Instructions Gripout hot drink powder for oral solution package 6 g No. 10
Composition
active ingredients: paracetamol, pheniramine maleate, phenylephrine hydrochloride, ascorbic acid;
1 sachet of 6 g contains: paracetamol 500 mg, pheniramine maleate 25 mg, phenylephrine hydrochloride 10 mg, ascorbic acid 200 mg;
excipients: sucrose, sodium citrate, tartaric acid, aspartame (E 951), anhydrous citric acid, lemon essence, quinoline yellow dye (E 104).
Dosage form
Powder for oral solution.
Main physicochemical properties: granular loose powder – a mixture of white, pale yellow and/or yellow granules of various sizes with a lemon taste and smell.
Pharmacotherapeutic group
Analgesics and antipyretics. Anilides. Paracetamol, combinations without psycholeptics. ATX code N02B E51.
Pharmacological properties
Pharmacodynamics.
Paracetamol has antipyretic, analgesic and mild anti-inflammatory effects. It inhibits the synthesis of prostaglandins in the central nervous system (CNS) and blocks the conduction of pain impulses.
Ascorbic acid enhances the body's nonspecific resistance.
Pheniramine maleate is a histamine H1 receptor blocker that reduces vascular permeability, eliminates tearing, and itching of the eyes and nose.
Phenylephrine hydrochloride is an α-adrenomimetic, has a vasoconstrictor effect, reduces swelling of the nasal mucosa and paranasal sinuses.
Pharmacokinetics.
Paracetamol is well absorbed, crosses the placental barrier, penetrates to a small extent into breast milk, is metabolized by the cytochrome P450 system, is excreted by the kidneys, the half-life is 1–4 hours. The duration of action is 3–4 hours.
Pheniramine maleate is well absorbed from the digestive tract. It is metabolized in the liver by the cytochrome P450 system, the half-life is 16–18 hours, 70–83% is excreted by the kidneys.
Phenylephrine hydrochloride has a rapid onset of action and lasts approximately 20 minutes. It is metabolized in the liver or in the digestive tract and excreted by the kidneys.
Ascorbic acid is rapidly absorbed from the digestive tract, metabolized in the liver, and excreted by the kidneys.
Indication
Symptomatic treatment of acute respiratory infections and influenza:
elevated body temperature;
headache;
nasal congestion;
runny nose;
muscle pain and aches.
Contraindication
Hypersensitivity to the components of the drug, severe liver and/or kidney dysfunction, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, glutathione reductase, alcoholism, blood diseases, severe anemia, leukopenia, thrombosis, thrombophlebitis, conditions accompanied by increased arousal; sleep disorders; severe arterial hypertension; organic diseases of the cardiovascular system, rare hereditary conditions of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose insufficiency in severe arterial hypertension, decompensated heart failure, cardiac conduction disorders, bronchial asthma, severe atherosclerosis, tendency to vasospasm, ischemic heart disease, glaucoma (especially angle-closure), pheochromocytoma. Pregnancy and breastfeeding.
The drug is contraindicated in elderly patients; in epilepsy, hyperthyroidism, acute pancreatitis, prostatic hypertrophy with urinary retention, bladder neck obstruction, pyloroduodenal obstruction, severe forms of diabetes mellitus. Do not use simultaneously with monoamine oxidase inhibitors (MAO) and within 2 weeks after discontinuation of MAO inhibitors. Contraindicated in patients taking tricyclic antidepressants or beta-blockers, other sympathomimetics, drugs that suppress or increase appetite, and amphetamine-like psychostimulants.
Interaction with other medicinal products and other types of interactions
The rate of absorption of paracetamol may be increased by metoclopramide and domperidone and decreased by cholestyramine (this effect is insignificant if cholestyramine is administered 1 hour later).
Antacids and food reduce the absorption of paracetamol. The anticoagulant effect of warfarin and other coumarins may be enhanced by long-term regular daily use of paracetamol, increasing the risk of bleeding. Barbiturates reduce the antipyretic effect of paracetamol. Hepatotoxic drugs increase the likelihood of paracetamol accumulation and overdose.
The simultaneous use of high doses of paracetamol with isoniazid increases the risk of hepatotoxicity. Paracetamol reduces the effectiveness of diuretics, may prolong the half-life of chloramphenicol; may induce the metabolism of lamotrigine in the liver, which reduces its bioavailability and efficacy. With regular use of paracetamol and zidovudine, neutropenia and an increased risk of liver damage are possible. When taking probenecid, the dose of paracetamol should be reduced, because it affects the metabolism of paracetamol. Paracetamol may affect the results of determining the level of uric acid by the phosphoric-tungstic acid method. The hepatotoxicity of paracetamol may increase with prolonged or excessive alcohol consumption. Do not use simultaneously with alcohol.
