Active substanceParacetamol + PhenylephrineParacetamol + Phenylephrine
Dosage form: & nbspPpowder for solution for oral administration [lemon]
Composition:

One package contains:

active ingredients: paracetamol 1000 mg, phenylephrine hydrochloride 12.2 mg;

auxiliary components: powdered sugar 1333.3 mg, fine milling sucrose 840 mg, citric acid anhydrous granulated 780 mg, sodium citrate 544 mg, flavoring lemon 190 mg, aspartame 61.5 mg, ascorbic acid 15 mg, sodium saccharinate 12 mg, curcumin WD 12 mg.

Description:

The powder is light yellow with the smell of lemon.

Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic remedy + alpha-adrenomimetic)
ATX: & nbsp

N.02.B.E   Anilides

N.02.B.E.51   Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

The mechanism of action of paracetamol is due to the inhibition of the synthesis of prostaglandins in the central nervous system (CNS).

Paracetamol has an analgesic and antipyretic effect.

Phenylephrine hydrochloride is mainly a postsynaptic alpha receptor with a low affinity for cardioselective beta receptors, and in usual doses it has a minimal stimulating effect on the CNS.

Phenylephrine hydrochloride narrows the vessels of the nose, reduces the swelling of the nasal mucosa, facilitating the runny nose and stuffiness of the nose.

The effect of the drug is noted 15-20 minutes after administration and lasts for 4-6 hours.

Pharmacokinetics:

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract (GIT). Rapidly spread to all tissues of the body. The half-life (T1/2) - about 2 hours. It is excreted by the kidneys, mainly in the form of metabolites - glucuronides and sulfate compounds.

Phenylephrine hydrochloride is absorbed from the gastrointestinal tract, but has a reduced bioavailability for oral administration due to irregular absorption, the effect of "first passage" through the liver and metabolism with the participation of monoamine oxidase (MAO) inhibitors in the intestine. When ingested, it retains its activity as a nasal anticongestant.

Indications:

To alleviate the symptoms of acute respiratory infections ("colds") and flu:

- increased body temperature, chills,

- headache,

- nasal congestion, runny nose,

- pain in the throat and nasal sinuses.

Contraindications:

- Hypersensitivity to paracetamol and other components that make up the drug;

- aboutsimultaneous reception of other drugs containing paracetamol;

- aboutsimultaneous reception of beta adrenoblockers, tricyclic antidepressants, MAO inhibitors (including within 14 days after their cancellation);

- tischemic heart disease or cardiovascular disease: arterial hypertension, severe coronary artery atherosclerosis, severe aortic stenosis, acute myocardial infarction, tachyarrhythmia;

- ghyperthyroidism;

- thepatic liver failure or liver disease in the active phase;

- Pacute insufficiency of severe severity (creatinine clearance <30 ml / min);

- fenylketonuria;

- Mr.fructose intolerance, glucose-galactose malabsorption, insufficiency of sucrose-isomaltase;

- dEthnic age under 18;

- bVariability, the period of breastfeeding.

Carefully:

In the presence of conditions specified in this section, before using the drug should consult a doctor.

Allergic reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized pustular exanthema; bronchial asthma, chronic obstructive pulmonary disease, hepatitis, liver function disorders caused by alcohol, hyperbilirubinemia; renal failure (creatinine clearance less than 30-60 ml / min), hyperoxalaturia, diabetes mellitus, angle-closure glaucoma and prostatic hyperplasia; Raynaud's disease; pheochromocytoma; deficiency of glucose-6-phosphate dehydrogenase; diseases of the blood system.

Pregnancy and lactation:

The drug is contraindicated during pregnancy and during breastfeeding.

Dosing and Administration:

Read the instructions carefully before taking the drug.

DFor reception inside. Only for short-term use.

The contents of one packet correspond to a single dose. To make a hot beverage, dissolve the contents of the packet in one glass of hot water (but not boiling water). Stir until dissolved.Drink a freshly prepared hot or warm drink.

Recommended for adults and children over 18 years of age for 1 package, with an interval between meals at least 4 hours. The maximum daily dose is 4 packages.

Do not exceed the indicated dose.

The course of treatment is no more than 5 days.

