Coldrex HotRem - instructions for use, dose, side effects, contraindications

Active substances: paracetamol 750 mg, phenylephrine hydrochloride 10 mg, ascorbic acid (coated with ethyl cellulose) 60 mg; Excipients: citric acid, anhydrous - 600 mg, sodium saccharinate - 40 mg, sodium citrate - 500 mg, sucrose - 2714.9 mg, flavoring Tutti-Frutti AP05.51 - 166.7 mg, crimson flavoring AP05.52 - 66.7 mg , black currant flavoring AR05.51 - 66.7 mg, food coloring Rojo Conacert M659 (dye azorubin (E122), dye sunset yellow (E110) and dye black PN Extra (E151) - 15 mg.

Description:

Crystalline powder from pale yellow to yellow with a characteristic smell of lemon. The contents of one sachet are dissolved in 200 ml of hot water to form a solution of yellow color with a characteristic smell of lemon.

Crystalline powder of violet color with a characteristic smell of black currant. The contents of one sachet are dissolved in 200 ml of hot water to form a solution of violet color with a characteristic smell of black currant.

Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic agent + alpha-adrenomimetic + vitamin)

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.51 Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:The drug "Coldrex"® HotRem "is a combined preparation. Paracetamol has analgesic and antipyretic effect. Phenylephrine vasoconstrictor, relieves nasal congestion (narrows the vessels of the nasal mucosa and paranasal sinuses) and facilitates breathing. Ascorbic acid (vitamin C) replenishes the increased demand for vitamin C at colds and flu. Active substances of the preparation "Coldrex® HotRem" do not cause drowsiness.

Pharmacokinetics:

Paracetamol is quickly and almost completely absorbed from the gastrointestinal tract, distribution in body fluids is relatively even. Metabolized mainly in the liver with the formation of several metabolites. The half-life with a therapeutic dose is 2-3 hours.

The majority of the drug is excreted after conjugation in the liver.In unchanged form, not more than 3% of the received dose of paracetamol is released.

Phenylephrine is poorly absorbed from the gastrointestinal tract and is metabolized by the "primary passage" in the intestine and liver under the action of monoamine oxidase. When taking phenylephrine inside the bioavailability of the drug is limited. It is excreted almost completely in the form of a sulfuric acid conjugate. Ascorbic acid well absorbed from the gastrointestinal tract, bond with plasma proteins 25%, distribution in the tissues of the body is wide. Metabolized in the liver, excreted in the urine in the form of oxalate and unchanged. Ascorbic acid, taken in excessive amounts, is quickly excreted unchanged in the urine.

Indications:

Elimination of the symptoms of "colds" and flu:

-increased temperature,

-headache,

- chills,

- pain in the joints and muscles,

nasal congestion,

boli in the sinuses of the nose and in the throat.

Contraindications:

- hypersensitivity to any component of the drug;

- marked violations of the liver and kidneys;

- hyperthyroidism (thyrotoxicosis);

- diabetes mellitus and hereditary violations of sugar absorption (contains sugar);

- heart disease (pronounced stenosis of the aortic aorta, acute myocardial infarction, tachyarrhythmia);

- arterial hypertension;

- reception of tricyclic antidepressants, beta-adrenoblockers, MAO inhibitors, incl. in the period up to 14 days after cancellation;

- taking other paracetamol-containing drugs and drugs to relieve the symptoms of "colds", flu and nasal congestion;

- prostate adenoma;

- an angle-closure glaucoma;

- age up to 12 years;

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption, t. the composition of the drug includes sucrose.

Carefully:In the genetic absence of glucose-6-phosphate dehydrogenase, benign hyperbilirubinemia, pheochromocytoma, vasospastic diseases (Raynaud's syndrome), diseases of the cardiovascular system, simultaneous reception with other antihypertensive drugs.

If you have any of these diseases, consult a doctor before taking the drug.

Pregnancy and lactation:With caution and only after consulting a doctor. Phenylephrine can penetrate into breast milk.

Dosing and Administration:The contents of 1 sachet pour into a mug, pour hot water, stir until dissolved. If necessary, add cold water and sugar. Inside.

