Citric powder for oral solution 22.13g x 10 sachets — Made in Germany — Free Delivery

(Citric )
Citric powder for oral solution 22.13g x 10 sachets — Made in Germany — Free Delivery
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Description Citric powder for oral solution 22.13g x 10 sachets — Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics. A combined preparation for relieving symptoms of flu and colds. has antipyretic, analgesic and anti-allergic effects.
Paracetamol has an analgesic, antipyretic and mild anti-inflammatory effect, which is 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 that predominantly acts directly on α-adrenergic receptors. When used in therapeutic doses to eliminate nasal congestion, the preparation does not reveal a significant stimulating effect on β-adrenergic receptors of the heart and a significant effect on the central nervous system. It is an established nasal decongestant and acts by vasoconstriction to reduce swelling and congestion of the nasal mucosa.
Pheniramine maleate - a blocker of H1-receptors, has an antiallergic effect, reduces the severity of local exudative manifestations, reduces lacrimation, rhinorrhea, itching in the eyes and nose. A decrease in the severity of common allergic symptoms is associated with respiratory diseases, which causes mild sedation. It also has antimuscarinic effects.
Ascorbic acid may be helpful in compensating for the increased need for vitamin C in the body during fever and flu.
Pharmacokinetics. After oral administration, paracetamol is rapidly and almost completely absorbed from the digestive tract. Cmax in blood plasma is reached after 10-60 minutes.
Paracetamol is distributed in most body tissues. It crosses the placental barrier and is excreted in breast milk. When using conventional therapeutic doses, paracetamol binds to blood plasma proteins slightly, but with increasing concentrations, the degree of binding increases.
Paracetamol is predominantly metabolized in the liver in two ways: by glucuronidation and sulfation. It is excreted in the urine mainly in the form of glucuronide and sulfate conjugates. T½ is 1 to 3 hours.
Cmax of pheniramine maleate in blood plasma is achieved after 1–2.5 h; T½ is 16-19 hours. 70-83% of the dose taken orally is excreted in the urine unchanged or in the form of metabolites.
Phenylephrine hydrochloride is absorbed in the digestive tract and undergoes first-pass metabolism by MAO in the intestine and liver; thus, when taken orally, phenylephrine has reduced bioavailability. It is excreted in the urine almost entirely as a sulfate conjugate. Cmax in blood plasma is observed after 45 minutes – 2 hours, and T½ from blood plasma is 2–3 hours.
Ascorbic acid is rapidly and completely absorbed in the digestive tract and distributed in all cells of the body, 25% binds to blood plasma proteins. Excess ascorbic acid, which is not necessary for the body's needs, is excreted in the urine as metabolites.

Indications

Relief of flu and cold symptoms, including fever and chills, headache, runny nose, nasal and sinus congestion, sneezing, and body pain.

Application

Adults and children over the age of 12 years: 1 packet every 4-6 hours (if necessary to reduce the severity of symptoms), but no more than 3-4 bags per day. a single dose should not exceed 1 packet. it is not recommended to use the preparation for more than 5 days. The contents of 1 packet should be dissolved in a glass of boiled hot water (but not boiled water!) and drunk hot.
Patients with hepatic impairment. Patients with impaired liver function or Gilbert's syndrome need to reduce the dose or increase the interval between using the preparation.
Elderly patients. No dose adjustment is required for elderly patients.

Contraindications

Hypersensitivity to any component of the preparation. severe course of cardiovascular diseases, severe liver and / or kidney dysfunction, congenital hyperbilirubinemia, ag, acute pancreatitis, hyperthyroidism, pheochromocytoma, blood diseases (including severe anemia, leukopenia), thrombosis, thrombophlebitis, angle-closure glaucoma, glucose deficiency 6-phosphate dehydrogenase, severe diabetes mellitus, alcoholism, prostatic hypertrophy with urinary retention, bladder neck obstruction, pyloroduodenal obstruction, BA, epilepsy, sleep disturbance.
The use of the preparation is contraindicated in concomitant treatment with MAO inhibitors and for 2 weeks after discontinuation of their use, as well as in concomitant treatment with tricyclic antidepressants, β-adrenergic receptor blockers, and other sympathomimetics.
Children under 12 years of age.

