Citramon-Borimed tablets №6×1

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Citramon-Borimed tabl. in kont.byach pack No. 6×1
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Light brown tablets with white patches, with cocoa smell, with a flat surface, a notch and a bevel. The main active ingredient Acetylsalicylic acid + caffeine + paracetamol Release form tablets Pharmacological properties Pharmacodynamics Acetylsalicylic acid has analgesic, antipyretic and anti-inflammatory properties, primarily due to inhibition of the biosynthesis of prostaglandins and thromboxanes from arachidonic acid by irreversible acetylation of the cyclooxygenase enzyme (COX). Paracetamol has analgesic and antipyretic properties, but unlike acetylsalicylic acid, it does not inhibit platelet aggregation. The addition of caffeine increases the antinociceptive effects of acetylsalicylic acid and paracetamol. PharmacokineticsAcetylsalicylic acid After oral administration, absorption usually occurs quickly and in full. Acetylsalicylic acid is largely hydrolyzed to salicylates in the gastrointestinal tract, liver and blood, and then further metabolized, primarily in the liver. Paracetamol Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations. This occurs within 30 minutes to 2 hours after ingestion. Paracetamol is metabolized in the liver and excreted in the urine mainly as glucuronide and sulfate conjugates. Less than 5% of paracetamol is excreted unchanged from the body. The half-life is from 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, but increases with increasing concentrations. The hydroxylated metabolite, which is usually formed in very small amounts in the liver by mixed-function oxidases and which is usually detoxified by conjugation with hepatic glutathione, can accumulate as a result of paracetamol overdose and cause liver damage. Caffeine Caffeine is completely and rapidly absorbed after oral administration at maximum concentrations. This occurs within 5-90 minutes after taking a dose on an empty stomach. There is no evidence for first pass metabolism. In adults, there is a pronounced individual variability in the rate of excretion. The mean plasma half-life is 4.9 hours with a range of 1.9-12.2 hours. Caffeine is distributed to all body fluids. The average binding of caffeine to plasma proteins is 35%. Caffeine is almost completely metabolized by oxidation, demethylation and acetylation and excreted in the urine. The main metabolites are 1-methylxanthine, 7-methylxanthine, 1,7-dimethylxanthine (paraxanthine). Minor metabolites include 1-methyluric acid and 5-acetylamino-6-formylamino-3-methyluracil (AMFU). Combination In a combination of three active ingredients, the amount of each substance is low. Therefore, there is no suppression of elimination processes with subsequent risks of increased half-life and toxicity. Pharmacokinetic data for the fixed combination of acetylsalicylic acid, paracetamol and caffeine correspond to the pharmacokinetic profiles established either for each substance separately or for the combination of each analgesic component with caffeine. Critical drug interactions between acetylsalicylic acid, paracetamol and caffeine, or any increased risks of interactions with other drugs when used together, are not known. Interactions between the three active substances were not observed. Indications for use Citramon-Borimed is indicated for adults for the treatment of acute headache. Dosage and administrationAdults The usual recommended dose is 1 tablet; you can take an additional tablet, the interval between doses should be from 4 to 6 hours. In case of very severe pain, if necessary, you can take 2 more tablets, the interval between doses should be from 4 to 6 hours. Citramon-Borimed is intended for intermittent use, with a headache it can be taken up to 4 days. For headaches, the medication should be limited to no more than 6 tablets per 24 hours. The drug should not be used for a longer period of time or at a higher dosage without first consulting a doctor. Each dose should be taken with a full glass of water. Children and adolescents (under 18 years of age) The safety and efficacy of Citramon-Borimed in children and adolescents have not been evaluated. Therefore, the use of the drug in children and adolescents is not recommended (see section “Precautions”). Elderly patients Based on general medical advice, caution should be exercised when taking the drug in elderly patients, especially elderly patients with low body weight. Hepatic and renal insufficiency The effect of hepatic or renal insufficiency on the pharmacokinetics of Citramon-Borimed has not been evaluated. Due to the mechanism of action of acetylsalicylic acid (aspirin) and paracetamol, renal or hepatic failure may increase. Thus, Citramon-Borimed is contraindicated in patients with severe hepatic or renal insufficiency (see section “Contraindications”). It should be used with caution in patients with mild or moderate hepatic or renal insufficiency. Application during pregnancy and lactation Pregnancy There is no information on the use of Citramon-Borimed in pregnant women. Animal studies have not been conducted on the combination of acetylsalicylic acid (aspirin), paracetamol and caffeine. Acetylsalicylic acid Due to the presence of acetylsalicylic acid in the drug, its