Instructions Gripotsitron Hot lemon powder for oral solution package 4 g No. 10
Composition
active ingredients: paracetamol; ascorbic acid (vit C); pheniramine; phenylephrine;
1 packet contains paracetamol 500 mg, ascorbic acid 50 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg;
excipients: sorbitol (E 420), citric acid anhydrous, sodium saccharin, lactose monohydrate, succinic acid, sodium citrate, povidone, colloidal anhydrous silicon dioxide, tartrazine (E 102); "Lemon" flavoring containing maltodextrin, gum arabic, citric acid.
Dosage form
Powder for oral solution.
Main physicochemical properties: the contents of the package are a mixture of granules and powder of yellow and white color with a fruity odor.
Pharmacotherapeutic group
Other analgesics and antipyretics. Anilides. Paracetamol, combinations without psycholeptics. ATX code N02B E51.
Pharmacological properties
Pharmacodynamics. Paracetamol has antipyretic, analgesic and 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. Its effect occurs quickly and lasts about 20 minutes.
Pharmacokinetics. Paracetamol is well absorbed, penetrates 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 (T½) is 1-4 hours. The duration of action is 3-4 hours.
Ascorbic acid is rapidly absorbed from the digestive tract. It is metabolized in the liver and excreted by the kidneys.
Pheniramine maleate is well absorbed from the digestive tract. It is metabolized in the liver by the cytochrome P450 system, T½ is 16-18 hours, 70-83% is excreted by the kidneys.
Phenylephrine hydrochloride is metabolized in the liver or in the digestive tract and excreted by the kidneys.
Indication
Symptomatic treatment of acute respiratory infections and influenza:
elevated body temperature;
headache;
nasal congestion;
runny nose;
pain and aches in the muscles.
Contraindication
Hypersensitivity to the components of the drug; severe liver and/or kidney dysfunction; congenital hyperbilirubinemia; glucose-6-phosphate dehydrogenase deficiency; phenylketonuria, alcoholism; blood diseases; leukopenia; anemia; severe forms of arrhythmia, arterial hypertension, atherosclerosis, ischemic heart disease; hyperthyroidism; acute pancreatitis; prostatic hypertrophy with urinary retention; bladder neck obstruction; pyloroduodenal obstruction; bronchial asthma; angle-closure glaucoma; pheochromocytoma; thrombosis; thrombophlebitis; diabetes mellitus; epilepsy; states of increased excitement; sleep disorders, concomitant treatment with tricyclic antidepressants, β-blockers, other sympathomimetics, drugs that suppress or increase appetite, and amphetamine-like psychostimulants; concomitant treatment and 2 weeks after the use of MAO inhibitors.
Interaction with other medicinal products and other types of interactions
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 effectiveness of heparin and indirect anticoagulants; increases the risk of crystalluria in treatment with salicylates and the risk of glaucoma in treatment with glucocorticosteroids; large doses reduce the effectiveness of tricyclic antidepressants. 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 during treatment with disulfiram inhibits the disulfiram-alcohol reaction. Absorption of ascorbic acid is reduced when taking oral contraceptives, drinking fruit or vegetable juices, and drinking alkaline drinks.
Pheniramine enhances the anticholinergic effect of atropine, antispasmodics, tricyclic antidepressants, antiparkinsonian drugs, inhibits the effect of anticoagulants. Simultaneous use of pheniramine with hypnotics, barbiturates, sedatives, neuroleptics, tranquilizers, anesthetics, narcotic analgesics, alcohol can significantly increase its suppressive effect.
The interaction of phenylephrine with MAO inhibitors causes a hypertensive effect, 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 arterial 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.
Application features
Do not exceed the recommended doses. If the condition does not improve within 5 days or is accompanied by a high fever, fever lasting more than 3 days, rash or persistent headache, you should consult a doctor, as these phenomena may be symptoms of a more serious illness.
Due to the risk of severe liver damage in case of overdose, do not use simultaneously with other drugs for the symptomatic treatment of colds and rhinitis (vasoconstrictors, paracetamol-containing). Use the drug with caution in Raynaud's disease, arterial hypertension, heart disease, arrhythmia, bradycardia, thyroid, liver and kidney diseases, acute hepatitis, glaucoma, chronic lung diseases, prostatic hypertrophy (since there is a risk of urinary retention), elderly people, with increased blood clotting, hemolytic anemia, chronic malnutrition, dehydration, stenosing peptic ulcer. The risk of hepatotoxicity increases in people with alcoholic liver damage and in people who abuse alcohol.
Before using the drug, you should consult a doctor if you have liver or kidney diseases; if you are taking warfarin or similar anticoagulants; if you are taking analgesics every day for mild arthritis; if you have 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 using paracetamol with flucloxacillin due to the increased risk of metabolic acidosis with a high anion gap, especially in patients with severe renal failure, sepsis, malnutrition and other causes of glutathione deficiency (e.g. chronic alcoholism), and when maximum daily doses of paracetamol are used. Close monitoring is recommended, including measurement of urinary 5-oxoproline. Symptoms of metabolic acidosis include deep, rapid or difficult breathing, nausea, vomiting, loss of appetite. If these symptoms occur, seek medical attention immediately.
