Flucomp, 650mg+20mg+10mg 10 pcs

.

Indications

Active ingredient

Composition

active ingredients:

paracetamol 650 mg,

phenylephrine hydrochloride 10 mg,

pheniramine maleate 20 mg.

accessory substances: citric acid, sodium hydrocitrate, dextrin, maltodextrin, sucrose (sugar), aspartame, lemon or orange flavoring, dye (quinoline yellow when using lemon flavoring or sunset yellow when using orange flavoring).

How to take, the dosage

Ingestion. Adults and children over 12 years – the contents of one sachet dissolved in 1 cup of boiled hot water. You can add sugar to taste. Use hot. A second dose may be taken every 4 hours (up to three doses in 24 hours).

It is possible to use at any time of the day, but the best effect is to take the drug before going to bed, at night. If there is no relief of symptoms within 3 days after starting the drug, a physician should be consulted. Patients should not take the drug for more than 5 days.

Particular populations:

Hepatic impairment: patients with impaired liver function or Gilbert syndrome should reduce the dose or increase the interval between doses of Flucomp®.

Renal failure: in the presence of acute renal failure (creatinine clearance < 10 ml/min) the interval between doses of Flucomp® should be at least 8 hours.

Interaction

The effects of paracetamol

Probenecid affects the metabolism of paracetamol. In patients taking probenecid concomitantly, the dose of paracetamol should be reduced.

Hepatotoxicity of paracetamol may be increased with chronic or excessive alcohol consumption.

Paracetamol may affect the results of a uric acid test using the precipitating reagent phosphovolframate.

The effect of pheniramine.

The effects of other substances on the central nervous system (e.g., MAO inhibitors, tricyclic antidepressants, alcohol, anti-Parkinsonian drugs, barbiturates, tranquilizers and narcotic drugs) may be enhanced. Pheniramine may inhibit the effect of anticoagulants.

The effects of phenylephrine.

Special Instructions

The drug should not be combined with the use of alcoholic beverages to avoid toxic liver damage.

Impact on the ability to drive:

Contraindications

Hypersensitivity to the components of the drug, simultaneous use of tricyclic antidepressants, beta-adrenoblockers or other sympathomimetic drugs, simultaneous or within the previous 2 weeks taking monoamine oxidase inhibitors (MAO), portal hypertension, alcoholism, severe cardiovascular disease, arterial hypertension, hyperthyroidism, closed-angle glaucoma, pheochromocytoma, diabetes mellitus, sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, phenylketonuria, pregnancy, breastfeeding, children under 12 years of age.

Side effects

The adverse reactions listed below were classified as follows: very common (≥10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<10000), frequency unknown.

Blood and lymphatic system disorders

Very rare: thrombocytopenia, agranulocytosis, leukopenia, pancytopenia

Immune system disorders

Rare: Hypersensitivity reactions (skin rash, shortness of breath, anaphylactic shock), angioedema

Frequency unknown: anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis

Mental disorders

Rarely: hyperexcitability, sleep disturbance

Nervous system disorders

Often: drowsiness

Rarely: dizziness, headache

Visual organ disorders

Rarely: mydriasis, accommodation paresis, increased intraocular pressure.

Heart disorders

Rare: tachycardia, palpitations

Vascular disorders

Rare: Increased blood pressure

Gastrointestinal disorders

Often: nausea, vomiting

Rarely: dry mouth, abdominal pain, constipation, diarrhea

Liver and biliary tract disorders

Rarely: increased liver enzyme activity

Skin disorders

Rare: skin rash, itching, erythema, urticaria

Renal and urinary tract disorders

Rare: Difficulty urinating

General disorders and disorders at the site of administration

Rarely: malaise.

Overdose

Symptoms: pale skin, anorexia, nausea, vomiting, epigastric pain, seizures, hypokalemia, hepatotoxic and nephrotoxic effects; glucose metabolism disorders and metabolic acidosis (including lactoacidosis) may occur; in severe cases – encephalopathy and coma.

Frequent clinical manifestations after 3-5 days in chronic paracetamol overdose are jaundice, fever, liver breath, hemorrhagic diathesis, hypoglycemia, liver failure. The severity of overdose depends on the dose, so it is necessary to warn patients about the prohibition of concomitant administration of paracetamol-containing drugs. The threshold of overdose may be lowered in elderly patients and children, in patients taking certain drugs (e.g., inducers of microsomal liver enzymes), alcohol or patients suffering from exhaustion.

Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy, administration of donors of SH-groups and precursors of glutathione synthesis – methionine in 8-9 hours after overdose and N-acetylcysteine in 12 hours.

Pregnancy use