Coldrex MaxGripp powder d/d/internal pack No. 10 lemon

Contraindications

Hypersensitivity to the components of the drug. Concomitant use of other sympathomimetic decongestants (even local ones). Severe dysfunction of the liver and/or kidneys, severe forms of diabetes mellitus, prostatic hypertrophy with urinary retention, hyperthyroidism, severe diseases of the cardiovascular system, severe arterial hypertension.

Pheochromocytoma, glucose-6-phosphate dehydrogenase deficiency, blood diseases (including severe anemia, leukopenia), acute pancreatitis, epilepsy, glaucoma. Do not use simultaneously and within 2 weeks after using MAO inhibitors, along with tricyclic antidepressants, beta blockers, and other antihypertensive drugs.

Do not use in patients with phenylketonuria due to the presence of aspartame (E 951).

Coldrex®

Manufacturer: GlaxoSmithKline Consumer Healthcare (UK)

◊ tab.: 5, 6, 8, 10, 12, 16 or 24 pcs. Reg. No.: P N015713/01

Clinical and pharmacological group:

Drug for symptomatic treatment of acute respiratory diseases

Release form, composition and packaging

◊ Pills

two-layer, orange-white, the orange layer may contain white inclusions; capsule-shaped, with the “Coldrex” marking embossed on one side.

Excipients:

soluble starch, corn starch, povidone, potassium sorbate, sodium lauryl sulfate, dye, stearic acid, talc.

5 pieces. — blisters (1) — packs of plastic covers. 5 pieces. - blisters (2) - plastic packs-covers. 6 pcs. - blisters (1) - cardboard boxes. 6 pcs. - blisters (2) - cardboard boxes. 6 pcs. — blisters (1) — packs of plastic covers. 6 pcs. - blisters (2) - plastic packs-covers. 8 pcs. — blisters (1) — packs of plastic covers. 8 pcs. - blisters (2) - plastic packs-covers. 12 pcs. - blisters (1) - cardboard boxes. 12 pcs. - blisters (2) - cardboard boxes. 12 pcs. (4 pcs. - blisters (1) and 8 pcs. - blisters (1)) - packs of plastic covers.

Description of the active components of the drug "Coldrex®"

pharmachologic effect

Combined drug for symptomatic treatment of acute respiratory diseases.

Paracetamol has an analgesic and antipyretic effect, phenylephrine reduces swelling of the mucous membranes and sinuses, resulting in easier breathing, caffeine has a general tonic effect, ascorbic acid (vitamin C) replenishes the increased need for vitamin C during colds and flu.

Indications

Relieving symptoms of colds and flu, such as:

- elevated temperature;

- headache;

- chills;

- pain in joints and muscles;

- feeling of nasal congestion;

- pain in the sinuses and throat.

Dosage regimen

Adults and children over 12 years old

2 tablets are prescribed.
up to 4 times/day. Children aged 6-12 years -
1 tablet. up to 4 times/day.

Do not exceed the recommended dose. It is not recommended to use the drug for more than 5 days without consulting a doctor. If symptoms persist, you should consult a doctor.

Side effect

At recommended doses, the drug is usually well tolerated.

Paracetamol

rarely has side effects.

Sometimes:

allergic reactions, for example, skin rash, urticaria, angioedema.

Rarely:

blood picture abnormalities.

With
long-term use in excess of the recommended dose,
hepatotoxic and nephrotoxic effects may occur.

Phenylephrine

may cause:

From the digestive system:

nausea,

From the cardiovascular system:

headache, slight increase in blood pressure and, in rare cases, palpitations, which disappear after discontinuation of the drug.

Contraindications

- genetic absence of glucose-6-phosphate dehydrogenase;

— diseases of the blood system;

- severe impairment of liver or kidney function;

- thyrotoxicosis;

- diabetes;

- arterial hypertension;

- simultaneous use with other paracetamol-containing drugs;

- hypersensitivity to the ingredients included in the drug.

Pregnancy and lactation

You can take the drug with caution and only after consulting a doctor during pregnancy and lactation.

special instructions

Excessive consumption of tea or coffee while taking Coldrex® may cause irritability and nervous tension.

