Helpex Anticold Neo Ginger Sugar Free 10 sachets — Made in Switzerland — Free Delivery

Pharmacological properties

Pharmacodynamics. Paracetamol has analgesic, antipyretic and mild anti-inflammatory effects.

The mechanism of action of paracetamol is associated with the effect of the preparation on the center of thermoregulation in the hypothalamus, the ability to inhibit the synthesis of prostaglandins and inflammatory mediators (kinin, serotonin) and an increase in the pain threshold.

Levocetirizine dihydrochloride is a non-sedative antihistamine, an active stable metabolite (R-enantiomer) of cetirizine, belongs to the group of competitive histamine antagonists. The pharmacological action is due to the blocking of H1 receptors. The affinity for H1 receptors in levocetirizine is 2 times higher than that of cetirizine. Affects the histamine-dependent stage of the development of an allergic reaction, reduces the migration of eosinophils, vascular permeability, and limits the release of inflammatory mediators. It prevents the development and suppresses the course of allergic reactions, has an anti-exudative, antipruritic, anti-inflammatory effect, does not have an anticholinergic and antiserotonin effect, does not penetrate the central nervous system.

Levocetirizine inhibits the late phase of the inflammatory response induced in patients with chronic urticaria by intradermal administration of kallikrein. It also reduces the severity of adhesion of molecules such as ICAM-1 and VCAM-1, which are markers of allergic inflammation. Due to a decrease in the adhesiveness of ICAM-1, an indirect antiviral effect is carried out, since the resistance of cells to rhinovirus increases. Also, when using levocetirizine, the level of secondary adhesion of Staphylococcus aureus and Haemophilus influenzae to epithelial cells of the nasopharynx infected with rhinoviruses decreases.

Phenylephrine hydrochloride is a relatively selective α1-adrenergic agonist. Has a weak effect on α2 - and β-adrenergic receptors. Due to the vasoconstrictor effect, phenylephrine reduces swelling of the nasal mucosa, the volume of nasal secretions and improves nasal breathing due to the facilitation of the passage of air through the nose. Use to temporarily reduce the severity of nasal congestion with colds, SARS, hay fever and other allergic reactions.

Pharmacokinetics. Paracetamol is rapidly and almost completely absorbed in the gastrointestinal tract. T½ is 1–4 hours. It is evenly distributed in all body fluids. Plasma protein binding is variable. It is excreted mainly by the kidneys in the form of conjugated metabolites.

Levocetirizine dihydrochloride - pharmacokinetic parameters have a linear relationship and almost do not differ from those of cetirizine. It is rapidly absorbed when taken orally, food intake does not affect the degree of absorption, but reduces its rate.

There is no information on the distribution of levocetirizine in human tissues, as well as on its penetration through the BBB. The volume of distribution is 0.4 l / kg. Plasma protein binding - 90%. In the body, about 14% of levocetirizine is metabolized. Given the low degree of metabolism and the absence of an increase in the inhibitory effect, the interaction of levocetirizine with other substances (and vice versa) is unlikely. Excretion of the preparation occurs mainly due to glomerular filtration and active tubular secretion. T½ is 7.9 ± 1.9 h, total clearance is 0.63 ml / min / kg. It does not accumulate, it is completely excreted from the body in 96 hours. 85.4% of the dose of the active substance is excreted unchanged in the urine, about 12.9% in the feces.

In patients with impaired renal function (creatinine clearance 40 ml / min), the clearance of levocetirizine decreases, and T½ increases (for example, in patients on hemodialysis, the total clearance decreases by 80%), which requires the selection of an appropriate dosing regimen. When carrying out a standard 4-hour hemodialysis, an insignificant part (10%) of levocetirizine is removed. Penetrates into breast milk.

Phenylephrine hydrochloride - the action occurs quickly and lasts about 20 minutes. It is metabolized in the liver or in the gastrointestinal tract, excreted by the kidneys.

Indications

Helppex anti-cold neo / helppex anti-cold neo max. treatment of symptoms arising from acute respiratory viral infections, flu, allergic rhinitis (to reduce fever, reduce rhinitis, relieve swelling of the nasal mucosa, eliminate body aches, headaches, reduce general intoxication, improve general well-being).

Application

Helppex anti-cold neo / helppex anti-cold neo max. Dissolve the powder in a glass of hot water and drink. doses for adults and children over the age of 12 years - 1 sachet up to 4 times a day. the intervals between doses should be at least 4 hours. Do not exceed the recommended dose. the duration of treatment should not exceed 7 days.

