Fervex powder for preparation of oral solution [lemon], 4pcs

Composition

Each sachet contains: Active ingredient: paracetamol-0.500 g, ascorbic acid-0.200 g, phenyramine maleate-0.025 g. excipients: mannitol 3,515 g; citric acid 0,050 g; povidone KZO 0,010 g; magnesium citrate 0,400 g;aspartame 0,050 g, lemon-rum flavor* 0,200 g.

Pharmacological action

Means for eliminating the symptoms of acute respiratory diseases (ARI) and “colds” (non-narcotic analgesic + H1-hisamine receptor blocker + vitamin). ATX code: N02BE51Pharmacological PROPERTIESPHARMACODYNAMICAFERVEX® is a combination drug that contains paracetamol, phenyramine and ascorbic acid. Paracetamol is a non-narcotic analgesic that blocks cyclooxygenase, mainly in the central nervous system, affecting the centers of pain and thermoregulation; it has analgesic and antipyretic effects. Phenyramine is a blocker of H1-histamine receptors, reduces rhinorrhea and lacrimation, eliminates spastic phenomena, swelling and hyperemia of the nasal mucosa, nasopharynx and paranasal sinuses. Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, in the synthesis of steroid hormones; reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. Improves the tolerance of paracetamol and prolongs its action (due to the prolongation of Half-life). Pharmacokineticsparacetamol After oral use, it is rapidly absorbed from the gastrointestinal tract. Maximum concentrations of the drug in the blood plasma are reached in 10-60 minutes after use. It is rapidly distributed throughout the body’s tissues, penetrates through the blood-brain barrier. The association with plasma proteins is insignificant and has no therapeutic significance, but increases as the dose increases. Metabolism occurs in the liver,80% of the dose is conjugated with glucuronic acid and sulfates to form inactive metabolites; 17% is hydroxylated to form 8 active metabolites, which are conjugated with glutathione to form already inactive metabolites. One of the hydroxylated intermediates of metabolism exhibits a hepatotoxic effect. This metabolite is neutralized by conjugation with glutathione, but it can also accumulate with an overdose of paracetamol (150 mg of paracetamol/kg or 10 g of paracetamol orally) and cause hepatocyte necrosis. It is excreted by the kidneys in the form of metabolites, mainly in the form of conjugates. Less than 5% of the dose is excreted unchanged. The elimination half-life is 1 to 3 hours. Phenyramine: It is well absorbed in the digestive tract. The half-life from blood plasma is from one to one and a half hours. It is excreted from the body mainly through the kidneys. Ascorbic acid:  It is well absorbed in the digestive tract. The time to create the maximum therapeutic concentration (TMAX) after oral use is 4 hours. It is mainly metabolized in the liver. It is excreted by the kidneys, through the intestines, with sweat, in unchanged form and in the form of metabolites. * Fragrance ingredients: maltodextrin, acacia gum, α-pinene, β-pinene, limonene, γ-terpinene, linaloal, neral, α-terpineol, geranal, dextrose, silicon dioxide E 551, butylhydroxyanisole.

Indications

It is used for acute respiratory diseases, acute respiratory viral infections, rhinopharyngitis to relieve the following symptoms:

• rhinorrhea, nasal congestion;
• headache;
• fever;
• watery eyes;
• sneezing.

Contraindications

• Hypersensitivity to paracetamol, ascorbic acid, phenyramine or any other component of the drug.
• Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase).
• Liver failure.
• Angle-closure glaucoma.
• Urinary retention associated with prostate diseases and urinary disorders.
• Portal hypertension.
• Alcoholism.
• Phenylketonuria.
• Children’s age (up to 15 years).
• Pregnancy and lactation (safety has not been studied).

With caution: Renal insufficiency, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, old age.

