Gastrodenol 120 mg film-coated tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gastrodenol 120 mg film-coated tablets
Colloidal bismuth subcitrate
Read the entire 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Gastrodenol is and what it is used for
- What you need to know before taking Gastrodenol
- How to take Gastrodenol
- Possible side effects
- How to store Gastrodenol
- Contents of the pack and other information
1. What Gastrodenol is and what it is used for
Colloidal bismuth subcitrate is a drug that acts directly on Helicobacter pylori, a pathogenic microorganism associated with gastritis, duodenal ulcer, and gastric ulcer.
Gastrodenol is indicated in the treatment of:
- Chronic gastritis associated with Helicobacter pylori
- Gastric and duodenal ulcers
2. What you need to know before taking Gastrodenol
- If you are allergic to bismuth subcitrate or to any of the other ingredients of this medicine (listed in section 6).
- If you have severe renal (kidney) disorders.
- If you are pregnant.
- Paediatric population (children under 12 years of age).
Warnings and precautions
Prolonged use of high doses of bismuth-containing compounds is not recommended, as it may occasionally cause neurological toxicity (encephalopathy), which is reversible. If Gastrodenol is used at the recommended doses, the likelihood of this occurring is very small. However, concomitant use of other medicinal products containing bismuth is not recommended.
Alcoholic beverages should also be avoided, as bismuth subcitrate is a potent inhibitor of alcohol dehydrogenase, the enzyme that prevents bacterial oxidation of ethanol to acetaldehyde.
Typical symptoms of this acetaldehyde excess include skin rash, tachycardia, shortness of breath, nausea, and vomiting (disulfiram-like reaction).
Warning about excipients
Patients with renal impairment or those on low-potassium diets should be aware that this medicine contains 40 mg (1 mmol) of potassium per tablet.
Children and adolescents
Gastrodenol is contraindicated in children under 12 years of age and is not recommended for patients aged 12 to 18 years.
Other medicines and Gastrodenol
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Concomitant administration of Gastrodenol and tetracyclines (a group of antibiotics) may inhibit the absorption of orally administered tetracyclines.
Other medicines, food, and beverages—particularly antacids, milk, fruit, or fruit juices—should not be ingested within half an hour before or after taking Gastrodenol, as they may interfere with its action.
During treatment with Gastrodenol, administration of other medicinal products containing bismuth is not recommended, as prolonged use of any bismuth-containing compound at high doses may lead to neurological toxicity (encephalopathy), which is reversible.
Taking Gastrodenol with food, drinks, 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 may be consumed, as they do not cause significant interference.
During treatment with Gastrodenol, consumption of alcoholic beverages is not recommended.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.
There is insufficient information available on the use of Gastrodenol during pregnancy and breastfeeding to assess the possibility of harmful effects. No adverse effects have been observed in animals. Due to the lack of data, its use during pregnancy is not recommended.
Driving and using machines
The influence of Gastrodenol on the ability to drive and operate machinery is negligible or none.
3. How to take Gastrodenol
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is 4 tablets per day.
The tablets must be swallowed whole with a little still water and must not be chewed.
Dosage
Adults: 240 mg (2 tablets), twice daily, on an empty stomach, half an hour before breakfast and half an hour before dinner or bedtime.
Alternatively: 120 mg (1 tablet), four times daily, on an empty stomach, half an hour before breakfast, lunch, afternoon snack, and two hours after dinner.
Elderly patients: 240 mg (2 tablets), twice daily, on an empty stomach, half an hour before breakfast and half an hour before dinner or bedtime.
Alternatively: 120 mg (1 tablet), four times daily, on an empty stomach, half an hour before breakfast, lunch, afternoon snack, and two hours after dinner.
Do not take Gastrodenol for longer than two consecutive months. After this, a rest period of at least another two months must be taken without taking Gastrodenol or other medications containing bismuth.
For the treatment of gastric or duodenal ulcer, the duration of treatment is 4 to 8 weeks.
For eradication of Helicobacter pylori, combination therapy with other medications is recommended, with a treatment duration of 7 to 14 days.
Prolonged administration of the drug, or its use as maintenance therapy, is not recommended.
Paediatric population:
Gastrodenol is contraindicated in children under 12 years of age and is not recommended in patients aged 12 to 18 years.
If you take more Gastrodenol than you should
An acute or massive overdose may impair kidney function, which may not become apparent until 10 days later.
After a single very high dose, treatment consists of gastric lavage, followed by repeated doses of activated charcoal and osmotic laxatives (medicines that draw water into the stools, resulting in softer stools and more frequent and easier bowel movements). Generally, bismuth absorption does not require additional treatment.
Your doctor will determine bismuth concentrations in blood and urine, in both acute and chronic intoxication, to confirm that symptoms are due to increased bismuth absorption. In such cases, appropriate treatment (known as chelation therapy) will be administered.
If there is severe impairment of kidney function, after chelation therapy, haemodialysis will be performed (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 Toxicology Information Service. Telephone (91) 562 04 20, indicating the medicine and the amount taken.
If you forget to take Gastrodenol
Take the missed dose as soon as possible, provided doing so will not result in a double dose.
Do not take a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.
The possible adverse effects are listed according to the following categories:
? Very common adverse effects (may affect more than 1 in 10 people)
? Common adverse effects (may affect up to 1 in 10 people)
- Uncommon adverse effects (may affect up to 1 in 100 people)
- Adverse effects with frequency not known: cannot be estimated from the available data.
Very common adverse effects
- Blackening of the stools
Uncommon adverse effects
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Skin rashes
- Pruritus (itching)
Adverse effects with frequency not known
- Anaphylactic reaction (allergic reaction)
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Gastrodenol
Keep this medicine out of the sight and reach of children. Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste.
Dispose of unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
- The active substance is colloidal bismuth subcitrate. Each film-coated tablet contains 120 mg of bismuth trioxide (Bi2O3).
- The other components are: potassium citrate E332, ammonium citrate, corn starch, povidone K-30, polacrilin potassium, macrogol 6000, magnesium stearate and hypromellose E461.
Nature and contents of the pack
Pack containing 50 film-coated tablets.
Marketing Authorisation Holder
Tora Laboratories, S.L.U.
Avenida de Oporto, 60
28019 Madrid, Spain
Manufacturer
Industria Química y Farmacéutica VIR, S.A.
C/ Laguna, 66-68-70 Polígono Industrial Urtinsa II 28923 Alcorcón (Madrid)
Spain
Date of the most recent review of this leaflet:
September 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/