Contraindications

Helppex anti-cold neo / helppex anti-cold neo max. hypersensitivity to the components of the preparation or to any piperazine derivatives in history. ag, cardiovascular disease, hyperthyroidism. severe impairment of liver and / or kidney function, congenital hyperbilirubinemia; deficiency of glucose-6-phosphate dehydrogenase, severe hereditary galactose intolerance, deficiency of the enzyme lactase (β-galactosidase) or impaired absorption of glucose and galactose; alcoholism, blood diseases (including severe anemia, leukopenia). simultaneous use with tricyclic antidepressants; with MAO inhibitors and within 2 weeks after discontinuation of their use.

The period of pregnancy and lactation. Do not use in children under 12 years of age.

Side effects

Helppex anti-cold neo / helppex anti-cold neo max.

From the side of the cardiovascular system: increased blood pressure, decreased blood pressure, tachycardia, increased heart rate.

From the side of the kidneys and genitourinary system: spasm of the urethral canals and vesical sphincters, dysuria, enuresis, urinary retention.

From the digestive system: nausea, vomiting, dry mouth, gastrointestinal discomfort, epigastric pain, diarrhea.

From the hepatobiliary system: impaired liver function, increased activity of hepatic enzymes without the development of jaundice.

From the immune system: hypersensitivity reactions, including itching, rash (generalized, erythematous, urticaria), anaphylactic shock, angioedema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the side of the central nervous system: sedation, drowsiness (when the therapeutic dose is exceeded), insomnia, dizziness, fainting, lethargy, apathy, increased fatigue, decreased mental and physical performance, anxiety, dysphoria, mood changes, headache, paresthesia, convulsions, tremors, tic, dysgeusia, dyskinesia, dystonia, memory impairment, anxiety, aggressiveness, depression, hallucinations, suicidal thoughts.

From the respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs, pharyngitis, rhinitis.

From the side of the organ of vision: vertigo, violation of accommodation, blurred vision, involuntary movements of the eyeball.

From the endocrine system: hypoglycemia, up to hypoglycemic coma.

From the blood and lymphatic system: thrombocytopenia, agranulocytosis, anemia, including hemolytic anemia (bruising or bleeding), sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain).

General disorders: asthenia, malaise, edema, increased appetite, weight gain.

In case of any adverse reactions, you should stop using the preparation and consult a doctor.

Special instructions

Helppex anti-cold neo / helppex anti-cold neo max. Do not exceed the indicated dose. simultaneous use with other medicinal products containing paracetamol should be avoided. do not use simultaneously with alcohol. the risk of paracetamol overdose increases with alcoholic liver disease.

Paracetamol should be used with caution in patients with impaired liver or kidney function, consult your doctor before use.

If symptoms persist, seek medical attention. If the headache becomes persistent, you should see your doctor.

Care must be taken when using phenylephrine in patients with diabetes mellitus and angle-closure glaucoma. Phenylephrine can increase blood pressure, therefore, special care must be taken when using the preparation in patients receiving antihypertensive therapy, as well as β-adrenergic receptor blockers.

In patients with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency, the preparation is contraindicated.

Before using the preparation, it is necessary to consult a doctor if the patient is using warfarin or similar preparations that have an anticoagulant effect.

The preparation may affect the results of laboratory tests on the content of glucose and uric acid in the blood.

Use with caution in patients prone to urinary retention (eg spinal cord injury), as cetirizine may increase the risk of urinary retention.

It is recommended to prescribe with caution to patients at risk of seizures.

Antihistamines suppress allergic skin test, therefore, before taking it, the preparation should be discontinued 3 days before the study (elimination period).

Use with caution in patients with chronic renal failure (dosage adjustment is required) and elderly patients with renal insufficiency (glomerular filtration may decrease).

Use during pregnancy and lactation. The safety of using paracetamol, phenylephrine hydrochloride and levocetirizine dihydrochloride during pregnancy has not been established, so the preparation is not used in pregnant women (see CONTRAINDICATIONS). Since paracetamol, cetirizine and phenylephrine pass into breast milk to a certain extent, breastfeeding should be discontinued during the treatment period.

Children. Do not use in children under 12 years of age.

The ability to influence the reaction rate when driving or working with other mechanisms. An objective assessment of the ability to drive vehicles, sleep latency and the ability to work on an assembly line did not show a clinically significant effect when used at the recommended dose. Patients who drive vehicles, are involved in potentially hazardous work or operate mechanized equipment should take into account the reaction of their own body to the preparation.