To avoid toxic liver damage, patients taking Coldrex® should refrain from drinking alcohol. It is not recommended to prescribe the drug for chronic alcoholism.

Use in pediatrics

children under 6 years of age without consulting a doctor.

.

Overdose

In case of overdose, you should immediately seek medical help, even if you feel well.

Symptoms:

nausea, vomiting, stomach pain, sweating, pale skin, cardiac arrhythmias. After 1-2 days, signs of liver damage may be detected. In severe cases, liver failure and coma develop.

Treatment:

perform gastric lavage during the first 4 hours after taking the drug, then carry out symptomatic therapy. The specific antidote for paracetamol poisoning is acetylcysteine.

Drug interactions

The drug should not be taken simultaneously with tricyclic antidepressants, beta-blockers, MAO inhibitors and within 14 days after their discontinuation.

The risk of developing hepatotoxicity increases with simultaneous use of barbiturates, diphenine, carbamazepine, rifampicin, zidovudine and other inducers of microsomal liver enzymes.

Metoclopramide and domperidone increase the rate of absorption of paracetamol, and cholestyramine reduces it.

Conditions for dispensing from pharmacies

The drug is approved for use as a means of OTC.

Storage conditions and periods

The drug should be stored in a dry place, out of reach of children. Shelf life: 4 years.

Drug interactions

The drug should not be taken simultaneously with tricyclic antidepressants, beta-blockers, MAO inhibitors and within 14 days after their discontinuation.

The risk of developing hepatotoxicity increases with simultaneous use of barbiturates, diphenine, carbamazepine, rifampicin, zidovudine and other inducers of microsomal liver enzymes.

Metoclopramide and domperidone increase the rate of absorption of paracetamol, and cholestyramine reduces it.

Mode of application

The drug is taken orally. Pour the contents of one sachet into a 200-300 ml cup and fill up to half the cup with hot water (not boiling water). Stir until completely dissolved. Add cold water if necessary. Take warm.

Adults and children over 12 years of age: 1 sachet every 4-6 hours, if necessary. Do not take more than every 4 hours. The maximum daily dose is 6 sachets. The maximum duration of treatment without consulting a doctor is 7 days.

Exceed the indicated doses. If symptoms do not go away, you should consult a doctor.

The lowest effective dose should be used.

Overdose

Paracetamol. The risk of overdose is increased in patients with liver disease and in those who abuse alcohol. An overdose of paracetamol may cause liver failure, may require a liver transplant, or may lead to death.

Liver damage is possible in adults who have taken more than 10 g of paracetamol, and in children who have taken more than 150 mg/kg body weight. The use of 5 g or more of paracetamol may cause liver damage in patients with risk factors (long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other drugs that induce liver enzymes; regular intake of excess amounts of ethanol; glutathione cachexia (digestive disorders , cystic fibrosis, HIV infection, hunger, cachexia).

