Instructions Anticataral powder for oral solution sachet No. 10
Composition
active ingredients: paracetamol, phenylephrine hydrochloride, chlorphenamine maleate;
1 sachet contains paracetamol 650 mg, phenylephrine hydrochloride 10 mg, chlorphenamine maleate 4 mg;
excipients: colloidal anhydrous silicon dioxide, anhydrous citric acid, sodium saccharin, sucrose, sodium cyclamate, orange flavoring.
Dosage form
Powder for oral solution.
Main physicochemical properties: white, homogeneous powder without lumps, has an orange taste after dissolution in water.
Pharmacotherapeutic group
Analgesics and antipyretics. Paracetamol, combinations without psycholeptics.
ATX code N02B E51.
Pharmacological properties
Pharmacodynamics
A combined drug with analgesic, antipyretic, anti-inflammatory and antiallergic effects, due to the effects of the components that make up the drug.
Paracetamol is an analgesic-antipyretic, has a pronounced analgesic, antipyretic effect. The indicated action of paracetamol is associated with its effect on the thermoregulation center in the hypothalamus, the ability to inhibit the synthesis of prostaglandins in the central nervous system.
Phenylephrine hydrochloride is a sympathomimetic that acts primarily by direct action on α-adrenergic receptors. It causes vasoconstriction, reduces swelling and hyperemia of the mucous membrane of the nasal cavity and paranasal sinuses.
Chlorphenamine maleate is a histamine H1 receptor blocker, has an antiallergic effect, reduces capillary permeability, constricts blood vessels, eliminates swelling and hyperemia of the nasal mucosa, nasopharynx and paranasal sinuses; reduces local exudative manifestations, suppresses symptoms of allergic rhinitis (sneezing, rhinorrhea, itching of the eyes, nose, throat irritation).
Pharmacokinetics
After oral administration, paracetamol is rapidly absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is reached after 30–60 minutes. When using therapeutic doses, the half-life is 1–4 hours. Paracetamol is metabolized in the liver mainly by conjugation. Depending on the concentration in plasma, it is partially deacetylated or hydroxylated. The main route of excretion is with urine (90–100% within 24 hours), in the form of glucuronide conjugates (60%), sulfates (35%) or cysteine (3%).
The half-life of phenylephrine after oral administration is 2.1–3.4 hours.
The maximum concentration of chlorphenamine 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 in the form of metabolites.
Indication
Symptomatic treatment of influenza and acute respiratory infections accompanied by fever, sore throat, nasal congestion, runny nose, headache, muscle and joint pain, and tearing.
Contraindication
Hypersensitivity to the components of the drug; severe liver and/or kidney diseases; hematopoietic disorders; blood diseases; severe leukopenia, anemia; severe cardiovascular diseases, including severe cardiac conduction disorders, severe ischemic heart disease, severe arterial hypertension, decompensated heart failure, severe coronary artery atherosclerosis; congenital deficiency of glucose-6-phosphate dehydrogenase (can lead to hemolytic anemia); Gilbert's syndrome (intermittent benign jaundice resulting from glucuronyltransferase deficiency), Dubin-Johnson syndrome; pulmonary emphysema, chronic obstructive pulmonary diseases; bronchial asthma; diabetes mellitus; alcoholism; hyperthyroidism; angle-closure glaucoma; bladder neck obstruction; pyloroduodenal obstruction; peptic ulcer disease in the acute stage; arrhythmias; benign prostatic hyperplasia with difficulty urinating; acute pancreatitis; increased excitability; sleep disorders; pheochromocytoma; epilepsy; old age; risk of respiratory failure.
Do not use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuing MAOIs, with tricyclic antidepressants, beta-blockers.
The drug Anticataral is contraindicated for use during pregnancy or breastfeeding.
