Instructions Citrik powder for oral solution sachet 13.6 g No. 10
Composition
substances: paracetamol, phenylephrine hydrochloride, pheniramine maleate, ascorbic acid;
- 1 sachet contains paracetamol 325 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg, ascorbic acid 50 mg
Excipients: sodium, malic acid, citric acid, calcium phosphate, sucrose, curcumin (E 100), titanium dioxide (E171), lemon flavoring.
Dosage form
Powder for oral solution
Main physicochemical properties
Free-flowing granular powder with white and yellow granules, which may contain soft lumps, with a lemon odor.
Pharmacological group
Analgesics and antipyretics. Paracetamol, combinations without psycholeptics. ATX code N02B E51.
Pharmacological properties
Pharmacological
A combination drug for the treatment of flu and cold symptoms.
It has antipyretic, analgesic and antiallergic effects.
Paracetamol has analgesic, antipyretic and weak anti-inflammatory effects, mainly mediated by inhibition of prostaglandin synthesis in the central nervous system. It does not affect platelet function and hemostasis.
Phenylephrine hydrochloride is a sympathomimetic amine, acting primarily directly on alpha-adrenergic receptors. When used in therapeutic doses for nasal congestion, the drug has no significant stimulating effect on beta-adrenergic receptors of the heart and no significant effect on the central nervous system. It is a well-known nasal decongestant and acts by vasoconstriction, reducing swelling of the nasal mucosa.
Pheniramine maleate is a blocker of H 1 receptors, has antiallergic effect, reduces the severity of local exudative manifestations, reduces lacrimation, rhinorrhea, itching in the eyes and nose. Reduction of general allergic symptoms associated with respiratory diseases, which causes a moderate sedative effect. It also has antimuscarinic effect.
Ascorbic acid can be useful for compensating for the body's increased need for vitamin C during fever and flu.
Pharmacokinetics. After oral administration, paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentration is reached after 10-60 minutes.
Paracetamol is distributed in most body tissues. It crosses the placental barrier and is excreted in breast milk. At usual therapeutic doses, paracetamol binds to plasma proteins to a negligible extent, but the degree of binding increases with increasing concentrations.
Paracetamol is mainly metabolized in the liver by two routes: by glucuronidation and by sulfation. It is excreted in the urine mainly as glucuronide and sulfate conjugates. The half-life is 1 to 3 hours.
The maximum concentration of pheniramine maleate in plasma is reached after 1 - 2.5 hours; the half-life is 16 - 19 hours. 70 - 83% of the oral dose is excreted in the urine in unchanged form or as metabolites.
Phenylephrine hydrochloride is absorbed from the gastrointestinal tract and undergoes presystemic metabolism by MAO in the intestine and liver; thus, phenylephrine has a reduced bioavailability when taken orally. It is excreted in the urine almost entirely as the sulfate conjugate. Peak plasma concentrations are reached after 45 minutes to 2 hours, and the plasma half-life is 2 to 3 hours.
Ascorbic acid is rapidly and completely absorbed in the digestive tract and distributed in all cells of the body, 25% binds to plasma proteins. Excess ascorbic acid is not necessary for the body's needs and is excreted in the urine in the form of metabolites.
Indication
Treating symptoms of flu and colds, including fever and chills, headache, runny nose, nasal and sinus congestion, sneezing, and body aches.
Contraindication
Contraindications. Hypersensitivity to the components of the drug. Severe cardiovascular diseases, severe liver and/or kidney dysfunction, congenital hyperbilirubinemia, arterial hypertension, acute pancreatitis, hyperthyroidism, pheochromocytoma, blood diseases (including severe anemia, leukopenia), thrombosis, thrombophlebitis, thrombophlebitis, thrombophlebitis 6-phosphate dehydrogenase, severe forms of diabetes mellitus, alcoholism, prostatic hypertrophy with urinary retention, bladder neck obstruction, pyloroduodenal obstruction, bronchial asthma, epilepsy, sleep disorders.
The use of the drug is contraindicated during concomitant treatment with MAO inhibitors and within 2 weeks after discontinuation of their use, as well as during concomitant treatment with tricyclic antidepressants, beta-blockers and other sympathomimetics.