Ascorbic acid when taken orally enhances iron absorption, increases the level of ethinyl estradiol, penicillins, tetracyclines, reduces the level of antipsychotics, phenothiazine derivatives in the blood, reduces the effect of heparin and indirect anticoagulants. When used simultaneously with salicylates, the risk of crystalluria and the risk of glaucoma during treatment with glucocorticosteroids increases; large doses reduce the effectiveness of tricyclic antidepressants.
Antidepressants, antiparkinsonian and antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation. Glucocorticosteroids increase the risk of glaucoma.
Absorption of ascorbic acid is reduced with simultaneous use of oral contraceptives, consumption of fruit or vegetable juices, alkaline drinks. Ascorbic acid when taken orally increases the absorption of penicillin, iron, reduces the effectiveness of heparin and indirect anticoagulants, increases the risk of crystalluria during treatment with salicylates. Simultaneous administration of ascorbic acid and deferoxamine increases tissue toxicity of iron, especially in the heart muscle, which can lead to decompensation of the circulatory system. Ascorbic acid can be taken only 2 hours after the injection of deferoxamine, since their simultaneous administration increases iron toxicity, especially in the myocardium, which can lead to cardiac decompensation. Long-term administration of large doses in persons treated with disulfiram inhibits the disulfiram-alcohol reaction. Absorption of ascorbic acid is reduced by oral contraceptives, fruit or vegetable juices, alkaline drinks. Large doses of the drug reduce the effectiveness of tricyclic depressants.
When used simultaneously with alcohol, drowsiness may increase.
Due to the content of pheniramine, the effect of drugs that depress the central nervous system (hypnotics, anesthetics, barbiturates, tranquilizers, narcotic analgesics, as well as ethanol) is enhanced. Pheniramine can inhibit the effect of anticoagulants and interact with progesterone, reserpine, thiazide diuretics. Simultaneous use of contraceptives can lead to a decrease in the effectiveness of the antihistamine component of the drug.
Phenylephrine, which is part of the drug Gripout Hot Drink, is incompatible with sympathomimetics and MAO inhibitors due to the risk of increasing blood pressure, negative effects on the cardiovascular system and CNS, with tricyclic antidepressants (amitriptyline) - increases the risk of cardiovascular side effects, with digoxin and cardiac glycosides - leads to arrhythmias and heart attack, with other sympathomimetics increases the risk of adverse cardiovascular reactions and hypertension, may reduce the effectiveness of β-blockers and other antihypertensive drugs (reserpine, methyldopa, debrisoquine, guanethidine) with an increased risk of arterial hypertension and adverse cardiovascular reactions. Simultaneous use of phenylephrine with ergot alkaloids (ergotamine and methysergide) may increase the risk of ergotism. Caution should be exercised when using paracetamol with flucloxacillin, as concomitant administration has been associated with metabolic acidosis with an increased anion gap, especially in patients with risk factors (see section "Special warnings and precautions for use").
Application features
Do not exceed recommended doses.
The drug should be used with caution in patients with impaired liver, digestive tract and kidney function, benign hyperbilirubinemia, urinary retention, severe cardiovascular diseases, diabetes mellitus, bronchial asthma, productive cough. With prolonged use of the drug, it is necessary to monitor peripheral blood and liver function (once every 10 days).
In sensitive patients, even small doses may cause insomnia, dizziness, palpitations, tremors, or cardiac arrhythmias. If the above symptoms occur, the drug should be discontinued.
You should not drink alcohol while using the drug.
During treatment, sedatives (especially barbiturates) should not be used, as they enhance the sedative effect of the antihistamine component of the drug (pheniramine maleate).
If the disease is caused by a bacterial infection, simultaneous treatment with antibiotics is recommended.
If hemolysis of erythrocytes or drug-induced hemolytic anemia occurs while using Gripout Hot Drink, the drug should be discontinued immediately.
The drug contains: phenylephrine, which may cause angina attacks; sucrose, which is contraindicated in patients with intolerance and malabsorption of fructose, glucose-galactose or sucrose-isomaltose. If the patient has been diagnosed with intolerance to some sugars, consult a doctor before taking this medicine, use with caution in diabetics. May be harmful to teeth.
Before using the drug, you should consult a doctor in the following cases:
with liver and kidney diseases;
when taking warfarin or similar anticoagulants;
when taking analgesics every day for mild arthritis;
with bronchopulmonary diseases (asthma, emphysema, chronic bronchitis).
The drug may affect the results of laboratory tests for blood glucose, uric acid, creatinine, inorganic phosphates. The result of the study of occult blood in the stool may be negative.
