Coldrex menthol active powder for oral solution sachet No. 10

Instructions Coldrex menthol active powder for oral solution sachet No. 10

Composition

active ingredients: paracetamol, phenylephrine hydrochloride, ascorbic acid;

1 sachet contains paracetamol 600 mg, ascorbic acid 40 mg, phenylephrine hydrochloride 10 mg;

excipients: sucrose, sodium citrate, anhydrous citric acid, corn starch, menthol powder E41580, lemon flavor 610399E, honey flavor PFWIS PHS-050860, honey flavor F7624/P, plain caramel 626E150A, aspartame (E 951), sodium saccharin.

Dosage form

Powder for oral solution.

Main physicochemical properties: almost white/beige, free-flowing, heterogeneous powder with a smell of honey, lemon and menthol.

Pharmacotherapeutic group

Analgesics and antipyretics. Paracetamol, combinations without psycholeptics. ATX code N02B E51.

Pharmacological properties

Pharmacodynamics.

Paracetamol is an analgesic and antipyretic. Its mechanism of action is explained by the inhibition of prostaglandin synthesis, primarily in the central nervous system. Phenylephrine hydrochloride is a sympathomimetic. Its action is associated primarily with direct stimulation of adrenoreceptors, mainly alpha-adrenoreceptors. Phenylephrine hydrochloride reduces swelling of the nasal mucosa. Ascorbic acid is a vital vitamin that is added to the composition of the drug to compensate for the loss of vitamin C, which may occur at the beginning 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.

Pharmacokinetics.

Paracetamol is well absorbed in the digestive tract, metabolized in the liver and excreted in the urine mainly in the form of glucuronide and sulfate conjugates. Ascorbic acid is easily absorbed in the digestive tract, 25% binds to blood proteins. The remainder of ascorbic acid, exceeding the body's needs, is excreted in the urine in the form of metabolites.

Phenylephrine hydrochloride is metabolized by monoamine oxidase in the intestine and liver. It is excreted in the urine in the form of sulfate conjugates.

Indication

For the relief of symptoms of colds and flu, including headache, sore throat, body aches and pains, nasal congestion, sinusitis and associated pain, acute catarrhal rhinitis, fever.

Contraindication

Hypersensitivity to any of the components of the drug. Simultaneous use of other sympathomimetic decongestants (even local action). Severe liver and/or kidney dysfunction, 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, angle-closure glaucoma.

Do not use simultaneously with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuing their use, together with tricyclic antidepressants, beta-blockers, other antihypertensive agents.

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

Interaction with other medicinal products and other types of interactions

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

Caution should be exercised when using paracetamol with flucloxacillin, as such co-administration has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section "Special warnings and precautions for use").

Caution is required when combining phenylephrine with the following drugs:

Ascorbic acid when taken orally enhances the absorption of penicillin, iron, reduces the effectiveness of heparin and indirect anticoagulants, increases the risk of crystalluria during treatment with salicylates. Antidepressants, antiparkinsonian and antipsychotic drugs, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation. Ascorbic acid can be taken only 2 hours after the injection of deferoxamine, since their simultaneous administration increases iron toxicity, especially in the myocardium. Long-term administration of large doses in persons treated with disulfiram inhibits the disulfiram-alcohol reaction.

Application features

Do not use for liver and kidney diseases without consulting a doctor.

Patients with arterial hypertension, cardiovascular diseases, diabetes mellitus, prostatic hypertrophy, Raynaud's disease (occlusive vascular disease) should consult a doctor before using the drug.

Concomitant use with other drugs intended for the symptomatic treatment of colds and flu, vasoconstrictor drugs for the treatment of rhinitis, and drugs containing paracetamol should be avoided.

As this medicine contains paracetamol, concomitant use with other medicines containing paracetamol may lead to overdose. Paracetamol overdose may cause liver failure, which may require liver transplantation or lead to death.

