Recommended for the symptomatic treatment of gastritis, heartburn, nausea, and diarrhea.
What Intestal tablets contain:
Active ingredient: bismuth subsalicylate. Each tablet contains 262.5 mg of bismuth subsalicylate. Recommended for the symptomatic treatment of gastritis, heartburn, nausea, and diarrhea.
Excipients: calcium carbonate, microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone K30, magnesium stearate, colloidal anhydrous silica.
Bismuth subsalicylate has an antibacterial effect against the bacterium Helicobacter pylori, which may cause inflammation of the mucous membrane and peptic ulcer.
- Helps eliminate or reduce infections caused by Helicobacter pylori.
- A doctor may prescribe other medications together with Intestale tablets to eradicate Helicobacter pylori.
- Bismuth in the form of bismuth subsalicylate is absorbed by the body in very small amounts, whereas salicylate is absorbed to a significant extent.
For the symptomatic treatment of gastritis, heartburn, nausea, and diarrhea, consult a doctor if symptoms do not improve or, on the contrary, worsen within 2 days.
Do not take Intestale tablets:
- if you are allergic to bismuth subsalicylate or any other ingredient of this medicine,
- if you have a history of asthmatic reactions caused by salicylates or any other non-steroidal anti-inflammatory or analgesic medicines,
- if you suffer from gastrointestinal ulcer,
- if you have an increased risk of bleeding,
- if you suffer from severe renal failure, severe hepatic failure or severe heart failure,
- if you are being treated with methotrexate at a dose of 15 mg/week or higher,
- 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 Intestale tablets.
Caution is recommended:
- if you are in the first or second trimester of pregnancy,
- if you are breastfeeding,
- if you have increased sensitivity to anti-inflammatory and antirheumatic medicines,
- if you are taking anticoagulants (such as coumarin derivatives, heparin, except low-dose heparin),
- if you are taking oral blood glucose-lowering medicines, tetracycline-containing antibiotics, or medicines for gout,
- if you have renal insufficiency or cardiovascular disease, as salicylates may further increase the risk of kidney damage or acute renal failure,
- if you have a history of chronic or recurrent gastrointestinal ulcer or gastrointestinal bleeding,
- if you suffer from asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease, or have had other allergic reactions to medicines such as rash, itching, urticaria, since in sensitive patients salicylates may cause bronchospasm, asthma attack, or other hypersensitivity reactions,
- if you have hepatic insufficiency,
- if you have acute glucose-6-phosphate dehydrogenase (G6PD) deficiency, as in such cases salicylates may cause breakdown of red blood cells (hemolysis) or hemolytic anemia. The increased risk of hemolysis may depend on the following factors: high dose, fever, acute infection,
- if you are debilitated or elderly and have lost large amounts of fluids and electrolytes due to diarrhea.
- Intestal tablets must not be used for the symptomatic treatment of gastritis, heartburn, nausea, and diarrhea if symptoms are severe or last longer than 2 days, except in cases where the doctor considers prolonged treatment appropriate.
- Intestal tablets may increase bleeding during and after surgical procedures (including minor procedures such as tooth extraction).
Children and adolescents: Do not give Intestale tablets to children under 12 years of age.
- In children and adolescents over 12 years of age with fever, Intestale tablets may be given only by a doctor’s decision or if no other medicine was effective. In case of persistent vomiting, seek medical attention immediately, as this may be a sign of a rare but very serious disease (Reye’s syndrome).
Other medicines and Intestal tablets: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- During treatment with methotrexate (used to treat autoimmune diseases and cancer), Intestale tablets must not be taken at doses of 15 mg/week or higher.
Avoid taking the following medicine together with Intestale tablets:
- streptokinase (a medicine used to dissolve blood clots)
- Taking the following medicines together with Intestale tablets requires special caution
- methotrexate prescribed at doses lower than 15 mg/week
- anticoagulants, thrombolytics, antiplatelet medicines
- other non-steroidal anti-inflammatory medicines
selective serotonin reuptake inhibitors (SSRIs) used to treat depression and anxiety
- digoxin used to treat heart diseases
- lithium used to treat mental disorders
- certain sedative and hypnotic agents: barbiturates
- blood glucose-lowering medicines such as insulin or oral antidiabetic medicines
- diuretics
steroidal anti-inflammatory medicines.