If the symptoms persist or worsen during the course of 5 days, stop treatment and consult a doctor.

Side effects:

The frequency of adverse reactions associated with paracetamol and phenylephrine hydrochloride is estimated based on the following criteria: very frequent (≥ 1/10), frequent (≥ 1/100, <1/10), infrequent (≥ 1/1000, <1 / 100), rare (≥ 1/10000, <1/1000), very rare (<1/10000) and the frequency is unknown (there is no data on frequency estimation).

Violations of the blood and lymphatic system

The frequency is unknown: thrombocytopenia, agranulocytosis.

Disturbances from the nervous system

The frequency is unknown: headache, dizziness, insomnia, increased excitability.

Disturbances on the part of the organ of sight

The frequency is unknown: mydriasis, increased intraocular pressure (in most cases in patients with closed glaucoma).

Disorders from the cardiovascular system

The frequency is unknown: a feeling of palpitation, increased blood pressure, tachycardia.

Disturbances from the skin and subcutaneous tissues

HAstota is unknown: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's Syndrome), acute generalized exanthematous pustulosis, skin rash, hives, angioedema.

Disorders from the gastrointestinal tract

The frequency is unknown: nausea, vomiting, dry mouth.

Disturbances from the liver and bile ducts

HAstota is unknown: a violation of the liver.

Disorders from the nochek and urinary tract

The frequency is unknown: retention of urine, dysuria.

With prolonged use with exceeding the recommended dose, nephrotoxic effect can be observed.

Overdose:

Symptoms: symptoms of paracetamol overdose during the first 24 hours: pallor of the skin, nausea, vomiting, anorexia and abdominal pain. Damage to the liver can occur 12-48 hours after admission, so you need to see a doctor even if you have no symptoms. Possible disturbance of glucose metabolism and metabolic acidosis.In severe poisoning, liver failure may progress with complications such as encephalopathy, hemorrhage, hypoglycemia, cerebral edema and death. Acute renal failure with acute tubular necrosis (defined by pain in the lower back, hematuria and proteinuria) can develop even in the absence of severe liver damage. There are reports of heart rhythm disturbances and pancreatitis.

An overdose of phenylephrine hydrochloride can also cause nausea and vomiting. In addition, the symptoms include nervousness, headache, dizziness, insomnia, hypertension, reflex bradycardia, mydriasis, acute closed-angle glaucoma (most likely in patients with closed-angle glaucoma), tachycardia, palpitations, allergic reactions (eg, rash, hives, allergic dermatitis), dysuria and urinary retention (most likely in patients with obstruction of the bladder outlet, for example prostatic hypertrophy). Features of severe overdose of phenylephrine hydrochloride include hemodynamic changes and cardiovascular insufficiency with respiratory depression, hallucinations, seizures and arrhythmias.However, in the case of this combined preparation containing paracetamol and phenylephrine hydrochloride, an overdose will rather cause symptoms of liver toxicity associated with paracetamol than toxicity symptoms associated with phenylephrine.

Treatment: symptomatic. You need immediate treatment with an overdose of paracetamol. Despite the lack of significant early symptoms, patients should be rushed to the hospital for immediate medical examination. Symptoms can be limited by nausea or vomiting and do not correspond to the severity of the overdose or the risk of organ damage. Damage to the liver can occur 12-48 hours after paracetamol enters the interior, so you need to see a doctor even if you have no symptoms.

Treatment with activated charcoal and gastric lavage should be considered if an excessive dose has been taken less than 1 hour ago. The concentration of paracetamol in plasma should be measured after 4 hours or more after administration (earlier concentrations are unreliable).

Treatment N-acetylcysteine ​​can be conducted up to 2-hours after taking paracetamol, but the maximum protective effect is achieved about 8 hours after taking the drug. The effectiveness of the antidote gradually decreases after this time. If necessary, enter intravenously N-acetylcysteine ​​according to the established scheme of use.

Outside the hospital, if there is no vomiting, you can apply methionine inside.

Patients who have been treated with serious hepatic dysfunction within 24 hours after taking the drug, must be sent to a specialist for poisoning.

In hypertensive effects of phenylephrine hydrochloride overdose, intravenous alpha-receptor blockers, such as phentolamine, can be used.

