Composition, form of production and packaging
? Powder for the preparation of solution for ingestion (lemon) crystalline, from pale yellow to yellow, with a characteristic smell of lemon; the prepared solution is yellow, with a characteristic smell of lemon.
1 pack.
paracetamol 750 mg
phenylephrine hydrochloride 10 mg
ascorbic acid 60 mg
Auxiliary substances: citric acid - 600 mg, sodium saccharin - 40 mg, sodium citrate - 500 mg, lemon tetras 100% P05.51 - 50 mg, flavoring lemon 52293 / TP.05.51 - 83.33 mg, quinoline yellow 14031 (E104) - 0.75 mg, sucrose - 2904.42 mg.
5 g - sachets of laminate (5) - packs of cardboard.
5 g - bags made of laminate (10) - packs of cardboard.
? Powder for the preparation of solution for ingestion (lemon-honey) is heterogeneous, from greyish-white to beige to light brown with white, light brown and dark brown inclusions; The prepared solution is from light yellow to light brown with insoluble inclusions of white color and a characteristic smell of lemon and honey.
1 pack.
paracetamol 750 mg
phenylephrine hydrochloride 10 mg
ascorbic acid 60 mg
Auxiliary substances: citric acid - 600 mg, sodium saccharinate - 10 mg, sodium citrate - 500 mg, flavoring lemon PHS-163671 - 100 mg, flavoring honey PFW PHS-050860 - 75 mg, flavoring honey Felton F7624P - 125 mg, dye caramel 626 - 50 mg, corn starch - 200 mg, aspartame - 50 mg, sucrose - 2468.5 mg.
5 g - sachets of laminate (5) - packs of cardboard.
5 g - bags made of laminate (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Combined drug for the symptomatic treatment of acute respiratory diseases.
Paracetamol has an antipyretic, analgesic effect.
Phenylephrine hydrochloride is a sympathomimetic, narrows the vessels of the nasal mucosa and paranasal sinuses, thereby reducing edema and facilitating nasal breathing.
Ascorbic acid replenishes the increased need for vitamin C for colds and flu, especially in the initial stages of the disease.
Active components of the drug do not cause drowsiness.
PHARMACOKINETICS
Paracetamol is quickly and almost completely absorbed from the digestive tract, distribution in body fluids is relatively even.
Metabolized mainly in the liver with the formation of several metabolites.
T 1/2 when taking a therapeutic dose is 2-3 hours. The main amount of the drug is excreted after conjugation in the liver. In unchanged form, not more than 3% of the received dose of paracetamol is released.
Phenylephrine is poorly absorbed from the digestive tract and metabolized at the first passage in the intestine and liver under the influence of MAO. When taking phenylephrine inside the bioavailability of the drug is limited.
It is excreted in urine almost completely in the form of a sulfuric acid conjugate.
Ascorbic acid is well absorbed from the digestive tract, binding to plasma proteins is 25%. Distribution in the tissues of the body is wide.
Metabolized in the liver, excreted in the urine in the form of oxalate and unchanged.
Ascorbic acid, taken in excessive amounts, is quickly excreted unchanged in urine.
INDICATIONS
To eliminate symptoms of acute respiratory disease and influenza, including:
increased fever;
- headache;
- chills;
- pain in the joints and muscles;
- stuffiness of the nose;
- pain in the throat and in the sinuses of the nose.
DOSING MODE
Adults are recommended to take 1 packet every 4-6 h, but not more than 4 sachets within 24 hours. The interval between doses should be at least 4 hours.
Children over 12 years of age are prescribed 1 packet every 6 hours, but not more than 3 sachets within 24 hours.
The contents of 1 sachet should be poured into a glass with hot water (about 250 ml), stir until completely dissolved, if necessary, you can add cold water or sugar.
The maximum duration of the drug is 5 days. If symptoms persist for more than 5 days, the patient should consult a doctor.
SIDE EFFECT
Determination of the frequency of side effects: very often (? 1/10), often (? 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 recommended doses, the drug is usually well tolerated.
Paracetamol rarely has a side effect.
From the hemopoietic system: very rarely - thrombocytopenia, leukopenia, agranulocytosis.
Allergic reactions: very rarely - anaphylactic shock, skin rash, hives, angioedema, Stevens-Johnson syndrome.
On the part of the respiratory system: very rarely - bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.
From the liver and bile ducts: very rarely - a violation of the liver.
With prolonged use with excess of the recommended dose, hepatotoxic and nephrotoxic effects can be observed.
Phenylephrine
From the nervous system: often - increased excitability, headache, dizziness, insomnia; very rarely - irritability, nervous tension.
From the cardiovascular system: often - increased blood pressure; rarely tachycardia, palpitation.
From the digestive system: often - nausea, vomiting.
From the sense organs: rarely - mydriasis, an acute attack of glaucoma in most cases in patients with closed-angle glaucoma.
