnings concerning pseudoephedrine hydrochloride: − The dose, the maximum recommended duration of treatment (5 days), and the contraindications (see section 4.3) must be strictly observed. − Patients/parents of paediatric patients should be informed that treatment must be discontinued if hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea, or any […]