Coldact with vitamin C pills, 10pcs

Composition

Each film-coated tablet contains

Active ingredients:

**: contains 1.35 mg of stearic alcohol

Excipients: colloidal silicon dioxide 15.00 mg, pregelatinized starch 50.00 mg, microcrystalline cellulose 95.65 mg, sodium carboxymethyl starch 30.00 mg, povidone K 30 30.00 mg, talc 5.00 mg, magnesium stearate 9.00 mg.

Film shell: Opadray brown OY56524 27.90 mg.

The composition of brown fall OY56524: hypromellose 63.650%, titanium dioxide (E 171) 20.140%, iron oxide dye (red) (E 172) 8.860%, macrogol 6000 6.300%, iron oxide dye (yellow) (E 172) 1.050%.

Pharmacological action

Pharmacological PROPERTIESTHE combined preparation has antipyretic, anti-inflammatory, decongestant, analgesic and anti-allergic effects, eliminates the symptoms of the “cold”. Pharmacodynamicaparacetamol. It has analgesic and antipyretic effects similar to those of salicylates. Paracetamol also shows weak anti-inflammatory activity. In the same doses, the degree of analgesic and antipyretic effects is comparable to that of aspirin. Paracetamol reduces body temperature in patients with fever, but rarely reduces normal temperature. Antipyretic action is carried out through the hypothalamus. Reduced heat is achieved due to vasodilation and increased peripheral blood flow. Phenylephrine hydrochloride. It is a vasoconstrictor from the group of sympathomimetics. It has a direct effect on a-adrenergic receptors. In therapeutic doses, it does not affect the beta-1-adrenergic receptors of the heart. Phenylephrine does not stimulate the beta-2-adrenergic receptors of the bronchi or peripheral blood vessels. It is believed that α-adrenergic effects lead to suppression of cyclic adenosine-3,5-monophosphate (cAMP) production by inhibiting adenyl cyclase, while β-adrenergic effects are caused by increasing the activity of adenyl cyclase. Phenylephrine indirectly promotes the release of norepinephrine. Vasoconstriction is the main effect of phenylephrine in therapeutic doses. Chlorphenamine maleate. It has a pronounced antagonistic effect on histamine H1-receptors. Antihistamines reduce or eliminate the effects of histamine by reversibly binding histamine H1 receptors in tissues. Chlorphenamine also has anticholinergic activity. Antihistamines prevent the release of histamine, prostaglandins, and leukotrienes, as well as the migration of inflammatory mediators. The action of chlorpheiamine includes inhibition of histamine in smooth muscle tissue, reduction of capillary permeability and, consequently, reduction of edema in allergic reactions. Ascorbic acid (vitamin C). Replenishes the increased need for vitamin C in colds and flu, especially in the initial stages of the disease. Increases the body’s resistance to infections, improves the tolerance of paracetamol. It participates in various biochemical oxidation-reduction reactions. It is an effective antioxidant. Taking ascorbic acid softens the course of the disease and shortens its duration. Pharmacokinetics: Paracetamol. It is rapidly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentrations are reached 10-60 minutes after oral use. Paracetamol is widely distributed in all body tissues. It penetrates the placental barrier and is secreted in breast milk. Binding to plasma proteins is insignificant at normal therapeutic concentrations, but increases with increasing concentrations. Paracetamol is primarily metabolized in the liver in two ways: glucuronidation and sulfation. It is excreted by the kidneys, mainly in the form of glucuronide and sulfate conjugates. The elimination half-life is 1 to 3 hours. In severe renal impairment (creatinine clearance less than 30 ml/min), the elimination of paracetamol and its metabolites is delayed. Phenylephrine hydrochloride. It is absorbed from the gastrointestinal tract and metabolized by monoamine oxidase during primary passage through the intestinal wall and in the liver, so when taken orally, phenylephrine hydrochloride has limited bioavailability. It is excreted by the kidneys almost completely in the form of a sulfate conjugate. Maximum concentrations of the drug in blood plasma are reached within 45 minutes-2 hours, and the half-life of the drug from plasma is 2-3 hours. Chlorphenamine maleate. Relatively slowly absorbed from the gastrointestinal tract, the maximum concentration of chlorphenamine in the blood plasma is reached in 2.5-6 hours after taking the drug. The substance has a low bioavailability of 25-50%. About 70% of chlorphenamine in the bloodstream binds to plasma proteins. It is widely distributed in body tissues, including the central nervous system (CNS). Chlorphenamine undergoes significant metabolism during primary passage. The duration of action is 4-6 hours. Children showed faster and more complete absorption, faster clearance, and a shorter half-life. The elimination half-life ranges from 2 to 43 hours, even with an average duration of 4-6 hours. Part of chlorphenamine in unchanged form with metabolites was excreted by the kidneys. Ascorbic acid. Easily absorbed after oral use. With the usual dosage regimen (30-180 mg / day), about 70-90% of the vitamin is absorbed; with a further increase in the dose, absorption decreases (50-20%). Ascorbic acid is widely distributed in the tissues. High concentrations of the vitamin are found in the liver, white blood cells, platelets, glandular tissue and the lens of the eye. About 25% of the vitamin binds to plasma proteins. Ascorbic acid passes through the placental barrier. The concentration in umbilical cord blood is usually 2-4 times higher than in maternal blood. Ascorbic acid is reversibly oxidized to dehydroascorbic acid. Some amounts are metabolized to inactive derivatives(sulfates and oxalates) and excreted in the urine.

