Instructions for Helpex Anticold Neo ginger powder for oral solution sachet 4 g No. 10
Composition
active ingredients: paracetamol, levocetirizine dihydrochloride, phenylephrine hydrochloride;
1 sachet of 4 g contains paracetamol 500 mg, phenylephrine hydrochloride 10 mg, levocetirizine dihydrochloride 1.25 mg;
excipients: aspartame (E 951), sucralose, honey flavoring, ginger flavoring, colloidal anhydrous silicon dioxide, sodium lauryl sulfate, sucrose, anhydrous citric acid, tartrazine (E 102), maltodextrin, ginger extract (6:1).
Dosage form
Powder for oral solution.
Main physicochemical properties: white to light yellow powder.
Pharmacotherapeutic group
Analgesics and antipyretics. Anilides. Paracetamol, combinations without psycholeptics.
ATX code N02B E51.
Pharmacological properties
Pharmacodynamics.
Combined drug for the symptomatic treatment of acute respiratory viral infections, flu and colds. Has antipyretic, analgesic, antiallergic and weak anti-inflammatory properties. Eliminates symptoms of nasal congestion, runny nose, tearing, sneezing, headache, body aches.
Paracetamol has analgesic, antipyretic and weak anti-inflammatory effects.
The mechanism of action of paracetamol is associated with the drug's effect on the thermoregulation center in the hypothalamus, its ability to inhibit the synthesis of prostaglandins and inflammatory mediators (kinin, serotonin), and an increase in the pain threshold.
Levocetirizine dihydrochloride is a non-sedating antihistamine, an active stable R-enantiomer of cetirizine, belonging to the group of competitive histamine antagonists. The pharmacological action is due to the blocking of H1-histamine receptors. The affinity for H1-histamine receptors of levocetirizine is 2 times higher than that of cetirizine. It affects the histamine-dependent stage of the development of an allergic reaction, reduces eosinophil migration, vascular permeability, limits the release of inflammatory mediators. It prevents the development and suppresses the course of allergic reactions, has antiexudative, antipruritic, anti-inflammatory effects, does not have anticholinergic and antiserotonin effects, does not penetrate the central nervous system.
Levocetirizine inhibits the late phase of the inflammatory response induced in patients by intradermal administration of kallikrein. It also reduces the expression of adhesion molecules such as ICAM-1 and VCAM-1, which are markers of allergic inflammation. By reducing the adhesion of ICAM-1, an indirect antiviral effect is exerted, since cell resistance to rhinovirus increases. Levocetirizine also reduces the level of secondary adhesion of Staphylococcus aureus and Haemophilus influenzae to nasopharyngeal epithelial cells that have been infected with rhinovirus.
Phenylephrine hydrochloride is a relatively selective α1-adrenomimetic. It has a weak effect on α2- and β-adrenergic receptors. Due to its vasoconstrictor effect, phenylephrine reduces swelling of the nasal mucosa, the volume of nasal secretions and improves nasal breathing due to easier passage of air through the nose. Use for temporary relief of nasal congestion in acute respiratory viral infections and colds.
Pharmacokinetics.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The half-life is 1–4 hours. It is evenly distributed in all body fluids. Binding to plasma proteins is variable. It is excreted mainly by the kidneys in the form of conjugated metabolites.
Levocetirizine dihydrochloride. Pharmacokinetic parameters have a linear relationship and are almost the same as those of cetirizine. Rapidly absorbed when administered orally, food intake does not affect the extent 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 blood-brain barrier. The volume of distribution is 0.4 l/kg. Plasma protein binding is 90%.
About 14% of levocetirizine is metabolized in the body. Given the low degree of metabolism and the lack of increased inhibitory effect, the interaction of levocetirizine with other substances (and vice versa) is unlikely.
