Bismuth Oxide 120 mg 56 tablets

Trade name:

Bismuth oxide 120 mg 56 Film-coated tablets.

Composition:

Bismuth subcitrate powder 295.1mg equivalent to 120 mg of bismuth oxide

Description:

Colloidal bismuth subcitrate is a drug with direct action on Helicobacter pylori, a pathogenic microorganism related to gastritis, duodenal ulcer and gastric ulcer.

Indication:

Bismuth oxide is indicated in the treatment of:

• Chronic gastritis associated with Helicobacter pylori
• Gastric and duodenal ulcer

Dosage and method of administration:

-The tablets should be swallowed with some still water and not chewed.

Adults: 240 mg (2 tablets), 2 times a day, on an empty stomach, half an hour before breakfast and half an hour before dinner or at bedtime.

As an alternative: 120 mg (1 tablet), 4 times a day, on an empty stomach, half an hour before breakfast, lunch, snack and two hours after dinner.

Elderly patients: 240 mg (2 tablets), 2 times a day, on an empty stomach, half an hour before breakfast and half an hour before dinner or at bedtime.

As an alternative: 120 mg (1 tablet), 4 times a day, on an empty stomach, half an hour before breakfast, lunch, snack and two hours after dinner.

-The maximum duration of a course of treatment is 2 months. Treatment will be followed by at least a 2-month period without the use of Bismuth oxide or other bismuth-containing medicines.

-For the treatment of gastric or duodenal ulcer the duration of a course of treatment is 4 to 8 weeks.

-For the eradication of Helicobacter pylori, the selection of a combination therapy and a treatment duration of 7 to 14 days taking into account the individual drug tolerance of each patient and according to regional resistance patterns and treatment guidelines.

-Prolonged administration of the drug is not advisable, nor as maintenance treatment.

Pediatric population:

Bismuth oxide is contraindicated in children under 12 years of age and is not recommended in patients aged 12 to 18 years.

Contraindications:

Bismuth oxide should not be administered in the following cases:

• Hypersensitivity to bismuth subcitrate or to any of the excipients
• If you have severe kidney problems
• if you are pregnant
• Pediatric population (in children under 12 years of age)

Special warnings and precautions:

-Prolonged use of high doses of bismuth compounds is not recommended because it can occasionally cause reversible encephalopathy.

-The concomitant use of other medicines containing bismuth is not recommended.

-Drinking alcoholic beverages is also not recommended, since bismuth subcitrate is a potent inhibitor of alcohol dehydrogenase, an enzyme that prevents bacterial oxidation of ethanol to acetaldehyde.

Typical symptoms of this excess acetaldehyde include skin rash, tachycardia, shortness of breath, nausea and vomiting.

Warning:

This medicinal product contains (36.8 mg) of potassium per tablet, which should be taken into account in the treatment of patients with renal insufficiency or with a diet low in potassium.

Interaction with other medicinal products and other forms of interaction:

-Other medicines, foods and drinks, particularly antacids, milk, fruit or fruit juices should not be taken half an hour before or haif an hour after taking Bismuth oxide because they can alter its effect.

Small amounts of milk can be taken with coffee or tea, taken with meals, as they do not cause significant interference.

-Tetracyclines:

Concomitant administration of Bismuth oxide and tetracyclines may inhibit the absorption of orally administered tetracyclines.

Pregnancy and lactation:

-Pregnancy: Due to lack of data its use is not recommended during pregnancy.

Lactation: There are limited data regarding the use of bismuth subcitrate during lactation in humans to evaluate the potential for harmful effects.

Side Effects:

Anaphylactic reaction

Gastrointestinal disorders, Black stools

Nausea, vomiting, constipation, diarrhea, rash, itching

Storage:

Store below 30°C at dry place

Keep out of the reach of children