Age up to 12 years.
Interaction with other medicinal products and other types of interactions
The drug interactions of each component of the drug are well known. There is no reason to assume that the use of these substances in combination would affect the drug interaction profile.
Regular long-term use of paracetamol may enhance the anticoagulant effect of warfarin or other coumarin derivatives, and may also increase the risk of bleeding. With occasional use of paracetamol, this effect is not pronounced.
Hepatotoxic drugs increase the likelihood of paracetamol accumulation and overdose. The risk of developing hepatotoxic effects of paracetamol is increased in patients receiving drugs that induce liver microsomal enzymes, such as barbiturates and antiepileptic drugs (phenytoin, phenobarbital, carbamazepine) and the antituberculosis drugs rifampicin and isoniazid.
Metoclopramide increases the rate of absorption of paracetamol and leads to an increase in its maximum plasma levels. Similarly, domperidone may increase the rate of absorption of paracetamol.
Paracetamol may prolong the half-life of chloramphenicol.
Paracetamol may reduce the bioavailability of lamotrigine with a decrease in its effect due to the probable induction of its metabolism in the liver.
The absorption of paracetamol may be reduced when co-administered with cholestyramine, but the reduction in absorption is insignificant if cholestyramine is administered 1 hour later.
Regular use of paracetamol simultaneously with zidovudine may lead to the development of neutropenia and an increased risk of liver damage. Paracetamol reduces the effectiveness of diuretics.
Probenecid affects the metabolism of paracetamol. Patients taking probenecid should reduce the dose of paracetamol.
The hepatotoxicity of paracetamol may be increased by prolonged or excessive alcohol consumption.
Paracetamol may affect the results of tests for determining uric acid levels using the phosphorotungstic acid method.
Pheniramine maleate
First-generation antihistamines, such as pheniramine maleate, may enhance the central nervous system depressant effects of other drugs (e.g., MAO inhibitors, tricyclic antidepressants, hypnotics and sedatives, neuroleptics, alcohol, antiparkinsonian drugs, barbiturates, anesthetics). Pheniramine enhances the anticholinergic effects of atropine, antispasmodics. Pheniramine maleate may inhibit the effects of anticoagulants.
Phenylephrine hydrochloride
The use of the drug is contraindicated during therapy with MAO inhibitors (MAOIs) and within 2 weeks after the end of treatment with MAOIs. Phenylephrine may enhance the effect of MAO inhibitors and provoke a hypertensive crisis.
Concomitant use of phenylephrine with other sympathomimetic agents or tricyclic antidepressants (e.g. amitriptyline) increases the risk of cardiovascular side effects.
Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive drugs (e.g. debrisoquine, guanethidine, reserpine, methyldopa). The risk of developing arterial hypertension and other cardiovascular side effects may increase.
Concomitant use of phenylephrine with digoxin and cardiac glycosides increases the risk of heart rhythm disturbances or heart attack.
Concomitant use of phenylephrine with ergot alkaloids (ergotamine and methysergide) increases the risk of developing ergotism.
Ascorbic acid when taken orally enhances the absorption of penicillin, iron, 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. Antidepressants, antiparkinsonian and antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation. Ascorbic acid can be taken only 2 hours after the injection of deferoxamine, since their simultaneous administration increases iron toxicity, especially in the myocardium. Long-term administration of large doses in treatment with disulfiram inhibits the disulfiram-alcohol reaction.
Features of the use of the drug
The drug should be used with caution in patients with:
- impaired kidney and/or liver function;
- acute hepatitis;
- hemolytic anemia
- chronic malnutrition and dehydration;
- cardiovascular diseases;
- diabetes mellitus,
- prostatic hypertrophy, as they may be prone to developing urinary retention
- stenosing peptic ulcer disease.
The simultaneous use of other medicines containing paracetamol should be avoided due to the risk of severe liver damage in case of overdose. The drug is not recommended for use simultaneously with vasoconstrictors. Exceed the indicated doses.
