Caffetin - instructions for use, dose, side effects, contraindications

Active substanceCodeine + Caffeine + Paracetamol + PropyphenazoneCodeine + Caffeine + Paracetamol + Propyphenazone

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Dosage form: & nbsppills

Composition:

for 1 tablet:

Active substances: paracetamol 250.00 mg, propiphenazone 210.00 mg, caffeine 50.00 mg, codeine phosphate sesquihydrate 10.00 mg.

Excipients: glyceryl dibehenate 6.30 mg, calcium hydrophosphate dihydrate 21.10 mg, carboxymethyl starch sodium 14.50 mg, silicon dioxide colloidal anhydrous 2.50 mg, croscarmellose sodium 9.60 mg, magnesium stearate 13.50 mg, sodium lauryl sulfate 1.50 mg, povidone 12.50 mg, cellulose microcrystalline 28.50 mg.

Description:

Round, flat tablets of white color with a bevel, with engraving "©" on one side and "CAFFETIN" another.

Pharmacotherapeutic group:analgesic combined (antitussive opioid means + NSAIDs + analgesic non-narcotic remedy + psychostimulating agent).

ATX: & nbsp

N.02.B.E.71 Paracetamol in combination with psycholeptics

Pharmacodynamics:

Combined drug, the effect of which is determined by the components that make up its composition.

Paracetamol has antipyretic, analgesic effect.

Caffeine stimulates the psychomotor centers of the brain, has an analeptic effect,enhances the effect of analgesics, reduces drowsiness and fatigue, increases mental and physical performance, increases heart rate, increases blood pressure in arterial hypotension. Caffeine improves the absorption of other active ingredients of the combined analgesic preparation.

Codeine has a central antitussive effect (by suppressing the excitability of the cough center), as well as an analgesic effect caused by the excitation of opiate receptors in various parts of the central nervous system and peripheral tissues, leading to stimulation of the antinociceptive system and a change in the emotional perception of pain.

Propyphenazone has analgesic and antipyretic effect. Anesthetic effect of the drug is achieved within 30 - 60 minutes, and the duration of anesthesia is 4-8 hours.

Pharmacokinetics:

Paracetamol. Absorption is high, maximum concentrations in the plasma are achieved after 0.5-2 hours after administration. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier. Metabolised in the liver in three main ways: conjugation with glucuronides, conjugation with sulfates, oxidation with microsomal enzymes of the liver.In the latter case, toxic intermediate metabolites are formed, which are subsequently conjugated to glutathione. With a deficiency of glutathione, these metabolites can cause damage and necrosis

hepatocytes. The half-life is 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates.

Propyphenazone. Quickly absorbed from the gastrointestinal tract. Maximum concentrations in the plasma are reached approximately in 0,5 - 0,6 hours after administration. Metabolized in the liver and excreted in the urine and bile in the form of metabolites. The half-life is 2.1 - 2.4 hours.

Codeine. After oral administration, it is rapidly absorbed. Maximum plasma concentrations are achieved through 2-4 hours. The connection with plasma proteins is 30%. Metabolized in the liver to active metabolites. It is excreted by the kidneys and with bile. The half-life is 2.5-4 hours.

Caffeine. When ingested absorption is good, occurs throughout the intestine. The maximum concentration in the blood plasma is reached after 50-75 minutes after ingestion. Quickly distributed in all organs and tissues of the body; easily penetrates the blood-brain barrier and the placenta.Connection with blood proteins (albumins) - 25 - 36 %. Metabolism in the liver is exposed to more than 90%. The half-life is 3.9-5.3 hours. The excretion of caffeine and its metabolites is carried out by the kidneys.

Indications:

Pain syndrome of moderate severity of different genesis: headache and toothache, migraine, neuralgia, myalgia, post traumatic pains, arthralgia, algodismenorea.

Contraindications:

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

Hypersensitivity, hepatic and / or renal insufficiency; leukopenia; violation of hematopoiesis; anxiety disorders (agoraphobia, panic disorder); organic diseases of the cardiovascular system (including acute myocardial infarction, atherosclerosis, stenocardia); arrhythmias, arterial hypertension; deficiency of glucose-6-phosphate dehydrogenase; sleep disorders; pregnancy and lactation; children's age till 18 years.

Carefully:

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

Acute abdominal pain of unclear etiology, asthma attack, COPD, seizures, drug dependence (including in history), alcoholism, increased excitability, benign hyperbilirubinemia (incl.Gilbert's syndrome), viral hepatitis, glaucoma, and advanced age.

Pregnancy and lactation:contraindicated

Dosing and Administration:

Inside, adults - 1 tablet 3-4 times a day. For severe pain, taking 2 tablets at once is recommended. The maximum daily dose is 6 tablets. The duration of taking the drug is no more than 5 days. An increase in the daily dose of the drug or the duration of treatment is possible only after consulting a doctor.