use is contraindicated in the third trimester of pregnancy (see section “Contraindications”), care should be taken when using the drug in the first two trimesters of pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Epidemiological data suggest an increased risk of miscarriage, heart failure, and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. It is believed that the risk increases with increasing dose and duration of treatment. It has been shown that the administration of prostaglandin synthesis inhibitors in animals leads to an increase in pre-implantation losses, post-implantation losses, and embryo/fetal death. In addition, an increase in the number of cases of the development of various disorders, including cardiovascular, was recorded in animals that were injected with prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters of pregnancy, acetylsalicylic acid (aspirin) should not be prescribed unless clearly necessary. If acetylsalicylic acid (aspirin) is used by a woman trying to conceive or during the first and second trimesters of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may have the following effects: On the fetus: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydroamniosis; On the mother and newborn : at the end of pregnancy – a possible prolongation of bleeding time, an antiplatelet effect that can occur even when taking very low doses; inhibition of uterine contractions, leading to a delay or prolonged labor. Therefore, acetylsalicylic acid is contraindicated during the third trimester of pregnancy. Paracetamol Epidemiological studies show that therapeutic doses of paracetamol can be used during pregnancy. However, it should only be used after a careful assessment of the risk/benefit ratio. Caffeine Pregnant women are advised to limit caffeine intake to a minimum, as available data on the effects of caffeine on the fetus indicate a potential risk. Breastfeeding Salicylates, paracetamol and caffeine are excreted in breast milk. Caffeine may affect the behavior of an infant (anxiety, poor sleep). Salicylates can also have a potentially harmful effect on infant platelet function (may cause minor bleeding), although no cases have been reported. In addition, the use of acetylsalicylic acid has the potential to influence the development of Reye’s syndrome in infants. Therefore, Citramon-Borimed is not recommended during breastfeeding. Fertility Acetylsalicylic acid There is some evidence that drugs that inhibit the synthesis of cyclooxygenase/prostaglandins can lead to impaired reproductive function in women due to effects on ovulation. This effect is reversible upon discontinuation of treatment. Precautions General: Citramon-Borimed should not be taken with medicines containing acetylsalicylic acid or paracetamol. Patients who vomit more than 20% of migraine episodes or need bed rest for more than 50% of migraine episodes should not use Citramon-Borimed. If the migraine does not subside in a patient after taking the first two tablets of Citramon-Borimed, then the patient should seek medical help. Prolonged use of any type of pain reliever for headaches can lead to a worsening of the condition. If such a situation occurs or is expected, medical advice should be sought and treatment should be discontinued. The diagnosis of headache due to overuse of drugs should be suspected in patients with chronic headaches (15 days or more per month) with concomitant overuse of headache drugs for more than 3 months. Therefore, Citramon-Borimed should not be used for more than 10 days per month for more than 3 months. Caution should be exercised in patients at risk of dehydration (for example, due to illness, diarrhea, before or after major surgery). Citramon-Borimed may mask signs and symptoms of infection due to its pharmacodynamic properties. Due to the presence of acetylsalicylic acid: Citramon-Borimed should be used with caution in patients suffering from gout, as well as in patients with impaired renal or hepatic function, dehydration, uncontrolled hypertension and diabetes mellitus. Citramon -Borimed should be used with caution in patients with severe glucose-6-phosphate dehydrogenase (G6PD) deficiency, as acetylsalicylic acid may cause hemolysis or hemolytic anemia. Factors that may increase the risk of hemolysis are, for example, high doses, fever, or acute infections. Citramon-Borimed may lead to an increased risk of bleeding during and after surgery (including minor surgery, such as tooth extraction) due to the inhibitory effect of acetylsalicylic acid on platelet aggregation, which persists for many days after administration. Citramon-Borimed should not be taken together with anticoagulants or other drugs that inhibit platelet aggregation, without medical supervision (see section “Interaction with other drugs” ). Patients with impaired hemostasis should be carefully monitored. Caution should be exercised with metrorrhagia or menorrhagia. Citramon-Borimed should be stopped immediately if patients receiving this drug experience gastric bleeding or ulceration of the gastrointestinal tract (GIT). Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs. They can occur at any time during treatment with or without symptoms, or with a history of serious gastrointestinal disease. As a rule, they carry more serious consequences for older patients. The risk of gastrointestinal bleeding may be increased by alcohol, corticosteroids and NSAIDs (see section “Interaction with other drugs”). Citramon-Borimed can cause bronchospasm and exacerbation of asthma (so-called analgesic intolerance) or other hypersensitivity reactions. Risk factors are asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infection (especially if associated with allergic rhinitis-like symptoms). This also applies to patients who have allergic reactions (eg skin reactions, itching, urticaria) to other substances. For such patients, special precautions are recommended (readiness for emergency care). Citramon-Borimed should not be prescribed to children and adolescents under the age of 18, unless there is a special indication, since there is an association between acetylsalicylic acid and Reye’s syndrome. Reye’s syndrome is a very rare disease that affects the brain and liver and can be fatal. Acetylsalicylic acid can interfere with thyroid function tests due to falsely low concentrations of levothyroxine (T4) or triiodothyronine (T3) (see section “Interaction with other drugs means”. Due to the presence of paracetamol: Citramon-Borimed should be administered with caution to patients with impaired renal or hepatic function, or alcohol dependence. The risk of paracetamol toxicity may increase in patients taking other potentially hepatotoxic drugs or drugs that induce microsomal liver enzymes (eg, rifampicin, isoniazid, chloramphenicol, hypnotics, and antiepileptics, including phenobarbital, phenytoin, and carbamazepine). Patients who abuse alcohol in the past are at particular risk of liver damage (see section “Interaction with other drugs”). Patients should be warned not to take other drugs containing paracetamol at the same time, due to the risk of developing serious damage. liver in case of overdose (see section “Overdose”). While taking this drug, you should avoid drinking alcoholic beverages, since alcohol in combination with paracetamol can lead to liver damage (see section “Interaction with other drugs”). Paracetamol should be administered with caution to patients with alcohol dependence. Due to the presence of caffeine: Citramon-Borimed should be administered with caution to patients with gout, hyperthyroidism and arrhythmia. nervousness, irritability, insomnia and sometimes an accelerated heartbeat. Interactions with other drugs Interactions of individual components that make up Citramon-Borimed with other substances are well known. There are no conditions leading to the fact that the nature of interactions will change when used together. There are no interactions between acetylsalicylic acid and paracetamol that could adversely affect safety. Contraindications hypersensitivity to acetylsalicylic acid (aspirin), paracetamol, caffeine or any of the excipients listed in the “Composition” section. Patients in whom acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs such as diclofenac or ibuprofen may provoke the development asthma attacks, hives or coryza. exacerbation of gastric or intestinal ulcers, gastrointestinal bleeding or perforation, and patients with a history of gastric ulcers; hemophilia or other hemorrhagic diseases; severe liver or kidney failure; severe heart failure; taking methotrexate at a dose of more than 15 mg per week (see . section “Interaction with other drugs”); the last trimester of pregnancy (see section “Precautions”) Composition One tablet contains: active ingredients: acetylsalicylic acid – 220 mg, paracetamol – 200 mg, caffeine – 27 mg, excipients: cocoa powder, citric acid monohydrate, potato starch, talc, stearic acid. OverdoseOverdose of acetylsalicylic acid Symptoms Symptoms of mild salicylates intoxication include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion. They can occur at plasma concentrations from 150 µg/mL to 300 µg/mL. These symptoms can be controlled by reducing the dose or interrupting treatment. More serious intoxication occurs at concentrations above 300 µg/ml. Symptoms of severe intoxication include hyperventilation, fever, restlessness, ketosis, respiratory alkalosis, and metabolic acidosis. CNS depression can lead to coma. Cardiovascular collapse and respiratory failure may also develop. Treatment The patient should be taken to the hospital immediately. If it is suspected that the patient has ingested salicylates in excess of 120 mg/kg in the last hour, repeated oral doses of activated charcoal should be given. Plasma concentrations should be measured in patients who have ingested salicylates above 120 mg/kg, although the severity of poisoning cannot be determined from these alone. Both clinical and biochemical features should be considered. At plasma concentrations greater than 500 µg/mL (350 µg/mL in children under 5 years of age), intravenous sodium bicarbonate is effective. Hemodialysis or hemoperfusion are the preferred treatments for overdose when plasma salicylates are above 700 µg/mL or below in children and the elderly, and in severe metabolic acidosis. Paracetamol overdose Symptoms Overdose (> 10 g total for adults or > 150 mg/kg at a single dose) can provoke liver cytolysis, which can lead to complete and irreversible necrosis (liver failure, metabolic acidosis, renal failure) and eventually to coma and possibly death. Rarely, renal tubular necrosis