FLOGAR FEB DOL 120ML 120MG/5ML

FLOGAR FEVER AND PAIN 120 MG/5 ML ORAL SOLUTION

active ingredients

100 ml of oral solution contain; Active ingredient: paracetamol 2.4 g Excipients with known effects: sucrose, p-hydroxybenzoate methyl and p-hydroxybenzoate propile. For the full list of excipients, see paragraph 6.1

Excellent

Saccarosio, macrogol 6000, citrate sodium, anidro citric acid, sodium saccarin, parahydroxybenzoate methyl, parahydroxybenzoate propile, straw/mandarin aroma, purified water.

Therapeutic indications

How antipyretic: symptomatic treatment of feverish affections such as influenza, hexanthomatic diseases, acute affections of the respiratory tract, etc. As analgesic: cephales, neuralgies, myalgies and other painful manifestations of medium-sized, of various origin.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Paracetamol-based products are contraindicated in patients with severe haemolytic anemia. Severe hepatocellular failure.

Population

The package contains a measuring measuring measuring measuring measuring measuring measuring cups corresponding to the capacity of 2.5 ml; 5 ml; 10 ml. Children under one year: 1 dose of 2.5 ml every 4-6 hours. Children from 1 to 4 years: 1 dose of 2.5 ml or 1 dose of 5 ml every 4-6 hours. Children over 4 years: 1 dose of 5 ml or 1 dose of 10 ml every 4-6 hours. Adults: 1 dose of 10 ml every 4 hours.

Conservation

This medicine does not require any special condition for conservation.

Warnings

In rare cases of allergic reactions, administration must be suspended and appropriate treatment must be established. Use carefully in subjects with glucose-6-phosphate-dehydrogenase deficiency. High or prolonged doses of the product may result in a high-risk hepatopathy and alterations to the kidney and blood. Carefully administer in subjects with kidney or liver failure. During treatment with paracetamol before taking any other medication check that does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur. Invite the patient to contact the doctor before associating any other medication. See also the voice "Interactions". Flogar Fever and Pain contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. This medicine contains 3.5 g sucrose (sugar) per dose of 10 ml. To consider in people with diabetes mellitus. Flogar Fever and Pain contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose of 10 ml, i.e. essentially ‘without sodium’. Flogar Fever and Pain contains benzoate parahydroxys. This medicine may cause allergic reactions (also delayed). Flogar Fever and Pain contains alcohol. This medicine contains small amounts of ethanol (alcohol) less than 100 mg per dose of 10 ml. After a short period of treatment without appreciable results, consult your doctor. Do not administer for more than 3 consecutive days without consulting your doctor.

Interactions

In the course of therapy with oral anticoagulants it is recommended to reduce the doses. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of liver monoxygenases or in case of exposure to substances that may have such an effect (e.g. rifampin, cimetidine, antiepileptics such as glutethymmides, phenobarbital, carbamazepine). Paracetaminol administration may interfere with the determination of uricemia (by means of the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase).

Effects

With the use of paracetamol, skin reactions of various types and severity were reported including cases of multiform erythema, Stevens Johnson syndrome and epidermal necrolysis. Angioedema, larynx edema, anaphylactic shock have been reported. The following side effects have also been reported: thrombocytopenia, leucopenia, anemia, agranulocytosis, alterations of liver and hepatitis functionality, alterations to the kidney (acute kidney failure, interstitial nephritis, hematuria, anuria), gastrointestinal reactions and dizziness. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

In case of accidental intake of very high doses, acute intoxication occurs with anorexia, nausea and vomiting followed by deep decay of general conditions. In case of hyperdosage (doses greater than 6 g/die), the paracetamol can cause hepatic cytolysis that can evolve towards massive and irreversible necrosis. The measures to be taken consist of early gastric emptiness and hospital treatment.

Despite clinical studies in pregnant or breastfeeding patients, no particular contraindications have been made to the use of paracetamol or caused undesirable effects to the mother or child, it is recommended to administer the product only in cases of actual need and under the direct control of the doctor. A large amount of data on pregnant women do not indicate neither malformative toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for as short as possible and with the lowest frequency possible.

Source: Farmadati