Excretion of the drug occurs mainly due to glomerular filtration and active tubular secretion. The half-life (T1/2) is 7.9 ± 1.9 hours, 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 is reduced, and the half-life (T1/2) is prolonged (for example, in patients on hemodialysis, the total clearance is reduced by 80%), which requires the selection of an appropriate dosage regimen. During standard 4-hour hemodialysis, a small part (less than 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.
Indication
Treatment of symptoms that occur during acute respiratory viral infections, influenza (to reduce elevated body temperature, reduce runny nose, relieve swelling of the nasal mucosa, relieve headaches, eliminate body aches).
Contraindication
Hypersensitivity to any component of the drug, piperazine derivatives in history. Severe forms of cardiovascular diseases, arterial hypertension, conduction disorders, ischemic heart disease, atherosclerosis, heart failure. Hyperthyroidism, pheochromocytoma. Epilepsy, increased excitability, sleep disorders. Thrombosis, thrombophlebitis, tendency to vasospasm. Bronchial asthma. Blood diseases (including severe anemia, leukopenia). Acute pancreatitis. Severe liver and/or kidney dysfunction (creatinine clearance < 10 ml/min). Alcoholism. Prostatic adenoma with difficulty urinating, bladder neck obstruction. Diabetes mellitus. Angle-closure glaucoma. Congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency. Concomitant use with tricyclic antidepressants, beta-blockers or other antihypertensive drugs, sympathomimetics; with monoamine oxidase inhibitors and within 2 weeks after discontinuation of their use; drugs that suppress or increase appetite; amphetamine-like psychostimulants.
Interaction with other medicinal products and other types of interactions
When used simultaneously with paracetamol, the following types of interactions may occur:
the elimination of antibiotics from the body may be slowed down;
barbiturates reduce the antipyretic effect of paracetamol;
with simultaneous use of paracetamol with hepatotoxic agents, the toxic effect on the liver increases;
Inducers of liver microsomal enzymes (anticonvulsants (phenytoin, barbiturates, carbamazepine), rifampicin), alcohol and isoniazid increase the hepatotoxicity of paracetamol;
metoclopramide and domperidone increase, and cholestyramine, antacids and food reduce the absorption of paracetamol;
salicylamide prolongs the elimination period of paracetamol;
tetracycline increases the risk of developing anemia and methemoglobinemia caused by paracetamol;
paracetamol reduces the effectiveness of diuretics;
Taking paracetamol may affect the results of blood glucose and uric acid tests.
With simultaneous long-term use, the anticoagulant effect of coumarins (e.g. warfarin) is enhanced, increasing the risk of bleeding.
Concomitant use of paracetamol with nonsteroidal anti-inflammatory drugs increases the risk of renal dysfunction.
When used simultaneously with flucloxacillin, there is a risk of metabolic acidosis with a high anion gap, especially in patients with risk factors (see section "Special instructions").
No interaction studies have been conducted with levocetirizine. Studies with cetirizine (racemic mixture) have shown that concomitant use with antipyrine, pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide or diazepam does not reveal clinically significant adverse interactions. When co-administered with theophylline (400 mg/day), a small decrease (by 16%) in the total clearance of levocetirizine was observed (theophylline distribution was not changed). In a study of multiple doses of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the exposure of cetirizine increased by approximately 40%, while the distribution of ritonavir was slightly impaired (-11%) with concomitant use of cetirizine.
Food intake does not affect the extent of absorption of the drug, but reduces the rate of its absorption.
Concomitant use of cetirizine or levocetirizine and alcohol or other central nervous system depressants in susceptible patients may cause additional impairment of alertness and ability to perform work.
The use of phenylephrine hydrochloride with monoamine oxidase inhibitors, tricyclic antidepressants (amitriptyline), indomethacin and bromocriptine can cause severe arterial hypertension; may reduce the effectiveness of ß-blockers and other antihypertensive drugs (debrizoquine, guanethidine, reserpine, methyldopa) with an increased risk of arterial hypertension and adverse cardiovascular reactions; with sympathomimetic amines, digoxin and cardiac glycosides increases the risk of arrhythmias and myocardial infarction. Rauwolfia alkaloids reduce the therapeutic effect of phenylephrine hydrochloride; α-blockers (phentolamine), phenothiazines, furosemide and other diuretics prevent vasoconstriction.
