Caffetin cold: instructions for use. Caffetin® Cold Tablets, Caffetin® Cold description of the medicinal product, Caffetin® Cold pharmacological actions and indications, as well as interactions of Caffetin® Cold with other drugs.

Drug for symptomatic treatment of acute respiratory diseases

Release form, composition and packaging

10 pcs. - contour cell packaging (1) - cardboard packs.

Pharmacological action

Paracetamol has analgesic and antipyretic effects. In the central nervous system it blocks cyclooxygenase, affecting the centers of pain and thermoregulation. Unlike non-steroidal anti-inflammatory drugs, paracetamol has virtually no anti-inflammatory effect. Does not cause irritation to the mucous membrane of the stomach and intestines. Has no effect on water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.

Pseudoephedrine promotes constriction of blood vessels in the mucous membrane of the nose and pharynx, reduces swelling, which leads to a decrease in secretion in the nasal cavity and easier nasal breathing.

Dextromethorphan acts on the cough center and increases the cough threshold, which leads to a decrease in dry cough associated with irritation of the nasopharyngeal mucosa in most “cold” diseases.

Ascorbic acid replenishes vitamin C deficiency in case of colds.

Pharmacokinetics

Suction paracetamol occurs mainly in the small intestine and maximum plasma concentration is usually achieved 0.5-1.5 hours after oral administration. The half-life of paracetamol from blood plasma is 1.5-2.5 hours. Metabolized in the liver (90-95%): 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which conjugate with glutathione to form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The isoenzyme CYP2E1 is also involved in the metabolism of the drug, T 1/2 - 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged. In elderly patients, the clearance of preiarate decreases and T1/2 increases.

Pseudoephedrine is well absorbed after oral administration, the maximum concentration in the blood plasma is reached after 1.5-2 hours. The half-life from the blood plasma is approximately 5.5 hours. Pseudoephedrine is partially metabolized in the liver to form an active metabolite and is excreted in the urine.

Dextromethorphan is well absorbed after oral administration and maximum plasma concentrations are usually achieved 2 hours after dosing. Dextromethorphan is metabolized in the liver and excreted in the urine unchanged and in the form of metabolites.

Ascorbic the acid is completely absorbed in the gastrointestinal tract and is well distributed in the tissues of the body. Ascorbic acid is reversibly oxidized to dehydroxyascorbic acid, and partially metabolized to ascorbate-2-sulfate; excreted in urine.

Indications

- symptomatic treatment of colds and flu ( headache, muscle pain, sore throat, elevated temperature body dry cough, runny nose, nasal and paranasal sinus congestion).

Contraindications

- hypersensitivity to the drug or any of its components;

- arterial hypertension, ischemic heart disease (coronary heart disease), angina pectoris;

- severe liver or kidney dysfunction, hepatitis;

- simultaneous use of MAO inhibitors (monoamine oxidase), antidepressants, antiparkysonic drugs;

- use of MAO inhibitors (monoamine oxidase) in the previous two weeks before starting the drug;

- congenital deficiency of glucose-6-phosphate dehydrogenase;

- children under 12 years of age;

- pregnancy, lactation period.

With caution: benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholism, arrhythmias, prostatic hyperplasia with urinary retention, diabetes mellitus, hyperthyroidism, bronchial asthma, COPD (chronic obstructive pulmonary disease), weakened and exhausted patients.

Dosage

The recommended dose of Caffetin Cold for adults and children over 12 years of age is one tablet 4 times a day. You can take 2 tablets at once. The interval between doses should be at least 4 hours. The maximum single dose is 2 tablets, and the maximum daily dose is 2 tablets 4 times within 24 hours.

If fever persists for more than 3 days from the start of treatment, and cough for more than 5 days, you should consult a doctor.

Side effects

From the digestive system: nausea, dry mouth, rarely, epigastric pain; with long-term use in large doses - hepatotoxicity.

From the side of the central nervous system: drowsiness, irritability, agitation, rarely - dizziness.

Allergic reactions: skin rash, skin itching, urticaria, angioedema.

From the cardiovascular system: promotion blood pressure, tachycardia.

From the hematopoietic organs: rarely - anemia, thrombocytopenia, agranulocytosis; with long-term use in large doses - hemolytic anemia, aplastic anemia, pancytopenia.