Adults: one sachet every 4-6 hours. Do not take more than 4 sachets in 24 hours. Do not take the drug more than 4 hours later.

Children over 12 years: one sachet every 6 hours. Do not take more than 3 sachets in 24 hours.

Do not give the drug to children under 12 without a doctor's prescription.

It is not recommended to use more than 5 days without consulting a doctor. If symptoms persist, consult a physician.

DO NOT EXCEED THE INDICATED DOSE.

Side effects:Side effects

are classified according to organ systems and frequency. The frequency of side effects is defined as follows: very often (greater than or equal to 1/10), often (greater than or equal to 1/100 and less than 1/10), infrequently (greater than or equal to 1/1000 and less than 1/100), rarely greater than or equal to 1/10 000 and less than 1/1000) and very rarely (greater than or equal to 1/100 000 or less 1/10 000).

In recommended doses, the drug is usually well tolerated.

Paracetamol rarely has a side effect.

From the hematopoiesis:

Very rarely: thrombocytopenia, leukopenia, agranulocytosis.

Allergic reactions:

Very rarely: anaphylactic shock, hypersensitivity reactions including skin rash, hives, angioedema, Stevens-Johnson syndrome.

From the respiratory system:

Very rarely: bronchospasm in patients susceptible to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).

From the liver and bile ducts:

Very rarely: a violation of the liver.

With prolonged use with excess of the recommended dose, hepatotoxic and nephrotoxic effects can be observed.

Phenylephrine

From the nervous system:

Often: headache, dizziness, insomnia.

From the central nervous system:

Often: increased excitability.

From the cardiovascular system:

Often: increased blood pressure.

Rarely: tachycardia, palpitation.

From the digestive system:

Often: nausea, vomiting.

From the sense organs:

Rarely: mydriasis, an acute attack of glaucoma in most cases in patients with closed-angle glaucoma.

From the skin and subcutaneous tissues:

Rarely: allergic reactions (skin rash, hives, allergic dermatitis).

From the urinary system:

Rarely: dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy.

Ascorbic acid

The incidence of side effects has not been established.

Allergic reactions: skin rash, skin hyperemia.

From the digestive side system: irritation of the mucous membrane of the gastrointestinal tract.

From the hematopoiesis: thrombocytosis, hyperprotrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.

When taking ascorbic acid more than 600 mg / day, moderate pollakiuria is possible.

In case of side effects immediately stop taking the medication and consult a doctor as soon as possible.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:PREPARATION NEXT ACCEPT ONLY IN RECOMMENDED DOSES.

If you suspect an overdose, even with a good state of health, It is necessary to stop the use of the drug and immediately seek medical help, tk.there is a risk of delayed severe liver damage.

Symptoms (due to paracetamol): within 24 hours: pallor of the skin, decreased appetite, nausea, vomiting, abdominal pain. After 12-48 hours, signs of impaired liver function may appear. There may be signs of impaired glucose metabolism and metabolic acidosis. Toxic effect in adults is possible after one-stage administration of more than 10 g of paracetamol: an increase in the activity of "liver" transaminases, a clinical picture of liver damage manifests itself after 1-6 days. In case of severe poisoning, severe hepatic insufficiency may develop, including hepatic encephalopathy, coma, and death. Acute renal failure with acute necrosis tubules, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without a serious impairment of liver function. There are reports of cardiac arrhythmias and pancreatitis in case of an overdose of paracetamol.

In the early period, the symptomatology can be limited only by nausea and vomiting and may not reflect the severity of the overdose or the risk of injury to the internal organs.

Treatment: During the first hour after the proposed overdose, it is advisable to assign the activated carbon inside. Four or more hours after the alleged overdose, a determination of the paracetamol concentration in the plasma is required (an earlier determination of the paracetamol concentration may be unreliable). Specific antidote for paracetamol poisoning acetylcysteine. Treatment acetylcysteine can be performed up to 24 hours after taking paracetamol, but the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After that, the effectiveness of the antidote drops sharply. If necessary acetylcysteine can be administered intravenously. In the absence of vomiting an alternative option (in the absence of the possibility of rapid receipt of inpatient care) is the appointment of methionine inside. Treatment of patients with severe impairment of liver function 24 hours after taking paracetamol should be done in conjunction with specialists from the toxicology center or specialized department of liver diseases.

