Coldrex HotRem lemon powder, # 5

Symptomatic treatment of colds and flu, accompanied by fever, headache, chills, nasal congestion, sore throat and sinuses.

For oral administration.

Do not exceed the indicated dose!

The smallest dose necessary to achieve the effect should be used!

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

Pour the contents of 1 sachet into a mug, pour hot water, stir until dissolved. Add cold water and sugar if necessary.

Adults (including the elderly) and children over 12 years of age: By mouth, single dose - 1 sachet. Re-use of the drug is possible no earlier than after 4-6 hours and no more than 4 times / day. The maximum daily dose should not exceed 4 sachets. The maximum duration of use of the drug without consulting a doctor should be no more than 5 days.

Do not take with other paracetamol-containing products, decongestants and remedies for the relief of cold and flu symptoms, as well as with ethanol-containing products and drinks.

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

If the recommended dose is exceeded, seek immediate medical attention, even if you feel well. Paracetamol overdose can cause liver and / or kidney failure.

Special patient groups

Patients with impaired renal function:

Before using ColdrexЃ HotRem, patients with impaired renal function should first consult a doctor. The limitations associated with the use of drugs containing such a combination of active substances in patients with impaired renal function are mainly associated with the content of paracetamol in the drug.

Patients with impaired liver function:

Before using ColdrexЃ HotRem, patients with impaired liver function should first consult a doctor. The restrictions associated with the use of drugs containing this combination of active substances in patients with impaired liver function are mainly associated with the content of paracetamol in the drug.

Composition for 1 sachet:

Paracetamol 750

Phenylephrine hydrochloride 10.00

Ascorbic acid coated with ethyl cellulose *. (In terms of ascorbic acid) 61.50 (60.00)

Excipients:

Sucrose 2904.42

Sodium citrate dihydrate 500

Anhydrous citric acid 600

Sodium saccharinate 40.00

Lemon flavor P0551 50.00

Lemon flavor 52293 / TP 0551 83.33

Quinoline yellow dye (E104) 0.75

Note: * - contains 1.5 mg of ethyl cellulose.

• Severe liver dysfunction;

• severe renal dysfunction;

• hyperthyroidism (including thyrotoxicosis);

• diseases of the cardiovascular system (severe aortic stenosis, acute myocardial infarction, tachyarrhythmia);

• arterial hypertension;

• hyperplasia of the prostate;

• angle-closure glaucoma;

• simultaneous administration of tricyclic antidepressants, beta-blockers, MAO inhibitors (including within 14 days after their cancellation), other paracetamol-containing drugs;

• children under 12 years of age (for dosage forms intended for adults);

• hypersensitivity to the components of the combination.

With care

Benign hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, pregnancy, lactation (breastfeeding), obliterating vascular diseases (Raynaud's syndrome), glaucoma (excluding angle-closure glaucoma).

pharmachologic effect

Combined drug.

Paracetamol is an antipyretic analgesic. It has analgesic, antipyretic and weak anti-inflammatory effects. The mechanism of action is associated with inhibition of the synthesis of prostaglandins, a predominant effect on the center of thermoregulation in the hypothalamus.

Phenylephrine is an alpha-1-adrenergic agonist that causes vasoconstriction, eliminates swelling and hyperemia of the nasal mucosa.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, in the synthesis of steroid hormones; increases the body's resistance to infections, reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. Improves the tolerance of paracetamol and lengthens its action (associated with lengthening T1 / 2).

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax in plasma is achieved within 10-60 minutes after ingestion. Distributed in most body tissues. Penetrates through the placental barrier, excreted in breast milk. At therapeutic concentrations, binding to plasma proteins is negligible, but increases with increasing concentration. Undergoes primary metabolism in the liver. It is excreted mainly in the urine in the form of glucuronides and sulfates. T1 / 2 is from 1 to 3 hours.

Phenylephrine is absorbed from the gastrointestinal tract. It is metabolized during the 'first pass' through the intestinal wall and in the liver, therefore, when taken orally, phenylephrine hydrochloride is characterized by limited bioavailability. Cmax in plasma is achieved in the range from 45 minutes to 2 hours. It is excreted by the kidneys almost completely in the form of sulfate compounds. T1 / 2 is 2-3 hours.

Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Plasma protein binding - 25%. It is excreted in the form of metabolites in the urine. Ascorbic acid, taken in excessive amounts, is rapidly excreted unchanged in the urine.

Side effect

From the hematopoietic system: very rarely - thrombocytopenia.

Allergic reactions: rarely - skin rash, urticaria, allergic dermatitis; very rarely - anaphylaxis, hypersensitivity reactions, incl. angioedema, Stevens-Johnson syndrome.

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

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

From the side of the central nervous system: very rarely - dizziness, headache, insomnia.

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

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

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

With prolonged use in excess of the recommended dose, hepatotoxic and nephrotoxic effects can be observed.

Application during pregnancy and lactation

It should be used with caution during pregnancy and during breastfeeding.

Application for violations of liver function

Contraindication - severe liver failure.

Application for impaired renal function

Contraindication - severe renal failure.

special instructions

If symptoms of the disease persist after 5 days of using this drug, you should stop taking it and consult your doctor.

Should not be taken concomitantly with other drugs containing paracetamol, as well as other non-narcotic analgesics (metamizole sodium), NSAIDs (acetylsalicylic acid, ibuprofen), barbiturates, anticonvulsants, rifampicin and chloramphenicol, sympathomimetics (such as decongestants, drugs, amphetamine-like psychostimulants), with other drugs to relieve symptoms of colds and flu.

Influence on the ability to drive vehicles and mechanisms

If dizziness appears on the background of the use of drugs containing this combination, it is not recommended to drive vehicles or work with mechanisms.

Drug interactions

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which makes it possible to develop severe intoxication with small overdoses.

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

Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives - the risk of urinary retention, dry mouth, constipation.

GCS - the risk of developing glaucoma.

Phenylephrine reduces the hypotensive effect of guanethidine.

Guanethidine enhances the alpha-adrenostimulating effect, and tricyclic antidepressants enhance the sympathomimetic effects of phenylephrine.

With the simultaneous use of oral contraceptives, the concentration of ascorbic acid in the blood plasma decreases. It is possible to increase the concentration of ethinyl estradiol in the blood plasma with its simultaneous use as part of oral contraceptives.

When used simultaneously with iron preparations, ascorbic acid, due to its regenerating properties, converts trivalent iron into bivalent, which helps to improve its absorption.

With simultaneous use with warfarin, it is possible to reduce the effects of warfarin.

With the simultaneous use of ascorbic acid increases the excretion of iron in patients receiving deferoxamine.

With simultaneous use with tetracycline, the excretion of ascorbic acid in the urine increases.