Coldrex MaxGripp Lemon Powder, No. 5

Coldrex-MaxGripp is used in adults as a remedy for cold and flu symptoms, including:

• elevated temperature;

• headache;

• chills;

• joint and muscle pain;

• sinus pain and nasal congestion;

• sore throat.

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 Coldrex 'MaxFlu 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: Inside, 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 is no more than 5 days.

Do not take at the same time with other paracetamol-containing products, dekongestants 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 failure.

Special patient groups

Patients with impaired renal function:

Before using Coldrex 'MaxGripp, 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 the drug Coldreksk MaxGripp, 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.

Active ingredient:
paracetamol 1000 mg, phenylephrine hydrochloride 10 mg, ascorbic acid 40 mg
Excipients: sucrose - 3725 mg, citric acid - 680 mg, sodium citrate - 430 mg, corn starch - 200 mg, lemon flavoring - 200 mg, sodium cyclamate - 79 mg, sodium saccharinate - 54 mg, dye curcumin (E100) - 7 mg, colloidal silicon dioxide - 2 mg. '

The drug Coldreksk MaxFlu is not recommended for patients with:

Х hypersensitivity to paracetamol, phenylephrine, ascorbic acid (vitamin C) or any other component of the drug;

Х severe liver and kidney dysfunctions;

Х arterial hypertension;

Х hyperfunction of the thyroid gland (including thyrotoxicosis);

Х diseases of the blood system;

Х heart disease (with severe aortic stenosis, acute myocardial infarction, tachyarrhythmias);

Х hyperplasia of the prostate gland;

Х diabetes mellitus and diseases associated with hereditary malabsorption of sugar - each packet contains about 4 g of sugar;

Х genetic absence of glucose-6-phosphate dehydrogenase;

Х deficiency of sucrase / isomaltase, with fructose intolerance, glucose-galactose malabsorption, because the preparation contains sucrose;

Х angle-closure glaucoma;

Х diseases accompanied by portal hypertension;

Х concurrent use of tricyclic antidepressants, beta-blockers, MAO inhibitors, including in the period up to 14 days after their cancellation;

Х concomitant use of other paracetamol-containing drugs, decongensants, non-narcotic analgesics, non-steroidal anti-inflammatory drugs, drugs to relieve the symptoms of a cold, flu and nasal congestion, drugs that regulate appetite, amphetamine-like psychostimulants, barbiturates, antiepileptic drugs see the section 'Interaction with other medicinal products');

Х simultaneous intake of ethanol-containing drinks and medications;

Х chronic alcoholism;

Х under the age of 18;

Х pregnancy and during breastfeeding.

CAREFULLY

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

Х Benign hyperbilirubinemia.

Х Dysfunction of the liver and kidneys of mild to moderate severity.

Х Acute hepatitis.

Х Alcoholic liver disease.

Х Difficulty urinating.

Х Pyloroduodenal obstruction.

Х Stenosing ulcer of the stomach and / or duodenum.

Х Bronchial asthma.

Х Cardiovascular diseases, including high blood pressure, obliterating vascular disease (Raynaud's syndrome).

Х Pheochromocytoma.

Х The presence of severe infections, including sepsis. taking the drug may increase the risk of metabolic acidosis.

Х Patients with glutathione deficiency (particularly in severely malnourished patients with anorexia, chronic alcoholism, or patients with a low body mass index).

Х Simultaneous intake of antihypertensive drugs.

Coldrex MaxGripp is a combined preparation, the action of which is due to the active ingredients included in the composition:

Х Paracetamol has an analgesic and antipyretic effect.
Х Phenylefrin - a vasoconstrictor, relieves nasal congestion (narrows the vessels of the nasal mucosa and paranasal sinuses) and makes breathing easier.
Х Accorbic acid (Vitamin C) fulfills the need for Vitamin C in case of cold and flu.

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.