Pharmacological properties of the drug Coldrex

Pharmacodynamics. Paracetamol is an analgesic-antipyretic. The mechanism of action is explained by inhibition of prostaglandin synthesis in the central nervous system and an effect on the thermoregulation center in the hypothalamus. Caffeine has a pronounced stimulating effect on the central nervous system, potentiates the analgesic effect of paracetamol, belongs to the group of methylxanthines, stimulates the respiratory and vasomotor centers, causes dilation of the blood vessels of the muscles, heart, kidneys, constriction of the blood vessels of the abdominal organs and brain, reduces platelet aggregation, increases diuresis, gastric secretion. Ascorbic acid is a vital vitamin, included in the drug to compensate for the loss of vitamin C that occurs during the initial period of a viral infection. It is known that ascorbic acid plays an important role in the implementation of the body’s protective function against infection and is necessary for the normal functioning of T-lymphocytes and the effective phagocytic activity of leukocytes. Normalizes capillary permeability. Phenylephrine is a sympathomimetic. Its action is associated primarily with direct stimulation of adrenergic receptors and partly with an effect mediated through the release of norepinephrine. Phenylephrine reduces swelling of the nasal mucosa, facilitating nasal breathing. Causes constriction of arterioles, increases peripheral vascular resistance and blood pressure levels. Terpin hydrate stimulates bronchial secretion and is used as an expectorant. Pharmacokinetics . Paracetamol is well absorbed from the gastrointestinal tract. Maximum plasma concentrations are achieved 0.5–2 hours after oral administration (at a dose of 1 g in adults). Metabolized in the liver, excreted in the urine, mainly in the form of glucuronide and sulfate conjugates. The half-life is 1–4 hours. Caffeine is rapidly absorbed after oral administration. The maximum concentration in blood plasma is reached after approximately 20–60 minutes. Metabolized in the liver, excreted in the urine in the form of 1-methyluronic acid, 1-methylxanthine, 1,7-dimethylxanthine and other metabolites, less than 1% unchanged. The half-life is about 4 hours. Ascorbic acid is well absorbed from the gastrointestinal tract. About 25% binds to blood proteins. Metabolized in the liver, mainly to dehydroascorbic acid. Ascorbic acid and its metabolites are excreted in urine and bile. Excess ascorbic acid, exceeding the body's need for it, is excreted in the urine in the form of metabolites. Phenylephrine hydrochloride is absorbed inconsistently from the gastrointestinal tract and undergoes first-pass metabolism with the participation of MAO in the intestine and liver. After oral administration, the maximum concentration in the blood plasma is reached after 1–2 hours. The half-life is on average 2–3 hours. It is excreted in the urine in the form of a sulfate conjugate. There are no data on the pharmacokinetics of terpin hydrate in the literature.

Side effects

• From the blood and lymphatic system: anemia (including hemolytic), sulfhemoglobinemia and methemoglobinemia, thrombocytopenia, leukopenia, agranulocytosis, bruising or bleeding.
• From the immune system: anaphylaxis, allergic skin reactions (including rash, angioedema, Stevens-Johnson syndrome / toxic epidermal necrolysis),
• hypersensitivity reactions.
• From the respiratory system, chest and mediastinal organs: bronchospasm in patients sensitive to aspirin and other NSAIDs.
• Hepatobiliary system: impaired liver function, increased activity of liver enzymes, hepatonecrosis (dose-dependent effect), liver failure.
• Mental disorders: anxiety, nervous agitation, irritability, sleep disturbance.
• Neurological disorders: headache, dizziness, insomnia.
• On the part of the hearing and vestibular apparatus: tinnitus.
• Gastrointestinal disorders: nausea, vomiting, dry mouth, hypersalivation, abdominal discomfort and pain, loss of appetite, heartburn, diarrhea.
• Visual impairment: mydriasis, increased intraocular pressure, acute attack of glaucoma in patients with angle-closure glaucoma.
• From the cardiovascular system: increased blood pressure, tachycardia or reflex bradycardia, palpitations, shortness of breath.
• From the skin and subcutaneous tissue: allergic skin reactions (for example, rash, urticaria, allergic dermatitis). Cross-hypersensitivity reactions with other sympathomimetics are possible.
• From the kidneys and urinary system: impaired urination, urinary retention (more often in patients with prostatic hypertrophy), renal colic, nephrotoxic effect.

Interaction

The rate of absorption of paracetamol may increase when used simultaneously with metoclopramide and domperidone and decrease when used with cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced with an increased risk of bleeding during concomitant long-term, regular daily use of paracetamol. With short-term use in accordance with the recommended regimen, these interactions are not clinically significant. Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of microsomal liver enzymes, may increase the toxic effects of paracetamol on the liver due to increased conversion of the drug to hepatotoxic metabolites. The simultaneous use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome. Do not use simultaneously with alcohol.

Special instructions for the use of Coldrex

The simultaneous use of other drugs for the symptomatic treatment of influenza and colds, vasoconstrictor drugs for the treatment of rhinitis, as well as drugs containing paracetamol should be avoided. Use with caution to treat patients with impaired renal and liver function, patients with coronary artery disease, with benign hyperbilirubinemia, and elderly patients. With long-term use, it is necessary to monitor the functional state of the liver and hemogram. During pregnancy and breastfeeding. The use of the drug during this period is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or child. Impact on the ability to drive a car or operate machinery. The drug does not have a hypnotic effect. There is no effect on the ability to drive a car or equipment.

Note!

Description of the drug Coldrex Menthol Active por. d/oral. solution No. 10 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.