Coldrex MaxGrippe, lemon 6 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

Angina, Runny nose (rhinitis), Joint pain (arthralgia), Headache, Sore throat, Colds, Muscle pain (myalgia), Flu, Fever, SneezingRemoves symptoms of colds and flu:

• high body temperature;
• headache;
• chills;
• pain;
• nasal congestion.
• Sore throat.
• Sinus pain.

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Active ingredient

Paracetamol, phenylephrine, ascorbic acid

Composition

Paracetamol;

How to take, the dosage

For oral administration.

Do not exceed the specified dose!

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

The minimum interval between doses of the drug Coldrex® MaxGrippe should be 4 hours.

Put 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: By mouth, single dose – 1 sachet. The drug may be used again not earlier than after 4-6 hours and not more than 4 times a day.

The maximum daily dose should not exceed 4 sachets.

The maximum duration of the drug without consulting the physician is not more than 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 beverages.

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

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 the above diseases / conditions / risk factors, before taking the drug, be sure to consult with your doctor:

• Benign hyperbilirubinemia.
• Liver and kidney function disorders of mild to moderate severity.
• Acute hepatitis.
• Alcoholic liver disease.
• Disorders of urination.
• Pyloroduodenal obstruction.
• Stenotic gastric and or duodenal ulcer.
• Bronchial asthma.
• 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 emaciated patients with anorexia, chronic alcoholism, or patients with low body mass index).
• Current use of hypotensive drugs.

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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 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.

When testing for uric acid and blood glucose levels, the patient should inform the doctor about the use of the drug Caldrex® MaxGrippe, as the drug can distort the results.because the drug may distort the results of laboratory tests that assess the concentration of glucose and uric acid.
Before taking Cauldrex® MaxGrippe it is necessary to consult a physician in case of:

-taking metoclopramide, domperidone (used to relieve nausea and vomiting) or colestiramine used to lower blood cholesterol;
-taking drugs to reduce blood clotting (such as warfarin);
-maintaining a sodium-reduced diet – each bag contains 0.Severe infectious diseases (including sepsis) in patients with glutathione deficiency, because while taking paracetamol the risk of metabolic acidosis may increase, the signs of which are disorders of respiratory rate and depth, accompanied by shortness of breath (shortness of breath), nausea, vomiting, loss of appetite. If the patient discovers these, you should immediately consult a physician.

To avoid toxic liver damage, paracetamol should not be combined with alcoholic beverages, as well as taken by persons who use alcohol chronically.

Influence on the ability to drive vehicles and mechanisms

When administered 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. In case of dizziness it is not recommended to drive vehicles or operate mechanisms.

Synopsis

Powder for preparation of solution for oral administration (lemon) of light yellow color, with lemon odor; prepared solution is turbid, yellowish-green color, with lemon odor, without surface foam and solid inclusions.

Contraindications

• High sensitivity to the ingredients.
• Pregnancy and lactation.
• Severe liver or kidney disease.
• Disease of the blood system.
• Elevated thyroid function (thyrotoxis).
• Arterial hypertension .
• Heart disease: severe aortic stenosis, acute myocardial infarction, tachyarrhythmias.
• Prostatic hyperplasia.
• Open angle glaucoma.
• Simultaneous use of tricyclic antidepressants, beta-adrenoblockers, Mao inhibitors and for up to 14 days after their withdrawal.
• Diabetes mellitus and diseases associated with hereditary sugar absorption disorders – each sachet contains 4 grams of sugar.
• Genetic lack of glucose-6-phosphate dehydrogenase.
• Age under 18 years.

With caution:

• Benign hyperbilirubinemia.

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Side effects

Determination 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.

Urinary system: with prolonged use in excess of the recommended dose nephrotoxic effect may be observed.

Phenylephrine

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

Cardio-vascular system: very rarely – increase of blood pressure, tachycardia, palpitations.

Digestive system: very rarely – nausea, vomiting.

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

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

Urinary system disorders: very rarely – 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® MaxGrippe (even if you feel well), consider the risk of delayed signs of serious liver damage.

Overdose is usually caused by paracetamol. Liver damage in adults is possible if ≥10 g of paracetamol is ingested.

≥5 g of paracetamol can cause liver damage in patients with the following risk factors:

-long treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John’s wort preparations, or other drugs that stimulate liver enzymes;