Side effects

From the blood and lymphatic system: thrombocytopenia, agranulocytosis, leukopenia, anemia, including hemolytic, pancytopenia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), bruising or bleeding;
from the immune system: hypersensitivity, Quincke's edema, anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis;
mental disorders: nervousness, insomnia, confusion, psychomotor agitation and disorientation, anxiety, fear, irritability, sleep disturbances, hallucinations, depressive states;
from the nervous system: drowsiness; dizziness, headache, paresthesia, tinnitus;
on the part of the cardiovascular system: tachycardia, palpitations, hypertension;
from the endocrine system: hypoglycemia, up to hypoglycemic coma;
from the digestive tract: nausea, vomiting; dry mouth, constipation, abdominal pain and discomfort, diarrhea, heartburn, decreased appetite, hypersalivation;
from the respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs;
from the liver and biliary tract: impaired liver function, increased levels of liver enzymes, usually without the development of jaundice;
from the kidneys and urinary system: dysuria, nephrotoxicity, renal colic;
from the skin and subcutaneous tissues: rash, itching, erythema multiforme, urticaria;
general disorders: general weakness, malaise.
Unlike second generation antihistamines, the use of pheniramine is not associated with prolongation of the Q – Tc interval and cardiac arrhythmias.

Special instructions

The preparation should be used with caution in patients with:
  • impaired renal and / or liver function;
  • acute hepatitis;
  • hemolytic anemia;
  • chronic malnutrition and dehydration;
  • cardiovascular disease;
  • diabetes mellitus;
  • hypertrophy of the prostate gland, as they may be prone to the development of urinary retention;
  • stenosing peptic ulcer.
The simultaneous use of other medicinal products containing paracetamol should be avoided due to the risk of severe liver damage in case of overdose. The preparation is not recommended to be used simultaneously with vasoconstrictor agents. Do not exceed the indicated doses.
When using the preparation, you should avoid drinking alcoholic beverages, since ethyl alcohol while taking 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 patients taking medications that affect the liver, and the elderly ...
Patients should consult a doctor:
if they have breathing problems such as asthma, emphysema, or chronic bronchitis;
if symptoms persist within 5 days or if symptoms are accompanied by a high fever, fever that lasts more than 3 days, rash, or prolonged headache;
regarding the possibility of using the preparation in case of impaired renal and liver function.
These phenomena can be symptoms of a more serious illness.
The preparation may interfere with laboratory results regarding blood glucose levels.
The preparation contains phenylephrine, which can cause an attack of angina pectoris.
The preparation should be used with caution in patients with recurrent urate kidney stones. In patients with severe infections, such as sepsis, accompanied by a decrease in glutathione levels, the risk of metabolic acidosis increases with paracetamol. The symptoms of metabolic acidosis are deep, rapid or labored breathing, nausea, vomiting, and loss of appetite. You should immediately consult a doctor if these symptoms appear.
1 package of the preparation contains 20 g of sucrose, which should be taken into account in patients with diabetes mellitus. Patients with rare hereditary diseases such as fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this preparation.
1 package of the preparation contains 28.4 mg of sodium. Sodium content should be considered in patients on a sodium-limited diet.
It is important to report suspected adverse reactions to the doctor after preparation registration. This makes it possible to continue monitoring the benefit / risk ratio when using the preparation.
Use during pregnancy and lactation. The use of the preparation is not recommended during pregnancy and lactation, since the safety in such cases has not been studied.
Pregnancy. The results of epidemiological studies involving pregnant women did not indicate the presence of any negative effects in connection with oral administration of paracetamol in the recommended doses.
The results of studies of the effect of the preparation on reproductive function when administered orally did not indicate any signs of malformations or fetotoxicity. Provided that it is used in the recommended doses, paracetamol can be used during pregnancy after assessing the benefit / risk ratio.
Currently, there are no necessary data regarding studies of reproductive function and embryo- / fetotoxicity with the use of pheniramine.
Currently, there are limited data regarding the use of phenylephrine hydrochloride in pregnant women. The vasoconstriction of the uterus and the impairment of uterine circulation associated with the use of phenylephrine can lead to fetal hypoxia. Phenylephrine hydrochloride should be avoided during pregnancy.
Lactation. Paracetamol is excreted in breast milk, but in amounts that are not clinically relevant. The available published data do not support the recommendation of avoiding breastfeeding during paracetamol therapy.
There is not enough information regarding the excretion of pheniramine in breast milk and the amount of the preparation that can enter the infant's body.
There are no data on whether phenylephrine passes into breast milk. Phenylephrine should be avoided by women who are breastfeeding babies.
Ascorbic acid is excreted in breast milk, but reaches saturation levels. The use of ascorbic acid is compatible with breastfeeding.
Fertility The effect of the preparation on fertility has not been specifically investigated. The results of preclinical studies of paracetamol do not indicate the presence of a danger to fertility when using the preparation in therapeutic doses. There have been no adequate studies of reproductive toxicity in animals using phenylephrine and pheniramine.
Children. Do not use the preparation in children under 12 years of age.
The ability to influence the reaction rate when driving or working with other mechanisms. The preparation may cause drowsiness. Care should be taken when driving or operating machinery that requires concentration.