Side effects

The drug is well tolerated in the recommended doses. Dry mouth, nausea, vomiting, abdominal pain, urination disorders, constipation, allergic reactions (erythema, skin rash, pruritus, urticaria, angioedema, anaphylactic shock), drowsiness, accommodation disorders, palpitation, orthostatic hypotension, dizziness, coordination disorders, tremor, confusion, hallucinations, impaired concentration (more often in elderly patients). Rarely-anemia, leukopenia, agranulocytosis, thrombocytopenia, agitation, nervousness, insomnia. If any adverse reactions occur, stop taking the drug and consult your doctor.

Interaction

Ethanol increases the sedative effect of antihistamines (phenyramine), so it should be avoided during treatment with Fervex®. In addition, ethanol, when used concomitantly with phenyramine, contributes to the development of acute pancreatitis. Pheniramine in the composition of the drug Fervex® enhances the effect of sedatives: morphine derivatives, barbiturates, benzodiazepines and other tranquilizers, neuroleptics (meprobamate, phenogiazine derivatives), antidepressants (amitriptyline, mirtazapine, mianserin), central-acting antihypertensive drugs, sedatives belonging to the group of H1 blockers, baclofen; at the same time, the sedative effect increases, but it also increases the risk of side effects of the drug (urinary retention, dry mouth, constipation). Consideration should be given to the possibility of enhancing central atropine-like effects when used in combination with other substances with anticholinergic properties (other antihistamines, imipramine group antidepressants, phenothiazine-type neuroleptics, m-holinoblocking antiparkinsonian agents, atropine-like antispasmodics, disopyramide). When using the drug, together with inducers of microsomal oxidation: barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxic effects significantly increases (due to the paracetamol included in the composition). Concomitant use of glucocorticosteroids increases the risk of glaucoma. Concomitant use with salicylates increases the risk of nephrotoxic effects. When used concomitantly with levomycetin (chloramphenicol), the toxicity of the latter increases. Paracetamol contained in the preparation enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.

How to take, course of use and dosage

Inside – 1 sachet 2-3 times a day. Before use, the contents of the sachet should be dissolved in a glass (200 ml) of warm water – The maximum duration of treatment is 5 days. The maximum daily dose of paracetamol is 4 g (8 sachets of Fervex®) for a body weight of more than 50 kg. The interval between doses of the drug should be at least 4 hours. In patients with impaired renal function (creatinine clearance If there is no relief of symptoms within 5 days after starting the drug, if the body temperature remains elevated, or if it suddenly rises again after the initial decrease, you should consult a doctor.

Overdose

Signs of acute paracetamol poisoning include anorexia, nausea, vomiting, epigastric pain, sweating, pallor of the skin, and drowsiness. After 1-2 days, signs of liver damage appear. In severe cases, liver failure, hepatonecrosis, encephalopathy and coma develop, which can lead to death. Signs of phenyramine poisoning include seizures, impaired consciousness, and coma. If symptoms of poisoning occur, you should immediately stop using the drug and consult a doctor. Gastric lavage, use of enterosorbents (activated carbon, hydrolytic lignin), intravenous or oral use of the antidote acetylcysteine (if possible, in the first 10 hours after overdose), and symptomatic treatment are recommended.

Special instructions

The drug does not contain sugar and can be used by patients with diabetes mellitus. Fervex® should not be used simultaneously with other medications containing paracetamol. In order to avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, as well as taken by people who are prone to chronic alcohol consumption. The risk of developing liver damage increases in patients with alcoholic hepatosis. If the recommended doses are exceeded and prolonged use occurs, mental dependence on the drug may occur. To avoid an overdose of paracetamol, make sure that the total daily dose of paracetamol contained in all medications taken by the patient does not exceed 4 g. Influence on the ability to drive vehicles and mechanisms Taking into account the possibility of developing undesirable effects such as drowsiness and dizziness, it is recommended to refrain from driving and mechanisms during treatment with the drug.

Storage conditions

At a temperature of 15 to 25°C. Keep out of reach of children!

Shelf

life is 3 years.

Active ingredient

Paracetamol, Phenyramine, Ascorbic acid

Dosage form

powder for oral use