Side effects:

From the nervous system and sense organs: increased excitability, tremor, anxiety, insomnia.

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

From the digestive system: exacerbation of peptic ulcer, increased activity of "liver" transaminases, nausea, vomiting.

Allergic reactions: less often - skin rash, hives, itching, face swelling, bronchospasm, laryngeal edema, laryngospasm, angioedema.

Disorders of hematopoiesis: rarely - anemia, thrombocytopenia, methemoglobinemia; leukopenia, agranulocytosis.

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

Overdose:

Symptoms: In the case of an overdose, each active ingredient can cause specific symptoms.

Paracetamol: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12 to 48 hours after an overdose. Hepatotoxic effect in adults is manifested when taking 10 g or more.

Caffeine: in doses of more than 300 mg / day (including against the background of the abuse of coffee - more than 4 cups of natural coffee of 150 ml) can cause anxiety, tremor, headache, confusion, extrasystole.

Codeine: Symptoms of acute and chronic overdose: cold clammy sweat, confusion, dizziness, drowsiness, decreased blood pressure, nervousness, fatigue, bradycardia, severe weakness, slow labored breathing, hypothermia, anxiety, cramps, convulsions.

Treatment: gastric lavage, reception of activated charcoal, maintenance of cardiac activity and blood pressure, maintenance therapy.

Intravenous introduction of a specific antagonist opioid analgesics - naloxone.

Introduction donators SH-groups and precursors of the synthesis of glutathione-methionine for 8 to 9 hours after an overdose and acetylcysteine-for 8 hours.

If you suspect a poisoning, you should immediately seek medical help.

Interaction:

Caffeine: with the joint use of caffeine and barbiturates, anticonvulsant drugs, it is possible to increase metabolism and increase caffeine clearance; cimetidine, oral contraceptive drugs, disulfiram, ciprofloxacin, norfloxacin - a decrease in the metabolism of caffeine in the liver.

Reduces the effect of narcotic and hypnotic drugs.

Joint use of caffeine with beta-blockers can lead to mutual suppression of therapeutic effects; with adrenergic bronchodilating drugs - to additional stimulation of the central nervous system and other additive toxic effects.

Caffeine accelerates the absorption of ergotamine.

MAO inhibitors - large doses of caffeine can cause the development of dangerous cardiac arrhythmias or a marked increase in blood pressure.

Caffeine can reduce the clearance of theophylline and, possibly, other xanthines, increasing the possibility of additive pharmacodynamic and toxic effects. Codeine: with the simultaneous use of ethanol, muscle relaxants, as well as drugs that depress the central nervous system, it is possible to strengthen the sedation effect, suppress the respiratory center and inhibit the central nervous system.

Drugs with anticholinergic activity, antidiarrhoeal drugs (incl. loperamide) increase the risk of constipation.

Reduces the effect of metoclopramide.

Paracetamol: inducers of microsomal oxidation in the liver (anticonvulsant drugs, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which allows the development of severe intoxication even with a slight overdose.

The concomitant use of paracetamol in high doses can enhance the effect of indirect anticoagulants (dicumarin derivatives).

Reduces the effectiveness of uricosuric drugs.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Under the influence of paracetamol T 1/2 Chloramphenicol increased by 5 times. Metoclopramide accelerates the absorption of paracetamol.

Special instructions:

Without consulting a doctor, the drug is taken no more than 5 days.At long (more than 1 week) application control of a picture of peripheric blood and a functional status of a liver is necessary.

During the use of the drug should be abandoned the use of ethanol (increased risk of hepatotoxicity).

Distorts the indicators of laboratory studies in the quantitative determination of glucose and uric acid in plasma.

Taking the drug may change the results of doping control tests of athletes, and also make it difficult to establish a diagnosis in acute abdominal pain syndrome.

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

Influence on the ability to drive vehicles and engage in other activities that require concentration of attention and speed of psychomotor reactions.

During treatment, care must be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Pills.

Packaging:

Primary packaging. 6 or 10 tablets per perforated strip of AL / PE foil.
Secondary packaging. 1 strip (10 tablets) or 2 strips (6 tablets each), along with instructions for use, are placed in a cardboard box.

Storage conditions:

At a temperature of 15 to 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:П N015444 / 01

Date of registration:21.11.2008

The owner of the registration certificate:Alkaloid, JSCAlkaloid, JSC Macedonia

Manufacturer: & nbsp

ALKALOID, AD Macedonia

Information update date: & nbsp28.02.2011

Illustrated instructions

Instructions

Kaffetin® (Caffetin® )