Grippolek powder for solution for oral administration (raspberries and cranberries) in bags No. 10

Name:
Grippolek. Release formPowder. INN Paracetamol + phenylephrine + pheniramine. FTGS Means for eliminating the symptoms of acute respiratory infections and the “cold” (non-narcotic analgesic + vasoconstrictor + h1-histamine receptor blocker).
Description:
Powder from white to white with a yellowish tint, with the smell of lemon or with the smell of raspberries and cranberries. Inclusions of white, yellow and dark yellow are allowed. Composition One package contains: active ingredients: paracetamol – 325 mg, pheniramine maleate – 20 mg, phenylephrine hydrochloride – 10 mg. excipients: anhydrous citric acid, sodium citrate, aspartame, anhydrous colloidal silicon dioxide, sugar, lemon lime flavor (powder for oral solution (lemon) or raspberry flavor and cranberry flavor (powder for oral solution (raspberry and cranberry).Pharmacotherapeutic groupparacetamol in combination with other drugs, excluding psycholeptics.Code ATC:N02BE51.Pharmacological actionCombined drug, the action of which is due to its constituent components.Paracetamol has analgesic, antipyretic and weak anti-inflammatory effects mainly by inhibiting the synthesis of prostaglandins in the central nervous system, and It also has an effect on the centers of pain and thermoregulation.Pheniramine has antiallergic activity, provides a quick elimination of symptoms such as runny nose and nasal congestion, sneezing, irritation of the eyes and nose, and lacrimation.Phenylephrine is a sympathomimetic agent that has a moderate vasoconstrictor effect – helps to eliminate edema and mucus, reduce rhinorrhea and nasal congestion. Indications for use To relieve symptoms associated with colds and flu, including chills, body aches, headache and muscle pain, runny nose, nasal congestion, sneezing, high fever. Method of application and dosage Dissolve the contents of 1 packet in a glass of boiled hot water, mix and drink hot. It is necessary to take the drug with a large amount of liquid 1-2 hours after eating. Adults and children over 12 years of age: take one sachet 3-4 times a day with an interval between doses of 4-6 hours (no more than 4 sachets per day). Grippolec can be used at any time of the day, but the best effect is when taking the drug before bedtime, at night. The maximum duration of treatment without consulting a doctor is 3 days (when taken as an antipyretic) and no more than 5 days (as an anesthetic). The drug Grippolek is not suitable for the relief of pain not associated with colds, because. contains components that together eliminate the symptoms of a cold. Special populations: Liver failure: Patients with impaired liver function or Gilbert’s syndrome should reduce the dose or increase the interval between doses. Renal failure: in the presence of acute renal failure (creatinine clearance < 10 ml / min), the interval between doses should be at least 8 hours. With a creatinine clearance of 10 to 50 ml / min, the interval between doses should be at least 6 hours. Elderly patients: No dose adjustment is necessary in elderly patients. Side effect Disturbances from the blood and lymphatic system: thrombocytopenia, leukopenia, agranulocytosis, pancytopenia, neutropenia, hemolytic anemia; Immune system disorders: anaphylactic reactions, skin hypersensitivity reactions (eg, urticaria, allergic dermatitis, exfoliative dermatitis, skin rash, Quincke's edema and Stevens-Johnson syndrome), including cross-sensitivity with other sympathomimetics; Respiratory, thoracic and mediastinal disorders: bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs, increased density of bronchial secretions; Liver and biliary tract disorders: liver dysfunction; Gastrointestinal disorders: nausea, dry mouth, vomiting, abdominal pain, diarrhea, dyspepsia; Metabolic and nutritional disorders: anorexia; Cardiovascular disorders: increased blood pressure, hypotension, tachycardia and arrhythmia, palpitations; Musculoskeletal and connective tissue disorders: muscle twitching, muscle weakness; Renal and urinary disorders: urinary retention (most likely in patients with infravesical obstruction such as prostatic hypertrophy), dysuria; Psychiatric disorders: nervousness, irritability*, restlessness and excitability*, confusion*, nightmares*; Nervous system disorders: inhibition, drowsiness, impaired attention, impaired coordination, dizziness, headache; On the part of the organs of vision: blurred vision, mydriasis, paresis of accommodation, increased intraocular pressure, acute and angle-closure glaucoma; General disorders and disorders at the injection site: fatigue, chest tightness. * - children and the elderly are more susceptible to neurological cholinergic effects and paradoxical arousal (eg, increased energy, anxiety, nervousness). In the event of the above adverse reactions or adverse reactions not listed in these instructions for medical use of the drug, you should consult a doctor. Contraindications Hypersensitivity to individual components of the drug, simultaneous use of tricyclic antidepressants, beta-blockers or other sympathomimetic drugs, simultaneous or within the previous 2 weeks of taking monoamine oxidase (MAO) inhibitors, portal hypertension, alcohol abuse, diabetes mellitus, sucrase / isomaltase deficiency, intolerance fructose, glucose-galactose malabsorption, pregnancy, breastfeeding, children under 12 years of age, severe cardiovascular disease, arterial hypertension, hyperthyroidism, angle-closure glaucoma, pheochromocytoma. With caution: Severe atherosclerosis of the coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma, severe liver or kidney disease, prostatic hyperplasia, difficulty urinating due to prostatic hypertrophy, blood diseases, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), chronic malnutrition (caloric deficiency) and dehydration, pyloroduodenal obstruction, stenosing gastric and / or duodenal ulcer, epilepsy, concomitant use of drugs that can adversely affect the liver (barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other microsomal liver enzyme inducers). Paracetamol overdose Liver damage is possible in adults who have taken 10 g or more of paracetamol. Taking 5 g or more of paracetamol can lead to liver damage if the patient has the following risk factors: a) the patient is on long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort and other drugs that induce liver enzymes; b) the patient regularly consumes ethanol in excess of the recommended amounts; c) the patient is exhausted, for example, in the presence of cystic fibrosis, HIV infection, during fasting. Symptoms caused by paracetamol Symptoms of paracetamol overdose in the first 24 hours include: pallor, nausea, vomiting, loss of appetite and abdominal pain. Liver damage may appear within 12-48 hours after taking paracetamol. Possible violation of glucose metabolism and the occurrence of metabolic acidosis. In severe poisoning, liver failure can progress to encephalopathy, bleeding, hypoglycemia, cerebral edema, and death. Acute renal failure with acute necrosis, low back pain, hematuria, and proteinuria may develop even in the absence of severe liver damage. There have been reports of cardiac arrhythmias and pancreatitis. Treatment Immediate measures are of great importance in the treatment of paracetamol overdose. Despite the absence of significant early symptoms of overdose, the patient should be immediately taken to the hospital. Symptoms may be limited to vomiting and may not be consistent with the severity of the overdose or the risk of organ damage. Care must be provided in accordance with established standards of care. Treatment with activated charcoal should be considered if an overdose has been diagnosed within 1 hour of taking paracetamol. Plasma concentrations of paracetamol should be measured every 4 hours after taking the drug. Treatment with N-acetylcysteine can be used within 24 hours after taking paracetamol, however, the maximum protective effect is achieved within 8 hours after taking the drug. The effectiveness of the antidote drops sharply after this time. If necessary, N-acetylcysteine can be administered intravenously. In the absence of hypersensitivity to methionine in a patient, methionine may be a suitable alternative for emergency medical care. Symptoms caused by potentiation of the parasympathetic action of the antihistamine component (pheniramine) An overdose of pheniramine can lead to effects similar to those listed in the "Side effect" section. Additional symptoms may include paradoxical arousal, toxic psychosis, convulsions, apnea, dystonic reactions and cardiovascular insufficiency, drowsiness that may be arousal (especially in children); ulcers of the oral mucosa, coma, convulsions, behavioral changes, bradycardia, atropine-like "psychosis". Treatment Symptomatic treatment. Symptoms caused by phenylephrine Overdose symptoms include increased blood pressure and associated with hypertension reflex bradycardia and arrhythmias. Treatment Elevated blood pressure should be treated with an alpha receptor antagonist, such as intravenous phentolamine. A decrease in blood pressure leads to a reflex increase in heart rate, so if necessary, this condition can be alleviated by the administration of atropine. Precautions Attention should be paid if symptoms: do not improve within 5 days; accompanied by a fever that lasts more than 3 days; - include a sore throat that does not go away for more than 3 days accompanied by fever, headache, rash, nausea or vomiting. Avoid the simultaneous appointment of other drugs containing paracetamol. Long-term use of painkillers, especially a combination of different analgesics, can lead to irreversible kidney damage with the development of kidney failure (analgesic nephropathy). Chronic use of analgesics for headaches can lead to a persistent, intractable headache (drug headache). Due to the presence of sugar in the composition, the drug is not recommended for patients with rare congenital fructose intolerance or glucose-galactose malabsorption. When using the drug, it is not recommended to drink alcoholic beverages, since ethyl alcohol, when taken simultaneously with paracetamol, can cause liver dysfunction. It is imperative that you consult your doctor before taking this medicine if you have the following conditions: hypertension, cardiovascular disease, diabetes, hyperthyroidism, increased intraocular pressure (glaucoma), pheochromocytoma, enlarged prostate, vascular endarteritis obliterans (e.g. Raynaud's phenomenon) , epilepsy, bronchitis, bronchiectasis, bronchial asthma, liver and kidney diseases. Caution should be exercised in patients with impaired renal function and in patients with hepatic insufficiency due to the fact that this drug contains paracetamol and pheniramine, which increase the risk of paracetamol-related liver damage. Patients who have been diagnosed with hepatic and / or renal insufficiency should consult a doctor before taking this drug. Pheniramine can enhance the effect of alcohol, so their simultaneous use should be avoided. Simultaneous use with drugs that cause sedation, such as tranquilizers and hypnotics (especially