Interactions

The preparation interactions for each individual component of the preparation are well known. there is no reason to believe that the use of these substances in combination may affect the preparation interaction profile.
Paracetamol. With regular long-term use of paracetamol, the anticoagulant effect of warfarin or other coumarin derivatives may increase, and the risk of bleeding may increase. With occasional use of paracetamol, this effect is not pronounced.
Hepatotoxic preparations increase the likelihood of paracetamol cumulation and overdose. The risk of developing hepatotoxic effects of paracetamol increases in patients receiving preparations that induce microsomal liver enzymes, such as barbiturates and antiepileptic preparations (phenytoin, phenobarbital, carbamazepine), as well as anti-tuberculosis preparations (rifampicin and isoniazid).
Metoclopramide increases the rate of absorption of paracetamol and leads to an increase in its Cmax in blood plasma. Similarly, domperidone can increase the absorption rate of paracetamol.
Paracetamol can lengthen the T½ of chloramphenicol.
Paracetamol may reduce the bioavailability of lamotrigine with a decrease in its effect due to the likely induction of its metabolism in the liver.
Absorption of paracetamol may decrease with simultaneous use with cholestyramine, but the decrease in absorption is insignificant if cholestyramine is used after 1 hour.
Regular use of paracetamol along with zidovudine can 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 at the same time should reduce the dose of paracetamol.
The hepatotoxicity of paracetamol can be exacerbated by prolonged or excessive alcohol consumption.
Paracetamol may interfere with the results of phosphorus-tungstic acid uric acid tests.
Pheniramine maleate. First-generation antihistamines, such as pheniramine maleate, can increase the CNS depressant effect of certain preparations (eg, MAO inhibitors, tricyclic antidepressants, hypnotics and sedatives, antipsychotics, ethanol, antiparkinsonian preparations, barbiturates, anesthetics, tranquilizers, and narcotic analgesics). Pheniramine enhances the anticholinergic effect of atropine, antispasmodics. Pheniramine maleate can also inhibit the action of anticoagulants.
Phenylephrine hydrochloride. The use of the preparation is contraindicated during therapy with MAO inhibitors and for 2 weeks after the end of treatment with MAO inhibitors. Phenylephrine can potentiate the action of MAO inhibitors and provoke a hypertensive crisis.
The simultaneous use of phenylephrine with other sympathomimetic agents or tricyclic antidepressants (for example, amitriptyline) increases the risk of side effects from the cardiovascular system.
Phenylephrine may reduce the effectiveness of β-adrenergic receptor blockers and other antihypertensive preparations (eg, debrisoquine, guanethidine, reserpine, methyldopa).
There may be an increased risk of hypertension and other cardiovascular side effects.
The simultaneous use of phenylephrine with digoxin and cardiac glycosides increases the risk of irregular heartbeat or heart attack.
The simultaneous use of phenylephrine with ergot alkaloids (ergotamine and methysergide) increases the risk of developing ergotism.
Oral ascorbic acid enhances the absorption of penicillin, iron, reduces the effectiveness of heparin and indirect anticoagulants, increases the risk of crystalluria in the treatment of salicylates and the risk of glaucoma in the treatment of corticosteroids, high doses reduce the effectiveness of tricyclic antidepressants. Antidepressants, antiparkinsonian and antipsychotic preparations, phenothiazine derivatives increase the risk of urinary retention, dry mouth, and constipation. Ascorbic acid can be taken only 2 hours after the injection of deferoxamine, since their simultaneous intake increases the toxicity of iron, especially in the myocardium. Long-term use of high doses during treatment with disulfiram inhibits the disulfiram-alcohol reaction.

