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

Auxiliary substances: citric acid 600.0 mg, sodium saccharinate 10.0 mg, sodium citrate 500.0 mg, flavoring lemon PHS-163671 100.0 mg, flavoring honey PFW PHS-050860 75.0 mg, honey flavoring Felton F7624P 125 , 0 mg, caramel dye 626 50.0 mg, corn starch 200.0 mg, aspartame 50.0 mg, sucrose 2468.50 mg.

Description:

The contents of the sachet

Heterogeneous powder from greyish-white with a beige shade to light brown with white, light brown and dark brown inclusions.

Solution in hot water

A cloudy solution from light yellow to light brown with insoluble inclusions of white color and a characteristic smell of lemon and honey.

Pharmacotherapeutic group:Remedy for elimination of symptoms of acute respiratory disease and "cold" non-narcotic remedy + alpha-adrenomimetic + vitamin)

ATX: & nbsp

N.02.B.E Anilides

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

Pharmacodynamics:

Combined drug, the effect of which is due to its constituent components: paracetamol has antipyretic, analgesic effect; phenylephrine - sympathomimetic, narrows the vessels of the nasal mucosa and paranasal sinuses, as a result of which edema decreases and nasal breathing is facilitated; ascorbic acid replenishes the increased need for vitamin C for "colds" and flu, especially in the initial stages of the disease.

Does not cause drowsiness and does not disturb concentration.

Indications:

Elimination of the symptoms of "colds" and flu:

increased body temperature,

headache,
chills,
pain in the joints and muscles,
nasal congestion,
pain 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 (including thyrotoxicosis);

- diabetes mellitus and sugarase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (because the preparation contains sucrose);

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

- arterial hypertension;

- simultaneous administration of tricyclic antidepressants, beta-blockers, monoamine oxidase (MAO) inhibitors, including. in the period up to 14 days after their cancellation;

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

- hyperplasia of the prostate;

- angle-closure glaucoma;

- age up to 12 years.

Carefully:With a deficiency of glucose-6-phosphate dehydrogenase, with benign hyperbilirubinemia; with liver or kidney disease; with increased blood pressure, heart disease, obliterating vascular diseases (Raynaud's syndrome), glaucoma (excluding closed-angle glaucoma), pheochromocytoma. 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 about 250 ml of hot water, stir until dissolved. If necessary, add cold water and sugar.

Adults and children over 12 years of age:

Inside, single dose - 1 packet. Repeated use of the drug is possible not earlier than 4-6 hours and no more than 4 times / day. The maximum daily dose should not exceed 4 sachets. The maximum duration of the drug without consulting a doctor is no more than 5 days.

Do not take concomitantly with other paracetamol-containing drugs, decongestants, and agents to relieve the symptoms of "colds" and flu.

If symptoms persist while taking the drug, you should consult a doctor.

DO NOT EXCEED THE SPECIFIED DOSE.

In case of an overdose, even with a good state of health, urgent medical attention is needed. there is a risk of delayed severe liver damage.

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 and less than 1/10 000).

In recommended doses, the drug is usually well tolerated.

Paracetamol rarely has a side effect.

On the part of the organs of hematopoiesis: Very rarely: thrombocytopenia, leukopenia, agranulocytosis.

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

On the part of the respiratory system: Very rarely: bronchospasm in patients sensitive to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).

From the liver and biliary tract: 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 side of the central nervous system: Often: increased excitability. Very rarely: irritability, nervous tension.

From the cardiovascular system: Often: increased blood pressure. Rarely: tachycardia, palpitations.

From the side of the digestive system: Often: nausea, vomiting.

From the sense organs: Rarely: mydriasis, 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 system: irritation of the mucous membrane of the gastrointestinal tract.

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

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

In case of side effects, stop taking the medication immediately 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, tell your doctor.

Stop taking the drug and consult a doctor immediately if:

- You experience allergic reactions: skin itching or redness of the skin, difficulty breathing or swelling of the lips, tongue, throat, or face;

- a rash or scaling on the skin, the formation of sores on the oral mucosa;

- you have bruises or bleeding;

- You experience a loss of vision. This may be a consequence of increased intraocular pressure. Very rarely, but this side effect is most likely in patients with glaucoma;

- You feel a strong palpitation or feel an increase in frequency or a disturbance of the heart rhythm;

- You have trouble urinating. More often this side effect is observed in patients with prostatic hypertrophy.

Do not take the drug if you have had a history of breathing problems with acetylsalicylic acid or non-steroid anti-inflammatory drugs.

Overdose:

PREPARATION SHOULD BE ACCEPTED ONLY IN RECOMMENDED DOSES.

If you suspect an overdose, even if you feel well, stop using the drug and seek medical help immediately. 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 tubular necrosis, 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 alleged overdose, it is advisable to administer 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). Treatment with acetylcysteine can be carried out 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-blockers, such as phentolamine.

Symptoms (due to ascorbic acid): high doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and disorders of the gastrointestinal tract, 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, enhances 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. Paracetamol reduces the effectiveness of uricosuric drugs. Metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol. Paracetamol enhances the effects of MAO inhibitors, sedatives, ethanol.

Phenylephrine when taken with MAO inhibitors can lead to increased blood pressure. Phenylephrine reduces the effectiveness of beta-blockers and other antihypertensive drugs, increases the risk of developing hypertension and cardiovascular disorders. Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine, 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. The simultaneous use of digoxin and other cardiac glycosides increases the risk of cardiac rhythm and heart attack. Simultaneous use of phenylephrine with simpametemic amines can increase the risk of side effects from the cardiovascular system.

Ascorbic acid increases the risk of developing crystalluria in the treatment of short-acting salicylates and sulfonamides, slows the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), and 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 at the same time paratsetamolsoderzhaschimi with other drugs, as well as other non-narcotic analgesics, NSAIDs (metamizol sodium, acetylsalicylic acid, ibuprofen and the like), drugs for relief of symptoms "cold", sympathomimetics such as decongestants, with drugs that regulate appetite, amfetaminpodobnymi stimulants, barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

To avoid toxic damage to the liver, the drug should not be combined with ethanol-containing drugs. 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.

Patients suffering from phenylketonuria, the drug is not recommended, tk. contains aspartame, which is a source of phenylalanine.

Before taking this medication "Koldreks® Hawtrey" need to consult with your doctor if you are taking:

- warfarin or other indirect anticoagulants for the dilution of blood;

- medicines for controlling blood pressure, for example, beta-blockers;

- digoxin or other cardiac glycosides for the treatment of heart failure;

- drugs to reduce appetite or psychostimulants;

- drugs for the treatment of depression (tricyclic antidepressants-amitriptyline);

- metoclopramide, domperidone (used to eliminate nausea and vomiting) or colestramineused to lower blood cholesterol;

- when it is necessary to observe a hyponatrial diet (each packet contains 0.12 g of sodium).

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-honey).

Packaging:

5 grams of powder in a bag of laminate (paper / polyethylene / aluminum foil / polyethylene).

For 3, 5 or 10 bags, along with the instructions for use are placed in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

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

Terms of leave from pharmacies:Without recipe

Registration number:LSR-008004/10

Date of registration:12.08.2010

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: & nbsp11.02.2014

Illustrated instructions

Instructions

Coldrex® Hotem (Coldrex® HotRem)