Properties
What is it?
Composition 1 capsule contains: Paracetamol _ 500 mg, Phenylephrine hydrochloride _ 10 mg, Chlorpheniramine maleate _ 2 mg. Excipients: Corn starch, Magnesium stearate. Main physical-chemical properties: Opaque white gelatin capsules, filled with white powder. Pharmacological properties Effe-flu is a combined preparation, whose action is due to the properties of its components. Paracetamol is an effective analgesic and antipyretic agent, which also has a weakly expressed anti-inflammatory effect. The preparation affects the thermoregulation center localized in the hypothalamus and inhibits prostaglandin synthesis, primarily in the CNS. Paracetamol effectively and reliably relieves throat, head, muscle, and joint pain associated with colds. Paracetamol does not affect water-electrolyte balance (does not cause sodium and water retention in the body) and does not damage the gastrointestinal mucosa. Phenylephrine hydrochloride belongs to α1-adrenomimetic agents. The preparation has a pronounced vasoconstrictive effect. By reducing hyperemia and edema of the mucous membrane of the upper respiratory tract (nasal cavity, paranasal sinuses, pharynx), it reduces rhinorrhea, sneezing, lacrimation, and restores nasal breathing, which is impaired during flu, colds, and allergic diseases. Chlorpheniramine maleate is a histamine H1 receptor blocker, prevents the development of allergic reactions. It is characterized by peripheral anticholinergic activity, and also has sedative and antipruritic effects. It reduces vascular permeability, reduces edema and hyperemia of the mucous membranes of the conjunctiva, nose, nasopharynx, and paranasal sinuses. Pharmacokinetics Paracetamol is rapidly and almost completely absorbed after oral administration. It reaches maximum plasma concentration within 1 hour. The analgesic effect appears within 0.5–2 hours after administration. The bioavailability of paracetamol in tissues is 80%. It is 20% bound to plasma proteins. The half-life in plasma is 2-3 hours. Paracetamol is metabolized in the liver. The resulting conjugates (glucuronides and sulfates) are excreted from the body by the kidneys. Phenylephrine hydrochloride is easily absorbed after oral administration. It reaches maximum plasma concentration within 1-2 hours, bioavailability is 40%, half-life is 2-3 hours, it is metabolized in the liver and intestines by the enzyme monoamine oxidase. Phenylephrine hydrochloride and its metabolites are excreted from the body by the kidneys. Chlorpheniramine maleate is easily absorbed after oral administration. Maximum plasma concentration is observed after 2 hours, bioavailability in tissues is 25-50%, the half-life of the parent substance is approximately 20 hours. It is metabolized in the liver and eliminated by the kidneys and intestines. Indications Symptomatic treatment of colds and infectious-inflammatory diseases of the upper respiratory tract (acute respiratory viral infection, flu, acute rhinitis, sinusitis, tonsillitis, pharyngitis); Moderate and mild pain syndrome (headache and sore throat, myalgia, arthralgia); Allergic conditions of the upper respiratory tract (sneezing, rhinitis, rhinorrhea). Dosage and administration For adults and children from 12 years of age, 1 capsule 3 times a day. For children from 6 to 12 years old - 1 capsule 2 times a day. The preparation is taken after meals. Side effects When the preparation is taken at the recommended dose, side effects are not observed. Rarely, the following may occur: From the digestive system: decreased appetite, dyspeptic symptoms; From the genitourinary system: urinary retention; From the cardiovascular system: tachycardia, arterial hypertension; From the hematopoietic system: thrombocytopenia, leukopenia, agranulocytosis; Allergic reactions: skin rash, itching, urticaria; Other: dryness of mucous membranes, drowsiness, restlessness, weakness. Contraindications Hypersensitivity to any component of the preparation, genetic deficiency of glucose-6-phosphate dehydrogenase, blood diseases, severe liver and/or kidney dysfunction, Gilbert's syndrome (constitutional hyperbilirubinemia), severe forms of arterial hypertension and ischemic heart disease, glaucoma, prostatic hypertrophy, severe forms of hyperthyroidism. Prescribe with caution in patients with epilepsy. Pregnancy and lactation Use of the preparation during pregnancy and lactation is not recommended. Special instructions Precautions: Use with caution in patients with impaired liver and/or kidney function, chronic heart diseases, hyperthyroidism, as well as in elderly patients. To avoid toxic liver damage, the preparation should not be taken with alcohol. Effect on ability to drive and operate machinery: When using the preparation, avoid activities that require attention and rapid psychomotor reactions. Overdose In case of overdose, the following symptoms are possible: paleness, dizziness, nausea, vomiting, pain in the epigastric region. In severe cases, signs of liver damage, kidney failure, encephalopathy, and coma develop. Treatment: Gastric lavage, bowel cleansing, administration of adsorbents (activated charcoal) and symptomatic treatment. Appropriate antidotes may be used: methionine 8-9 hours after overdose and N-acetylcysteine - 12 hours after. Drug interactions Simultaneous use of Effe-flu with barbiturates, diphenylhydantoin, carbamazepine, rifampicin, zidovudine and other inducers of liver microsomal enzymes, as well as metoclopramide, domperidone, and cholestyramine, may enhance hepatotoxic effects. Simultaneous use with indirect-acting anticoagulants (including warfarin) increases the risk of bleeding. It is not recommended to prescribe the preparation with monoamine oxidase inhibitors, cholinoblockers, adreno-blockers, and preparations containing paracetamol. Taking the preparation with tranquilizers, sleeping pills, and psychotropic drugs enhances their sedative effect. Storage conditions and shelf life Store at a temperature not exceeding 25ºC, in a dry, protected from light and children place. Shelf life: 3 years. The preparation is not allowed to be used after the expiry date indicated on the packaging. Dispensing from pharmacy: Available without a prescription.