Overdose

In case of an overdose of the preparation, the symptoms caused by paracetamol will be most pronounced.
Symptoms caused by the use of paracetamol: hepatotoxic effect, in severe cases, liver necrosis develops. Paracetamol overdose, including a high total dose that has been received over a long period, can cause analgesic-induced nephropathy with irreversible liver dysfunction.
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 consumption 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 liver enzyme inducers (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort). In severe poisoning, liver failure can progress to encephalopathy, coma, and be fatal.
With prolonged use of the preparation in high doses on the part of the blood-forming organs, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia may develop. When taking high doses from the central nervous system - dizziness, psychomotor agitation and disorientation; from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).
Symptoms of a paracetamol overdose, which appear in the first 24 hours, are as follows: 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, within a period of up to 4–6 days after using the preparation. Liver damage usually occurs within 72–96 hours after preparation administration. There may be deviations from the norm on the part of glucose metabolism (hypoglycemia) and metabolic acidosis, hemorrhages. ARF with acute tubular necrosis can 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. In case of an overdose of paracetamol, emergency medical attention is needed. Perhaps the appointment of N-acetylcysteine ​​in / in or orally as an antidote to paracetamol at an early stage. Gastric lavage and / or oral methionine may be beneficial up to 48 hours after overdose.
Taking activated charcoal and monitoring respiration and circulation may be helpful. Diazepam can be used if seizures occur.
Symptoms caused by the use of pheniramine maleate and phenylephrine hydrochloride. Symptoms due to the mutual potentiation of the parasympatholytic effect of an antihistamine and the sympathomimetic effect of phenylephrine hydrochloride include drowsiness, after which agitation (especially in children) or depression of the central nervous system, blurred vision, rash, nausea, vomiting, persistent headache, hyperhidrosis, nervousness, dizziness may develop , tremor, insomnia, hyperreflexia, irritability, anxiety, circulatory disorders, hypertension and bradycardia.
In case of an overdose of phenylephrine in severe cases, impaired consciousness, arrhythmias, coma, convulsions are possible.
Cases of atropine-like psychosis associated with an overdose of pheniramine have been reported. Atropine-like symptoms may include: mydriasis, photophobia, dry skin and mucous membranes, hyperthermia, intestinal atony.
Symptoms of an ascorbic acid overdose will be attributed to severe liver failure caused by the paracetamol overdose.
Treatment. There is no specific antidote for treating an overdose of antihistamines. The patient should be given urgent care, including giving activated charcoal, a saline laxative, and measures to maintain the cardiorespiratory system. Stimulants are not allowed; vasoconstrictors can be used to treat hypotension.
To eliminate hypertensive effects, you can use a blocker of α-adrenergic receptors for intravenous administration, and in the event of seizures, diazepam.

Storage conditions

In original packaging at a temperature not exceeding 25 ° c.

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