Caution is advised when paracetamol is used concomitantly with flucloxacillin due to the increased risk of high anion gap metabolic acidosis, especially in patients with severe renal insufficiency, sepsis, malnutrition and other causes of glutathione deficiency (e.g. chronic alcoholism), and when maximum daily doses of paracetamol are used. Close monitoring, including measurement of urinary 5-oxoproline, is recommended.

Should not be used concomitantly with sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like psychostimulants).

Each sachet contains 118 mg sodium. This should be taken into consideration by patients on a controlled sodium diet.

1 sachet (1 dose) contains 3755 mg of sucrose. This should be taken into account by diabetics.

The medicine contains a source of phenylalanine (aspartame, E 951), which may be harmful for people with phenylketonuria.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine.

Do not exceed recommended doses. If symptoms persist or worsen after more than 7 days of treatment with the drug, or are accompanied by high fever, rash, or persistent headache, you should consult a doctor.

If, on the recommendation of a doctor, the drug is used for a long period, it is necessary to monitor the functional state of the liver and the picture of peripheral blood. With prolonged use in high doses, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia are possible.

The risk of overdose occurs in patients with non-cirrhotic alcoholic liver disease. Cases of hepatic dysfunction/hepatic failure have been reported in patients with reduced glutathione levels, such as those with severe wasting, anorexia, low body mass index, or chronic alcoholism.

Patients with severe infections such as sepsis, which are accompanied by a decrease in glutathione levels, are at increased risk of metabolic acidosis when taking paracetamol. Symptoms of metabolic acidosis include deep, rapid or difficult breathing, nausea, vomiting, loss of appetite. You should seek immediate medical attention if these symptoms occur.

Use during pregnancy or breastfeeding

Do not use during pregnancy or breastfeeding. Phenylephrine may pass into breast milk.

Ability to influence reaction speed when driving vehicles or other mechanisms

In case of side effects such as dizziness, it is recommended to avoid driving and working with complex mechanisms.

Method of administration and doses

The medicine is used internally. Pour the contents of one sachet into a cup with a volume of 200–300 ml and fill the cup halfway with hot water (not boiling water). Stir until completely dissolved. Add cold water if necessary. Consume warm.

Do not exceed the indicated doses. If symptoms persist, consult a doctor.

The lowest effective dose should be used.

Children.

Do not use in children under 16 years of age.

Overdose

Paracetamol.

The risk of overdose is increased in patients with liver disease and in those who abuse alcohol. Paracetamol overdose can cause liver failure, which may require a liver transplant or 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 of body weight. The use of 5 g or more of paracetamol can lead to 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 excessive amounts of ethanol; glutathione cachexia (digestive disorders, cystic fibrosis, HIV infections, starvation, cachexia)].

Symptoms.

In the first 24 hours - pallor, nausea, vomiting, anorexia, abdominal pain. Liver damage develops within 12–48 hours after overdose. Glucose metabolism disorders and metabolic acidosis, cardiac arrhythmia may occur.

In severe poisoning, liver dysfunction may progress to encephalopathy with impaired consciousness, hemorrhage, hypoglycemia, cerebral edema, and in some cases, death. Acute renal failure with acute tubular necrosis may present with severe lumbar pain, hematuria, and proteinuria and may occur even in the absence of severe liver damage. Acute pancreatitis has also been reported, usually in patients with liver dysfunction and toxicity.

Treatment.

In case of overdose, urgent medical attention is required. The patient should be taken to hospital immediately, even if there are no early symptoms of overdose. Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or the risk of organ damage. Full assistance should be provided in all circumstances. Treatment with activated charcoal should be considered if an overdose of paracetamol has been taken within 1 hour. The concentration of paracetamol in the blood plasma should be measured 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine can be used within 24 hours of paracetamol ingestion, but the maximum protective effect occurs when it is used within 8 hours of ingestion. The effectiveness of the antidote decreases sharply after this time. If necessary, the patient should be administered intravenously N-acetylcysteine according to the established dosage. Provided there is no vomiting, oral methionine may be used as a suitable alternative in remote areas outside the hospital. Treatment of serious liver dysfunction after 24 hours of ingestion should be guided by a toxicologist or hepatologist.