Interaction with other medicinal products and other types of interactions
The simultaneous use of Anticataral with monoamine oxidase inhibitors (MAO), tricyclic antidepressants, methyldopa is contraindicated due to the likelihood of severe arterial hypertension, tachycardia, hyperthermia, dysfunction of vital organs, which can lead to death. The drug enhances the effects of sedatives and antiepileptic drugs, ethanol and ethanol-containing drugs. With simultaneous use of Anticataral with antihypertensive drugs, the effectiveness of the latter may decrease. Barbiturates and alcohol may increase the hepato- and nephrotoxicity of paracetamol, barbiturates reduce the antipyretic effect of paracetamol. Anticonvulsants (phenytoin, barbiturates, carbamazepine), isoniazid and rifampicin may increase the hepatotoxic effect of paracetamol. Tetracycline increases the risk of developing anemia and methemoglobinemia caused by paracetamol. When using paracetamol simultaneously with azidothymidine, neutropenia may develop. When used simultaneously, paracetamol enhances the hepatotoxicity of chloramphenicol. Paracetamol potentiates the effect of indirect anticoagulants, increasing the risk of bleeding. The rate of absorption of paracetamol may be increased by metoclopramide and domperidone and decreased by cholestyramine. Antacids and food reduce the absorption of paracetamol. Simultaneous use of Anticataral with β-blockers may lead to arterial hypertension and bradycardia. Anticataral may reduce the effectiveness of diuretics. When used simultaneously with antibiotics, the excretion of the latter may be slowed down.
When using paracetamol with hepatotoxic drugs, the toxic effect of the drugs on the liver increases. Anticataral is not recommended for use with sedatives, hypnotics or drugs containing alcohol due to the increased risk of hepatotoxicity. It is also not recommended for use simultaneously with vasoconstrictors.
Caution should be exercised when using paracetamol with flucloxacillin, as such co-administration is associated with metabolic acidosis with an increased anion gap, especially in patients with risk factors (see section "Special warnings and precautions for use").
Concomitant use of Anticataral with the following drugs may significantly enhance the depressant effect of chlorphenamine on the central nervous system (CNS): hypnotics, barbiturates, sedatives, neuroleptics, tranquilizers, anesthetics, narcotic analgesics, ethanol-containing drugs.
Chlorphenamine enhances the anticholinergic effect of atropine, antispasmodics, tricyclic antidepressants, antiparkinsonian drugs. Chlorphenamine may inhibit the effect of anticoagulants.
Phenylephrine may cause hypertensive crisis and/or arrhythmia when used simultaneously with other adrenomimetic agents or MAO inhibitors, cause severe arterial hypertension when combined with indomethacin and bromocriptine. Simultaneous use of phenylephrine with other sympathomimetic agents or tricyclic antidepressants (e.g. amitriptyline) increases the risk of developing side effects from the cardiovascular system. Rauwolfia alkaloids reduce the therapeutic effect of phenylephrine. Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive agents. The risk of developing arterial hypertension and other side effects from the cardiovascular system also increases.
Simultaneous use of phenylephrine with digoxin or other cardiac glycosides increases the risk of cardiac arrhythmias and heart attack. Antidepressants, antiparkinsonian and antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation. Simultaneous use with ergot alkaloids (ergotamine, methysergide) increases the risk of ergotism.
Application features
You should not exceed the recommended doses of the drug and you should not take the drug for more than 3 consecutive days, as it contains paracetamol, which, if the dose is exceeded, exhibits hepatotoxicity.
While taking the drug, it is not recommended to use other drugs containing paracetamol, sympathomimetics (phenylephrine, pseudoephedrine), barbiturates, tranquilizers, other sedatives and hypnotics, as well as to drink alcohol (including as part of other medications), since they can cause liver dysfunction when taken simultaneously with paracetamol.
Prolonged use may lead to serious liver complications such as cirrhosis. Acute or chronic overdose may lead to severe liver damage and, in rare cases, death. Prolonged use of paracetamol in high doses may lead to irreversible kidney damage and the development of renal failure. Prolonged use of paracetamol in high doses may lead to liver and kidney damage. If, on the recommendation of a doctor, paracetamol must be used for a long period, it is necessary to monitor the functional state of the liver and the peripheral blood picture.
Caution is recommended when paracetamol is used concomitantly with flucloxacillin due to the increased risk of metabolic acidosis with an increased anion gap, especially in patients with severe renal insufficiency, sepsis, malnutrition and other causes of glutathione deficiency (e.g. chronic alcoholism), as well as in patients taking maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.
You should consult a doctor before use:
if the patient is taking warfarin or similar anticoagulants;
if the patient has breathing problems or chronic bronchitis;
if the patient suffers from liver disease or infectious liver lesions, such as viral hepatitis;
if the patient suffers from kidney disease, as dose adjustment may be necessary. In case of renal insufficiency, the doctor should assess the benefit/risk ratio before starting the drug. Dose adjustment and monitoring of the patient's condition are necessary;
with arterial hypertension;
with daily use of analgesics.