From the urinary system: with long-term use in large doses, nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis).

Overdose

Symptoms Pseudoephedrine - irritability, anxiety, tremor, convulsions, arrhythmias, arterial hypertension.

Paracetamol (especially in patients with impaired renal and hepatic function) - pallor of the skin, anorexia, nausea, vomiting, impaired liver function.

Dextromethorphan - nausea, vomiting, dizziness, drowsiness, blurred vision, lethargy, impaired coordination of movement, difficulty breathing.

Treatment. Gastric lavage in the first 6 hours, followed by activated carbon, symptomatic therapy, administration of SH-group donors and precursors for the synthesis of glutathione-methionine 8-9 hours after an overdose and acetylcysteine - after 12 hours.

Drug interactions

Concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs.

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) and hepatotoxic drugs increase the production of hydroxylated active metabolites of paracetamol, which makes it possible to develop severe intoxications even with a small dose.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney and bladder cancer. Long-term combined use of paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of developing “analgesic” nephropathy and renal papillary necrosis, and accelerates the onset of end-stage renal failure.

Diflunisal increases the plasma concentration of paracetamol by 50%, thereby increasing the risk of hepatotoxicity.

When pseudoephedrine is used concomitantly with other sympathomimetic drugs, medicines additive effects and development of toxic effects are possible; with monoamine oxidase inhibitors - the development of a hypertensive crisis is possible (the drug can be used no earlier than 2 weeks after stopping taking monoamine oxidase inhibitors).

Propranolol may enhance the pressor effect of pseudoephedrine; Pseudoephedrine may reduce the hypotensive effects of reserpine, methyldopa, mecamylamine and hellebore alkaloids.

Amiodarone, fluoxetine, quinidine, by inhibiting the cytochrome P450 system, can increase the concentration of dextromethorphan in the blood.

Special instructions

During the treatment period, peripheral blood parameters and the functional state of the liver are monitored.

For liver dysfunction

Contraindicated in severe liver dysfunction.

Conditions for dispensing from pharmacies

According to the recipe.

Storage conditions and periods

Store at a temperature not exceeding 25°C, out of the reach of children. Shelf life - 2 years

Instructions for the medicine Caffetin Cold, contraindications and methods of use, side effects and reviews about this drug. Doctors' opinions and the opportunity to discuss on the forum.

Medicine

Instructions for use

Name of the drug on English

Composition of Caffetin Cold

Film-coated tablets	1 table
active substances:
paracetamol (paracetamol granules DC 90%)*	500-555 mg
pseudoephedrine hydrochloride	30 mg
dextromethorphan hydrobromide***	15 mg
ascorbic acid (ascorbic acid DC 97%)**	60-62 mg
excipients: colloidal silicon dioxide; magnesium stearate; croscarmellose sodium; talc; MCC
film shell: Opadry II blue (indigo carmine (E132); macrogol (PEG 3350); polyvinyl alcohol, partially hydrolyzed; talc; titanium dioxide (E171)
*paracetamol used in granulate form. In 1 g of granulate - about 900 mg of paracetamol (paracetamol - 90%; pregelatinized starch - 8.4%; povidone (K30) - 0.6%; stearic acid - 1%)
** ascorbic acid used in granulate form. In 1 g of granulate - about 970 mg of ascorbic acid (ascorbic acid - 97%; hypromellose (hydroxypropyl methylcellulose - 3%)
***dextromethorphan hydrobromide according to Ph. Eur., dextromethorphan hydrobromide monohydrate

Release form Caffetin Cold

Film-coated tablets. 10 tablets each in a perforated blister made of aluminum foil and three-layer transparent film (PVC/TE/PVdC).

1 blister (10 tablets) is placed in a cardboard box.

Pharmacological action

Pharmacological action- antitussive, analgesic.

Pharmacokinetics

Absorption of paracetamol occurs mainly in the small intestine, and Tmax in blood plasma is usually 0.5-1.5 hours after oral administration.

T1/2 paracetamol from blood plasma - 1.5-2.5 hours.

Metabolized in the liver (90-95%): 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which conjugate with glutathione to form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The isoenzyme CYP2E1 is also involved in the metabolism of the drug. T1/2 - 1-4 hours. Excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% - unchanged. In elderly patients, drug clearance decreases and T1/2 increases.

