Leaflet: information for the user

Gastrodenol 120 mg film-coated tablets

Colloidal bismuth subcitrate

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

5Storage of Gastrodenol

6.Contents of the pack and additional information

The colloidal bismuth subcitrate is a direct-acting drug onHelicobacter pylori, a pathogenic microorganism related to gastritis, duodenal ulcer, and gastric ulcer.

Gastrodenol is indicated for the treatment of:

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

• If you are allergic to bismuth subsalicylate or any of the other components of this medication (listed in section 6).
• If you have severe kidney problems.
• If you are pregnant.
• Pediatric population (children under 12 years old).

Warnings and precautions

The prolonged use of high doses of bismuth compounds is not recommended due to the occasional risk of neurological toxicity (encephalopathy) that is reversible. If Gastrodenol is used at the recommended doses, the probability of this occurring is very small. However, concomitant use with other medications containing bismuth is not recommended.

Drinking alcoholic beverages is also not recommended, as bismuth subsalicylate is a potent inhibitor of alcohol dehydrogenase, the enzyme that prevents bacterial oxidation of ethanol to acetaldehyde..

The typical symptoms of this excess of acetaldehyde include skin rash,tachycardia, shortness of breath,nauseaandvomiting(antabus effect).

Warning about excipients

Patients with renal insufficiency or those on low-potassium diets should note that this medication contains 40 mg (1 mmol) of potassium per tablet.

Children and adolescents

Gastrodenol is contraindicated in children under 12 years old and is not recommended for patients aged 12 to 18 years.

Other medications and Gastrodenol

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

The administration of Gastrodenol and tetracyclines (a group of antibiotics) at the same time may inhibit the absorption of orally administered tetracyclines.

Other medications, foods, and beverages, particularly antacids, milk, fruit, or fruit juice, should not be taken within 30 minutes before or after taking Gastrodenol, as they may alter its action.

During treatment with Gastrodenol, it is not recommended to administer other medications containing bismuth, as the prolonged use of any bismuth compound at high doses may cause reversible neurological toxicity (encephalopathy).

Taking Gastrodenol with food, beverages, and alcohol

During treatment, it is recommended not to drink milk, as it may interfere with the mechanism of action of Gastrodenol. Small amounts of milk with coffee or tea, taken with meals, do not cause significant interference.

During treatment with Gastrodenol, it is not recommended to consume alcoholic beverages.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using any medication.

There is insufficient information available on the use of Gastrodenol during pregnancy and lactation to evaluate the possibility of adverse effects. There is no indication of adverse effects in animals. Due to the lack of data, its use during pregnancy is not recommended.

Driving and operating machines

The influence of Gastrodenol on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 4 tablets per day.

The tablets must be swallowed whole with a little water without gas and not chewed.

Dosage

Adults:240 mg (2 tablets), 2 times a day, on an empty stomach, 30 minutes before breakfast and 30 minutes before dinner or at bedtime.

Alternatively:120 mg (1 tablet), 4 times a day, on an empty stomach, 30 minutes before breakfast, lunch, snack, and 2 hours after dinner.

Elderly patients:240 mg (2 tablets), 2 times a day, on an empty stomach, 30 minutes before breakfast and 30 minutes before dinner or at bedtime.

Alternatively:120 mg (1 tablet), 4 times a day, on an empty stomach, 30 minutes before breakfast, lunch, snack, and 2 hours after dinner.

Do not take Gastrodenol for more than 2 consecutive months. After that, you must take a break of at least 2 months without taking Gastrodenol or other medications containing bismuth.

The treatment duration for gastric or duodenal ulcers is 4 to 8 weeks.

For the eradication of Helicobacter pylori, a combined therapy with other medications and a treatment duration of 7 to 14 days is recommended.

It is not advisable to administer the medication for a prolonged period, nor as maintenance treatment.

Pediatric population:

Gastrodenol is contraindicated in children under 12 years and not recommended in patients 12 to 18 years old.

If you take more Gastrodenol than you should

A single acute or massive overdose can damage kidney function, which may take 10 days to appear.

After a single very high dose, treatment consists of gastric lavage, followed by repeated doses of activated charcoal and osmotic laxatives (medications that incorporate water into the stool, making it softer and more frequent). Generally, bismuth absorption does not require additional treatment.

Your doctor will determine bismuth concentrations in blood and urine, both in acute and chronic intoxication, to confirm that symptoms are due to increased bismuth absorption. In that case, you will be administered the appropriate treatment (called chelation therapy).

If there has been a severe alteration of kidney function, after chelation therapy, hemodialysis will be applied (a procedure that removes waste products from the blood when the kidneys can no longer perform their function).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicological Information Service. Phone (91) 562 04 20, indicating the medication and the amount taken.

If you forgot to take Gastrodenol

Take the dose as soon as possible, as long as it does not lead to taking a double dose.

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The possible adverse effects are listed according to the following categories:

?Adverse effectsvery frequent(may affect more than 1 in 10 people)

?Adverse effects frequent (may affect up to 1 in 10 people)

• Adverse effectsinfrequent(may affect up to 1 in 100 people)
• Adverse effects ofunknown frequency: cannot be estimated from available data.

Very frequent adverse effects

• Black stools

Infrequent adverse effects

• Nausea
• Vomiting
• Constipation
• Dysentery
• Rashes
• Pruritus (itching)

Adverse effects of unknown frequency

• Anaphylactic reaction (allergic reaction)

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children. Store below 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.

Deposit unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.

• The active principle is colloid bismuth subcitrate. Each tablet contains 120 mg of bismuth trioxide (Bi2O3).
• The other components are: potassium citrate E332, ammonium citrate, cornstarch, povidone K-30, potassium polacrilin, macrogol 6000, magnesium stearate and hypromellose E461.

Appearance of the product and contents of the packagingPackaging with 50 film-coated tablets.Holder of the marketing authorization

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid, Spain

Responsible for manufacturing

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna, 66-68-70 Industrial Estate Urtinsa II 28923 Alcorcón (Madrid)

Spain

Date of the last review of this leaflet:

September 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/