Properties
What is it?
What Intesal Tablet Contains: Active substance: Bismuth subsalicylate. Each tablet contains 262.5 mg of bismuth subsalicylate. Recommended for symptomatic treatment of gastritis, heartburn, nausea, and diarrhea. Excipients: Calcium carbonate, microcrystalline cellulose, sodium starch glycolate (Type A), povidone K30, magnesium stearate, colloidal anhydrous silica. Bismuth subsalicylate has an antibacterial effect against Helicobacter pylori bacteria, which can cause inflammation of the mucous membrane and peptic ulcers. - Helps to eradicate or reduce infections caused by Helicobacter pylori bacteria. - A doctor may prescribe other medications along with Intesal tablets to eradicate Helicobacter pylori. - Bismuth in the form of bismuth subsalicylate is absorbed in very small amounts by the body, while salicylate is significantly absorbed. For symptomatic treatment of gastritis, heartburn, nausea, and diarrhea, consult a doctor if symptoms do not improve or worsen within 2 days. Do not take Intesal tablet: - If you are allergic to bismuth subsalicylate or any other ingredient of this preparation. - If you have a history of asthmatic reactions caused by salicylates or any other non-steroidal anti-inflammatory and analgesic drug. - If you suffer from gastrointestinal ulcers. - If you have an increased risk of bleeding. - If you suffer from severe renal insufficiency, severe hepatic insufficiency, or severe cardiac insufficiency. - If you are being treated with methotrexate - 15 mg: per week or higher dose. - If you are in the last trimester of pregnancy. - Children under 12 years of age. Warnings and Precautions: Talk to your doctor or pharmacist before taking Intesal tablets. Caution is recommended: - If you are in the first and second trimester of pregnancy. - You are breastfeeding. - If you have increased sensitivity to anti-inflammatory and anti-rheumatic drugs. - If you are taking anticoagulants (such as coumarin derivatives, heparin, except low-dose heparin). - If you are taking oral blood sugar lowering drugs, antibiotics containing tetracycline, or anti-gout drugs. - If you have renal insufficiency or cardiovascular disease, as salicylate may further increase the risk of kidney damage or acute renal failure. - If you have a history of chronic or recurrent peptic ulcer disease, or gastrointestinal bleeding. - If you suffer from asthma, hay fever, nasal polyps, have chronic obstructive pulmonary disease, or have had other allergic reactions to medications, such as rash, itching, hives, as salicylates can cause bronchospasm and asthma attacks or other hypersensitivity reactions in sensitive patients. - If you have hepatic insufficiency. - If you have acute glucose-6-phosphate dehydrogenase (G6PD) deficiency, as in such cases salicylate can cause erythrocyte breakdown (hemolysis) or hemolytic anemia. The risk of hemolysis may be increased depending on the following factors: high dose, fever, acute infection. - If you are weakened or elderly and have lost a large amount of fluid and electrolytes due to diarrhea. - Intesal tablet cannot be used for symptomatic treatment of gastritis, heartburn, nausea, and diarrhea if symptoms are severe or last longer than 2 days; exceptions are cases where the doctor considers prolonged treatment relevant. - Intesal tablets may increase bleeding during and after surgical procedures (including minor procedures such as tooth extraction). Children and Adolescents: Do not give Intesal tablets to children under 12 years of age. In children and adolescents over 12 years of age and with fever, Intesal tablets can only be given by doctor's decision, or if no other medicine was effective. In case of persistent vomiting, please seek immediate medical attention, as this may be a sign of a rare but very dangerous disease (Reye's syndrome). Other Medicines and Intesal Tablet: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. - When treating with methotrexate (used to treat autoimmune diseases and cancer), taking Intesal tablets at a dose of 15 mg per week or more is not allowed. Avoid taking the following medications with Intesal tablets: - Streptokinase (a drug prescribed to dissolve blood clots). Taking the following medications with Intesal tablets requires special attention: - Methotrexate, prescribed at a dose of less than 15 mg per week. - Anticoagulants, thrombolytic drugs, antiplatelet drugs. - Other non-steroidal anti-inflammatory drugs. - Selective serotonin reuptake inhibitors (SSRIs), used to treat depression and anxiety. - Digoxin, used to treat heart disease. - Lithium, used to treat mental illness. - Some sedatives and sleeping pills: barbiturates. - Blood sugar lowering medications, such as insulin or oral antidiabetic drugs. - Diuretics. - Steroidal, anti-inflammatory drugs. - Some antihypertensive drugs, ACE inhibitors: for example, captopril, enalapril. - Valproic acid, used to treat epilepsy. - Uricosuric drugs, used to treat gout, for example: benzbromarone, probenecid. - Tetracyclines (a type of antibiotic). These tablets should be taken several hours before or several hours after taking Intesal tablets. Taking Intesal Tablets with Food and Drink: - For symptomatic treatment of