may develop. Early signs of overdose (most commonly nausea, vomiting, anorexia, pallor, lethargy, and sweating) usually develop within the first 24 hours. Abdominal pain may be the first symptom of liver damage, usually does not appear within the first 24-48 hours, and may appear 4-6 days after an overdose. Liver damage usually occurs a maximum of 72-96 hours after an overdose. Glucose metabolism disorders and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cases of cardiac arrhythmias and pancreatitis have been reported. Patients taking enzyme-inducing drugs such as carbamazepine, phenytoin, phenobarbital, rifampicin, and St. John’s wort, or patients with a history of alcohol abuse or eating disorders, are considered at increased risk. Treatment If it is suspected that the patient has taken oral paracetamol at a dose of more than 150 mg/kg in the last hour, then oral repeated doses of activated charcoal should be administered. However, if acetylcysteine or methionine is to be administered orally, it is best to remove the charcoal from the stomach to prevent decreased absorption of the antidote. Antidotes N-acetylcysteine should be administered intravenously or orally as soon as possible after an overdose event – it is most effective within the first 8 hours. Then the effectiveness of the antidote gradually decreases. However, treatment before and after 24 hours after an overdose has also been shown to be effective. Methionine is most effective during the first 10 hours after an overdose of paracetamol. Liver damage is more common and more severe if methionine treatment is started more than 10 hours after an overdose event. Oral absorption may be reduced by vomiting or activated charcoal. Caffeine Overdose Symptoms Common symptoms include restlessness, nervousness, restlessness, insomnia, agitation, muscle twitching, confusion, and seizures. With a large overdose of caffeine, hyperglycemia may also develop. Cardiac symptoms include tachycardia and cardiac arrhythmia. Treatment Reduce dosage, stop taking caffeine. Side Effects Many of the following adverse reactions are dose dependent and vary from one person to another. Adverse reactions are listed below in accordance with organ systems, as well as the frequency of occurrence. The following principles are used: very often (?1/10), often (? 1/100 to <1/100), rarely (? 1/10000 to <1/1000), very rarely (<1/10000), including individual reports and not known (cannot be estimated from available data). Infections and invasions: rarely - pharyngitis. Immune system disorders: not known - hypersensitivity, anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis (very rare cases of serious skin reactions have been reported). Metabolism and nutrition disorders: rarely - loss of appetite. Mental disorders: very often - nervousness; often - insomnia; rarely - anxiety, euphoria, tension; not known - excited state. Nervous system disorders: very often - dizziness; often - tremor, paresthesia, headache; rarely - dysgeusia, impaired attention, amnesia, impaired coordination, hyperesthesia, headache in the paranasal sinuses; not known - migraine, drowsiness. On the part of the organs of vision: rarely - pain in the eyes, blurred vision. Hearing and balance disorders: often - ringing in the ears. Cardiac disorders: often - arrhythmia; not known - rapid pulse. Vascular disorders: rarely - hyperemia, peripheral vascular disorders; not known - hypotension. Respiratory, thoracic and mediastinal disorders: rarely - epistaxis, hypoventilation, rhinorrhea; not known - shortness of breath, asthma. From the gastrointestinal tract: very often - nausea, discomfort in the abdomen; often - dry mouth, diarrhea, vomiting; rarely - belching, flatulence, dysphagia, oral paresthesia, salivary hypersecretion; not known - pain in the upper abdomen, dyspepsia, abdominal pain, gastrointestinal bleeding (including bleeding in the upper gastrointestinal tract, gastric bleeding, bleeding stomach ulcer, bleeding intestinal ulcer, rectal bleeding), gastrointestinal ulcer -intestinal tract (including gastric ulcer, duodenal ulcer, colon ulcer, peptic ulcer). On the part of the hepatobiliary system: not known - liver failure, increased liver enzymes. Skin and subcutaneous tissue disorders: rarely - hyperhidrosis, itching, urticaria. Musculoskeletal and connective tissue disorders: rarely - musculoskeletal stiffness, neck pain, back pain, muscle spasms. General diseases and disorders at the injection sites: often - fatigue, a feeling of anxiety; rarely - asthenia, chest discomfort; not known - erythema, rash, angioedema, erythema multiforme, malaise, unusual sensations. There is no information to suggest that the side effects of individual substances increase or the range of side effects expands when using the fixed combination in accordance with the instructions, there is no. The increased risk of bleeding may persist for 4-8 days after taking acetylsalicylic acid. Very rarely, severe bleeding (eg, intracerebral bleeding) is possible, especially in patients with hypertension, in the absence of treatment, and / or concomitant treatment with anticoagulants. In some cases, death may occur. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25? Keep out of the reach of children. Buy Citramon-Borimed tablets No. 6x1 Price for Citramon-Borimed tablets No. 6x1