Citramon P tabs #20

Citramon P instruction for use

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Clinical and pharmacological group

An analgesic-antipyretics of a combined composition

Form of release, composition and packaging

Tablets of light brown color with patches, flat-cylindrical, with a risk and facet, with the smell of cocoa.
1 tab.
acetylsalicylic acid 240 mg
paracetamol 180 mg
caffeine (in terms of monohydrate) 30 mg
Excipients: cocoa powder - 22.5 mg, citric acid monohydrate - 5 mg, potato starch - 64.2 mg, talc - 4.9 mg, calcium stearate - 2.8 mg, polysorbate 80 - 0.6 mg.

pharmachologic effect

Combined drug.
Acetylsalicylic acid has antipyretic and anti-inflammatory effect, relieves pain, especially caused by the inflammatory process, and also moderately inhibits platelet aggregation and thrombosis, improves microcirculation in the inflammatory focus.
Paracetamol has analgesic, antipyretic and weak anti-inflammatory effects, which is related to its influence on the thermoregulatory center in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins (Pg) in peripheral tissues.
Caffeine increases the reflex excitability of the spinal cord, excites the respiratory and vasomotor centers, dilates the blood vessels of skeletal muscles, brain, heart, kidneys, reduces platelet aggregation; reduces drowsiness, fatigue. In this combination, caffeine in a small dose has practically no stimulating effect on the central nervous system, but it contributes to the regulation of the tone of the vessels of the brain.

Indications

- pain syndrome of mild and moderate severity (of various origins): headache, migraine, toothache, neuralgia, myalgia, arthralgia, algodismenorea;
- febrile syndrome: with acute respiratory diseases, incl. influenza.

Contraindications

- hypersensitivity to the components of the drug;
- erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);
- gastrointestinal bleeding (including in the anamnesis);
- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinus intolerance to acetylsalicylic acid or non-steroidal anti-inflammatory drugs (including in anamnesis);
- marked violations of the liver and / or kidney function;
- hemorrhagic diathesis, hypocoagulation, hemophilia, hypoprothrombinemia;
- Pregnancy (I and III trimesters);
- the period of breastfeeding;
- surgical interventions, accompanied by heavy bleeding;
- deficiency of glucose-6-phosphate dehydrogenase;
- glaucoma;
- severe arterial hypertension;
- portal hypertension;
- severe course of ischemic heart disease;
- avitaminosis K;
- Children under 15 years of age (the risk of developing Reye's syndrome in children with hyperthermia on the background of a viral disease);
- increased excitability, sleep disturbance.

Carefully

Renal failure of mild to moderate degree, liver disease, alcoholism, epilepsy and propensity to convulsive seizures, elderly age, gout, pregnancy (II trimester).

Dosage

Inside (during or after a meal), 1 tab. every 4 hours, with pain syndrome-1-2 tablets; the average daily dose is 3-4 tablets, the maximum daily dose is 8 tablets. The use of the drug is no more than 7-10 days.
To reduce the irritant effect on the gastrointestinal tract, you should drink the tablet with milk or alkaline mineral water.

Side effects

Side reactions typical of acetylsalicylic acid, paracetamol and caffeine can be observed: anorexia, nausea, vomiting, gastralgia (decreased platelet aggregation), erosive and ulcerative gastrointestinal lesions, gastrointestinal bleeding, allergic reactions, bronchospasm, multiforme exudative erythema (v. Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), renal insufficiency, hepatic insufficiency, dizziness, tachycardia, increased blood pressure.
With prolonged use, dizziness, headache, visual disturbances, tinnitus, reduced platelet aggregation, hypocoagulation, hemorrhagic syndrome (nosebleeds, bleeding gums, purpura, etc.), kidney damage with papillary necrosis; deafness, Reye's syndrome in children (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, impaired liver function).

Overdose

Do not exceed the recommended dose and duration of use!
Symptoms of overdose are due to acetylsalicylic acid.