- certain antihypertensive medicines, ACE inhibitors such as captopril, enalapril
- valproic acid used to treat epilepsy
- uricosuric medicines used to treat gout, such as benzbromarone, probenecid
- tetracyclines (a type of antibiotic). These tablets should be taken several hours before or several hours after taking Intestal tablets.
Taking Intestal tablets with food and drink:
- For the symptomatic treatment of gastritis, heartburn, nausea, and diarrhea, Intestale tablets may be taken without food.
- For the treatment of infections caused by Helicobacter pylori, Intestale tablets should be taken on an empty stomach (half an hour before main meals and at bedtime).
- Concomitant use with alcohol increases the risk of mucosal damage and gastrointestinal bleeding.
Pregnancy and breastfeeding:
- If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Intestal tablets may be used during the first 6 months of pregnancy only if clearly necessary and on a doctor’s advice; they must not be used during the last 3 months of pregnancy.
- A small amount of the active substance passes into breast milk. During breastfeeding, it may be used in small doses for intermittent treatment. If higher doses are required for a longer period, breastfeeding should be discontinued.
- There is evidence that the mechanism of action of salicylates may affect female fertility. This effect is reversible upon discontinuation of treatment.
Driving and using machines: Use of Intestal tablets does not affect the ability to drive or use machines.
How to take Intestal tablets: Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
For the symptomatic treatment of gastritis, nausea, and diarrhea:
Children from 12 years of age, adolescents, and adults: the single dose is 2 tablets. The single dose may be repeated as needed every 12–1 hours.
Do not take more than 16 tablets within 24 hours. Do not exceed the recommended dose.
Use in children: Due to the risk of Reye’s syndrome associated with salicylate content, this medicine is not prescribed for children under 12 years of age.
Route of administration: Oral
Intestale tablets may be taken without food for the symptomatic treatment of gastritis, heartburn, nausea, and diarrhea.
Eradication of Helicobacter pylori:
Adults:
4×1 tablet per day on an empty stomach (half an hour before main meals and at bedtime);
2×2 tablets per day on an empty stomach (half an hour before breakfast and dinner or at bedtime).
- The maximum duration of treatment is 2 months.
- At least 2 months must pass before starting another course of treatment with bismuth-containing products.
- Treatment of duodenal or gastric ulcer lasts from 4 to 8 weeks.
- For eradication of H. pylori, the components of combination therapy and duration of treatment (7–14 days) should be determined by the doctor, taking into account your tolerance to the medicines. Treatment should be carried out according to local resistance data and therapeutic guidelines.
If you take more Intestale tablets than you should: Inform your doctor immediately or contact the emergency department of the nearest hospital.
- Do not take more than a single dose and do not exceed the maximum daily dose (16 tablets).
- In cases of overdose of bismuth subsalicylate, brain damage has been reported.
If you forget to take Intestal tablets:
If you take Intestal tablets for the symptomatic treatment of gastritis, heartburn, nausea, and diarrhea:
- Regular intake is not required; take the tablets when symptoms occur.
- Take an additional single dose only if necessary according to your symptoms.
If you take Intestale tablets for the treatment of Helicobacter pylori infection:
- Do not take a double dose to make up for a missed tablet.
- If you forget to take a dose, take it as soon as you remember,
- unless it is almost time for the next dose. In that 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 effects: digestive system disorders, 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 during the pre- and postoperative period, nosebleeds, bleeding from the urinary and genital tracts, gum bleeding. Prolonged bleeding may cause anemia.
Hypersensitivity reactions may occur, such as asthma attack, rash, urticaria, itching, nasal congestion, runny nose, cardiovascular and respiratory disorders, and in very severe cases systemic hypersensitivity reactions (anaphylactic shock).
Dizziness, tinnitus, and ringing in the ears have been reported, which may be symptoms of overdose.
Side effects of unknown frequency: intracranial bleeding – reported in patients with untreated hypertension or concomitant use of anticoagulants.
Disorders of red blood cells (hemolysis) and hemolytic anemia have been reported in patients with acute glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Elevated transaminase levels (detected by blood tests).
Renal dysfunction and acute renal failure have been reported.
Storage conditions:
- Store at a temperature not exceeding 25°C.
- Keep out of the reach of children.
- Do not use this medicine after the expiry date stated on the package after “Expiry date”. The expiry date refers to the last day of that month.
- Do not dispose of medicines via 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
