Index of drugs

Symptomatic treatment of colds and flu, with fever, mild to moderate pain, swelling of the nasal mucosa with secretion.

1 sachet contains 1000 mg of Paracetamol, 10 mg of phenylephrine hydrochloride, 4 mg of chlorpheniramine maleate. The product contains sucrose.

paracetamol has analgesic and antipyretic effects and low anti-inflammatory activity. It is an active metabolite of phenacetin with much lower toxicity. Paracetamol works by inhibiting arachidonic acid cyclooxygenase (especially COX-3), inhibits the synthesis of prostaglandins in the central nervous system (o.u.n.). It reduces the sensitivity o.u.n. on kinin and serotonin, which increases the pain threshold. The reduction in the concentration of prostaglandins in the hypothalamus is responsible for the antipyretic effect. Paracetamol does not affect platelet aggregation. It is absorbed in a large amount and quickly, reaches the maximum concentration in the blood in the active form of the drug after 0.5-2 h. With plasma proteins is about 10%, the time required to achieve maximum effect is from 1 to 3 h, and its The effect lasts for 3-4 h. Metabolism of paracetamol undergoes hepatic first-pass effect and then proceeds according to linear kinetics. Paracetamol is primarily metabolised in the liver (90-95%) and is mainly excreted in the urine in the form of glucuronide conjugate, to a lesser extent in the form of sulphate and bound to the cysteine. Less than 5% is excreted unchanged. T0.5 is 1.5-3 h (increases in case of overdose and in patients with liver failure, the elderly and children). Higher doses can saturate the normal matabolic mechanisms of the liver, and then other metabolic pathways are used that can cause hepatotoxic matabolites and probably nephrotoxic due to the depletion of the glutathione pool.phenylephrine is a sympathomimetic, an alpha-1 adrenergic agonist. It works vasokonstrykcyjnie, which causes a temporary reduction of congestion and edema of the nasal mucosa. Its action on the heart is to accelerate the heart rhythm and reduce the efficiency of its work. Phenylephrine hydrochloride is rapidly and irregularly absorbed from the gastrointestinal tract. It is rapidly metabolised in the small intestine and liver via the monoamine oxidase enzyme. The pharmacological effect occurs quickly and can last for several hours. The bioavailability of phenylephrine after oral administration is 38% and the elimination half-life is 2-3 hours.chlorpheniramine it blocks H1 receptors. It inhibits excessive production of mucus nasal secretion. It is well absorbed from the gastrointestinal tract, reaching a maximum plasma concentration after 2-6 h after oral administration. Maximum plasma concentrations are achieved after 2-6 h after oral administration. Chorthinamine appears to be extensively metabolised during the first pass through the liver. It is distributed through the cerebrospinal fluid to the central nervous system and, besides, to all other tissues. Bioavailability is on the order of 25-45%. distribution in tissues and body fluids is not full. T0.5 in the elimination phase is 14-25 h.

Hypersensitivity to the active substances or to any of the excipients. Liver disease (liver failure or without) or viral hepatitis (increased risk of hepatotoxicity). Hypertension. Hyperthyroidism. Severe cardiovascular diseases (coronary heart disease, angina pectoris). Tachycardia. Treatment with MAO inhibitors. Glaucoma. Heart arythmia. Severe renal failure.

There are no indications for use in children <12 years due to the dose of paracetamol and the presence of other ingredients. Paracetamol should be administered with caution, avoiding prolonged treatment in patients with anemia, heart disease, lung disease. The use of pracetamol in patients who drink alcohol regularly (≥ 3 alcoholic drinks per day) may cause liver damage.Do not use more than 2 g of paracetamol per day for alcoholics. Caution is advised in asthmatic patients hypersensitive to Acetylsalicylic acid, because bronchospastic reactions have been reported after taking paracetamol (cross-reactivity) - it occurs in less than 5% of subjects. Cross-hypersensitivity may develop; Patients who are allergic to one antihistamine may be allergic to others. Exercise caution and assess the risk / benefit ratio in the following situations: kidney or lung disease, prostatic hyperplasia, diabetes mellitus, bronchial asthma, cardiovascular diseases (such as severe bradycardia, idiopathic orthostatic hypotension, atherosclerosis), pancreatitis, active gastric ulcer, narrowing of the connection of the pyloric and duodenal canal, anemia, thyroid disease. Caution should be exercised in patients who are sensitive to sedatives and patients with epilepsy as they may interact with the medicines used to treat these conditions. Patients treated with tricyclic antidepressants, maprotilin or other anticholinergic drugs including chlorpheniramine should report the occurrence of gastrointestinal problems as soon as possible due to the possible risk of paralytic ileus occlusion. Elderly patients are more susceptible to anticholinergic effects of antihistamines, such as dry mouth and residual urine; if these effects are continuous or significantly increased, it may be necessary to discontinue the use of the medicinal product. Due to the sucrose content, the preparation should not be used in patients with fructose intolerance, sucrase-isomaltase deficiency or malabsorption of glucose-galactose.