Indications

Elimination of symptoms of colds and flu, such as fever, headache, chills, pain in the joints and muscles, stuffy nose, runny nose, sneezing, pain in the nose and throat.

Use during pregnancy and lactation

The use of the drug is not recommended during pregnancy and lactation. Safety during pregnancy and lactation has not been specifically studied. Data on the potential effects of each Active ingredient on pregnancy and lactation are presented below. Pregnancy Epidemiological studies during pregnancy have shown no adverse effects when using oral paracetamol at the recommended dose. Studies of reproductive function based on the oral drug did not reveal signs of malformations or fetotoxicity. Under normal conditions of use, paracetamol can be used throughout pregnancy after evaluating the benefit-risk ratio. There are limited data on the use of phenylephrine in pregnant women. Narrowing of the uterine vessels and reduced blood flow in the uterus with the use of phenylephrine can lead to fetal hypoxia. The use of phenylephrine during pregnancy should be avoided. Epidemiological data on human use have not shown a link between chlorphenamine and congenital malformations. However, due to the lack of controlled clinical trials, the use of chlorphenamine maleate during pregnancy should be avoided. Breast-feedingparacetamol is excreted in breast milk, but in amounts that are not clinically significant. According to published data, paracetamol is not contraindicated during breastfeeding. There are no data on the excretion of phenylephrine in breast milk. Avoid taking phenylephrine during breastfeeding. There is no information about the use of chlorphenamine during breastfeeding. It should be avoided by women who are breast-feeding.

Contraindications

• Hypersensitivity to the components of the drug.

• Taking monoamine oxidase inhibitors (simultaneously or in the previous 14 days), tricyclic antidepressants, beta-blockers, and other sympathomimetics.

• Severe cardiovascular diseases, arterial hypertension, hyperthyroidism, angle-closure glaucoma, pheochromocytoma.

• Pregnancy, breast-feeding period.

• Children under 12 years of age.

With caution:

Diabetes mellitus, liver function disorders, kidney function disorders, prostatic hyperplasia, hemolytic anemia, bronchial asthma, chronic obstructive pulmonary disease (chronic bronchitis), emphysema, acute hepatitis, chronic exhaustion or dehydration, pyloroduodenal stenosis, epilepsy, cardiovascular diseases, glucose-6-phosphate dehydrogenase deficiency, congenital hyperbilirubinemia.

You should not simultaneously take other paracetamol-containing drugs, as well as other drugs that affect liver function.

It should be taken with caution in patients with alcohol dependence, as well as with recurrent formation of kidney stones.

Side effects

Classification of the frequency of adverse reactions: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (Blood and lymphatic system disorders:Very rare: thrombocytopenia, agranulocytosis, leukopenia, pancytopenia. From the immune system:Rarely: hypersensitivity, angioedema. Frequency unknown: anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis. Mental disorders:Rarely: nervousness, insomnia. Nervous system disorders:Often: drowsiness. Rarely: dizziness, headache. From the side of the heart:Rare: tachycardia, rapid heartbeat. From the side of blood vessels:Rare: arterial hypertension. From the gastrointestinal tract:Often: nausea, vomiting. Rarely: constipation, dryness of the oral mucosa. Liver and biliary tract disorders:Rarely: increased activity of “hepatic” transaminases. Skin and subcutaneous tissue disorders:Rare: skin rash, pruritus, erythema, urticaria. Ascorbic acidascorbic acid is usually well tolerated. High doses can cause diarrhea and other gastrointestinal disorders, as well as lead to hyperoxaluria and the formation of kidney stones.