gastritis, heartburn, nausea, and diarrhea, Intesal tablets can be taken without food. - For the treatment of Helicobacter pylori infection, Intesal tablets should be taken on an empty stomach (half an hour before main meals and before bedtime). - Simultaneous intake with alcohol increases the risk of mucous membrane damage and gastrointestinal bleeding. Pregnancy and Breastfeeding: - If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. - Intesal tablets can be used during the first 6 months of pregnancy, only in cases of necessity, according to the doctor's advice; it cannot be used during the last 3 months of pregnancy. - A small amount of the active substance passes into breast milk. It can be used in small doses during breastfeeding, for periodic treatment. If higher doses are needed for a longer period, breastfeeding should be discontinued. - There is data that the mechanism of action of salicylates may affect female fertility. This effect can be reversed by stopping treatment. Driving and Operating Machinery: Intesal tablets do not affect driving or operating machinery. How to Take Intesal Tablet: Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. For symptomatic treatment of gastritis, nausea, and diarrhea: Children from 12 years of age, adolescents and adults: The single dose of the medicine is 2 tablets. The single dose can be repeated as needed, every 12-1 hours. Take a maximum of 16 tablets in 24 hours. Do not exceed the recommended dose. Use in Children: Due to the risk of Reye's syndrome associated with the salicylate content in Intesal tablet, this medicine is not prescribed to children under 12 years of age. Route of Administration: Oral - Intesal tablets can be taken without food for symptomatic treatment of gastritis, heartburn, nausea, and diarrhea. Eradication of Helicobacter pylori bacteria: Adults: - 4x1 tablet per day on an empty stomach (half an hour before main meals and before bedtime); - 2x2 tablets per day on an empty stomach (half an hour before breakfast and dinner or before bedtime). - The maximum duration of treatment is 2 months. - A minimum of 2 months must pass before starting subsequent treatment with bismuth-containing agents. - The duration of treatment for duodenal or gastric ulcers lasts from 4 to 8 weeks. - To eradicate H. pylori, the components of combination therapy and the duration of treatment (7-14 days) should be determined by a doctor, taking into account your tolerance to the drug. Treatment should be carried out in accordance with local resistance data and treatment recommendations. If You Take More Intesal Tablet Than You Should: Inform your doctor immediately or go to the nearest hospital emergency department. - Do not take more than a single dose and do not exceed the maximum daily dose (16 tablets). - Brain damage has been described in cases of overdose of bismuth subsalicylate. If You Forget to Take Intesal Tablet: If you are taking Intesal tablets for symptomatic treatment of gastritis, heartburn, nausea, and diarrhea: - Regular intake of Intesal tablets is not necessary, but they should be taken as soon as symptoms develop. - Take an additional single dose only if necessary based on your symptoms. If you are taking Intesal tablets to treat Helicobacter pylori infection: - Do not take a double dose to make up for a missed tablet. - If you forget to take the medicine, take it as soon as you remember. - If it is already time for the next dose. In this case, do not take the missed dose. Possible Side Effects: Very common side effect: black stools. Common side effect: black discoloration of the tongue. Rare side effect: digestive system problems, abdominal pain, gastrointestinal inflammation, ulcer. Very rare side effects: hemophilia, acute bleeding, gastrointestinal bleeding, ulcer, hematoma. Symptoms of gastrointestinal bleeding include bloody vomiting and black stools. Bleeding before and after surgery, nosebleeds, bleeding from the urinary tract and genitals, bleeding from the gums. Prolonged bleeding can cause anemia. Hypersensitivity reactions may develop, such as asthma attacks, rash, hives, itching, nasal congestion, runny nose, heart and respiratory problems, and in very severe cases, hypersensitivity reactions affecting the whole body (anaphylactic shock) may develop. Dizziness, tinnitus, and ringing in the ears have been described, which may be symptoms of overdose. Side effects of unknown frequency: Intracranial hemorrhage - observed in patients with untreated hypertension or concomitant use of anticoagulants. Disorders of red blood cells (hemolysis) and hemolytic anemia have been observed in patients with acute deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD). Increased levels of transaminases (detected by blood test). Renal dysfunction and acute renal failure have been reported. Storage Conditions: - Store at a temperature not exceeding 25 C. - Keep out of reach of children. - Do not use this medicine after the expiry date indicated on the carton after "Expiry Date". The expiry date refers to the last day of that month. - Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. Marketing Authorization Holder and Manufacturer: MEDITOP Pharmaceuticals Ltd. H-2097 Pilisborosjeno, Ady Endre u. 1. Hungary