Pseudoephedrine well absorbed after oral administration, Tmax in blood plasma is 1.5-2 hours. T1/2 from blood plasma is approximately 5.5 hours. Pseudoephedrine is partially metabolized in the liver to form an active metabolite and is excreted in the urine.

Dextromethorphan is well absorbed after oral administration, and Tmax in blood plasma is usually 2 hours after dosing. Dextromethorphan is metabolized in the liver and excreted in the urine unchanged and in the form of metabolites.

Ascorbic acid completely absorbed in the gastrointestinal tract and well distributed in the tissues of the body. Ascorbic acid is reversibly oxidized to dehydroxyascorbic acid and partially metabolized to ascorbate-2-sulfate; excreted in urine.

Indications for use: Caffetin Cold

Information on what Caffetin Cold helps with:

Symptomatic treatment of colds and flu (headache, muscle pain, sore throat, fever, dry cough, runny nose, nasal and sinus congestion).

Contraindications Caffetin Cold

hypersensitivity to the drug or any of its components;

arterial hypertension, coronary heart disease, angina pectoris;

severe liver or kidney dysfunction, hepatitis;

simultaneous use of MAO inhibitors, antidepressants, antiparkinsonian drugs or use of MAO inhibitors in the previous 2 weeks before starting the drug;

congenital deficiency of glucose-6-phosphate dehydrogenase;

pregnancy;

lactation period;

children's age (up to 12 years).

With caution: benign hyperbilirubinemia (including Gilbert's syndrome); viral hepatitis; alcoholism, arrhythmias, prostatic hyperplasia with urinary retention; diabetes mellitus, hyperthyroidism, bronchial asthma, chronic obstructive pulmonary disease, weakened and exhausted patients.

Directions for use and dosage Caffetin Cold

Inside.

The recommended dose of the drug for adults and children over 12 years of age is 1 tablet. 4 times a day. You can take 2 tablets. straightaway. The interval between doses should be at least 4 hours. The maximum single dose is 2 tablets, the daily dose is 8 tablets. (2 tablets 4 times a day for 24 hours).

If fever persists for more than 3 days from the start of treatment, and cough for more than 5 days, you should consult a doctor.

Side effects of Caffetin Cold

From the digestive system: nausea, dry mouth, rarely - epigastric pain; with long-term use in large doses - hepatotoxicity.

From the side of the central nervous system: drowsiness, irritability, agitation; rarely - dizziness.

Allergic reactions: skin rash, itching, urticaria, angioedema.

From the SSS side: increased blood pressure, tachycardia.

From the hematopoietic organs: rarely - anemia, thrombocytopenia, agranulocytosis; with long-term use in large doses - hemolytic anemia, aplastic anemia, pancytopenia.

From the urinary system: with long-term use in large doses - nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis).

Drug interactions

Concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney and bladder cancer.

Long-term combined use of paracetamol and NSAIDs increases the risk of developing analgesic nephropathy and renal papillary necrosis, and accelerates the onset of end-stage renal failure.

Diflunisal increases plasma concentrations by 50%, thereby increasing the risk of hepatotoxicity.

With the simultaneous use of pseudoephedrine with other sympathomimetic drugs, additive effects and the development of toxic effects are possible; with MAO inhibitors, the development of a hypertensive crisis is possible (the drug can be used no earlier than 2 weeks after stopping taking MAO inhibitors).

Propranolol may enhance the pressor effect of pseudoephedrine; Pseudoephedrine may reduce the hypotensive effects of reserpine, methyldopa, mecamylamine and hellebore alkaloids.

Amiodarone, fluoxetine, quinidine, by inhibiting the cytochrome P450 system, can increase the concentration of dextromethorphan in the blood.

Special instructions

During the treatment period, peripheral blood parameters and the functional state of the liver are monitored.

During treatment, it is necessary to refrain from consuming ethanol (possible development of hepatotoxic effects) and caffeine.

Impact on the ability to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions. These activities should be avoided.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Best before date

2 years.

