PATIENT INFORMATION LEAFLET

Famotidine Mabo 20 mg Tablets EFG

1.- What is FAMOTIDINE MABO 20 mg Tablets and what is it used for

2.- Before taking FAMOTIDINE MABO 20 mg Tablets

3.- How to take FAMOTIDINE MABO 20 mg Tablets

4.- Possible side effects

5.- Storage of FAMOTIDINE MABO 20 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 20 mg Tablets:

if you are allergic (hypersensitive) to famotidine, to other H2 receptor antagonists, or to any of the other components of Famotidina Mabo 20 mg

Be especially careful with FAMOTIDINA MABO 20 mg Tablets:

• if your doctor has not ruled out the presence of gastric neoplasia before starting treatment with Famotidina. The symptomatic relief of gastric ulcer 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 central nervous system 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 him of any new or abnormal symptoms and circumstances.

Use in children:

The safety and efficacy of this medication 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 levels of phosphate in the blood (hyperphosphatemia) in patients undergoing dialysis.
• Famotidina may reduce the effect of oral suspension of posaconazole (a medication taken to prevent and treat certain fungal infections).
• Famotidina 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 20 mg with food.

The suspension of treatment will always be done gradually and under medical criteria to avoid relapses.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking a medication.

Pregnancy:

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

Breastfeeding:

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

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Driving and operating machinery:

It is unlikely that Famotidina will have any effect on the 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 test, inform your doctor that you are using this medication, as it may alter the results.

Important information about one of the components of FAMOTIDINA MABO 20 mg:

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for FAMOTIDINA MABO 20 mg as indicated by your doctor.

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

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

Famotidina Mabo 20 mg 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 2 Tablets (40 mg of Famotidina) at night. It can also be administered 1 tablet (20 mg of Famotidina) every 12 hours. Treatment should be maintained for4 to8 weeks.

Treatment of benign gastric ulcer:The usual dose is 2 Tablets (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 1 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 1 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 2 tablets (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 1 tablet (20 mg of Famotidina) 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 can be reduced to half or the dosing interval can be extended to 36-48 hours according to the patient's response.

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

If you forgot to take FAMOTIDINA MABO 20 mg Tablets::

If you forgot to take a dose, take it as soon as you remember, unless the time for the next dose is near. 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 dose.

If you interrupt treatment with FAMOTIDINA MABO 20 mg:

Do not stop treatment before time 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 20 mg Tablets may have adverse effects, although not everyone will experience them.

Rarely, diarrhea, headache, dizziness, and constipation have been described.

Other less frequent side effects included: fatigue, dry mouth, nausea and vomiting, abdominal discomfort or bloating, 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 20 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 20 mg tablets

• The active ingredient is famotidine. Each tablet contains 20 mg of famotidine.
• The other components (excipients) are: lactose, microcrystalline cellulose, cornstarch, polyvinylpyrrolidone, sodium croscarmellose, and magnesium stearate.

Appearance of the finished product and contents of the package

FAMOTIDINA MABO 20 mg tablets are presented in the form of tablets. Each package contains 28 tablets.

Holder of the 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. Industrial Estate Urtinsa II

28923 Alcorcón, Madrid

Spain

O

TEDEC-MEIJI FARMA, S.A.

Ctra. M-300, Km. 30,500

28802 Alcalá de Henares, Madrid

Spain

This leaflet was approved in August 2023

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/