When using the drug, you should avoid drinking alcoholic beverages, since ethyl alcohol, when taken simultaneously with paracetamol, can cause liver dysfunction. Paracetamol should be used with caution in patients with alcohol dependence, Raynaud's disease, heart disease (including arrhythmia, bradycardia), thyroid disease, glaucoma, chronic lung disease, as well as in patients taking medications that affect the liver, and in the elderly.
Patients should consult a doctor:
- if symptoms do not disappear within 5 days or if symptoms are accompanied by a high fever,
- a fever that lasts more than 3 days, a rash, or a persistent headache;
- about the possibility of using the drug in cases of impaired kidney and liver function.
Such phenomena may be symptoms of a more serious illness.
The drug may affect the results of laboratory tests for blood glucose.
The drug contains phenylephrine, which may lead to angina attacks.
The drug should be used with caution in patients with recurrent urate kidney stones. Patients with severe infections such as sepsis, accompanied by a decrease in glutathione levels, are at increased risk of metabolic acidosis when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or difficult breathing, nausea, vomiting, loss of appetite. You should immediately consult a doctor in case of these symptoms.
1 package of the drug contains 20 g of sucrose, which should be taken into account by patients with diabetes mellitus. Patients with rare hereditary diseases such as fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this drug.
1 packet of the drug contains 284 mg of sodium. Patients on a controlled sodium diet should take the sodium content into account.
Reporting suspected adverse reactions to the doctor after the drug is approved is important. This allows for continued monitoring of the benefit/risk ratio of the drug.
Use during pregnancy or breastfeeding
The use of the drug is not recommended during pregnancy and breastfeeding, as the safety of its use in such cases has not been studied.
Pregnancy
The results of epidemiological studies involving pregnant women did not indicate any negative effects due to oral administration of paracetamol at recommended doses.
The results of studies on the effects of the drug on reproductive function when administered orally did not indicate any signs of malformations or fetotoxicity. When used in recommended doses, paracetamol can be used during pregnancy after assessing the benefit/risk ratio.
Currently, there are no adequate data on reproductive function and embryo/fetotoxicity studies with pheniramine.
There are currently only limited data on the use of phenylephrine hydrochloride in pregnant women. Uterine vasoconstriction and impaired uterine blood flow associated with the use of phenylephrine may lead to fetal hypoxia. The use of phenylephrine hydrochloride should be avoided during pregnancy.
Breast-feeding
Paracetamol is excreted in breast milk, but in amounts that are not clinically significant. Available published data do not provide grounds to recommend discontinuation of breast-feeding during paracetamol therapy.
There is insufficient information about the excretion of pheniramine into breast milk and the amount of the drug that may enter the infant's body.
There is no data on whether phenylephrine passes into breast milk. The use of phenylephrine should be avoided by women who are breastfeeding.
Ascorbic acid is excreted in breast milk, but reaches saturation levels. The use of ascorbic acid is compatible with breastfeeding.
Fertility
The effect on fertility has not been specifically studied. The results of non-clinical studies with paracetamol do not indicate a risk to fertility when used in therapeutic doses. Adequate reproductive toxicity studies in animals have not been conducted with phenylephrine and pheniramine.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may cause drowsiness. Caution should be exercised when driving vehicles or operating machinery that requires concentration.
Method of administration and doses
Adults and children over 12 years of age should take 1 sachet every 4-6 hours (if necessary to relieve symptoms), but not more than 3-4 sachets per day. A single dose should not exceed 1 sachet. It is not recommended to use the drug for more than 5 days. Dissolve the contents of 1 sachet in a glass of boiled hot water (but not boiling water) and drink hot.
Patients with liver failure.
Patients with impaired liver function or Gilbert's syndrome should reduce the dose or increase the interval between doses.
Elderly patients: No dose adjustment is required for elderly patients.
Children
Do not use the drug in children under 12 years of age.
Overdose
In case of an overdose of the drug, the symptoms caused by paracetamol will be the most pronounced.
Liver damage is possible in adults who have taken 10 g or more of paracetamol, and in children who have taken more than 150 mg/kg of body weight. In patients with risk factors: regular excessive use of ethanol, glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, cachexia) - the use of 5 g or more of paracetamol can lead to liver damage.