Allergic reactions: rarely - skin rash, hives, allergic dermatitis.
From the urinary system: rarely - dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy.
Ascorbic acid
The incidence of side effects has not been established.
Allergic reactions: skin rash, skin hyperemia.
From the digestive system: irritation of the mucosa of the gastrointestinal tract.
From the hemopoietic system: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis.
Other: hypokalemia.
When taking ascorbic acid more than 600 mg / day, moderate pollakiuria is possible.
In case of side effects, the patient should immediately stop taking the drug and consult a doctor as soon as possible.
If any of the above side effects are aggravated, or any other side effects occur, the patient should notify the doctor.
CONTRAINDICATIONS
- pronounced violations of the liver function;
- severe renal dysfunction;
- hyperthyroidism (including thyrotoxicosis);
- diabetes;
- deficiency of sugarase / isomaltase, fructose intolerance, glucose / galactose malabsorption syndrome, tk. the preparation contains sucrose;
- heart disease (pronounced stenosis of the aortic aorta, acute myocardial infarction, tachyarrhythmia);
- arterial hypertension;
- simultaneous reception of tricyclic antidepressants, beta-blockers, MAO inhibitors and up to 14 days after their cancellation;
- simultaneous administration of other paracetamol-containing drugs and agents to relieve the symptoms of colds, flu and nasal congestion;
benign prostatic hyperplasia;
- an angle-closure glaucoma;
- children's age till 12 years;
- Hypersensitivity to the components of the drug.
With caution should be used with a deficiency of glucose-6-phosphate dehydrogenase, benign hyperbilirubinemia, liver and kidney disease, with increased blood pressure, obliterating vascular diseases (Raynaud's syndrome), glaucoma (excluding closed-angle glaucoma), pheochromocytoma.
PREGNANCY AND LACTATION
Caution should be used during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindications: severe renal dysfunction; with caution: kidney disease
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindications: severe liver dysfunction; with caution: liver disease
APPLICATION FOR CHILDREN
Contraindication: children under 12 years.
SPECIAL INSTRUCTIONS
The patient should be informed that if the symptoms persist after 5 days of use, stop taking it and consult a doctor.
The drug should be taken only at recommended doses.
The patient should stop taking the drug and immediately consult a doctor if the following side effects occur:
-Allergic reactions: skin itching or redness of the skin, difficulty breathing or swelling of the lips, tongue, throat, or face;
- rash or scaling on the skin, the formation of sores on the oral mucosa;
- bruising or bleeding;
loss of vision. This may be a consequence of increased intraocular pressure. Very rarely, but this side effect is most likely in patients with glaucoma;
-feeling of a strong palpitation or an increase in heart rate or heart rhythm disturbances;
difficulty in urinating. More often this side effect is observed in patients with prostatic hypertrophy.
Do not take the drug, if previously observed breathing disorders with the intake of acetylsalicylic acid or other NSAIDs.
The drug should not be taken concurrently 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, appetite suppressants , amphetamine-like psychostimulants), with other drugs to relieve the symptoms of colds and flu.
When performing tests for the determination of uric acid and the level of glucose in the blood, the patient should inform the doctor about the use of the preparation Koldrex В® HotRem. the drug may distort the results of laboratory tests evaluating the concentration of glucose and uric acid.
Before taking the drug Coldrex В® HotRem (lemon), consult a doctor in the following cases:
- taking metoclopramide, domperidone (used to eliminate nausea and vomiting), or colestyramine, used to lower the concentration of cholesterol in the blood;
- taking medications to reduce blood clotting (for example, warfarin);
- Compliance with a diet with a reduced sodium content - each packet contains 0.12 g of sodium;
-higher infectious diseases (including sepsis) in patients with glutathione deficiency, because they are not infected with HIV. against the background of paracetamol, the risk of metabolic acidosis may increase, the signs of which are a violation of the frequency and depth of breathing, accompanied by a feeling of shortness of breath (shortness of breath), nausea, vomiting, loss of appetite. If the patient finds these, you should immediately consult a doctor.
Patients suffering from phenylketonuria, it is not recommended to take Coldrex В® HotRem (lemon-honey), tk. it contains aspartame, which is a source of phenylalanine. Before taking Coldrex В® HotRem (lemon-honey) preparation, a doctor should be consulted in the following cases:
- taking warfarin or other indirect anticoagulants;
- taking medications to control blood pressure, for example, beta-blockers;
- administration of digoxin or other cardiac glycosides for the treatment of heart failure;
- taking medications to reduce your appetite or psychostimulants;
- taking drugs to treat depression (tricyclic antidepressants - amitriptyline);
-consumption of metoclopramide, domperidone (used to eliminate nausea and vomiting) or colestyramine, used
to lower cholesterol in the blood;
-If necessary to observe the hyponatrial diet (each packet contains 0.12 g of sodium).