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

LSR-006775/09-250809

Trade name: KAFFETIN® COLD

International nonproprietary or generic name: paracetamol + pseudoephedrine + dextromethorphan + ascorbic acid

Dosage form:

Compound

Active substances: 1 film-coated tablet contains paracetamol (paracetamol granules DC 90%) * 500.00 mg - 555.00 mg; pseudoephedrine hydrochloride 30 mg; dextromethorphan hydrobromide *** 15 mg and ascorbic acid (ascorbic acid DC 97%)** 60.00 mg-62.00 mg.

Excipients: colloidal silicon dioxide, magnesium stearate, croscarmellose sodium, talc, microcrystalline cellulose.

Shell: Opadry II blue (indigo carmine E132; macrogol (PEG 3350)); polyvinyl alcohol, partially hydrolyzed; talc; titanium dioxide E 171).
* Paracetamol is used in the form of granules: 1 g of granulate contains approximately 900 mg of paracetamol
Paracetamol 90.00%
Pregelatinized starch 8.40%
Povidone (K-30) 0.60%
Stearic acid 1.00%

** ascorbic acid is used in the form of granulate: 1 g of granulate contains about 970 mg of ascorbic acid ascorbic acid 97%
hypromellose (hydroxypropyl methylcellulose) 3%
*** dextromethorphan hydrobromide according to Ph. Eur dextromethorphan hydrobromide monohydrate

Description
Blue, oblong, biconvex, film-coated tablets with a score on one side.

Pharmacotherapeutic group:

A remedy for eliminating the symptoms of acute respiratory infections and “colds” (analgesic non-narcotic drug + sympathomimetic drug + antitussive opioid drug + vitamin)

ATX Code: R01BA52

Pharmacological properties

Pharmacodynamics
Paracetamol has analgesic and antipyretic effects. In the central nervous system it blocks cyclooxygenase, affecting the centers of pain and thermoregulation. Unlike non-steroidal anti-inflammatory drugs, paracetamol has virtually no anti-inflammatory effect. Does not cause irritation to the mucous membrane of the stomach and intestines. Does not affect water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.

Pseudoephedrine promotes vasoconstriction of the mucous membrane of the nose and pharynx, reduces swelling, which leads to a decrease in secretion in the nasal cavity and easier nasal breathing.

Dextromethorphan acts on the cough center and increases the cough threshold, which leads to a decrease in dry cough associated with irritation of the nasopharyngeal mucosa in most “cold” diseases. Ascorbic acid replenishes vitamin C deficiency in case of colds.

Pharmacokinetics
Absorption of paracetamol occurs mainly in the small intestine and the maximum concentration in the blood plasma is usually achieved 0.5-1.5 hours after oral administration. The half-life of paracetamol from blood plasma is 1.5-2.5 hours. Metabolized in the liver (90-95%): 80% enters into conjugation reactions with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which conjugate with glutathione to form inactive metabolites. With a lack of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. The CYP2E1 isoenzyme is also involved in the metabolism of the drug. T1/2 - 1-4 hours. Excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged. In elderly patients, drug clearance decreases and T1/2 increases.

Pseudoephedrine is well absorbed after oral administration, the maximum concentration in the blood plasma is reached after 1.5-2 hours. The half-life from the blood plasma is approximately 5.5 hours. Pseudoephedrine is partially metabolized in the liver to form an active metabolite and is excreted in the urine.

Dextromethorphan is well absorbed after oral administration and maximum plasma concentrations are usually achieved 2 hours after dosing. Dextromethorphan is metabolized in the liver and excreted in the urine unchanged and in the form of metabolites. Ascorbic acid is completely absorbed in the gastrointestinal tract and is well distributed in the tissues of the body. Ascorbic acid is reversibly oxidized to dehydroxyascorbic acid, and partially metabolized to ascorbate-2-sulfate; excreted in urine.

Indications for use
Symptomatic treatment of “colds” and flu (headache, muscle pain, sore throat, fever, dry cough, runny nose, nasal and sinus congestion).

Contraindications
Hypersensitivity to the drug or any of its components.
Arterial hypertension, ischemic heart disease (coronary heart disease), angina pectoris.
Severe liver or kidney dysfunction, hepatitis.
Simultaneous use of MAO inhibitors (monoamine oxidase), antidepressants, antiparkinsonian drugs. Use of MAO inhibitors (monoamine oxidase) in the previous two weeks before starting the drug
Congenital deficiency of glucose-6-phosphate dehydrogenase.
Childhood up to 12 years old.
Pregnancy, lactation period.