There is a risk of poisoning, especially in elderly patients, young children, patients with liver disease, patients with chronic malnutrition and patients receiving inducers of liver enzymes (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin). In severe poisoning, liver failure can progress to encephalopathy, coma and be fatal.
With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop from the hematopoietic system. When taking large doses, dizziness, psychomotor agitation and disorientation may occur from the central nervous system; nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis) may occur from the urinary system.
Symptoms of paracetamol overdose, which appear in the first 24 hours, are: pallor, nausea, vomiting and lack of appetite. The first sign of liver damage may be abdominal pain, which does not always appear in the first 24 - 48 hours, but may occur later, during a period of up to 4 - 6 days after taking the drug. Liver damage usually occurs a maximum of 72 - 96 hours after taking the drug. Abnormalities in glucose metabolism (hypoglycemia) and metabolic acidosis, hemorrhage may be observed. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage and manifest as severe back pain, hematuria, proteinuria. Cases of cardiac arrhythmias and pancreatitis have been reported.
Treatment: Paracetamol overdose requires immediate medical attention. N-acetylcysteine may be administered orally as an early antidote to paracetamol. Gastric lavage and/or oral methionine may be beneficial within 48 hours of overdose.
Administration of activated charcoal and monitoring of respiration and circulation may be helpful. Diazepam may be used in the event of convulsions.
Symptoms caused by the use of pheniramine maleate and phenylephrine hydrochloride
Symptoms due to mutual potentiation of the parasympatholytic effect of the antihistamine and the sympathomimetic effects of phenylephrine hydrochloride include drowsiness, which may progress to excitation (especially in children) or depression of the central nervous system, visual disturbances, rash, nausea, vomiting; dizziness, tremor, insomnia, hyperreflexia, irritability, restlessness, circulatory disorders, arterial hypertension and bradycardia.
In severe cases, an overdose of phenylephrine may cause loss of consciousness, arrhythmias, coma, and seizures.
Cases of atropine-like psychosis have been reported following pheniramine overdose. Atropine-like symptoms may include: mydriasis, photophobia, dry skin and mucous membranes, hyperthermia, and intestinal atony.
Symptoms of ascorbic acid overdose will be attributed to liver failure caused by paracetamol overdose.
Treatment. There is no specific antidote for antihistamine overdose. The patient should be given immediate medical attention, including activated charcoal, saline laxatives, and cardiorespiratory support. Stimulants should not be used; vasoconstrictors may be used to treat hypotension.
To eliminate hypertensive effects, an intravenous alpha-receptor blocker can be used, and if seizures occur, diazepam can be used.
Adverse reactions
From the blood and lymphatic system: thrombocytopenia, agranulocytosis, leukopenia, anemia incl.
Immune system: hypersensitivity, angioedema, anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Mental disorders: nervousness, insomnia, confusion, psychomotor agitation and disorientation, anxiety, feelings of fear, irritability, sleep disturbances, hallucinations, depressive states.
From the nervous system: drowsiness, dizziness, headache, paresthesia, tinnitus.
Cardiovascular system: tachycardia, palpitations, arterial hypertension.
On the part of the endocrine system: hypoglycemia, up to hypoglycemic coma.
On the part of the digestive tract: nausea, vomiting, dry mouth, constipation, abdominal pain and discomfort, diarrhea, heartburn, decreased appetite, hypersalivation.
Respiratory system: bronchospasm in patients sensitive to aspirin and other nonsteroidal anti-inflammatory drugs.
From the liver and biliary tract: impaired liver function, increased activity of liver enzymes, usually without the development of jaundice.
Renal and urinary disorders: dysuria, nephrotoxicity, renal colic.
Skin and subcutaneous tissue disorders: rash, itching, erythema multiforme, urticaria.
Unlike second-generation antihistamines, the use of pheniramine is not associated with QTc interval prolongation and cardiac arrhythmia.
Expiration date
2 years.
Do not use after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25°C.
Keep out of reach of children.
Packaging
13.6 g per sachet; 10 sachets per pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address.
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