Interactions

Helppex anti-cold neo / helppex anti-cold neo max. metoclopramide and domperidone increase, and cholestyramine, antacids and food reduce the absorption of paracetamol. salicylamide lengthens the time of paracetamol elimination. with simultaneous use with paracetamol, the following types of interactions are possible: the elimination of antibiotics from the body slows down; tetracycline increases the risk of anemia and methemoglobinemia caused by paracetamol; t 1/2 chloramphenicol (up to 5 times). with simultaneous long-term use, the anticoagulant effect of coumarins (for example, warfarin) is enhanced. barbiturates reduce the antipyretic effect of paracetamol. with the simultaneous use of preparations that increase the activity of liver enzymes, anticonvulsants (phenytoin, barbiturates, carbamazepine), isoniazid, rifampicin and ethyl alcohol can increase the hepatotoxicity of paracetamol. with the simultaneous use of paracetamol with hepatotoxic agents, the toxic effect of preparations on the liver increases. paracetamol reduces the effectiveness of diuretics. the simultaneous use of paracetamol with NSAIDs increases the risk of impaired renal function.

The use of phenylephrine hydrochloride with indomethacin and bromocriptine can cause severe hypertension. The simultaneous use of phenylephrine hydrochloride with sympathomimetic amines, digoxin and cardiac glycosides increases the risk of arrhythmia and myocardial infarction. May reduce the effectiveness of β-adrenergic receptor blockers and other antihypertensive preparations (reserpine, methyldopa) with an increased risk of hypertension and adverse cardiovascular reactions. Rauwolfia alkaloids reduce the therapeutic effect of phenylephrine hydrochloride.

Blockers of α-adrenergic receptors (phentolamine), phenothiazines, furosemide and other diuretics prevent vasoconstriction. With the simultaneous use of phenylephrine and ganglion blockers, adrenergic blockers, rauwolfia alkaloids or methyldopa, a decrease in blood pressure is possible.

Interaction studies of levocetirizine have not been conducted. Studies on cetirizine (racemic mixture) have shown that concomitant use with antipyrine, pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide or diazepam does not show clinically significant adverse interactions. Simultaneous use with theophylline (400 mg / day) reduces the total clearance of cetirizine by 16% (the theophylline kinetics does not change). In the study of repeated administration of ritonavir (600 mg 2 times a day) and cetirizine (10 mg / day), the degree of exposure of cetirizine increases by about 40%, while the distribution of ritonavir was somewhat disturbed (-11%) with the simultaneous use of cetirizine. There is no evidence of an increase in the effect of sedatives when used in therapeutic doses. But you should avoid the use of sedatives while taking the preparation.

Food intake does not affect the degree of absorption of the preparation, but reduces the rate of absorption.

Overdose

Helppex anti-cold neo / helppex anti-cold neo max. liver damage is possible in adults who have taken ≥10 g of paracetamol or 5 g of paracetamol with risk factors, and in children who have taken 150 mg / kg of body weight.

Clinical and biochemical signs of liver damage appear 12–48 hours after overdose. The first symptoms are pallor, nausea, vomiting, anorexia, and abdominal pain. The development of cardiac arrhythmias and pancreatitis have been reported.

Reception in high doses can lead to hepatocellular necrosis with the development of encephalopathy and impaired consciousness, hepatic coma, death and acute renal failure. ARF with acute tubular necrosis can present with severe lumbar pain, hematuria, proteinuria, nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis) and develop even in the absence of severe liver damage.

With prolonged use of the preparation in high doses on the part of the hematopoietic organs, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia may develop.

Possible hypoglycemic coma, thrombocytopenia, impaired glucose metabolism, and metabolic acidosis. In patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other preparations that induce liver enzymes); with regular intake of excessive amounts of ethanol; for glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, hunger, cachexia), ingestion of ≥5 g of paracetamol may lead to liver damage.

Symptoms of an overdose of levocetirizine dihydrochloride may include drowsiness in adults and initial agitation and increased irritability followed by drowsiness in children.

An overdose of phenylephrine hydrochloride can cause an increase in blood pressure and reflex bradycardia, tremor, anxiety, increased motor activity, agitation, hallucinations, however, in case of an overdose of a combination preparation, the toxic dose of paracetamol will be reached much earlier than the toxic effects of phenylephrine appear.

Overdose treatment: if an overdose is suspected, the patient should be hospitalized. Symptoms may be limited to nausea and vomiting and may not reflect the severity of the overdose or the risk of organ damage. In the first hours after administration, gastric lavage is advisable. Treatment with activated charcoal should be considered if an excessive dose of paracetamol was taken within 1 hour. Within 24 hours after taking paracetamol, the administration of acetylcysteine ​​can be used, the maximum effect from the application occurs within the first 8 hours after administration. During the first 8 hours after an overdose, methionine can be administered orally.

There is no specific antidote to levocetirizine. Hemodialysis is ineffective for removing levocetirizine from the body.

Storage conditions

Helppex anti-cold neo / helppex anti-cold neo max. at a temperature not exceeding 25 ° c.