Do not use in pregnancy unless it is absolutely necessary. It should not be used during breast-feeding.

Dependent on phenylephrine. Rarely: myocardial infarction, ventricular arrhythmias; pulmonary edema (generally at high doses or in susceptible individuals); intracerebral bleeding (generally at high doses or in susceptible individuals). Frequency unknown: anxiety, nervousness, nervousness, weakness, nausea, tremors, insomnia, irritability, headaches (at high doses it may be a symptom of hypotension), at high doses may occur convulsions, paraesthesia and psychosis with hallucinations; hypertension (generally at higher doses or in susceptible individuals), peripheral vasoconstriction with restricted blood flow to organs important for vital functions (vasodilator effects are more likely in hypovolemic patients), cold limbs, redness, hypotension; chest pain or discomfort, severe bradycardia, increased myocardial effort due to increased resistance of peripheral arterial vessels, especially in elderly patients or patients with impaired cerebral or coronary circulation, onset or exacerbation of heart failure associated with heart disease, as well as palpitations (when using high doses); deterioration of kidney blood supply and probably a decrease in the amount of urine, urinary retention; dyspnoea, respiratory disorders; paleness of the skin, piloering, excessive sweating; vomiting (when using high doses); hyperglycemia; hypokalemia, metabolic acidosis.Dependent on chlorpheniramine. Common: depression of the central nervous system in the form of drowsiness, nausea, muscle weakness, which in some patients disappear after 2-3 days of treatment; facial dyskinesias, coordination disorders (stiffness), tremors, paresthesia; dry mouth, loss of appetite, changes in the perception of flavors and odors, gastrointestinal discomfort (nausea, vomiting, diarrhea, constipation, epigastric pain), which may be reduced when using the drug together with food; urinary retention and / or difficulty in passing urine; dryness of the mucous membrane of the nose and throat, drying of mucous membranes; increased sweating; blurred vision, double vision. Uncommon or rare: sometimes paradoxical, especially when using high doses in children or the elderly, characterized by anxiety, insomnia, nervousness, delirium, palpitations and convulsions; tightness in the chest, wheezing; in general with overdose - rhythm disorders, palpitations, tachycardia; hypersensitivity reactions,anaphylactic reactions (cough, difficulty swallowing, fast heartbeat, itching, swollen eyelids or around the eyes, face, tongue, shortness of breath, fatigue), hypersensitivity to light, cross-sensitivity to similar drugs; hypotension, hypertension, edema; tinnitus, acute labyrinthitis; impotence, intermenstrual bleeding; rare: cholestasis, hepatitis or other liver problems (including abdominal or abdominal pain, dark urine), morphological disorders (agranulocytosis, leukopenia, aplastic anemia or thrombocytopenia) with symptoms such as unusual bleeding, sore throat or tiredness.Depends on paracetamol. Rare: toxic liver damage (jaundice); hypoglycemia; thrombocytopenia, leukopenia, agranulocytosis, neutropenia, hemolytic anemia; sterile pyoderma (turbid urine), renal side effects. Elderly patients are more likely to experience the following symptoms: dizziness, sedation, confusion, hypotension or a paradoxical reaction manifested by hyperactivity.

Orally. Adults and children aged> 12 years: 1 sachet every 6-8 h (3 or 4 times / day). Do not use more than 4 sachets (4 g of paracetamol) within 24 hours. The administration of the preparation depends on the occurrence of pain symptoms or fever. The contents of the sachet should be dissolved in a small amount of liquid, preferably in half a glass of water.