To avoid toxic damage to the liver, paracetamol should not be combined with the intake of alcoholic beverages, and should also be taken by persons who are chronically consuming alcohol.
Impact on the ability to drive vehicles and mechanisms
When taken in recommended doses, the drug does not affect the ability to drive vehicles and mechanisms, as well as engage in other potentially hazardous activities that require concentration and speed of psychomotor reactions. When dizziness occurs, it is not recommended to drive vehicles or work with mechanisms.
OVERDOSE
In case of an overdose of Coldrex В® HotRam (even if you feel well), you should consider the risk of delayed signs of serious liver damage.
Symptoms caused by paracetamol: within 24 hours - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; for 12-48 h may show signs of impaired liver function, signs of a violation of glucose metabolism and metabolic acidosis. Toxic effect in adults is possible after one-stage administration of more than 10 g of paracetamol - an increase in the activity of hepatic transaminases, a clinical picture of liver damage manifests itself after 1-6 days. In case of severe poisoning, severe hepatic insufficiency may develop, including hepatic encephalopathy, coma, and death. Acute renal failure with acute tubular necrosis, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without a serious impairment of liver function. There are reports of cases of cardiac arrhythmias and pancreatitis in case of an overdose of paracetamol.
In the early period, the symptomatology can be limited only by nausea and vomiting and may not reflect the severity of the overdose or the risk of injury to the internal organs.
Treatment: during the first hour after the alleged overdose, it is advisable to administer the activated carbon inside. After 4 or more hours after the alleged overdose, a determination of the paracetamol concentration in the plasma is required (an earlier determination of the paracetamol concentration may be unreliable). A specific antidote for paracetamol poisoning is acetylcysteine. Treatment with acetylcysteine ​​can be performed up to 24 hours after taking paracetamol, but the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After that, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine ​​can be administered iv. In the absence of vomiting, an alternative option (in the absence of the possibility of rapid receipt of inpatient care) is the appointment of methionine inside. Treatment of patients with severe impairment of liver function 24 hours after taking paracetamol should be done in conjunction with specialists from a toxicological center or specialized department of liver diseases.
Symptoms caused by phenylephrine : irritability, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, it is possible to develop hallucinations, confusion, seizures, arrhythmias. An overdose of phenylephrine can cause symptoms similar to side effects.
Treatment: symptomatic therapy, with severe arterial hypertension, the use of alpha-blockers, such as phentolamine.
Symptoms due to ascorbic acid: ascorbic acid in high doses (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances, such as nausea, discomfort in the stomach. Manifestations of an overdose of ascorbic acid can be categorized as those that are caused by severe liver damage as a result of an overdose of paracetamol.
Treatment: symptomatic, forced diuresis.
At the first signs of an overdose, it is necessary to immediately seek medical help, even if there are no distinct symptoms of poisoning.
DRUG 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 intake of a single dose of the drug has no significant effect on the effect of indirect anticoagulants.
Inducers of microsomal oxidation enzymes in the liver (barbiturates, diphenin, carbamazepine, rifampicin, zidovudine, phenytoin, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxic effects in overdoses and simultaneous administration with paracetamol.
Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects.
Paracetamol decreases the effectiveness of diuretic drugs.
Metoclopramide and domperidone are increased, and colestramine reduces the rate of absorption of paracetamol.
Paracetamol increases the effects of MAO inhibitors, sedatives, ethanol.
Phenylephrine when taken with MAO inhibitors may lead to an increase in blood pressure.
Phenylephrine reduces the effectiveness of beta-adrenoblockers and antihypertensive drugs, increases the risk of hypertension and cardiovascular disorders.
Simultaneous use of phenylephrine with sympathomimetic amines can increase the risk of side effects from the cardiovascular system.
Tricyclic antidepressants increase the sympathomimetic effect of phenylephrine, and may increase the risk of developing side effects from the cardiovascular system.
The simultaneous use of halothane with phenylephrine increases the risk of ventricular arrhythmia.
Phenylephrine reduces the hypotensive effect of guanethidine, which, in turn, enhances the alpha-adrenostimulating activity of phenylephrine.
Antidepressants, antiparkinsonics, antipsychotics, phenothiazine derivatives increase the risk of urinary retention, dry mouth, constipation.
Simultaneous administration of GCS with phenylephrine increases the risk of developing glaucoma.
When used simultaneously with digoxin and cardiac glycosides, there may be an increased risk of heart rhythm disturbances or heart attack.
Ascorbic acid increases the risk of developing crystalluria in the treatment of short-acting salicylates and sulfonamides, slows the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), and reduces the concentration of oral contraceptives in the blood.
Ethanol promotes the development of acute pancreatitis.
Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
TERMS OF RELEASE FROM PHARMACY
The drug is dispensed without a prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