Application features
Do not exceed the indicated dose; do not take the drug simultaneously with other products containing paracetamol, as an overdose of paracetamol is possible, which can cause liver failure.
You should consult a doctor if symptoms persist and/or are accompanied by a high fever that lasts more than 3 days; if the headache becomes persistent.
Do not use simultaneously with alcohol.
Before using the drug, patients who take analgesics every day for mild arthritis; patients who use warfarin or similar drugs that have an anticoagulant effect; patients with liver disease (the risk of hepatotoxic effects of paracetamol increases) or kidney disease should consult a doctor.
Cases of liver failure/dysfunction have been reported in patients with reduced glutathione levels, e.g. in severe wasting, anorexia, low body mass index or chronic alcoholism. Patients with reduced glutathione levels, e.g. in severe infections such as sepsis, 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 seek medical attention immediately if these symptoms occur.
Caution is advised when using paracetamol concomitantly with flucloxacillin due to an increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal insufficiency, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), and in patients taking the maximum daily dose of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
Use with caution in patients with chronic renal failure (dosage regimen adjustment required) and in elderly patients with renal failure (possible reduction in glomerular filtration).
Contains natural ginger extract, which has the ability to reduce blood glucose levels and glycosylated hemoglobin levels.
Phenylephrine may cause an attack of angina.
Use the drug with caution in patients prone to urinary retention (e.g. spinal cord injuries, prostatic hyperplasia), with difficulty urinating, as the risk of developing urinary retention increases; in patients with a risk of seizures or epilepsy.
There is no evidence of an increase in the effect of sedatives when used in therapeutic doses. However, the use of sedatives should be avoided while taking the drug.
Antihistamines suppress the skin allergy test, so before conducting it, the drug must be stopped 3 days before the test (withdrawal period).
The dye tartrazine (E 102) may cause allergic reactions.
Aspartame (E 951) is a derivative of phenylalanine, which is dangerous for patients with phenylketonuria.
The drug contains sucrose, therefore patients with established intolerance to some sugars should consult their doctor before taking this medicine.
Use during pregnancy or breastfeeding
Pregnancy
Do not use in pregnant women, as levocetirizine dihydrochloride is contraindicated for use during pregnancy.
Breast-feeding
Since the active substances of the drug penetrate into breast milk to some extent, the drug is not used during breastfeeding. If necessary, breastfeeding should be discontinued.
Fertility
There are no data on the effect of the drug on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment with the drug, you should refrain from activities that require increased concentration of attention (for example, driving a vehicle or working with other potentially dangerous mechanisms).
Method of administration and doses
Adults and children over 12 years of age: 1 sachet up to 4 times a day. The intervals between doses should be at least 4 hours. Dissolve the contents of the sachet in a glass of hot water and drink.
The duration of treatment should not exceed 5 days.
The maximum period of use without consulting a doctor is 3 days.
Children
Do not use in children under 12 years of age.
Overdose
Liver damage is possible in adults who have taken 10 g or more of paracetamol or 5 g in the presence of risk factors, and in children who have taken more than 150 mg/kg of body weight.
In case of paracetamol overdose, symptoms develop in the first 24 hours: pallor, nausea, vomiting, loss of appetite, abdominal pain.
The first clinical and biochemical signs of liver damage may appear 12–48 hours after overdose. Disorders of glucose metabolism, hypokalemia and metabolic acidosis (including lactic acidosis), increased activity of hepatic transaminases, increased bilirubin levels and increased prothrombin index, and hemorrhage may occur.
