Coldrex HotRem, honey and lemon 5 g 5 pcs

Paracetamol is an analgesic and antipyretic. The mechanism of its action is presumably to inhibit the synthesis of prostaglandins, mainly in the central nervous system.

Paracetamol has an extremely small effect on the synthesis of prostaglandins in the peripheral tissues, it does not change the water-electrolyte exchange and does not damage the mucous membrane of the gastrointestinal tract.

Indications

Colds, Nasal mucous membrane swelling, Fever, Runny nose (rhinitis), Sneezing, Sore throat, Flu, Pain in the muscles (myalgia), SARS, Headache, Angina, Increased body temperature, Pain in the joints (arthralgia) For treating the symptoms of colds and flu, including.For treating symptoms of Acute Respiratory Syndrome and Influenza, including:
– fever;
– headache;
– chills;
– joint and muscle pain;
– stuffy nose;
– sore throat and sinuses.

Active ingredient

Paracetamol, phenylephrine, ascorbic acid

Composition

Phenylephrine;

Paracetamol;

Ascorbic acid

How to take, the dosage

Do not exceed the specified dose!

Use the lowest dose necessary to achieve the effect!

The minimum interval between doses of Coldrex® HotRem should be at least 4 hours.

Pour the contents of 1 sachet in a mug, pour hot water, stir until dissolved.

If necessary, add cold water and sugar.

Adults (including elderly) and children over 12 years: Orally, single dose – 1 sachet. Reapplication of the drug is possible not earlier than 4-6 hours and not more than 4 times per day. Maximum daily dose should not exceed 4 sachets. The maximum duration of use without consulting the physician should not exceed 5 days.

Do not take simultaneously with other paracetamol-containing agents, decongestants and agents to relieve symptoms of colds and flu, as well as with ethanol-containing agents and drinks.

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

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 in concurrent use with paracetamol.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic effects.

Paracetamol reduces the effectiveness of diuretics.

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 may lead to increased BP.

Phenylephrine reduces the effectiveness of beta-adrenal blockers and antihypertensive agents, increases the risk of hypertension and cardiovascular disorders.

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

Tricyclic antidepressants increase the sympathomimetic effect of phenylephrine, may increase the risk of cardiovascular side effects.

Concomitant use of halothane with phenylephrine increases the risk of ventricular arrhythmia.

Phenylephrine reduces the hypotensive effect of guanethidine, which in turn increases the alpha-adrenergic stimulating activity of
phenylephrine.

Antidepressants, antiparkinsonics, antipsychotics, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation.

Simultaneous use of GCS with phenylephrine increases the risk of glaucoma.

Concomitant use with digoxin and cardiac glycosides may increase the risk of cardiac arrhythmias or heart attacks.

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 the development of acute pancreatitis.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Directions for use

If you have one of these diseases / conditions / risk factors, before taking the drug, be sure to consult with your doctor:

• Benign hyperbilirubinemia.
• Mild to moderate hepatic and renal dysfunction.
• Alcoholic liver disease.
• Cardiovascular disease, including high blood pressure, obliterating vascular disease (Raynaud’s syndrome).
• Pheochromocytoma.
• Having severe infections, including sepsis, because taking the drug may increase the risk of metabolic acidosis.
• Patients with glutathione deficiency (particularly in extremely malnourished patients with anorexia, chronic alcoholism, or patients with low body mass index).
• Simultaneous use of hypotensive agents.
• Pregnancy and breastfeeding.

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Special Instructions

The patient should be informed that if the symptoms of the disease persist after 5 days of using the drug, you should stop taking it and consult a doctor.
The drug should be taken only in the recommended doses.
The patient should stop taking the drug and immediately consult a physician if the following side effects occur:

• allergic reactions: Itching or redness of the skin, difficulty breathing or swelling of the lips, tongue, throat or face;
• rash or scaling of the skin, ulceration of the oral mucosa;
• bruising or bleeding;
• loss of vision. This may be due to increased intraocular pressure. Very rarely, but most likely, this side effect is seen in patients with glaucoma;
• feeling a strong heartbeat or increased heart rate or heart rhythm disturbances;
• painful urination difficulties. This side effect is more often seen in patients with prostatic hypertrophy.

You should not take the drug if you have previously had respiratory problems while taking acetylsalicylic acid or other NSAIDs.
The drug should not be taken simultaneously with other drugs containing paracetamol, as well as other non-narcotic analgesics (sodium metamizole), NSAIDs (acetylsalicylic acid, ibuprofen), barbiturates, anticonvulsants, Rifampicin and chloramphenicol, sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like psychostimulants), with other drugs for relief of cold and flu symptoms.

During uric acid and blood glucose tests, the patient should inform the physician about the use of Coldrex® HotRem because The drug may distort the results of laboratory tests evaluating glucose and uric acid concentrations.
Before taking Cauldrex® HotRem (lemon) it is necessary to consult a physician in case:

• taking metoclopramide, domperidone (used to eliminate nausea and vomiting) or colestyramine used to reduce blood cholesterol concentrations;
• taking drugs to reduce blood clotting (eg, warfarin);
• adhering to a sodium-reduced diet – each sachet contains 0.
• Severe infectious diseases (including sepsis) in patients with glutathione deficiency, because the risk of metabolic acidosis may increase while taking paracetamol, the signs of which are disturbance of respiratory rate and depth, accompanied by a feeling of shortness of breath (shortness of breath), nausea, vomiting, loss of appetite. If a patient develops these symptoms, he should see a physician immediately.

