Coldrex HotRem menthol and honey lemon sachets 5 g 5 pc. (Paracetamol, phenylephrine, ascorbic acid)

Release form

For 6 g of powder in bags of paper / PE / Al. / EMAA (copolymer of ethylene and methacrylic acid).

5 sachets each along with instructions for use in a cardboard box.

Pharmacological action

Combined drug whose action is due to its constituent components.

Paracetamol is an analgesic and antipyretic.

The mechanism of its action presumably consists in suppressing the synthesis of prostaglandins, mainly in the central nervous system. Does not affect platelet function and hemostasis.

Paracetamol has virtually no effect on the synthesis of prostaglandins in peripheral tissues, it does not alter water-electrolyte metabolism and does not damage the gastrointestinal mucosa.

Phenylephrine hydrochloride is a sympathomimetic drug whose action is aimed at stimulating adrenoreceptors (mainly -adrenoreceptors), which leads to a decrease in swelling of the nasal mucosa and facilitate nasal breathing.

Ascorbic acid (vitamin C) makes up for the increased need for vitamin C for colds and flu, especially in the initial stages of the disease.

The components included in the preparation do not cause drowsiness or disturb attention span.

Indications

In adults (including elderly patients) and children over 12 years of age to eliminate the symptoms of colds and flu, including:

fever headache chills joint and muscle pain sinus pain nasal congestion sore throat.

Contraindications

Hypersensitivity to any component of the

preparation severe liver and kidney dysfunctions

hyperthyroidism (including thyrotoxicosis)

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

heart disease (severe stenosis of the aortic orifice, acute myocardial infarction, tachyarrhythmias)

arterial hypertension

concomitant use of tricyclic antidepressants, beta-blockers, monoamine inhibitors (monoamine). h up to 14 days after their cancellation of

, concomitant use of other paracetamol-containing medicines and medicines to relieve symptoms of the common cold, flu and nasal congestion

prostatic hyperplasia

angle-closure glaucoma

age up to 12 years.

Caution: for deficiency of glucose-6-phosphate dehydrogenase, for benign hyperbilirubinemia in diseases of the liver or kidneys

with increased blood pressure, heart disease, obliterating vascular diseases (Raynaud's syndrome), glaucoma (excluding angle-closure glaucoma), pheochromocytoma. If you have one of these diseases, be sure to consult your doctor before taking the drug.

Use during pregnancy and lactation

Caution is advised to use the drug during pregnancy and during breastfeeding.

Pregnancy

The drug should not be used during pregnancy without first consulting a doctor.

In experimental animal studies and in clinical studies in humans, there was no risk of paracetamol during pregnancy or adverse effects on fetal development.

There are no sufficient data on the effect of drugs containing phenylephrine on pregnancy.

Breastfeeding period

The drug should not be used during breastfeeding without first consulting a doctor.

Paracetamol crosses the placental barrier, excreted in breast milk. In clinical studies in humans, no adverse effects on the baby’s body were detected during breastfeeding.

Phenylephrine may be excreted in breast milk.

Special instructions

The drug should not be taken simultaneously with other paracetamol-containing drugs, as well as other non-narcotic analgesics, NSAIDs (metamizole sodium, acetylsalicylic acid, ibuprofen, etc.), drugs to eliminate the symptoms of the common cold, such as sympathomimetics, , with appetite-regulating drugs, amphetamine-like psychostimulants, barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

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

When testing for uric acid and blood glucose, inform your doctor about the use of Coldrex HotRem, as the drug may distort the results of laboratory tests that measure glucose and uric acid.

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

Before taking Coldrex HotRem, you should consult your doctor if you are taking:

warfarin or other indirect anticoagulants for blood thinning

medicines to control 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 reduce and eliminate)

blood cholesterol if necessary, follow hyponatrium diet (each bag contains 0.12 g of sodium).

Influence on the ability to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions:

Does not (when taken in recommended doses). When dizziness occurs, it is not recommended to drive vehicles or work with mechanisms.

Composition

Composition per sachet 5 g:

Active ingredients:

paracetamol 750 mg,

phenylephrine hydrochloride 10 mg and ascorbic acid 60 mg.

