FREMEDOL COLD
FREMEDOL COLD
Active ingredients:
Paracetamol 500 mg; dextromethorphan hydrobromide 15 mg; phenylephrine hydrochloride 5 mg.
Dosage form: Film-coated tablet.
Packaging: Box of 10 blisters x 10 tablets.
Expiry date: 36 months.
Posology
Adults (including the elderly) and adolescents over 15 years of age
1-2 tablets are taken as needed up to 4 times within 24 hours with a time interval of at least 4 hours.
One tablet is suitable for people with a body weight of up to 60 kg, people with a body weight of more than 60 kg can take up to 2 tablets in one dose.
The highest single dose is 2 tablets (1 g paracetamol). The maximum daily dose, which must not be exceeded within 24 hours, is 8 tablets (4 g of paracetamol and 120 mg of dextromethorphan).
Adolescents from 12 to 15 years with a body weight over 40 kg
1 tablet is taken as needed at least 4-6 hours apart.
The maximum daily dose is 6 tablets (3 g of paracetamol).
Pediatric population
The preparation is not intended for children under 12 years of age and adolescents with a body weight of up to 40 kg.
Patients with reduced renal function
With glomerular filtration above 50 ml/min, it is not necessary to adjust the dose or the interval between doses. With a glomerular filtration rate of 50-10 ml/min, a maximum of 500 mg of paracetamol can be given every 6 hours, with a glomerular filtration rate of less than 10 ml/min, a maximum of 500 mg of paracetamol can be given every 8 hours.
Patients with reduced liver function
In stabilized chronic hepatic insufficiency, paracetamol usually does not cause liver damage when administered at the above dosage. Nevertheless, it is advisable not to administer maximum doses in these patients and to observe an interval between individual doses of at least 6 hours
Administration
Oral administration.
The tablets are swallowed whole and swallowed with liquid. If digestive problems occur during treatment, the product should be taken during meals. The usual duration of treatment is 3-5 days.
INDICATIONS
Symptomatic treatment of flu and acute inflammation of the upper respiratory tract in the presence of the following symptoms: fever, headache, muscle and joint pain, sore throat, irritating, dry cough, acute rhinitis or sinusitis with congestion of the mucous membranes of the upper respiratory tract.
The preparation is intended for adults and adolescents from 12 years of age with a body weight over 40 kg.
CONTRAINDICATIONS
- Hypersensitivity to active substances or to any excipient.
- Severe liver dysfunction, acute liver failure.
- Cough with excessive mucus production.
- Arterial hypertension, serious cardiovascular disease (e.g. ischemic heart disease, angina pectoris).
- Diabetes mellitus.
- Narrow-angle glaucoma.
- Treatment with MAO inhibitors and a period of at least 2 weeks after their discontinuation.
- Treatment with tricyclic antidepressants, beta blockers.
- Simultaneous use of other sympathomimetics (e.g. phenylpropanolamine, pseudoephedrine, oxymetazoline, ephedrine, methylphenidate).