Occasionally, nephrotoxicity has been observed from the urinary system, including renal colic, interstitial nephritis, and acute renal failure with acute tubular necrosis, which may present with severe lower back pain, hematuria, and proteinuria and may develop even in the absence of severe liver damage.
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; alcoholism; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia)), the use of 5 g or more of paracetamol may lead to liver damage.
Cardiac arrhythmia and acute pancreatitis, usually accompanied by liver dysfunction and hepatotoxicity, have also been reported.
When taking large doses, the central nervous system experiences disorientation.
With prolonged use of the drug in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia may develop on the part of the hematopoietic organs.
Treatment of overdose: In case of overdose, immediate medical attention is required. The patient should be taken to a hospital immediately, even if there are no early symptoms of overdose.
Symptoms may be limited to nausea and vomiting and may not reflect the severity of the overdose or the risk of organ damage. Gastric lavage should be performed within the first hours of a suspected overdose. Treatment with activated charcoal may be appropriate if the overdose of paracetamol was taken within 1 hour.
The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Intravenous N-acetylcysteine is used within 24 hours after ingestion of paracetamol according to current recommendations, the maximum effect of the use occurs within 8 hours after ingestion of paracetamol, after which the effectiveness of the antidote decreases sharply. In the absence of vomiting, oral methionine can be used as a suitable alternative in remote areas outside the hospital.
Symptoms of levocetirizine dihydrochloride overdose may include drowsiness in adults and initial agitation and increased irritability followed by drowsiness in children.
Treatment of overdose. There is no specific antidote for levocetirizine. In case of symptoms of overdose, symptomatic and supportive therapy is recommended. Gastric lavage may be considered shortly after ingestion. Hemodialysis is not effective in removing levocetirizine from the body.
Overdose of phenylephrine is manifested by symptoms from the cardiovascular system with respiratory depression. Nervousness, headache, dizziness, insomnia, nausea, vomiting, increased blood pressure or reflex bradycardia, tachycardia, palpitations, urinary retention (more often in patients with prostatic hypertrophy) may be present.
Treatment of overdose. Intravenous α-blockers are used to eliminate hypertensive effects; in case of convulsions, diazepam.
Side effects
Immune system disorders: hypersensitivity reactions including pruritus, urticaria, rash, angioedema, anaphylactic shock, erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
Nervous system: drowsiness, headache, fatigue, weakness, asthenia, tremor, convulsions, paresthesia, dizziness, fainting, dysgeusia, sleep disturbances, aggression, psychomotor agitation, insomnia, suicidal thoughts, hallucinations, nervousness, irritability, anxiety, fear, depression, disorientation.
On the part of the organs of vision: impaired vision and accommodation, mydriasis, increased intraocular pressure.
On the part of the heart: increased blood pressure, decreased blood pressure, tachycardia, feeling of increased heartbeat, shortness of breath, heart pain.
Renal and urinary disorders: dysuria, urinary retention, renal colic, nephrotoxicity.
From the organs of hearing and balance: tinnitus, vertigo.
Respiratory system: bronchospasm in patients sensitive to aspirin and other nonsteroidal anti-inflammatory drugs.
On the part of the digestive tract: nausea, vomiting, dry mouth, abdominal discomfort and pain, diarrhea, constipation, increased appetite, heartburn, flatulence, hypersalivation.
From the hepatobiliary system: impaired liver function, increased activity of liver enzymes, liver failure, hepatitis.
On the part of 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); leukopenia, pancytopenia, neutropenia.
Musculoskeletal system: myalgia, arthralgia.
General disorders: weight gain, fever, edema.
Expiration date
4 years.
Storage conditions
Store out of the reach of children in the original packaging at a temperature not exceeding 25 °C.
Packaging
4 g of powder in a sachet; 10 sachets in a cardboard box.
Vacation category
Without a prescription.
Producer
Alpex Pharma SA.
Location of the manufacturer and address of its place of business.
Via Cantonale, 6805 Mezzovico-Vira, Switzerland.
