Kaffetin KOLDMAX® (Caffetin COLDmax®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceParacetamol + PhenylephrineParacetamol + Phenylephrine
Dosage form: & nbspPowder for solution for oral administration
Composition:

One package contains:

Active substances: paracetamol 1000.00 mg; phenylephrine hydrochloride 12.20 mg.

Excipients: sucrose 3821.60 mg; ascorbic acid 50.00 mg; citric acid 38.40 mg; sodium citrate 29.40 mg; aspartame 35.00 mg; sodium saccharinate 14.40 mg; silicon dioxide colloid 5,00 mg; flavored lemon "MN", code 143 -48.00 mg [lemon oil natural (code 5243), lemon oil natural (code 5051) -13.2%; maltodextrin 20.9%; mannitol - 38.3%; gluconolactone - 16,7%; acacia gum (gum arabic) - 9.3%; sorbitol - 1,2%; silicon dioxide colloidal -0.4%]; flavoring lemon "OS", code 134 - 96.00 mg [flavoring lemon (code 5090R), lime flavor (code 5151), lemon oil natural (code 5050) -15.0%; maltodextrin - 49.85%; mannitol - 19.8%; gluconolactone - 8.7%; acacia gum (arabic gum) - 6.0%; sorbitol - 0.6%; a - tocopherol (E307) - 0.05%].

The weight of the contents of one packet is 5.15 g.

Description:Powder white with a yellowish tinge of color, with a characteristic odor.
Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic remedy + alpha-addressimimetic)
ATX: & nbsp

N.02.B.E   Anilides

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

Pharmacodynamics:

Combination drug containing analgesic non-narcotic remedy paracetamol and alpha-adrenoimimetic phenylephrine.

Paracetamol has antipyretic and analgesic effect, these effects are due to inhibition of the synthesis of prostaglandins in the central nervous system. The drug contains the maximum single dose of paracetamol, permitted for over-the-counter use.

Phenylephrine narrows the vessels and reduces the swelling of the nasal mucosa, facilitating nasal congestion.

The effect occurs 15-20 minutes after taking the drug and lasts 4-6 hours.

Pharmacokinetics:

Suction. Absorption of paracetamol occurs quickly and almost completely predominantly in the small intestine. The maximum concentration in the blood plasma is achieved after 0.5-1.5 hours after ingestion. Phenylephrine poorly absorbed from the gastrointestinal tract.

Distribution. Paracetamol evenly distributed in most body tissues. The estimated volume of distribution is 0.95 l / kg.

Phenylephrine is characterized by low bioavailability when administered orally as a result of the metabolism of the "first pass".

Metabolism. Paracetamol metabolized and liver with the formation of glucuronide and sulfate conjugates. About 10% of administered paracetamol is converted into a reactive metabolite, atsetamidohinon that rapidly conjugated with glutathione. When high doses of acetaminophen hepatic glutathione reserves depleted, whereby atsetamidohinon intensively accumulates in the liver, causing liver necrosis.

Phenylephrine is metabolized in the liver by monoamine oxidase (MAO).

Excretion. The half-life of paracetamol when used in therapeutic doses is 1.5-2.5 hours. It is excreted in the urine in the form of glucuronides and sulfate compounds.

The average half-life of phenylephrine from plasma is 2-3 hours. Phenylephrine is excreted in the urine as a sulfuric acid conjugate.

Indications:To eliminate and alleviate the symptoms of acute respiratory infections ("colds") and influenza: fever, headache, muscle pain, sore throat and paranasal sinuses, chills, nasal congestion, runny nose.
Contraindications:

If you have any of these diseases, consult a doctor before taking the drug.

Hypersensitivity to paracetamol and other components of the drug; simultaneous reception of beta adrenoblockers, tricyclic antidepressants, MAO inhibitors (including within 14 days after their cancellation); sugarase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (because the preparation contains sucrose and sorbitol); phenylketonuria (because the drug contains aspartame); deficiency of glucose-6-phosphate dehydrogenase; arterial hypertension; diseases of the cardiovascular system (pronounced atherosclerosis of the coronary arteries, ischemic heart disease, severe aortic stenosis, acute myocardial infarction, tachyarigmia); thyrotoxicosis; pheochromocytoma; angle-closure glaucoma; hyperplasia of the prostate; severe renal and / or hepatic insufficiency; pregnancy or lactation; children's age (under 18 years).

Carefully:

If you have any of these diseases, consult a doctor before taking the drug.

Bronchial asthma, chronic obstructive pulmonary disease, blood diseases, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor), hyperoxalaturia.

The drug should not be combined with ethanol. During the treatment period it is necessary to refrain from taking sleeping pills, anxiolytic (tranquilizers) medicines, as well as other medications containing paracetamol.

Pregnancy and lactation:The drug is contraindicated during pregnancy and during lactation.
Dosing and Administration:

Inside, previously dissolving the contents of 1 packet (corresponds to 1 single dose) in a glass of hot water, but not boiling water.

Adults - 1 packet every 4-6 h, but not more than 4 packets within 24 hours. The interval between doses of the drug should be at least 4 hours. The maximum daily dose is 4 packages. The drug is not recommended for more than 5 days as an anesthetic and 3 days as an antipyretic agent without consulting a doctor. Do not exceed the indicated dose.

Side effects:

Side effects are classified according to organ systems and frequency. The frequency of side effects is defined as follows: very often (greater than or equal to 1/10), often (greater than or equal to 1/100 and less than 1/10), infrequently (greater than or equal to 1/1000 and less than 1/100), rarely greater than or equal to 1/10000 and less than 1/1000), very rarely (greater than or equal to 1/100 000 and less than 1/10 000).