It should be used with caution in patients:
who are chronically malnourished and dehydrated;
with mild to moderate hepatic insufficiency (< 9 points on the Child–Pugh scale);
with Raynaud's disease;
with thyroid diseases, except for hyperthyroidism, in which Anticataral is contraindicated;
with glaucoma, except for angle-closure glaucoma, in which Anticataral is contraindicated.
It should be noted that patients with alcoholic liver disease are at increased risk of hepatotoxic effects of paracetamol.
Phenylephrine may cause false positive doping control results in athletes.
You should consult a doctor if:
– symptoms do not disappear and/or are accompanied by a high body temperature that lasts more than three days;
– symptoms are observed that include a sore throat that does not go away for more than 3 days and is accompanied by fever, headache, rash, nausea or vomiting;
– if the headache becomes constant.
Severe skin reactions have been reported very rarely. If skin redness, rash, blistering or peeling occurs, paracetamol should be discontinued and medical attention sought immediately. During the use of paracetamol in therapeutic doses, an increase in alanine aminotransferase (ALT) may occur.
The drug may affect the results of laboratory tests for glucose and uric acid in the blood.
This medicinal product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. It may be harmful to your teeth.
Use during pregnancy or breastfeeding
Pregnancy. From the 20th week of pregnancy, the use of the drug Anticataral may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after the start of treatment and is usually reversible after discontinuation of treatment. In addition, there are reports of narrowing of the ductus arteriosus after treatment in the second trimester of pregnancy, most of which resolved after discontinuation of treatment. Therefore, during the first and second trimesters of pregnancy, the drug Anticataral should not be prescribed. If Anticataral is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may pose risks:
risks to the fetus:
– cardiopulmonary toxicity (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);
– renal dysfunction (see above);
Risks for the mother at the end of pregnancy and for the newborn:
– possible prolongation of bleeding time, anti-aggregation effect, which can occur even at very low doses;
– suppression of uterine contractions, leading to delayed or prolonged labor.
Therefore, Anticataral is contraindicated during the third trimester of pregnancy (see the Contraindications section).
Lactation. Anticataral is contraindicated for use during breastfeeding. If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued for the entire period of use of the drug.
Fertility: There is some evidence that female fertility may be impaired due to the effect of cyclooxygenase/prostaglandin synthesis inhibitors on ovulation, which is reversible and disappears after discontinuation of treatment. Since paracetamol inhibits prostaglandin synthesis, it may have a negative effect on fertility, although no such cases have been reported so far.
Ability to influence reaction speed when driving vehicles or other mechanisms
While using the drug, you should refrain from driving vehicles and working with potentially dangerous mechanisms.
Method of administration and doses
A single dose for adults and children over 12 years of age is 1 sachet. If necessary, repeat every 4 hours, but do not exceed the maximum daily dose of 4 sachets. The duration of treatment is determined by the doctor. The maximum period of use without consulting a doctor is 3 days. Do not take with other products containing paracetamol.
Children
Anticatarrhal should be used in children over 12 years of age.
Overdose
In case of overdose, paracetamol causes hepatotoxic effects. Liver damage is possible in adults who have taken 10 g or more of paracetamol, and in children who have taken a dose of more than 150 mg/kg of body weight.
Clinical and biochemical signs of liver damage appear 24–72 hours after overdose, but may not appear for 12–48 hours. The following symptoms develop: anorexia, nausea, vomiting, abdominal pain, pallor of the skin. The activity of hepatic transaminases increases, the concentration of bilirubin increases and the level of prothrombin decreases, which is accompanied by hemorrhages. Disorders of glucose metabolism, hypokalemia and metabolic acidosis (including lactic acidosis) may occur.
In severe poisoning, liver failure can progress to encephalopathy, hemorrhage, hypoglycemia, coma, and death.
When taking high doses of paracetamol, the following symptoms may occur: dizziness, psychomotor agitation and disorientation, central nervous system depression, sleep disturbances, increased sweating; from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).
Acute renal failure with acute tubular necrosis 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; regular use of excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infection, starvation, cachexia)), the use of 5 g or more of paracetamol may lead to liver damage. Acute renal failure with acute tubular necrosis may manifest as severe lumbar pain, hematuria, proteinuria. Cardiac arrhythmia and pancreatitis may also occur.
Common clinical manifestations that appear after 3–5 days include jaundice, fever, hemorrhagic diathesis, hypoglycemia, hepatic halitosis, and liver failure.
With prolonged use of paracetamol in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia are possible.