Patients with phenylketonuria are not recommended to take Coldrex® HotRem (lemon-honey) because it contains aspartame, which is a source of phenylalanine. Before taking Coldrex® HotRem (lemon and honey), it is necessary to consult a physician in the following cases:

• taking warfarin or other indirect anticoagulants;
• taking medications to control BP, such as beta-adrenoblockers;
• taking medications to decrease appetite or psychostimulants;
• taking medications to treat depression (trisomy)taking medications to treat depression (tricyclic antidepressants – amitriptyline);
• taking metoclopramide, domperidone (used to relieve nausea and vomiting) or colestiramine used
• to lower blood cholesterol;
• when a hyponatremic diet is necessary (each sachet contains 0.12 g of sodium).

To avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, as well as taken by persons who use alcohol chronically.
Influence on the ability to drive vehicles and mechanisms
When taken in recommended doses, the drug does not influence the ability to drive vehicles and mechanisms as well as engage in other potentially dangerous activities requiring concentration and rapid psychomotor reactions. If dizziness occurs, it is not recommended to drive vehicles or operate machinery.

Synopsis

Powder for preparation of solution for oral administration (lemon-honey) heterogeneous, from grayish-white with beige color to light brown with white, light brown and dark brown inclusions; prepared solution – from light yellow to light brown color with insoluble inclusions of white and characteristic odor of lemon and honey.

Contraindications

– Severe liver function impairment;
– expressed renal function impairment;
– hyperthyroidism (including thyrotoxicosis);
– diabetes mellitus;
– sugar/isomaltase deficiency, fructose intolerance, glucose/galactose malabsorption syndrome, as the drug contains sucrose;
– cardiac diseases (expressed aortic stenosis, acute myocardial infarction, tachyarrhythmia). The drug contains sucrose;
– heart diseases (expressed aortic stenosis, acute myocardial infarction, tachyarrhythmias);
– arterial hypertension;
– concurrent use of tricyclic antidepressants, beta-adrenoblockers, MAO inhibitors and within 14 days after their withdrawal;
– concomitant use of other paracetamol-containing agents and agents to relieve cold, flu and nasal congestion symptoms;
– benign prostatic hyperplasia;
– closed-angle glaucoma;
– children under 12 years of age;
– hypersensitivity to the preparation components

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Side effects

Definition of the frequency of side effects: very frequently (≥1/10), frequently (≥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).

In the recommended doses, the drug is usually well tolerated.

Paracetamol rarely has side effects.

The blood system: very rarely – thrombocytopenia, leukopenia, agranulocytosis.

Allergic reactions: very rarely – anaphylactic shock, skin rash, urticaria, angioedema, Stevens-Johnson syndrome.

Respiratory system: very rare – bronchospasm in patients who are sensitive to acetylsalicylic acid and other NSAIDs.

Liver and biliary tract: very rarely – liver function disorders.

Hepatotoxic and nephrotoxic effect may be observed if used for a long time in excess of the recommended dose.
Phenylephrine

The nervous system: often – increased excitability, headache, dizziness, insomnia, very rarely – irritability, nervous tension.

The cardiovascular system: often – BP increase, rarely – tachycardia, palpitations.

The digestive system: often – nausea, vomiting.

The sensory system: rare – mydriasis, an acute attack of glaucoma in most cases in patients with closed-angle glaucoma.

Allergic reactions: rare – skin rash, urticaria, allergic dermatitis.

Urinary system: rare – dysuria, urinary retention in patients with bladder outlet obstruction due to prostatic hypertrophy.

Ascorbic acid

Frequency of side effects is not established.

Allergic reactions: skin rash, skin hyperemia.

Digestive system: irritation of the gastrointestinal mucosa.

Blood system: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophil leukocytosis.

Other: hypokalemia.

Ascorbic acid intake over 600 mg/day may cause moderate pollakiuria.

In case of side effects the patient should immediately stop taking the drug and consult a physician as soon as possible.
If any of the above side effects are aggravated, or any other side effects appeared, the patient should inform the physician.

Overdose

In case of overdose of Coldrex® HotRem (even if you feel well), consider the risk of delayed signs of serious liver damage.

Symptoms due to paracetamol: within 24 hours – pale skin, nausea, vomiting, anorexia, abdominal pain; within 12-48 hours there may be signs of liver dysfunction, signs of glucose metabolism disorders and metabolic acidosis. Toxic effect in adults is possible after simultaneous use of more than 10 g of paracetamol – increase in liver transaminases activity, clinical picture of liver damage appears after 1-6 days. In severe poisoning severe liver failure may develop up to hepatic encephalopathy, coma and death. Acute renal failure with acute tubular necrosis, which is diagnosed by severe lumbar pain, hematuria and proteinuria, can also develop without severe hepatic impairment. There are 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 overdose or the degree of risk of internal organ damage.