Excipients:

citric acid 600.0 mg,

sodium saccharin 10.0 mg,

sodium citrate 500.0 mg,

lemon flavor PHS-163671 100.0 mg,

honey flavor PFW PHS-050860 75.0 mg ,

honey flavor Felton F7624P 125.0 mg,

dye caramel 626 50.0 mg,

corn starch 200.0 mg,

aspartame 50.0 mg,

sucrose 2468.50 mg.

Dosage and administration

For oral administration.

Do not exceed the indicated dose.

Use the lowest dose necessary to achieve an effect.

The minimum interval between doses of Coldrex® HotRem Menthol and honey lemon should be 4 hours.

Put the contents of one sachet into a mug and pour half a mug of hot water. Stir until dissolved. Add cold water, if necessary, and sugar to taste.

Adults (including seniors) and children over 12 years of age: single dose - 1 sachet. Repeated use of the drug is possible no 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.

It is not recommended to take the drug as an antipyretic for more than 3 days without consulting a doctor.

Do not take concomitantly with other paracetamol-containing agents, decongestants, and cold and flu-relieving agents, as well as ethanol-containing agents and drinks.

If symptoms of the disease persist while taking the drug, consult a doctor.

If you exceed the recommended dose of the drug, you should immediately seek medical help, even if you feel good. An overdose of paracetamol can cause liver failure.

Before using Coldrex® HotRem Menthol and honey lemon, patients with impaired renal function should first consult a doctor. Limitations associated with the use of drugs containing this combination of active substances in patients with impaired renal function are mainly associated with the content of paracetamol in the drug.

Before using Coldrex® HotRem Menthol and honey lemon, patients with impaired liver function should first consult a doctor. Limitations associated with the use of drugs containing this combination of active substances, in patients with impaired liver function, they are mainly associated with the content of paracetamol in the drug.

Side effects of

At recommended doses, the drug is usually well tolerated.

The following adverse reactions were identified spontaneously during post-registration use of the drug.

Adverse reactions are classified according to body systems and according to the frequency of development. Determination of the frequency of side effects: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and < 1/1000), very rarely (? 1/100 000 and <1/10 000), the frequency is unknown (the frequency cannot be estimated from the available data).

Paracetamol

Paracetamol rarely has a side effect.

From the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, agranulocytosis.

On the part of the immune system: very rarely - anaphylactic shock, skin hypersensitivity reactions, including skin rash, urticaria, angioedema (Quincke's edema), Stevens-Johnson syndrome, frequency unknown - toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis.

From the respiratory system: very rarely - bronchospasm in patients with hypersensitivity to acetylsalicylic acid and intolerance to other NSAIDs.

From the liver and biliary tract: very rarely - impaired liver function, frequency is unknown - increased activity of liver enzymes.

From the urinary system: with prolonged use of the drug in doses exceeding the recommended dose, the likelihood of nephrotoxicity increases.

Phenylephrine

From the nervous system: very rarely - nervousness, irritability, headache, dizziness, insomnia.

From the cardiovascular system: very rarely - increased blood pressure, tachycardia, palpitations.

From the digestive system: very rarely - nausea, vomiting.

From the side of the organ of vision: very rarely - mydriasis, an acute attack of glaucoma in most cases in patients with angle-closure glaucoma.

From the side of the immune system: very rarely - allergic reactions (skin rash, urticaria, allergic dermatitis). Hypersensitivity reactions, including cross-sensitivity reactions to other sympathomimetics.

From the urinary system: very rarely - dysuria, urinary retention in patients with obstruction of the outlet of the bladder with prostatic hypertrophy.

If any of the following adverse reactions occur, the patient should immediately stop taking the drug and consult a doctor as soon as possible.

If any of the above adverse reactions are exacerbated, or the patient has noticed other adverse reactions, he should inform the doctor.

Drug interactions

Paracetamol when taken for a long time enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Occasional administration of a single dose of the drug does not significantly affect 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 case of overdose and concomitant use.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxicity.