Symptoms:

- with light intoxication: nausea, vomiting, stomach pain, dizziness, ringing in the ears;
- with severe intoxication: inhibition, drowsiness, collapse, convulsions, shortness of breath, anuria, bleeding.
Treatment: gastric lavage with activated charcoal, symptomatic therapy, depending on the state of metabolism - the introduction of sodium bicarbonate, sodium citrate or sodium lactate, which increases the excretion of acetylsalicylic acid due to urine alkalinization.

Drug Interactions

Strengthens the action of heparin, indirect anticoagulants, reserpine, steroid hormones and hypoglycemic drugs.
Simultaneous use with other non-steroidal anti-inflammatory drugs, methotrexate increases the risk of side effects.
Reduces the effectiveness of spironolactone, furosemide, antihypertensive drugs, as well as anti-arthritis drugs that promote the excretion of uric acid.
Barbiturates, rifampicin, salicylamide, antiepileptic drugs and other stimulants of microsomal oxidation contribute to the formation of toxic metabolites of paracetamol, which affect liver function.
Metoclopramide accelerates the absorption of paracetamol. Under the influence of paracetamol T1 / 2 chloramphenicol increases by 5 times. At repeated admission, paracetamol can enhance the effect of anticoagulants (dicumarin derivatives).
Caffeine accelerates the absorption of ergotamine.
With the simultaneous administration of the drug and alcohol-containing liquids, the risk of toxic damage to the liver increases.

special instructions

Acetylsalicylic acid slows blood clotting. If a patient is to undergo surgery, a doctor should be warned about taking the drug.
With continued use of the drug, control of peripheral blood and the functional state of the liver is necessary.
Patients with hypersensitivity or with asthmatic reactions to salicylic acid and its derivatives, including acetylsalicylic acid, can be prescribed only with special precautions (in emergency care settings).
In patients with a predisposition to the accumulation of uric acid, taking the drug may trigger a gout attack.
During the intake should refrain from drinking alcohol (increased risk of gastrointestinal bleeding and toxic damage to the liver).
Acetylsalicylic acid has a teratogenic effect; when applied in the first trimester leads to a developmental malformation - the cleavage of the upper palate; in the third trimester - to inhibition of labor (inhibition of Pg synthesis), to the closure of the arterial duct in the fetus, which causes hyperplasia of the pulmonary vessels and hypertension in the vessels of the small circle of blood circulation. Isolated with breast milk, which increases the risk of bleeding in the child due to impaired platelet function.
Children under 15 years of age should not be prescribed medications containing acetylsalicylic acid, since in the case of a viral infection they can increase the risk of developing Reye's syndrome. Symptoms of Reye's syndrome include prolonged vomiting, acute encephalopathy, and enlargement of the liver.
Influence on the management of the transport means and on the maintenance of machines and mechanisms requiring attention
There is no data on the impact on the management of vehicles and on the maintenance of machines and mechanisms that require concentration.

Pregnancy and lactemia

In pregnancy (I and III trimesters) and during breastfeeding, the drug is contraindicated. In the second trimester of pregnancy, the drug should be used with caution, correlating the perceived benefit to the mother and the potential risk to the fetus.

Application in childhood

It is forbidden to use the prep in children under the age of 15 (the risk of developing Reye's syndrome in children with hyperthermia in the presence of a viral disease);

In case of violations of kidney function

It is forbidden to apply the drug to patients with severe renal dysfunction.
With caution in renal failure of mild to moderate degree.

With violations of liver function

It is forbidden to apply the drug to patients with severe impairment of liver function.

Conditions of leave from pharmacies

The drug is approved for use as a means of OTC.

Terms and conditions of storage

The drug should be stored in a dry place inaccessible to children at a temperature of no higher than 25 ° C. Shelf life - 4 years.
After expiration date the drug should not be used.
Description of the drug CITRAMON P is based on an approved instruction for use and approved by the manufacturer.