Symptoms (due to phenylephrine): irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, it is possible to develop hallucinations, confusion, convulsions, arrhythmias. Overdose of phenylephrine can cause symptoms similar to side effects (see section "Side effects").

Treatment: symptomatic therapy, with severe arterial hypertension, the use of alpha-adrenoblockers, such as phentolamine.

Symptoms (due to ascorbic acid): high doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances, such as nausea, discomfort in the stomach. Manifestations of an overdose can be categorized as those caused by severe liver damage, as a result of an overdose of paracetamol.

Treatment: symptomatic, forced diuresis.

Interaction:

Paracetamol when taken for a long time increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding.Episodic intake of a single dose of the drug has no significant effect on the effect of indirect anticoagulants.

Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdoses and simultaneous administration with paracetamol.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects. Paracetamol reduces the effectiveness of diuretic drugs.

Metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol.

Paracetamol increases the effects of MAO inhibitors, sedatives, ethanol.

Phenylephrine when taken with MAO inhibitors may lead to an increase in blood pressure.

Phenylephrine reduces the effectiveness of beta-adrenoblockers and other antihypertensive drugs, increases the risk of developing hypertension and cardiovascular disorders. Simultaneous use of phenylephrine with sympathomimetic amines can increase the risk of side effects from the cardiovascular system.Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine, may increase the risk of developing side effects of the cardiovascular system.

The simultaneous use of halothane with phenylephrine increases the risk of ventricular arrhythmia. Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenostimulating activity of phenylephrine.

Antidepressants, antiparkinsonics, antipsychotics, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation. Simultaneous use of glucocorticosteroids with phenylephrine increases the risk of developing glaucoma.

When used simultaneously with digoxin and cardiac glycosides, there may be an increased risk of heart rhythm disturbances or heart attack.

Ascorbic acid increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood.

Ethanol promotes the development of acute pancreatitis. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:The drug should not be taken concurrently with other paracetamol-containing drugs, as well as other non-narcotic analgesics, NSAIDsmetamizol sodium, acetylsalicylic acid, ibuprofen , etc.), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol, sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like psychostimulants), with other agents to relieve the symptoms of "colds" and flu.

When performing tests for the determination of uric acid and blood glucose level, tell your doctor about the use of the drug "Coldrex® HotRem", as the drug may distort the results of laboratory tests assessing the concentration of glucose and uric acid.

Before taking the drug "Coldrex® HotRem", you should consult a doctor in the following cases:

- reception of metoclopramide, domperidone (used to eliminate nausea and vomiting) or colestyramine, used to lower the concentration of cholesterol in the blood;

- taking medications to reduce blood clotting (for example, warfarin);

- Compliance with a diet with a lower sodium content - each packet contains 0.12 g of sodium.

TO AVOID THE TOXIC DAMAGE OF THE LIVER PARACETAMOL DO NOT COMBINE WITH THE RECEPTION OF ALCOHOLIC BEVERAGES, AND ALSO TAKE PERSONS, CHRONICALLY

CONSUMER ALCOHOL.

Effect on the ability to drive transp. cf. and fur:Does not render (at reception in recommended doses). When dizziness occurs, it is not recommended to drive vehicles or operate machinery.

Form release / dosage:Powder for solution for oral administration (lemon, blackcurrant).

Packaging:5 grams in bags of laminate (FFP). By 3, 5 or 10 bags together with instructions for use placed in a cardboard box.

Storage conditions:In a place inaccessible to children at a temperature of no higher than 25 ° C.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N016305 / 01

Date of registration:06.05.2010

The owner of the registration certificate: GlaxoSmithClean Consumer Helscher GlaxoSmithClean Consumer Helscher United Kingdom

Manufacturer: & nbsp

SmithKline Beecham, S.A. Spain

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp27.09.2015

Illustrated instructions

Instructions

Coldrex® HotRem (Coldrex® HotRem)