Coldrex HotRem, menthol and honey lemon 5 g 5 pcs

Paracetamol is an analgesic and antipyretic.

Indications

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

Active ingredient

Paracetamol, phenylephrine, ascorbic acid

Composition

Composition per sachet 5 g:

Active ingredients:

paracetamol 750 mg,

phenylephrine hydrochloride 10 mg,

ascorbic acid 60 mg.

Auxiliary substances:

citric acid 600.0 mg,

sodium saccharinate 10.0 mg,

sodium citrate 500.0 mg, corn starch 200,0 mg,

aspartame 50,0 mg,

sucrose 2468,50 mg.

How to take, the dosage

For oral administration.

Do not exceed the specified dose.

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

Place the contents of one sachet in a mug and pour half a mug of hot water. Stir until dissolved. Add cold water, if necessary, and sugar to taste.
Adults (including elderly) and children over 12 years: single dose – 1 sachet. Repeated use of the drug is possible not earlier than 4-6 hours and no more than 4 times a day. The maximum daily dose should not exceed four bags.

The maximum duration of preparation use without physician’s consultation is five days.

It is not recommended to take the preparation as antipyretic for more than three days without physician’s consultation.

Do not take simultaneously with other paracetamol-containing agents, decongestants and agents for relief of symptoms of “colds” and flu, as well as with ethanol-containing agents and drinks.

If while taking the drug the symptoms of the disease persist, it is necessary to consult a physician.

When exceeding the recommended dose of the drug you should immediately seek medical attention, even if you feel well. Paracetamol overdose may cause liver failure.

Before using Coldrex® HotRem Menthol and Honey Lemon, patients with impaired renal function should consult a physician in advance.

Limitations associated with the use of drugs containing this combination of active ingredients in patients with impaired renal function are primarily associated with the content of paracetamol in the drug.

Before using Coldrex® HotRem Menthol and Honey Lemon, patients with impaired liver function should consult with their physician in advance.

Limitations associated with the use of drugs containing this combination of active ingredients in patients with impaired liver function are mainly related to the content of paracetamol in the drug.

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 administration of a single dose of the drug has no significant effect on the effect of indirect anticoagulants.

Inducers of enzymes of microsomal oxidation in the liver (barbiturates, diphenine, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxic effect in overdose and concomitant use with paracetamol. Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects.

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

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

Paracetamol increases 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-adrenoblockers and other hypotensive drugs, increases the risk of hypertension and cardiovascular disorders.

Tricyclic antidepressants increase the sympathomimetic effect of phenylephrine, simultaneous use of halothane with phenylephrine increases the risk of ventricular arrhythmia. Phenylephrine reduces the hypotensive effect of guanethidine that, in turn, increases the alpha-adrenergic stimulating activity of phenylephrine.

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

Concomitant use of digoxin and other cardiac glycosides increases the risk of cardiac arrhythmias and heart attacks.

Concomitant use of phenylephrine with sympathomimetic amines may increase the risk of cardiovascular side effects.

Ascorbic acid increases the risk of crystalluria during treatment with salicylates and sulfonamides of short action, slows renal excretion of acids, increases excretion of drugs with alkaline reactions (including alkaloids.

Ethanol promotes acute pancreatitis.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special Instructions

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

Synopsis

Powder for preparation of oral solution from almost white to light brown in color, loose, heterogeneous, with a smell of honey, lemon and menthol;

Contraindications

– Hypersensitivity to any component of the drug;

– expressed liver and kidney function abnormalities;

– hyperthyroidism (including thyrotoxicosis;

– diabetes mellitus, sugar and isomaltase deficiency, fructose intolerance, glycosinosis.

– hyperthyroidism (including thyrotoxicosis);

– diabetes mellitus and sugar/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (because the drug contains sucrose). The drug contains sucrose);

– heart diseases (expressed aortic stenosis, acute myocardial infarction, tachyarrhythmia);

– Arterial hypertension;

– Simultaneous use of tricyclic antidepressants, beta-adrenoblockers, monoamine oxidase inhibitors (MAOIs), including but not limited to.ч. up to 14 days after their withdrawal;

– concomitant use of other paracetamol-containing drugs and medicines to relieve symptoms of “colds”, flu and nasal congestion;
prostatic hyperplasia;

– closed-angle glaucoma;

– age under 12 years old.