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 can accelerate its own metabolism, which is why paradoxical hypovitaminosis is possible after discontinuation of treatment. The drug 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 phenylephrine, which may cause angina attacks.
If the patient has been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains 1.26 mmol (or 28.9 mg) sodium/dose (1 sachet). 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. It is known that preclinical studies have not revealed any special effect of paracetamol on fertility when used in therapeutic doses. Adequate studies of the effect of phenylephrine and pheniramine on reproductive toxicity in animals have not been conducted.
Ability to influence reaction speed when driving vehicles or other mechanisms
Since the drug may cause drowsiness and other adverse reactions from the nervous system and organs of vision, it is not recommended to drive a car or other complex mechanisms when using it.
Method of administration and doses
Take internally by adults and children over 12 years of age, 1 sachet every 3-4 hours, but no more than 3 sachets per day. Before use, dissolve the contents of 1 sachet in a glass of boiled hot water (not boiling water), take hot.
The maximum period of use without consulting a doctor is 3 days.
Children
The drug is contraindicated in children under 12 years of age.
Overdose
In case of paracetamol overdose, pallor of the skin, nausea, vomiting, anorexia and abdominal pain appear in the first 24 hours. When taking large doses, disorientation, psychomotor agitation, dizziness, sleep disturbances, heart rhythm disturbances, 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, especially with alcohol, and more than 150 mg/kg of body weight in children 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.
An overdose of ascorbic acid causes nausea, vomiting or diarrhea (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, impaired zinc and copper metabolism, 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.
In case of an overdose of 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, arterial hypotension, collapse). Symptoms caused by 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.
Treatment. Paracetamol overdose requires immediate medical attention. 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 of overdose. Paracetamol blood levels should be measured 4 hours or later after ingestion (earlier levels are unreliable). N-acetylcysteine can be used for up to 24 hours after ingestion of paracetamol, but the maximum effect occurs when administered within the first 8 hours, after which its effectiveness decreases abruptly. 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 in remote locations.
In case of an overdose of ascorbic acid, it is necessary to wash the stomach within the first 6 hours, and within the first 8 hours, administer methionine orally or cysteamine or N-acetylcysteine intravenously.
In the event of pheniramine overdose, there is no specific antidote for the treatment of overdose. The patient should be given standard emergency care, including activated charcoal, saline laxative, and standard measures to support the cardiorespiratory system. Stimulants should not be used; vasoconstrictors may be used to treat hypotension.
In case of phenylephrine overdose, an α-receptor blocker can be administered intravenously to eliminate hypertensive effects; diazepam can be administered to eliminate seizures.
Side effects
Skin: rash (usually generalized, erythematous), itching, dermatitis, urticaria, erythema multiforme exudative, Stevens-Johnson syndrome, Lyell's syndrome.
Immune system disorders: hypersensitivity reactions, including anaphylaxis, angioedema.
From the nervous system: headache, dizziness, tremor, psychomotor agitation and disorientation, anxiety, nervous excitement, feeling of fear, irritability, sleep disturbances, insomnia, drowsiness, confusion, hallucinations, depressive states, paresthesias, tinnitus, in some cases - coma, convulsions, dyskinesia, behavioral changes.
Respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.
On the part of the organs of vision: impaired vision and accommodation, mydriasis, increased intraocular pressure, dry eyes.
On the part of the digestive system: nausea, vomiting, heartburn, dry mouth, discomfort and pain in the epigastric region, constipation, diarrhea, flatulence, anorexia, aphthae, hypersalivation, hemorrhage, irritation of the mucous membranes.
On the part of the hepatobiliary system: impaired liver function, hypertransaminasemia, usually without jaundice, hepatonecrosis (when using high doses).
On the part of the endocrine system: hypoglycemia, up to hypoglycemic coma.
From the blood and lymphatic system: anemia, including hemolytic, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, pain in the heart area), thrombocytopenia, agranulocytosis, bruising or bleeding, neutropenia, leukopenia, pancytopenia.
Renal and urinary system: nephrotoxicity, interstitial nephritis, capillary necrosis, dysuria, urinary retention and difficulty urinating, renal colic, renal failure.
From the cardiovascular system: arterial hypertension, tachycardia, bradycardia, arrhythmia, shortness of breath, heart pain, angina attacks.
Others: general weakness, malaise.
Unlike second-generation antihistamines, the use of pheniramine is not associated with QT prolongation and cardiac arrhythmia.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
4 g in bags No. 5, No. 10 in a box.
Vacation category
Without a prescription.
Producer
Limited Liability Company "Pharmaceutical Company "Zdorovya".
Location of the manufacturer and address of the place of its activity. Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22.