With caution:
benign hyperbilirubinemia (including Gilbert's syndrome), viral hepatitis, alcoholism, arrhythmias, prostatic hyperplasia with urinary retention, diabetes mellitus, hyperthyroidism, bronchial asthma, COPD (chronic obstructive pulmonary disease), weakened and exhausted patients.

Directions for use and doses
The recommended dose of Caffetin Cold for adults and children over 12 years of age is one tablet 4 times a day. You can take 2 tablets at once. The interval between doses should be at least 4 hours. The maximum single dose is 2 tablets, and the maximum daily dose is 2 tablets 4 times within 24 hours.

If fever persists for more than 3 days from the start of treatment, and cough for more than 5 days, you should consult a doctor.

Side effect
From the digestive system: nausea, dry mouth, rarely, epigastric pain; with long-term use in large doses - hepatotoxicity.
From the side of the central nervous system: drowsiness, irritability, agitation, rarely - dizziness.
Allergic reactions: skin rash, itching, urticaria, angioedema.
From the cardiovascular system: increased blood pressure, tachycardia.
From the hematopoietic organs: rarely - anemia, thrombocytopenia, agranulocytosis, with long-term use in large doses - hemolytic anemia, aplastic anemia, pancytopenia.
From the urinary system: with long-term use in large doses, nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis).

Overdose
Symptoms Pseudoephedrine - irritability, anxiety, tremor, convulsions, arrhythmias, arterial hypertension. Paracetamol (especially in patients with impaired renal and liver function) - pallor of the skin, anorexia, nausea, vomiting, impaired liver function. Dextromethorphan - nausea, vomiting, dizziness, drowsiness, blurred vision, lethargy, impaired coordination of movement, difficulty breathing.

Treatment. Gastric lavage in the first 6 hours, followed by the administration of activated charcoal, symptomatic therapy, administration of SH-group donors and precursors for the synthesis of glutathione-methionine 8-9 hours after an overdose and acetylcysteine after 12 hours.

Interaction with other drugs
Concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs. Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) and hepatotoxic drugs increase the production of hydroxylated active metabolites of paracetamol, which makes it possible to develop severe intoxications even with a small dose.

Long-term use of barbiturates reduces the effectiveness of paracetamol. Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney and bladder cancer. Long-term combined use of paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of developing “analgesic” nephropathy and renal papillary necrosis, and accelerates the onset of end-stage renal failure.

Diflunisal increases the plasma concentration of paracetamol by 50%, thereby increasing the risk of hepatotoxicity.

With the simultaneous use of pseudoephedrine with other symlatomimetic drugs, additive effects and the development of toxic effects are possible; with monoamine oxidase inhibitors - the development of a hypertensive crisis is possible (the drug can be used no earlier than 2 weeks after stopping taking monoamine oxidase inhibitors).

Propranolol may enhance the pressor effect of pseudoephedrine; Pseudoephedrine may reduce the hypotensive effects of reserpine, methyldopa, mecamylamine and hellebore alkaloids.

Amiodarone, fluoxetine, quinidine, by inhibiting the cytochrome P450 system, can increase the concentration of dextromethorphan in the blood.

Special instructions
During the treatment period, peripheral blood parameters and the functional state of the liver are monitored.

During the treatment period, it is necessary to refrain from drinking ethanol (possible development of hepatotoxic effects) and caffeine, driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form
Film-coated tablets.

10 tablets each in a perforated blister made of aluminum foil and three-layer transparent film (PVC/TE/PVdC).

1 blister (10 tablets) along with instructions for use are placed in a cardboard box.

Storage conditions
Store at a temperature not exceeding 25°C, out of the reach of children.

Best before date
2 years. Do not use after expiration date.

Conditions for dispensing from pharmacies
Dispensed with a doctor's prescription.

Manufacturer
ALKALOID JSC, Republic of Macedonia. Boulevard Aleksandar Makedonski 12, 1000 Skopje.

Moscow representative office address: 117292 Moscow, st. Dmitry Ulyanov 16/2 - 267

When packaging the drug at ZAO PharmFirma Sotex, consumer complaints should be sent to: 141345, Moscow region, Sergiev Posad district, village Svatkovo, p/o Svatkovo