With caution:

– in glucose-6-phosphate dehydrogenase deficiency, in benign hyperbilirubinemia; in liver or kidney disease;

– In case of increased arterial pressure, heart diseases, obliterating vascular diseases (Raynaud’s syndrome), glaucoma (except for closed-angle glaucoma), pheochromocytoma.

If you have one of these diseases, before taking the drug you should consult with your doctor.

Side effects

The drug is usually well tolerated in the recommended doses. The following adverse reactions were detected spontaneously during post-registration use of the drug.

Adverse reactions are classified by body systems and according to the frequency of development. Definition of frequency of adverse effects: very common (≥1/10), common (≥1/100 and < 1/10), infrequent (≥1/1000 and < 1/100), rare (≥1/10 000 and < 1/1000), very rare (≥1/100 000 and < 1/10 000), frequency unknown (frequency cannot be estimated based on available data).

Paracetamol

Paracetamol rarely has side effects.

Blood and lymphatic system: very rarely – thrombocytopenia, leukopenia, agranulocytosis.

From the immune system: very rare – anaphylactic shock, skin hypersensitivity reactions, including skin rash, urticaria, angioedema (Quincke’s edema), Stevens-Johnson syndrome; frequency unknown – toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis.

As for the respiratory system: very rare – bronchospasm in patients with hypersensitivity to acetylsalicylic acid and intolerance to other NSAIDs.

Hepatic and biliary tract disorders:very rarely – liver function disorders; frequency is unknown – increased liver enzymes activity.

Urinary system disorders: prolonged use of the drug in doses higher than recommended increases the likelihood of nephrotoxic effect.

Phenylephrine

Nervous system disorders: very rarely – nervousness, irritability, headache, dizziness, insomnia.

From the cardiovascular system: very rarely – increased BP, tachycardia, palpitations.

Digestive system side: very rare – nausea, vomiting.

Visual organ:very rare – mydriasis, acute glaucoma attack in most cases in patients with closed-angle glaucoma.

immune system: very rarely – allergic reactions (skin rash, urticaria, allergic dermatitis). Hypersensitivity reactions, including cross-sensitivity reactions to other sympathomimetics: very rare – dysuria, urinary retention in patients with bladder outlet obstruction in prostatic hypertrophy.

If any of the listed adverse reactions occurs, the patient should immediately stop taking the drug and consult a physician as soon as possible.

If any of the above adverse reactions worsen, or if the patient noticed other adverse reactions, he should inform the physician.

Overdose

If an overdose is suspected, even if you feel well, discontinue use and seek medical advice immediately.

Symptoms (caused by paracetamol): For 24 hours: pale skin, decreased appetite, nausea, vomiting, abdominal pain. After 12-48 hours, signs of liver dysfunction may appear. There may be signs of impaired glucose metabolism and metabolic acidosis. Toxic effect in adults is possible after a single dose of more than 10 g of paracetamol: increase in “hepatic” transaminases activity, clinical manifestation of liver damage occurs 1-6 days later.

In severe poisoning severe hepatic failure may develop up to 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, may develop without severe liver function impairment. There have been reports of cases of cardiac arrhythmias and pancreatitis in paracetamol overdose.

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

Treatment:In the first hour after a suspected overdose, oral administration of activated charcoal is appropriate. Four or more hours after a suspected overdose, plasma paracetamol concentrations should be determined (earlier determination of paracetamol concentrations may not be reliable). Treatment with acetylcysteine can be carried out up to 24 hours after paracetamol administration, but the maximum hepatoprotective effect can be obtained in the first 8 hours after overdose.

After that, the effectiveness of the antidote drops dramatically. If necessary, acetylcysteine may be administered intravenously. In the absence of vomiting, oral administration of methionine is an alternative (in the absence of rapid inpatient care).

Treatment of patients with severe liver function impairment 24 hours after paracetamol administration should be done in conjunction with specialists from a toxicology center or a specialized liver disease unit.

Symptoms (due to phenylephrine): irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased agitation, reflex bradycardia. In severe cases of overdose, hallucinations, confusion, seizures, arrhythmia may develop. Phenylephrine overdose may cause symptoms similar to side effects (see section “Side effects”).

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

Symptoms (caused by ascorbic acid):High doses of ascorbic acid (over 3000 mg) may cause temporary osmotic diarrhea and gastrointestinal disturbances such as nausea, stomach discomfort. Manifestations of overdose may be classified as those caused by severe liver damage, as a result of paracetamol overdose.

treatment:symptomatic, forced diuresis.