Paracetamol

Allergic reactions: rarely: skin rashes, hives, angioedema, anaphylaxis, bronchospasm; very rarely: Stevens-Johnson syndrome.

From the central nervous system: rarely: dizziness, falling asleep, increased excitability.

From the urinary system: rarely: nephrotoxicity (papillary necrosis).

From the digestive system: rarely: hepatotoxic effect, nausea, vomiting, dryness of the oral mucosa.

Co sides of hemopoiesis: rarely: aplastic anemia, methemoglobinemia; very rarely: thrombocytopenia, agranulocytosis, neutropenia, leukopenia, pancytopenia, hemolytic anemia.

From the cardiovascular system: rarely: increased blood pressure, tachycardia.

Phenylephrine

Allergic reactions: rarely: skin rash, hives, anaphylaxis, bronchospasm.

From the central nervous system: very rarely: insomnia, nervousness, tremor, anxiety, increased excitability, confusion, irritability and headache.

From the urinary system: very rarely: dysuria, urinary retention.

From the digestive system: often: anorexia, nausea, vomiting.

Co side of the senses: very rarely: paresis of accommodation, mydriasis, increased intraocular pressure.

Co cardiovascular system: rarely: increased blood pressure, tachycardia.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Paracetamol

Liver involvement is possible in adults who take 10 or more grams of paracetamol. Taking 5 or more grams of paracetamol can cause liver damage if there are risk factors: prolonged treatment with carbamazepine, phenobarbital, phenytoin, primidon, rifampicin, St. John's wort preparations or other drugs,inducing liver enzymes, alcohol abuse, lack of glutathione (eg, malnutrition), cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms of overdose caused by paracetamol in the first 24 hours: pallor of the skin, nausea, vomiting, anorexia and pain in the abdomen. Liver damage can occur between 12 and 48 hours after application of the drug. There may also be signs of impaired glucose metabolism and metabolic acidosis. In case of an overdose of paracetamol, despite the presence of the primary symptoms of an overdose, it is necessary to seek qualified help in medical institutions. To prevent serious consequences of overdose, it is necessary to take the necessary measures in time.

Symptoms may manifest only partially, in the form of nausea or vomiting, and may not reflect the actual degree of overdose or the risk of organ damage. In severe overdose - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis.

Phenylephrine

Symptoms of an overdose of phenylephrine include irritability, headache, increased blood pressure.

In case of the above symptoms of an overdose, it is necessary to consult a doctor.

Treatment: introduction of donors of SH-groups and precursors of glutathione-methionine synthesis within 8-9 hours after overdose and acetylcystsine - within 8 hours. The need for additional therapeutic measures (further introduction of methionine, intravenous injection of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:

Stimulants of microsomal oxidation in the liver (incl. phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants, etc.) increase the production of hydroxylated active metabolites of paracetamol, which allows the development of severe intoxications. Paracetamol reduces the effectiveness of uricosuric medicines. The rate of absorption of paracetamol is increased by the action of metoclopramide or domperidone and decreases by the action of colestyramine.

The anticoagulant effect of warfarin and other coumarin derivatives increases with prolonged use of paracetamol.

The drug enhances the effects of MAO inhibitors, sedatives, ethanol. With the simultaneous use of phenylephrine with antidepressants, antiparkinsonian drugs, antipsychotic drugs, phenothiazine derivatives, urinary retention, dry mouth, constipation is possible. When used with glucocorticosteroids, the risk of developing glaucoma increases. Tricyclic antidepressants enhance the adrenosomimetic effect of phenylephrine, the simultaneous administration of halothane increases the risk of ventricular arrhythmia.

If you are taking other medications, consult a doctor before taking the drug to avoid drug interactions.

Special instructions:

The drug should not be combined with ethanol. During the treatment period it is necessary to refrain from taking sleeping pills, anxiolytic (tranquilizers) medicines, as well as other medications containing paracetamol.

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

Each sachet contains approximately 3.9 g of sucrose. It should be taken into account in patients with diabetes mellitus. Patients with a rare congenital intolerance to fructose or glucose-galactose malabsorption or sugar-isomaltase deficiency should not take the drug.

The preparation contains aspartame, which is a derivative of phenylalanine, which is for patients with phenylketonuria.

The preparation contains sorbitol (in the composition of lemon flavor). Patients with a rare congenital intolerance to fructose should not take the drug. If symptoms persist for more than 5 days, you should consult your doctor.

Effect on the ability to drive transp. cf. and fur:There were no reports of the negative effect of the drug Kaffetin KOLDMAX on the ability to drive vehicles and mechanisms. In case of side effects of the drug should be refrained from driving and other potentially hazardous activities.
Form release / dosage:
Powder for solution for oral administration.
Packaging:

Primary packaging: 5.15 g of powder is placed in hermetically sealed bags of paper with laminated aluminum foil.

Secondary packaging: For 10 packets together with the instruction for use are placed in a cardboard box.

Storage conditions:Store in a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
Shelf life:3 years. Do not use after expiry date.
Terms of leave from pharmacies:Without recipe
Registration number:LP-003283
Date of registration:30.10.2015
Expiration Date:30.10.2020
Date of cancellation:2020-10-30
The owner of the registration certificate:Alkaloid, JSCAlkaloid, JSC Macedonia
Manufacturer: & nbsp
Representation: & nbspALKALOID, AOALKALOID, AO
Information update date: & nbsp26.12.2017
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