Used for the treatment of symptoms of nasopharyngitis and influenza.
Each sachet contains:
Paracetamol — 0.500 g (500 mg)
Ascorbic acid (Vitamin C) — 0.200 g (200 mg)
Pheniramine maleate — 0.025 g (25 mg)
Excipients whose presence in the medicinal product should be taken into consideration:
Sucrose
Benzyl alcohol
Red colourant (E129)
Sunset Yellow FCF (E110)
Brilliant Blue FCF (E133)
Flavouring containing ethanol, propylene glycol (E1520), and traces of sodium
For the treatment of symptoms of nasopharyngitis and influenza, including:
Runny nose and watery eyes
Sneezing
Headache
Fever
Intended for adults weighing more than 50 kg.
The recommended single dose is 1 sachet, containing:
Paracetamol — 500 mg
Pheniramine maleate — 25 mg
Ascorbic acid — 200 mg
The maximum daily dose is 3 sachets, containing a total of:
Paracetamol — 1,500 mg
Pheniramine maleate — 75 mg
Ascorbic acid — 600 mg
There should be an interval of at least 4 hours between doses.
Children and adolescents:
Contraindicated in children and adolescents under 18 years of age.
For oral administration.
Dissolve the contents of one sachet in a sufficient amount of hot or cold water.
For flu-like symptoms, it is preferable to dissolve the product in hot water and take it in the evening.
The maximum duration of treatment is 5 days.
In patients with severe renal impairment (creatinine clearance below 10 mL/min), the interval between doses should be 8 hours.
Fervex is contraindicated in the following cases:
Hypersensitivity to the active substances or any of the excipients listed in Section 6.1
Hepatocellular insufficiency
Risk of angle-closure glaucoma
Risk of urinary retention associated with prostate disorders
Glucose-galactose malabsorption or sucrase-isomaltase deficiency due to the presence of sucrose in the formulation
Children and adolescents under 18 years of age
Pregnancy
Breastfeeding
Animal studies on reproductive toxicity are limited.
Available data from pregnant women do not indicate a risk of malformations, neonatal toxicity, or fetotoxicity associated with the use of paracetamol.
Epidemiological studies investigating the neurological development of children exposed to paracetamol during fetal development have produced inconsistent results.
There are no adequate data regarding the use of the combination of paracetamol, pheniramine maleate, and vitamin C during pregnancy. Therefore, as a precautionary measure, this medicinal product is not recommended during pregnancy.
Due to the limited amount of data from animal studies and clinical experience in humans, the risk to breastfed infants is unknown.
Therefore, this medicinal product is contraindicated during breastfeeding.
Through its potential effects on cyclooxygenase and prostaglandin synthesis, paracetamol may impair female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment.
The use of paracetamol is not recommended in women planning to become pregnant.
Effects on male fertility have been observed in one animal study. The relevance of these findings to humans is unknown.
Fervex has a strong influence on the ability to drive and operate machinery.
Particular attention should be paid to the risk of drowsiness, especially at the beginning of treatment.
This effect may be increased by the consumption of alcoholic beverages, alcohol-containing products, or sedative medicines.
Store at a temperature not exceeding 25°C.
Keep out of the reach and sight of children.
