Flucoldex^® Forte (Tablets) Instructions for Use

Marketing Authorization Holder

Nabros Pharma, Pvt. Ltd. (India)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Dosage Form

Flucoldex® Forte

Film-coated tablets: 12 pcs.

Dosage Form, Packaging, and Composition

12 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Acute respiratory diseases and “common cold” symptoms elimination agent (non-narcotic analgesic agent + psychostimulant + alpha-adrenergic agonist + expectorant + vitamin)

Pharmacological Action

A combined drug. It relieves the symptoms of colds, has antipyretic, psychostimulant, and analgesic properties; causes vasoconstriction in the nose, relieves swelling of the nasal mucosa and nasopharynx, and replenishes vitamin C deficiency during colds.

The onset of action is within 20-30 minutes, and the duration is 4-4.5 hours.

Indications

Colds, influenza, acute respiratory viral infections (ARVI).

ICD codes

Dosage Regimen

Administer orally with water.

For adults and children over 12 years, take one tablet every 4-6 hours.

Do not exceed four tablets in 24 hours.

For children aged 6 to 12 years, take one-half (1/2) tablet every 4-6 hours.

Do not exceed two tablets in 24 hours.

Contraindicated for children under 6 years of age.

Adjust the dosage interval based on clinical response; extend to every 8 hours if symptoms are controlled.

The maximum duration of self-treatment for fever is 3 days.

The maximum duration for pain relief is 5 days.

Consult a physician if symptoms persist beyond these durations.

In patients with hepatic impairment, renal impairment, or elderly patients, consider a longer dosing interval and do not exceed three tablets in 24 hours.

Avoid concomitant use with other paracetamol-containing products.

Adverse Reactions

From the cardiovascular system palpitations.

From the nervous system insomnia.

From laboratory parameters thrombocytopenia, hemolytic anemia.

Other allergic reactions (skin rash, angioedema, urticaria), hepatotoxicity.

Contraindications

Hypersensitivity; simultaneous administration of tricyclic antidepressants, MAO inhibitors, beta-blockers; pregnancy, lactation period; children under 6 years of age.

With caution

Severe coronary artery atherosclerosis, arterial hypertension, thyrotoxicosis, pheochromocytoma, diabetes mellitus, bronchial asthma, chronic obstructive pulmonary disease, glucose-6-phosphate dehydrogenase deficiency, blood diseases, congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson, and Rotor syndromes), hepatic and/or renal failure, angle-closure glaucoma, prostatic hyperplasia.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

With caution — hepatic insufficiency.

Use in Renal Impairment

With caution — renal insufficiency.

Pediatric Use

Contraindication — children under 6 years of age.

Special Precautions

During treatment, one should refrain from consuming alcohol, hypnotics, and anxiolytic (tranquilizers) drugs.

It distorts the results of laboratory tests assessing the concentration of glucose and uric acid in plasma.

Other drugs containing Paracetamol, as well as other non-narcotic analgesics, non-steroidal anti-inflammatory drugs (metamizole, ibuprofen, etc.), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol should not be used simultaneously.

Excessive consumption of tea or coffee while taking the drug may cause irritability and nervous tension.

Drug Interactions

It enhances the effects of MAO inhibitors, sedative drugs, ethanol.

Antidepressants, antiparkinsonian drugs, antipsychotic drugs, phenothiazine derivatives – increase the risk of urinary retention, dry mouth, constipation.

Corticosteroids increase the risk of glaucoma.

Paracetamol reduces the effectiveness of diuretic drugs.

Tricyclic antidepressants enhance the adrenomimetic effect of phenylephrine; simultaneous administration of halothane increases the risk of ventricular arrhythmia.

It reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenostimulating activity of phenylephrine.

When prescribed simultaneously with barbiturates, diphenylhydantoin, carbamazepine, rifampicin and other inducers of liver microsomal enzymes, the risk of the hepatotoxic effect of paracetamol increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.