Caution is advised when prescribing paracetamol concomitantly with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (HAGMA), especially in patients with severe renal insufficiency, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring of laboratory results, including measurement of urinary 5-oxoproline, is recommended. In patients with severe infections (sepsis) in which glutathione levels are reduced, the risk of metabolic acidosis is increased when taking paracetamol, the symptoms of which are deep, rapid or difficult breathing, nausea, vomiting, loss of appetite, in which case you should immediately consult a doctor.
It is not recommended to take this drug at the end of the day, since ascorbic acid in large doses has a mild stimulating effect. Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, monitoring of kidney function and blood pressure is required.
The drug should be prescribed with extreme caution to patients with impaired iron metabolism (hemosiderosis, hemochromatosis, thalassemia), with a history of nephrolithiasis (risk of hyperoxaluria and oxalate precipitation in the urinary tract after taking large doses of ascorbic acid).
Long-term use of large doses of ascorbic acid may accelerate its own metabolism, which is why paradoxical hypovitaminosis is possible after discontinuation of treatment. It should not be used simultaneously with other drugs containing vitamin C. Absorption of ascorbic acid may change in case of impaired intestinal motility, enteritis or reduced gastric secretion.
The drug contains aspartame, which is a source of phenylalanine, which may be harmful to patients with phenylketonuria.
Patients with diabetes should take into account that the medicine contains sucrose.
This medicinal product contains sodium citrate. Caution should be exercised when used in patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy or breastfeeding. The effect of the drug on fertility has not been specifically studied. Preclinical studies have not revealed any special effect of paracetamol on fertility when used in therapeutic doses. Adequate studies of the effects of phenylephrine and pheniramine on reproductive toxicity in animals have not been conducted.
Ability to influence reaction speed when driving vehicles or other mechanisms
While using the drug, you should avoid driving vehicles, working with mechanisms, and other potentially dangerous activities, as the drug may cause drowsiness and other adverse reactions from the nervous system and visual organs.
Method of administration and doses
Dissolve the contents of the sachet in a glass of hot water (not boiling water) and drink. The drug can be taken again every 3-4 hours, but no more than 3 sachets per day. The maximum period of use without consulting a doctor is 3 days, further use is recommended by a doctor.
Do not use in children under 14 years of age.
Overdose
Paracetamol. In the first 24 hours, pale skin, nausea, vomiting, anorexia and abdominal pain appear. When taking large doses, disorientation, psychomotor agitation, dizziness, sleep disorders, heart rhythm disorders, pancreatitis, hepatonecrosis may occur. The first sign of liver damage may be abdominal pain, which does not always appear in the first 12–48 hours, but may occur later, up to 4–6 days after taking the drug. Liver damage usually occurs a maximum of 72–96 hours after taking the drug. Glucose metabolism disorders and metabolic acidosis, hemorrhages may occur. With prolonged use of high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia are possible.
In isolated cases, acute renal failure with tubular necrosis has been reported, which is possible even in the absence of severe liver damage, manifested by severe lumbar pain, hematuria, proteinuria. Nephrotoxicity is possible: renal colic, interstitial nephritis, capillary necrosis.
The use of 10 g or more of paracetamol in adults and more than 150 mg/kg of body weight in children, especially with alcohol, can lead to hepatocellular necrosis with the development of encephalopathy, hemorrhages, hypoglycemia, hepatic coma and death. In patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; alcohol abuse; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia) the use of 5 g or more of paracetamol can lead to liver damage.
In case of overdose, urgent medical attention is required. The patient should be taken to hospital immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage. Activated charcoal should be administered within the first hour after overdose. The concentration of paracetamol in the blood should be measured 4 hours or later after ingestion (earlier concentrations are not reliable). Treatment with N-acetylcysteine can be used for 24 hours after ingestion of paracetamol, but the maximum effect occurs when used within the first 8 hours, after which its effectiveness decreases sharply. If intravenous N-acetylcysteine is necessary, it should be administered according to the established dose schedule. Alternatively, oral methionine can be used in the absence of vomiting away from the hospital.
Phenylephrine. Hyperhidrosis, psychomotor agitation or CNS depression, headache, dizziness, drowsiness, impaired consciousness, arrhythmia, tremor, hyperreflexia, convulsions, nausea, vomiting, irritability, restlessness, arterial hypertension, in severe cases - coma. To eliminate hypertensive effects, an alpha-receptor blocker can be used intravenously, and diazepam can be used to eliminate convulsions.
Pheniramine. Atropine-like symptoms occur: mydriasis, photophobia, dry skin and mucous membranes, hyperthermia, intestinal atony. CNS depression leads to disruption of the respiratory and cardiovascular systems (bradycardia, hypotension, collapse). Symptoms due to mutual potentiation of the parasympatholytic effect of pheniramine and the sympathomimetic effect of phenylephrine: drowsiness, which may develop into excitation (especially in children) or CNS depression, visual impairment, rash, persistent headache, nervousness, insomnia, hyperreflexia, irritability, circulatory disorders, bradycardia. There is no specific antidote for the treatment of antihistamine overdose. The patient should be provided with standard emergency care, including giving activated charcoal, a saline laxative and taking standard measures to support the cardiorespiratory system. Stimulants are not allowed; vasoconstrictors may be used to treat hypotension.