barbiturates), should be avoided, as this may increase the sedative effect. Grippolec should not be taken with other antihistamines. The elderly are more likely to experience neurological anticholinergic effects and paradoxical arousal (eg, increased energy, restlessness, nervousness). When taking pheniramine in the evening, the symptoms of gastroesophageal reflux may increase. When using pheniramine in combination with drugs that can cause an ototoxic effect, caution is necessary, as symptoms of ototoxicity may be masked. If symptoms persist, a doctor should be consulted. Phenylephrine may contribute to false positive doping control results in athletes. The risk of drowsiness increases with the use of alcoholic beverages, drugs containing alcohol, or sedatives. The risk of drug dependence appears only at doses exceeding those recommended or with long-term treatment. To avoid the risk of overdose, make sure that other medicines the patient is taking do not contain paracetamol. For adults weighing more than 50 kg, the total dose of paracetamol should not exceed 4 g per day. Use in pediatrics Children under 12 years of age, this drug is contraindicated. Children are more likely to experience neurological anticholinergic effects and paradoxical arousal (eg, increased energy, restlessness, nervousness). Use during pregnancy and breastfeeding The drug is contraindicated during pregnancy and breastfeeding. Influence on the ability to drive vehicles and other potentially dangerous mechanisms Grippolek can cause drowsiness, so during treatment it is not recommended to drive a car and engage in other activities that require concentration and high speed of psychomotor reactions. Interaction with other drugs Paracetamol Coumarins (including warfarin) The anticoagulant effect may be enhanced by prolonged daily use of drugs containing paracetamol, which may lead to an increased risk of bleeding. Random doses do not have a significant effect. The dose of anticoagulants may need to be reduced if treatment with drugs containing paracetamol is necessary Substances that increase gastric emptying (eg, metoclopramide) These substances increase the absorption of paracetamol Substances that reduce gastric emptying (eg, propanteline, antidepressants with anticholinergic properties, narcotic analgesics) These substances reduce absorption of paracetamol Chloramphenicol Paracetamol levels may be increased Potentially hepatotoxic drugs or agents that induce microsomal liver enzymes (eg, rifampicin, isoniazid, alcohol, anticonvulsants) Risk of drug hepatotoxicity may be increased Probenecid May interfere with paracetamol excretion and alter paracetamol concentrations in plasma Cholestyramine Decreases absorption of paracetamol if administered within 1 hour before or after paracetamol administration Drug interactions with paracetamol are common minor, but increased when concomitant medications are anticoagulants (warfarin and coumarin) and anticonvulsants with a low therapeutic index. Simultaneous use of paracetamol with NSAIDs may increase their nephrotoxicity. Pharmacodynamic interactions may occur with other pain relievers such as caffeine, opiates. Barbiturates reduce the antipyretic effect. Chloramphenicol: when taken simultaneously with paracetamol, the half-life of chloramphenicol increases by 5 times. Lamotrigine: Paracetamol may reduce the bioavailability and, as a result, the effectiveness of lamotrigine. Salicylamide prolongs the half-life of paracetamol and leads to the accumulation of hepatotoxic metabolites. Zidovudine: The simultaneous use of zidovudine and paracetamol increases the risk of neutropenia. Pheniramine Monooxidase inhibitors These substances increase the anticholinergic effects of pheniramine Anxiolytics, hypnotics, antiparkinsonian and antipsychotics, tricyclic antidepressants, alcohol Simultaneous use with pheniramine enhances the inhibitory effect of these drugs on the central nervous system Phenytoin Pheniramine inhibits the metabolism of phenytoin, which can lead to phenytoin toxicity Pheniramine reduces the effect of derivatives coumarin. Phenylephrine should be used with caution in combination with the following drugs: Monoamine oxidase inhibitors (including moclobemide) Interactions between phenylephrine and monoamine oxidase inhibitors may cause a hypertensive effect Sympathomimetic amines Concomitant use of phenylephrine with other sympathomimetic amines may increase the risk of cardiovascular side effects Beta- blockers and other antihypertensive drugs (including debrisoquine, guanethidine, reserpine, methyldopa) Phenylephrine may reduce the effectiveness of beta-blockers and antihypertensive drugs. Risk of hypertension and other cardiovascular side effects may be increased Tricyclic antidepressants (eg, amitriptyline) Possible increased risk of cardiovascular side effects of phenylephrine Ergot alkaloids (ergotamine and methylseride) Increased risk of ergotism Digoxin and cardiac glycosides Increased risk of irregular heartbeat and heart attack Storage conditions Protected from moisture and light at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiry date stated on the package. Packaging 5.0 g in bags of multilayer packaging material (polyethylene terephthalate film / polypropylene film / aluminum foil / polyethylene film). 5 or 10 packs along with instructions for medical use in a pack of cardboard. Conditions for dispensing from pharmaciesWithout a doctor's prescription. Buy Grippolek powder for oral solution (raspberry and cranberry) in bags No. 10 preparation of oral solution (raspberries and cranberries) in bags No. 10