Additional information about specific patient groups

The increased risk of liver damage with paracetamol overdose is most likely in:

- Patients receiving long-term treatment with enzyme-inducing agents (such as, carbamazepine, phenobarbitone, phenytoin, primidon, rifampicin and St. John's wort pitted);

- patients who consume alcohol in quantities higher than those recommended;

- patients with glutathione depletion (eg, patients with eating disorders, cystic fibrosis,HIV infection, cachexia, starvation).

Interaction:

- Monoamine oxidase inhibitors (MAO inhibitors): with the simultaneous administration of sympathomimetic amines, such as phenylephrine hydrochloride, and MAO inhibitors, an increase in blood pressure is possible.

- Cardiac glycosides: simultaneous application of cardiac glycosides (e.g., digoxin) and phenylephrine hydrochloride may increase the risk of arrhythmia and myocardial infarction.

- Tricyclic antidepressants: simultaneous use of tricyclic antidepressants (for example, amitriptyline) and phenylephrine hydrochloride may increase the risk of cardiovascular side effects.

- Sympathomimetics: simultaneous use of phenylephrine hydrochloride and other sympathomimetic amines can lead to increased blood pressure and other side effects from the cardiovascular system. Phenylephrine hydrochloride may reduce the effectiveness of beta-blockers and other antihypertensive agents.

- Anticoagulants: The anticoagulant effect of warfarin and other coumarins can be enhanced by a prolonged daily intake of paracetamol with an increased risk of bleeding.

- Antiemetic means: metoclopramine and domperidone can increase the rate of absorption of paracetamol.

- Kolestyramine: colestramine can reduce the rate of absorption of paracetamol.

- Glucocorticosteroids: increased risk of glaucoma.

- Urikozuric preparations: The simultaneous use of uricosuric drugs and paracetamol can reduce the effectiveness of uricosuric drugs.

- Inductors of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants, diphenyl, carbamazepine, zidovudine, flumecinol): increase in the production of hydroxylated active metabolites of paracetamol, which allows the development of severe intoxication with small overdoses.

- Inhibitors of microsomal oxidation (cimetidine): reducing the risk of hepatotoxic action.

- Sedative medicines: paracetamol enhances the effects of sedatives.

- Ethanol: Paracetamol enhances the effects of ethanol.

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

- Phenylephrine: phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs, increases the risk of developing hypertension and cardiovascular disorders.

- Halothane: simultaneous application of halothane and phenylephrine increases the risk of ventricular arrhythmia.

Special instructions:

It is recommended to take the drug as short a course as possible and at the minimum effective dose necessary to eliminate symptoms.

At the first appearance of skin rashes, lesions of the mucous membrane or any other signs of hypersensitivity, it is necessary to stop taking the drug and consult a doctor.

It is necessary to refrain from drinking alcohol during the application of the drug.

During treatment should refrain from taking sleeping pills and anxiolytic drugs (tranquilizers).

The drug should not be used concurrently with other drugs containing paracetamol.

The drug distorts the results of laboratory tests evaluating the concentration of glucose and uric acid in the blood plasma.

Each packet contains 2.2 g of sugar.

Effect on the ability to drive transp. cf. and fur:

Patients who report dizziness, drowsiness, blockage, or visual impairment should avoid driving vehicles or controlling mechanisms when taking medications containing paracetamol.

Form release / dosage:

Powder for solution for ingestion [lemon].

Packaging:

4.8 g of powder are placed in hermetically sealed three-layer bags of aluminum foil, polyethylene and paper.

For 5 or 10 bags in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C, in a dry place.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe
Registration number:LSR-001493/08
Date of registration:14.03.2008
Expiration Date:Unlimited
The owner of the registration certificate:Rekitt Benckiser Chelskar (United Kingdom) LimitedRekitt Benckiser Chelskar (United Kingdom) Limited United Kingdom
Manufacturer: & nbsp
Representation: & nbspREKITT BENKIZER HELSKER LTD. REKITT BENKIZER HELSKER LTD. United Kingdom
Information update date: & nbsp05.03.2018
Illustrated instructions
    Instructions
    Up