Interaction

Paracetamolanticoagulant effect of warfarin and other coumarins may be enhanced with prolonged regular use of paracetamol, while increasing the risk of bleeding. Periodic use of paracetamol has no significant effect. Hepatotoxic substances can lead to the accumulation of paracetamol and overdose. The risk of hepatotoxicity of paracetamol is increased by the use of drugs that induce microsomal liver enzymes, such as barbiturates, antiepileptic drugs (for example, phenytoin, phenobarbital, carbamazepine) and drugs for the treatment of tuberculosis, such as rifampicin and isoniazid. Metoclopramide increases the rate of absorption of paracetamol and increases its maximum concentration in blood plasma. Similarly, domperidone may increase the rate of absorption of paracetamol. Paracetamol may increase the elimination half-life of chloramphenicol. Paracetamol can lead to a decrease in the bioavailability of lamotrigine, with a possible decrease in the effect of the latter, which can lead to a possible induction of metabolism in the liver. The absorption of paracetamol may be reduced when co-administered with colestyramine, but the decrease in absorption is insignificant if colestyramine is used an hour later. Regular use of paracetamol concomitantly with zidovudine may cause neutropenia and increase the risk of liver damage. Probenecid affects the metabolism of paracetamol. The dose of paracetamol should be reduced in patients taking probenecid concomitantly. The hepatotoxicity of paracetamol increases with prolonged excessive use of ethanol (alcohol). Paracetamol may affect the results of phosphor-tungsten uric acid tests. Phenytoin reduces the effectiveness of paracetamol, therefore, patients taking phenytoin should avoid frequent use of paracetamol, especially in high doses. Indirect anticoagulants: repeated use of paracetamol for more than 4 days increases the anticoagulant effect. The international normalized ratio (INR) should be monitored during and after the end of concomitant use of paracetamol (especially in high doses and/or for a long time) and coumarin derivatives. Irregular use of paracetamol does not have a significant effect. Propanthelin and other drugs that slow gastric evacuation reduce the rate of absorption of paracetamol, which may delay or reduce the onset of the effect. Long-term concomitant use of paracetamol and other NSAIDs increases the risk of developing” analgesic ” nephropathy and renal papillary necrosis, the onset of end-stage renal failure. Concomitant long-term use of high-dose paracetamol and salicylates increases the risk of developing kidney or bladder cancer. Phenylephrine hydrochloride This drug is contraindicated in patients who have taken or have taken monoamine oxidase inhibitors in the last two weeks. Phenylephrine may potentiate the action of monoamine oxidase inhibitors and induce a hypertensive crisis. Concomitant use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (for example, amitriptyline) may increase the risk of side effects from the cardiovascular system. The use of phenylephrine may lead to a decrease in the effectiveness of beta-blockers and other antihypertensive agents (for example, debrisoquine, guanethidine, reserpine, methyldopa). There may be an increased risk of hypertension and other cardiovascular side effects. Concomitant use of phenylephrine with digoxin and cardiac glycosides may increase the risk of cardiac arrhythmia or heart attack. Concomitant use of ergot alkaloids (ergotamine) may increase the risk of ergotism. Chlorphenamine Maleate antihistamines such as chlorphenamine can enhance the effects of opioid analgesics, anticonvulsants, antidepressants (tricyclic and monoamine oxidase inhibitors), other antihistamines, antiemetics and antipsychotics, anxiolytics, sleeping pills, ethanol (alcohol) and other central nervous system depressants. Since chlorphenamine has some anticholinergic activity, the effects of anticholinergic drugs (for example, certain psychotropic drugs, atropine, and urinary incontinence medications) may be enhanced by the use of this drug. This can lead to tachycardia, dryness of the oral mucosa, gastrointestinal disorders (such as colic), urinary retention, and headache. Phenytoin metabolism may be inhibited by chlorphenamine, and phenytoin toxicity may develop. Ascorbic acid increases the absorption of penicillin and iron group drugs, reduces the clinical effect of heparin and indirect anticoagulants, increases the risk of crystalluria in the treatment with short-acting salicylates and sulfonamides, slows down the excretion of acids by the kidneys, increases the excretion of drugs with an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood. It should not be administered during the first month of deferoxamine treatment due to increased iron toxicity. High doses of ascorbic acid can lead to an increase in the concentration of ethinyl estradiol in blood plasma in women taking oral contraceptives. Simultaneous use of ascorbic acid and fluphenazine may lead to a decrease in the concentration of fluphenazine in blood plasma.

How to take, course of use and dosage

Inside. Adults – 1 tablet every 4-6 hours, but no more than 6 tablets per day. Children over 12 years of age – 1 tablet every 4-6 hours, but no more than 4 tablets per day. It is recommended to swallow the tablet whole, without chewing, with water. The course of treatment should not exceed 5 days. If there is no relief of symptoms within 3 days after starting the drug, you should consult a doctor. Doses for special categories of patienthepatic insufficiency In patients with impaired liver function or Gilbert’s syndrome, it is necessary to reduce the dose or increase the interval between doses. Renal insufficiency in case of severe renal insufficiency (creatinine clearance Elderly patients For elderly patients, no dose adjustment is required.

