Coldrex HotRem, 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

Nasal mucous membrane swelling, Pain in joints (arthralgia), Colds, Myalgia (muscle pain), Fever, runny nose (rhinitis), Sore throat, Fever, Sneezing, Flu, Headache, Angina, Pain in muscles (myalgia) To eliminate the symptoms of colds and flu, including.To eliminate symptoms of acute respiratory infections and influenza, including:
– fever;
– headache;
– chills;
– joint and muscle pain;
– stuffy nose;
– sore throat and sinuses.

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, lemon flavoring PHS-163671 100.0 mg, honey flavoring 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.

How to take, the dosage

For oral administration.
Do not exceed the specified dose!

Use the smallest 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 and 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 the drug 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 drugs 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.

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.

Synopsis

Powder for preparation of solution for oral administration (lemon) is crystalline, pale yellow to yellow in color, with a characteristic odor of lemon; prepared solution is yellow in color, with a characteristic odor of lemon.

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

Side effects are classified by organ system and frequency. The frequency of side effects is defined as follows: very common (greater than or equal to 1/10) common (greater than or equal to 1/100 and less than 1/10) infrequent (greater than or equal to 1/1000 and less than 1/100) rare (greater than or equal to 1/10 000 and less than 1/1000) and very rare (greater than or equal to 1/100 000 and less than 1/10 000).

The drug is usually well tolerated at the recommended doses.

Paracetamol rarely has side effects.

Hematopoietic organs: Very rare: thrombocytopenia leukopenia agranulocytosis.

Allergic reactions: Very rare: anaphylactic shock. hypersensitivity reactions including skin rash urticaria angioedema Stevens-Johnson syndrome.

Respiratory system disorders: Very rare: bronchospasm in patients sensitive to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).

Hepatic and biliary tract disorders: Very rare: liver dysfunction. When prolonged use with exceeding the recommended dose, hepatotoxic and nephrotoxic effects may be observed.

Phenylephrine

Nervous system disorders: Often: headache. dizziness insomnia.

Central nervous system disorders: Often: increased excitability. Very rare: irritability nervous tension.

Cardiovascular system: Often: increased blood pressure. Rarely: tachycardia palpitations.

Digestive system disorders: Often: nausea vomiting.

Senses: Rarely: mydriasis acute glaucoma attack in most cases in patients with closed-angle glaucoma.

Skin and subcutaneous tissue disorders: Rare: allergic reactions (skin rash urticaria allergic dermatitis).

Perior urinary system disorders: Rarely: dysuria delayed urination in patients with bladder outlet obstruction with prostatic hypertrophy.

Ascorbic acid

The incidence of side effects has not been established.

Allergic reactions: skin rash skin hyperemia.

Digestive system disorders: irritation of the mucous membranes of the gastrointestinal tract.

Hematopoietic organs: thrombocytosis hyperprothrombinemia erythropenia neutrophilic leukocytosis hypokalemia.

Moderate pollyacuria may occur when taking ascorbic acid more than 600 mg/day.

If side effects occur, stop taking the drug immediately and see a physician as soon as possible.

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Stop taking the medicine and see your doctor immediately if:

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

– a rash or peeling on the skin forming ulcers on the mucosa of the mouth;

– you experience bruising or bleeding;

– you experience loss of vision. This may be due to elevated intraocular pressure. Very rarely, but most likely, this side effect occurs in patients with glaucoma;

You have a palpitations or feel an increase in heart rate or a disturbance in heart rhythm;

You have difficulty urinating. This side effect is more common in patients with prostatic hypertrophy.

Do not take the drug if you have previously had breathing problems while taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs.

Overdose

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