Ascorbic acid. Nausea, vomiting or diarrhea occur (which disappear after its withdrawal); bloating and abdominal pain, itching, skin rashes, increased excitability. Doses of more than 3000 mg can cause temporary osmotic diarrhea and gastrointestinal disorders, zinc and copper metabolism disorders, myocardial dystrophy, with prolonged use in large doses, inhibition of the function of the insular apparatus of the pancreas and glucosuria are possible. Overdose can lead to changes in the renal excretion of ascorbic and uric acids during urine acetylation with the precipitation of oxalate stones.
Treatment is symptomatic: within the first 6 hours, it is necessary to wash the stomach, and within the first 8 hours, administer methionine orally or cysteamine or N-acetylcysteine intravenously.
Adverse reactions
Skin and subcutaneous tissue disorders: increased sweating, rash, itching, dermatitis, urticaria, erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis, skin and mucous membrane rash (usually generalized, erythematous rash, urticaria), Quincke's edema.
From the nervous system: drowsiness, general weakness, nervousness, headache, dizziness, psychomotor agitation and disorientation, anxiety, feeling of fear, irritability, hallucinations, sleep disturbances, paresthesias, insomnia, confusion, depressive states, tremor, epileptic seizures, dyskinesia, in some cases - coma, tingling and heaviness in the limbs, tinnitus, behavioral changes.
On the part of the organs of vision: impaired vision and accommodation, increased intraocular pressure, mydriasis, dry eyes, eye pain, burning sensation in the eyes, blurred vision, photophobia, acute angle-closure glaucoma.
On the part of the digestive tract: nausea, vomiting, dry mouth, discomfort and pain in the epigastric region, hypersalivation, decreased appetite, increased activity of liver enzymes, heartburn, diarrhea, constipation, flatulence, anorexia, aphthae, hemorrhages, irritation of the mucous membranes.
On the part of the hepatobiliary system: impaired liver function, hypertransaminasemia, usually without jaundice, hepatonecrosis (when using high doses).
From the side of the hematopoietic system: anemia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart area), hemolytic anemia, bruising or bleeding. With prolonged use in high doses - aplastic anemia, pancytopenia, which can cause nosebleeds and/or bleeding gums, bruising, agranulocytosis, neutropenia, leukopenia, thrombocytopenia.
On the part of the urinary system: when using high doses - nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis), urination disorders, especially in patients with prostatic hypertrophy, crystalluria, formation of urate and oxalate stones in the kidneys and urinary tract, dysuria, renal colic, renal failure.
Cardiovascular system: arterial hypertension, tachycardia or reflex bradycardia, shortness of breath, pain in the heart area, arrhythmia, palpitations, angina attacks.
On the part of the endocrine system: hypoglycemia, up to hypoglycemic coma, hyperglycemia, glycosuria.
Metabolic changes: zinc and copper metabolism disorders.
Respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.
Others: general weakness, malaise.
Adverse reactions that may be due to the presence of ascorbic acid in the medicinal product
From the urinary system: damage to the glomerular apparatus of the kidneys, crystalluria, renal failure.
Skin: eczema.
On the part of the endocrine system: impaired glycogen synthesis up to the appearance of diabetes mellitus.
From the cardiovascular system: myocardial dystrophy.
From the side of the hematopoietic system: thrombocytosis, hyperprothrombinemia, thrombocytopenia, erythrocytopenia, neutrophilic leukocytosis.
From the nervous system: sleep disturbances, feeling of heat, increased fatigue.
Metabolic disorders: zinc and copper metabolism disorders, high anion gap metabolic acidosis (HAGMA)*.
Unlike second-generation antihistamines, the use of pheniramine is not associated with QT prolongation and cardiac arrhythmia.
* Reported in the post-marketing period with concomitant use of paracetamol with flucloxacillin, usually in the presence of risk factors.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
6 g per sachet. 10 sachets per carton.
Vacation category
Without a prescription.
Producer
FDS Limited.
Location of the manufacturer and address of its place of business.
Plot No. B-8, MIDS, Industrial Area, Waluj, 431 136, Dist. Aurangabad, India.
Producer.
Evertogen Life Sciences Limited.
Location of the manufacturer and address of its place of business.
Plot No.: S-8, S-9, S-13/P and S-14/P T S I A C, S I Z Pharma, Green Industrial Park, Polepally (V), Yedcherla (M), Mahabubnagar, Telangana, IH-509301, India.