Phenylephrine.

Symptoms. Phenylephrine overdose is most often manifested by the symptoms described in the section "Adverse reactions". In addition, it can cause irritability, anxiety, hypertension and, possibly, reflex bradycardia. In severe cases, impaired consciousness, hallucinations, convulsions and arrhythmia are possible. However, a significantly larger amount of the drug is required to cause an overdose of phenylephrine than for an overdose of paracetamol.

Treatment: Treatment should be based on clinical symptoms. In severe hypertension, alpha-blockers such as phentolamine should be used.

Ascorbic acid.

Symptoms: High doses of ascorbic acid (over 3000 mg) may cause transient osmotic diarrhea and gastrointestinal disturbances such as nausea and abdominal discomfort. Symptoms of ascorbic acid overdose are usually masked by more severe symptoms of paracetamol overdose.

Side effects

The following are the most common adverse reactions observed during clinical trials of phenylephrine, paracetamol, and ascorbic acid.

From the blood and lymphatic system: anemia (including hemolytic), sulfhemoglobinemia and methemoglobinemia, thrombocytopenia, leukopenia, agranulocytosis, bruising or bleeding; with prolonged use of ascorbic acid in high doses - thrombocytosis, hyperprothrombinemia, thrombocytopenia, erythrocytopenia, neutrophilic leukocytosis; in patients with glucose-6-phosphate dehydrogenase deficiency of blood cells, hemolysis of erythrocytes may occur.

Immune system disorders: Anaphylaxis, allergic skin reactions (including rash, angioedema, Stevens-Johnson syndrome/toxic epidermal necrolysis), hypersensitivity reactions. Very rare cases of serious skin reactions have been reported.

Respiratory, thoracic and mediastinal disorders: bronchospasm in patients sensitive to aspirin and other nonsteroidal anti-inflammatory drugs.

Hepatobiliary disorders: liver dysfunction, increased activity of liver enzymes, hepatonecrosis (dose-dependent effect), liver failure.

Mental disorders: anxiety, nervous excitement, irritability, sleep disturbances, feeling hot.

Neurological disorders: headache, dizziness, insomnia, fatigue.

Gastrointestinal disorders: nausea, vomiting, dry mouth, hypersalivation, abdominal discomfort and pain, decreased appetite, heartburn, diarrhea; when using ascorbic acid in a dosage of more than 1 g per day - irritation of the digestive tract mucosa, vomiting.

From the cardiovascular system: increased blood pressure, tachycardia or reflex bradycardia, palpitations, shortness of breath, myocardial dystrophy.

On the part of the endocrine system: with prolonged use of ascorbic acid in high doses - damage to the insular apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the appearance of diabetes mellitus.

The following adverse reactions have been identified during post-marketing use. The frequency of these reactions is unknown, but they are likely to be rare.

Visual disturbances: mydriasis, increased intraocular pressure, acute glaucoma attack in patients with angle-closure glaucoma.

Skin and subcutaneous tissue disorders: allergic skin reactions (e.g. rash, urticaria, allergic dermatitis). Cross-hypersensitivity reactions with other sympathomimetics are possible.

On the part of the kidneys and urinary system: urination disorders, urinary retention (more often in patients with prostatic hypertrophy), renal colic, nephrotoxic effect.

Others: general weakness, fever, hypoglycemia, zinc and copper metabolism disorders.

The medicine may have a slight laxative effect.

Reporting of suspected adverse reactions.

Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.

Expiration date

2 years.

Storage conditions

Store at a temperature not exceeding 30 °C out of the reach of children.

Packaging

Powder in sachets. 10 sachets in a cardboard box.

Vacation category

Without a prescription.

Producer

HALEON ALCALA, S.A., Spain / HALEON ALCALA, SA, Spain.

Location of the manufacturer and address of its place of business.

Ctra. de Ajalvir, Km. 2,500, Alcala de Henares, 28806 Madrid, Spain / Ctra. de Ajalvir, Km. 2,500, Alcala de Henares, 28806 Madrid, Spain.