Overdose due to the action of phenylephrine and chlorphenamine maleate may cause increased sweating, psychomotor agitation or depression of the central nervous system, headache, dizziness, drowsiness, impaired consciousness, cardiac arrhythmias, tachycardia, extrasystole, tremor, hyperreflexia, convulsions, nausea, vomiting, irritability, anxiety, increased blood pressure.
In case of an overdose of chlorphenamine maleate, atropine-like symptoms may be observed: mydriasis, photophobia, dry skin and mucous membranes, increased body temperature, intestinal atony. CNS depression is accompanied by respiratory disorders and disorders of the cardiovascular system (decreased pulse rate, decreased blood pressure up to vascular insufficiency). In case of overdose (even in the absence of symptoms), emergency medical care and immediate hospitalization are required.
Treatment: Gastric lavage, which should be performed within 6 hours of suspected paracetamol overdose, as well as symptomatic therapy. In severe hypertension, use of α-blockers.
Emergency medical assistance should be sought and 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. Treatment with activated charcoal should be considered if an overdose of paracetamol has been taken within 1 hour. Plasma paracetamol concentrations should be measured 4 hours or later after ingestion (earlier concentrations are not reliable).
Treatment with N-acetylcysteine can be used within 24 hours of paracetamol ingestion, but the maximum protective effect is obtained when it is used within 8 hours of ingestion, after which its effectiveness decreases sharply. The effectiveness of the antidote decreases sharply after this time. If necessary, the patient should be given intravenous N-acetylcysteine according to current recommendations. In the absence of vomiting, oral methionine can be used as a suitable alternative in remote areas outside the hospital.
Adverse reactions
Skin and subcutaneous tissue disorders: hypersensitivity reactions, including itching, skin and mucous membrane rashes (erythema, urticaria, generalized rash), erythema multiforme (including Stevens-Johnson syndrome), allergic and angioedema, acute generalized exanthematous pustulosis, local drug dermatitis, toxic epidermal necrolysis (Lyell's syndrome), including fatal outcomes.
From the blood and lymphatic system: anemia, leukopenia, sulfhemoglobinemia and methemoglobinemia (cyanosis, shortness of breath, heart pain), hemolytic anemia, thrombocytopenia, agranulocytosis, bruising or bleeding.
On the part of the digestive tract: nausea, vomiting, dry mouth, abdominal discomfort and pain, hypersalivation, decreased appetite, heartburn, diarrhea, flatulence, constipation.
On the part of the hepatobiliary system: impaired liver function, increased activity of liver enzymes, usually without the development of jaundice, hepatonecrosis (dose-dependent effect).
On the part of the urinary system: urination disorders, urinary retention (more likely in patients with prostatic hypertrophy), renal colic and interstitial nephritis, aseptic pyuria.
On the part of the endocrine system: fluctuations in blood sugar levels, hypoglycemia up to hypoglycemic coma.
From the cardiovascular system: increased blood pressure, tachycardia or reflex bradycardia, palpitations, shortness of breath, heart pain, arrhythmia, with prolonged use in large doses, myocardial dystrophy is possible.
On the part of the respiratory system: bronchospasm in patients sensitive to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, dry nose.
On the part of the psyche: psychomotor agitation and disorientation, behavioral changes, euphoria, anxiety, nervous excitement, feelings of fear, irritability, sleep disturbances, drowsiness, insomnia, confusion, depressive states, hallucinations, anxiety, sedation.
From the side of the central nervous system: headache, weakness, dizziness, tremor, paresthesia, tingling and heaviness in the limbs, dyskinesia, epileptic seizures, in rare cases - coma.
From the side of the organs of hearing and vestibular apparatus: tinnitus, vertigo.
On the part of the organs of vision: impaired vision and accommodation, mydriasis, dryness of the mucous membrane of the eyes, increased intraocular pressure.
Reporting of suspected adverse reactions.
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 sachets per pack.
Vacation category
Without a prescription.
Producer
Laboratorios Alcala Pharma, S.L.
Laboratorios Alcala Farma, SL
Location of the manufacturer and address of its place of business
Avenida Madrid, 82, Alcala de Henares, 28802 Madrid, Spain.
Avenida de Madrid, 82, Alcala de Henares, 28802 Madrid, Spain.
Applicant
Joint Ukrainian-Spanish enterprise "Sperco Ukraine".
Location of the applicant and address of its place of business
21027, Ukraine, Vinnytsia, 600-anniversary St., 25.
Phone: + 38(0432)52-30-36. E-mail: trade@sperco.com.ua
www.sperco.com.ua