Paracetamol reduces the effectiveness of diuretic drugs. Paracetamol reduces the effectiveness of uricosuric drugs.

Metoclopramide and domperidone increase, and colestyramine decreases the rate of absorption of paracetamol.

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

Phenylephrine when taken with MAO inhibitors can lead to high blood pressure. Phenylephrine reduces the effectiveness of beta-blockers and other antihypertensive drugs, increases the risk of hypertension and disorders of the cardiovascular system. 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, antiparkinsonian drugs, antipsychotics, phenothiazine derivatives increase the risk of urinary retention, dry mouth, and constipation.

Concomitant use of glucocorticosteroids with phenylephrine increases the risk of developing glaucoma.

The simultaneous use of digoxin and other cardiac glycosides increases the risk of heart rhythm disturbance and heart attack.

The simultaneous use of phenylephrine with sympamimetic amines may increase the risk of side effects from the cardiovascular system.

Ascorbic acid increases the risk of crystalluria in the treatment of short-acting salicylates and sulfanilamides, slows the excretion of acid by the kidneys, increases the excretion of drugs with an alkaline reaction (including alkaloids), and reduces the concentration of oral contraceptives in the blood.

Ethanol contributes to the development of acute pancreatitis.

Myelotoxic drugs increase the hematotoxicity of the drug.

overdose

The drug should be taken ONLY at the recommended doses.

In case of suspected overdose, even with good health, it is necessary to discontinue use of the drug and seek immediate medical attention, as. there is a risk of delayed serious liver damage.

Symptoms (caused by paracetamol): within 24 hours: pale skin, decreased appetite, nausea, vomiting, abdominal pain. After 12-48 hours, signs of impaired liver function may manifest. There may be signs of impaired glucose metabolism and metabolic acidosis. Toxic effect in adults is possible after a single ingestion of more than 10 g of paracetamol: increased activity of "hepatic" transaminases, the clinical picture of liver damage manifests itself in 1-6 days.

In the case of severe poisoning, severe hepatic failure may develop up to hepatic encephalopathy, coma and death. Acute renal failure with acute tubal necrosis, which is diagnosed by severe lumbar pain, hematuria and proteinuria, can develop without severe liver dysfunction. There have been reports of cardiac arrhythmias and pancreatitis with an overdose of paracetamol.

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

Treatment: In the first hour after the presumed overdose, it is advisable to administer activated charcoal inside. Four or more hours after the presumed overdose, a determination of plasma acetaminophen is required (earlier determination of acetaminophen may be unreliable).

Acetylcysteine ​​treatment can be given up to 24 hours after taking acetaminophen, but the maximum hepatoprotective effect can be obtained within the first 8 hours after overdose.

After that, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine ​​may be given intravenously. In the absence of vomiting, an alternative option (in the absence of rapid inpatient care) is the appointment of methionine inside.

Treatment of patients with severe hepatic impairment 24 hours after taking acetaminophen should be performed in conjunction with a specialist at the toxicology center or specialist liver disease department.

Symptoms (caused by phenylephrine): irritability, headache, dizziness, insomnia, high blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose development of hallucinations, confusion, convulsions, arrhythmias is possible.

An overdose with phenylephrine may cause side effects similar to that seen (see "Side effects" section).

Treatment: symptomatic therapy with severe hypertension using alpha-blockers such as phentolamine.

Symptoms (caused by 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, stomach discomfort.

Manifestations of overdose can be categorized as those caused by severe liver damage as a result of paracetamol overdose.

Treatment: symptomatic, forced diuresis.

Storage conditions

Do not store above 25 ° C.

Keep out of the reach and sight of children!

Shelf life

2 years.

Deystvuyushtee substance

paracetamol Fenilэfrin, Askorbinovaya Chisloth

Terms and conditions

without prescription



oral solution



Coldrex HotRem menthol and honey lemon sachets 5 g 5 pc. (Paracetamol, phenylephrine, ascorbic acid) florida in pharmacy online. Cheap price, instruction, side effects, dosage. Coldrex HotRem menthol and honey lemon sachets 5 g 5 pc. - Sale. PayPal accept. Free shipping florida. Fast international shipping.