Overdose

Symptoms of overdose are mainly due to the presence of paracetamol. In acute overdose, paracetamol can have a hepatotoxic effect and even cause liver necrosis. An overdose of paracetamol, including an overall high dose level after a long period of therapy, can lead to analgesic-induced nephropathy with irreversible liver failure. Patients should be warned not to take other medications containing paracetamol at the same time. There is a risk of poisoning, especially in elderly patients and young children, people with liver disease, in the case of chronic alcoholism, patients with chronic malnutrition and patients receiving inducers of microsomal enzymes. An overdose of paracetamol can lead to liver failure, encephalopathy, coma, and death. Symptoms of paracetamol overdose on the first day include pallor, nausea, vomiting, and anorexia. Abdominal pain can be the first sign of liver damage, and it can appear only 24-48 hours, and sometimes 4-6 days after taking the drug. Most often, signs of liver damage occur 72-96 hours after taking the drug. Glucose metabolism disorders and metabolic acidosis may occur. Acute renal failure and acute necrosis of the renal tubules can develop even in the absence of severe liver damage. There were cases of cardiac arrhythmia and pancreatitis.Overdose can lead to intoxication, especially in elderly patients, children, patients with liver diseases (caused by chronic alcoholism), in patients with nutritional disorders, as well as in patients taking inducers of microsomal liver enzymes, which can develop lightning-fast hepatitis, liver failure, cholestatic hepatitis, cytolytic hepatitis, in the above cases – sometimes with a fatal outcome. The overdose threshold may be lowered in these categories of patients. The clinical picture of acute overdose develops within 24 hours after taking paracetamol. Symptoms of phenylephrine overdose include hemodynamic changes and cardiovascular collapse with respiratory depression, such as drowsiness, which may be followed by agitation (especially in children), visual disturbances, skin rash, nausea, vomiting, persistent headaches, nervousness, dizziness, insomnia, circulatory disorders (thrombocytopenia, agranulocytosis, leukopenia, pancytopenia), coma, convulsions, arterial hypertension and bradycardia. Symptoms of chlorphenamine maleate overdose include drowsiness, respiratory arrest, seizures, anticholinergic effects, dystonic reactions, and cardiovascular collapse, including arrhythmia. In children, overdose symptoms may include impaired coordination, agitation, tremors, behavior changes, hallucinations, seizures, and anticholinergic effects. Symptoms of ascorbic acid overdose: nephrolithiasis, insomnia, irritability, hypoglycemia. Treatment Immediate hospitalization is required to treat an overdose of paracetamol. Determination of the quantitative content of paracetamol in blood plasma before starting treatment as early as possible after an overdose. Laboratory tests of the activity of microsomal liver enzymes should be performed at the beginning of treatment and then every 24 hours. In most cases, the activity of microsomal liver enzymes normalizes within 1-2 weeks. In very severe cases, a liver transplant may be required. use of SH-group donors and glutathione synthesis precursors-methionine and acetylcysteine-is most effective in the first 8 hours. The need for additional therapeutic measures (further use of methionine, intravenous use of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its use. Symptomatic treatment. To treat an overdose of paracetamol, it is necessary to start treatment immediately. During the first 48 hours after overdose, it is advisable to use N-acetylcysteine intravenously or orally as an antidote to paracetamol, gastric lavage and/or oral methionine is possible. It is advisable to use activated carbon and monitor respiration and circulation. In case of seizures, diazepam may be used. Treatment of phenylephrine overdose includes rapid gastric lavage, symptomatic and supportive therapy. The hypertensive effect can be stopped by intravenous use of an alpha-receptor blocker. In case of seizures, diazepam may be used. Treatment of overdose with chlorphenamine maleate includes gastric lavage in case of a massive overdose or stimulation of vomiting. After that, it is possible to prescribe activated charcoal and laxatives to slow down absorption. In case of convulsions, sedation should be performed with intravenous diazepam or phenytoin. In severe cases, hemoperfusion may be performed. Treatment of ascorbic acid overdose is symptomatic, and it may be necessary to perform forced diuresis.

Special instructions

To avoid toxic liver damage, the drug should not be combined with the use of alcoholic beverages. Due to the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor kidney function and blood pressure. With prolonged use of large doses, the function of the pancreatic insular apparatus may be inhibited, so it should be regularly monitored during treatment. In patients with high iron content in the body, ascorbic acid should be used in minimal doses. Prescribing ascorbic acid to patients with rapidly proliferating and intensely metastatic tumors may worsen the course of the process. Ascorbic acid as a reducing agent can distort the results of laboratory tests (blood glucose, bilirubin, activity of “liver” transaminases and LDH). Influence on the ability to drive vehicles and mechanisms:During treatment, it is not recommended to drive a vehicle or other mechanisms that require concentration of attention and a high rate of psychomotor reactions.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Paracetamol, Phenylephrine, Chlorphenamine, [Ascorbic Acid]

Dosage form

Tablets