Famotidine Mabo 40 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Famotidine Mabo 40 mg tablets EFG
Read the entire package leaflet carefully before you start taking the medicine.
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Contents of the leaflet:
1.- What FAMOTIDINA MABO 40 mg tablets are and what they are used for
2.- Before taking FAMOTIDINA MABO 40 mg tablets
3.- How to take FAMOTIDINA MABO 40 mg tablets
4.- Possible side effects
5.- Storage of FAMOTIDINA MABO 40 mg tablets
6.- Additional information
1. What FAMOTIDINE MABO 40 mg tablets are and what they are used for
Famotidine belongs to a group of medicines called histamine H2-receptor antagonists. Famotidine reduces the amount of acid produced in the stomach.
Famotidine is indicated for:
- Treatment and prevention of relapses of duodenal and gastric ulcers
- Treatment of inflammation of the esophagus (reflux esophagitis)
- Prevention of reflux esophagitis
- Treatment of heartburn and acid regurgitation
- Treatment of Zollinger-Ellison syndrome
2. BEFORE TAKING FAMOTIDINE MABO 40 mg TABLETS
Do not take FAMOTIDINE MABO 40 mg tablets
If you are allergic (hypersensitive) to famotidine, to other H2 receptor antagonists, or to any of the other components of FAMOTIDINE MABO 40 mg.
Take special care with FAMOTIDINE MABO 40 mg
- If your doctor has not ruled out the presence of gastric neoplasia before starting treatment with famotidine. Symptomatic relief of gastric ulcer during treatment does not exclude the presence of a malignant gastric ulcer.
- Should be used with caution in patients with moderate or severe hepatic or renal dysfunction. Adverse reactions affecting the central nervous system (CNS) have been reported in patients with moderate to severe renal impairment, and it may be necessary to extend the dosing interval or reduce the dose.
- If you have been taking Famotidine Mabo for a long time, your doctor will likely monitor you regularly. During visits to your doctor, you should report any new or unusual symptoms or circumstances.
Use in children
The safety and efficacy of famotidine in children have not been established.
Use in elderly patients (over 65 years)
Patients over 65 years of age only require dose adjustment in case of moderate or severe renal impairment.
Use of other medicines
Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.
- Calcium carbonate, when used to treat elevated blood phosphate levels (hyperphosphatemia) in patients on dialysis.
- Famotidine may reduce the effect of oral posaconazole suspension (a medication taken by mouth used to prevent and treat certain fungal infections).
- Famotidine may reduce the effect of dasatinib, erlotinib, gefitinib, or pazopanib (medications used to treat cancer).
Taking Famotidine Mabo with food and drinks
Take the tablets with a little water. It does not matter whether you take FAMOTIDINE MABO 40 mg with food or not.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medication.
Pregnancy:
Treatment with famotidine is not recommended during pregnancy. You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
Breastfeeding
Famotidine passes into breast milk. Breastfeeding mothers should either discontinue treatment with famotidine or stop breastfeeding.
Driving and operating machinery
It is unlikely that famotidine will affect your ability to drive vehicles or operate machinery. Nevertheless, caution is recommended during the first months of treatment.
Interference with diagnostic tests:
If you are due to undergo any diagnostic tests, inform your doctor that you are taking this medicine, as it may alter test results.
Important information about some of the components of FAMOTIDINE MABO 40 mg
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.
3. How to TAKE FAMOTIDINE MABO 40 mg tablets
Follow exactly the instructions for use of FAMOTIDINE MABO 40 mg as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.
Your doctor will tell you how many tablets to take each day and for how long.
If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
Famotidine Mabo tablets are administered orally. Take each tablet with a sufficient amount of liquid.
Remember to take your medicine.
Treatment of duodenal ulcer: The usual dose is 1 tablet (40 mg famotidine) at night. Alternatively, half a tablet (20 mg) every 12 hours may be administered. Treatment should be maintained for 4 to 8 weeks.
Treatment of benign gastric ulcer: The usual dose is 1 tablet (40 mg famotidine) at night. Treatment should be maintained for 4 to 8 weeks.
Maintenance treatment of gastric or duodenal ulcer: Half a tablet (20 mg famotidine) at night is recommended. Your doctor will indicate how long you should continue taking the medicine.
Treatment of gastroesophageal reflux disease (GERD): The recommended dose is half a tablet (20 mg famotidine) twice daily. If there is no improvement after 4–8 weeks, consult your doctor.
Healing of reflux-associated ulceration: The recommended dose is 1 tablet (40 mg famotidine) twice daily. If there is no improvement after 4–8 weeks, consult your doctor.
Zollinger-Ellison syndrome: Treatment usually starts with a dose of half a tablet (20 mg) every 6 hours. Your doctor will subsequently adjust the dose according to individual patient needs.
Dose adjustment in patients with moderate or severe renal impairment: In adult patients with moderate or severe renal impairment, the dose of famotidine may be reduced by half or the dosing interval extended to 36–48 hours, depending on the patient's response.
If you take more FAMOTIDINE MABO 40 mg tablets than you should
Adverse reactions in cases of overdose are similar to those observed in normal clinical experience.
If you have taken more FAMOTIDINE MABO 40 mg than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20. If possible, bring this leaflet or the package with you and show it to the healthcare professional.
If you forget to take FAMOTIDINE MABO 40 mg tablets
If you forget to take a dose, take it as soon as possible unless the next dose is due soon. In that case, skip the missed dose and take the next tablets at the usual time. Do not take a double dose to make up for forgotten doses.
If you stop taking FAMOTIDINE MABO 40 mg:
Do not stop treatment prematurely, even if symptoms have improved. Your condition may not have been completely cured and could recur if you do not complete the full course of treatment.
4. Possible adverse effects
Like all medicines, FAMOTIDINE MABO 40 mg tablets can have adverse effects, although not everyone experiences them.
Diarrhea, headache, dizziness, and constipation have rarely been reported.
Other, even less frequent, side effects have included: fatigue, dry mouth, nausea and vomiting, abdominal discomfort or distension, excessive intestinal gas, loss of appetite, skin rash, pruritus, urticaria, alterations in liver enzymes, cholestatic jaundice, anaphylaxis, angioedema, and arthralgia. Very rarely, hair loss and toxic epidermal necrolysis have been reported with H2 receptor antagonists.
However, at present, the possibility cannot be ruled out of other adverse effects occurring similar to those observed with other H2 antagonists.
Reporting of 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 leaflet. You may 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 FAMOTIDINE MABO 40 mg tablets
Keep out of the reach and sight of children.
No special storage conditions are required. Store in the original container.
Expiry
Do not use FAMOTIDINE MABO 40 mg after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of FAMOTIDINE MABO 40 mg tablets
- The active substance is famotidine. Each tablet contains 40 mg of famotidine.
- The other components are: lactose, microcrystalline cellulose, corn starch, polyvinylpyrrolidone, colloidal silicon dioxide, sodium croscarmellose, and magnesium stearate.
Appearance of the product and contents of the pack
FAMOTIDINE MABO 40 mg tablets are presented as tablets. Each package contains 10, 14, or 28 tablets.
Marketing Authorization Holder
MABO-FARMA S.A.
Calle Rejas 2, planta 1
28821 Coslada, Madrid
Spain
Manufacturer
INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/Laguna 66-70. Polígono Industrial Urtinsa II
28923 Alcorcón, Madrid
Spain
or
TEDEC-MEIJI FARMA, S.A.
Ctra. M-300, Km. 30.500
28802 Alcalá de Henares, Madrid
Spain
This leaflet was last reviewed in March 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/