Famotidina mabo 40 mg comprimidos efg

PATIENT INFORMATION LEAFLET

Famotidine Mabo 40 mg Tablets EFG

1.- What is FAMOTIDINE MABO 40 mg Tablets and what it is used for

2.- Before taking FAMOTIDINE MABO 40 mg Tablets

3.- How to take FAMOTIDINE MABO 40 mg Tablets

4.- Possible side effects

5.- Storage of FAMOTIDINE MABO 40 mg Tablets

6.- Additional information

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 relapses of duodenal and gastric ulcers
• Treatment of esophagitis caused by acid reflux
• Prevention of esophagitis caused by acid reflux.
• Treatment of stomach burning and acid regurgitation.
• Treatment of Zollinger-Ellison syndrome.

Do not take FAMOTIDINA MABO 40 mg tablets

If you are allergic (hypersensitive) to famotidine, to other H2 receptor antagonists, or to any of the other components of FAMOTIDINA MABO 40 mg.

Be especially careful with FAMOTIDINA MABO 40 mg

• Your doctor has not ruled out the presence of gastric neoplasia before starting treatment with famotidine.The symptomatic relief of gastric ulcers during treatment does not rule out the presence of a malignant gastric ulcer.
• Use with caution in patients with moderate or severe hepatic or renal dysfunction. Adverse reactions on the CNS have been reported in patients with moderate and severe renal insufficiency, and it may be necessary to extend the dosing interval or reduce the dose.
• If you have been taking Famotidina Mabo for a long time, your doctor will probably perform regular checks. At your doctor's visits, you must inform them of any new or abnormal symptoms and circumstances.

Use in children

The safety and efficacy of famotidine have not been established in children.

Use in patients over 65 years

Patients over 65 years only require dose adjustment in cases of moderate or severe renal insufficiency.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

• Calcium carbonate, when used to treat elevated phosphate levels in the blood (hyperphosphatemia) in patients undergoing dialysis.
• Famotidine may reduce the effect of posaconazole oral suspension (a medication 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 Famotidina Mabo with food and beverages

Take the tablets with a little water. It does not matter if you take FAMOTIDINA MABO 40 mg with food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medication.

Pregnancy:

Treatment with famotidine is not recommended during pregnancy. Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding:

Famotidine passes into breast milk. Lactating mothers should discontinue treatment with famotidine or interrupt breastfeeding.

Driving and operating machinery

It is unlikely that famotidine will have any effect on your ability to drive vehicles or operate machinery. However, caution is recommended during the first few months of treatment.

Interference with diagnostic tests:

If you are to undergo any diagnostic tests, inform your doctor that you are using this medication, as it may alter the test results.

Important information about one of the components of FAMOTIDINA MABO 40 mg

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for FAMOTIDINA MABO 40 mg as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many tablets to take per day and for how long.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Famotidina Mabo tablets are administered orally. Take each tablet with a sufficient amount of liquid.

Remember to take your medication.

Treatment of duodenal ulcer:The usual dose is 1 tablet (40 mg of Famotidina) at night. It may also be administered half a tablet (20 mg) every 12 hours. Treatment should be maintained for4 to8 weeks.

Treatment of benign gastric ulcer:The usual dose is 1 tablet (40 mg of Famotidina) at night. Treatment should be maintained for4 to8 weeks.

Maintenance treatment of gastric or duodenal ulcer:It is recommended to take half a tablet (20 mg of famotidina) at night. Your doctor will tell you for how long you should take the medication.

Treatment of gastroesophageal reflux disease (GERD):The recommended dose is half a tablet (20 mg of famotidina) twice a day. If there is no improvement after 4-8 weeks, consult your doctor.

Healing of ulcers associated with gastroesophageal reflux disease:The recommended dose is 1 tablet (40 mg of Famotidina) twice a day. If there is no improvement after 4-8 weeks, consult your doctor.

Zollinger-Ellison syndrome:Normally, treatment will start with a dose of half a tablet (20 mg) every 6 hours. The doctor will later adjust the dose according to the needs of each patient.

Dose adjustment in patients with moderate or severe renal insufficiency:In adult patients with moderate or severe renal insufficiency, the dose of Famotidina may be reduced to half or the dosing interval may be extended to 36-48 hours according to the patient's response.

If you take more FAMOTIDINA MABO 40 mg tablets than you should

The adverse reactions in cases of overdose are similar to the adverse reactions found in normal clinical experience.

If you have taken more FAMOTIDINA MABO 40 mg than you should, consult your doctor or pharmacist immediately or call theToxicological Information Service. Phone 91 562 04 20. If possible, bring this leaflet or the packaging and show it to the healthcare professional.

If you forget to take FAMOTIDINA MABO 40 mg tablets

If you forget to take a dose, take it as soon as you remember, unless the time for the next dose is almost due. In this case, skip the missed dose and take the tablets as usual. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with FAMOTIDINA MABO 40 mg:

Do not stop treatment prematurely because the symptoms have improved. It is possible that your condition has not been completely cured and may recur if you do not complete the entire treatment.

Like all medications, FAMOTIDINA MABO 40 mg tablets may have adverse effects, although not everyone will experience them.

Dyspepsia, headache, dizziness, and constipation have been rarely described.

Other less frequent side effects include: fatigue, dry mouth, nausea and vomiting, abdominal discomfort or distension, excessive intestinal gas, loss of appetite, skin rash, pruritus, urticaria, liver enzyme alterations, cholestatic jaundice, anaphylaxis, angioedema, and arthralgia. Very rarely, hair loss and toxic epidermal necrolysis with H2 receptor antagonists have been reported.

However, it cannot be ruled out at this time that other adverse effects of the type observed in other H2 antagonists may occur.

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 of Pharmacovigilance of Medicinal Products for Human Use https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children

No special storage conditions are required. Store in the original packaging

Expiration Date

Do not use FAMOTIDINA MABO 40 mg 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 the packaging and medicines you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of FAMOTIDINA MABO 40 mg tablets

• The active ingredient is famotidine. Each tablet contains 40 mg of famotidine.
• The other components are; lactose, microcrystalline cellulose, cornstarch, polivinylpyrrolidone, colloidal silica, sodium croscarmellose and magnesium stearate.

Appearance of the product and contents of the package

FAMOTIDINA MABO 40 mg tablets are presented in the form of tablets. Each package contains 10, 14 and 28 tablets.

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada, Madrid

Spain

Responsible for manufacturing

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Urtinsa II Industrial Estate

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 revised in March 2025

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