FAMOTIDINE MABO 20 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Famotidine Mabo 20 mg tablets EFG

Contents of the pack:

1. What FAMOTIDINE MABO 20 mg tablets are and what they are used for

2. Before you take FAMOTIDINE MABO 20 mg tablets

3. How to take FAMOTIDINE MABO 20 mg tablets

4. Possible side effects

5. Storing FAMOTIDINE MABO 20 mg tablets

6. Further information

1. What FAMOTIDINE MABO 20 mg tablets are and what they are used for

Famotidine belongs to a group of medicines called H2 receptor antagonists. Famotidine reduces the amount of acid produced in the stomach.

Famotidine is indicated:

• Treatment and recurrence of duodenal and gastric ulcers
• Treatment of oesophageal inflammation (reflux oesophagitis)
• Prevention of reflux oesophagitis
• Treatment of heartburn and acid regurgitation.
• Treatment of Zollinger-Ellison syndrome

2. BEFORE YOU TAKE FAMOTIDINE MABO 20 mg tablets

Do not take FAMOTIDINE MABO 20 mg tablets:

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

Take special care with FAMOTIDINE MABO 20 mg tablets:

• If your doctor has not ruled out the existence of gastric neoplasia before starting treatment with Famotidina. Symptomatic relief of gastric ulcers during treatment does not rule out the presence of a malignant gastric ulcer.
• It should be used with caution in patients with moderate or severe hepatic or renal impairment. Adverse reactions on the CNS have been reported in patients with moderate and severe renal impairment, 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 have you checked regularly. During your doctor's visits, you should inform him of any new or abnormal symptoms and circumstances.

Use in children

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

Use in elderly over 65 years

Patient over 65 years only need a dose adjustment in case of moderate or severe renal impairment.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

• Calcium carbonate, when used to treat high blood phosphate levels (hyperphosphataemia) in patients on dialysis.
• Famotidine may decrease the effect of the oral suspension of posaconazole (a medicine used to prevent and treat some fungal infections).
• Famotidine may decrease the effect of dasatinib, erlotinib, gefitinib or pazopanib (medicines used to treat cancer).

Taking Famotidina Mabo with food and drinks:

Take the tablets with a little water. It does not matter if you take FAMOTIDINA MABO 20 mg with food.

Treatment should always be discontinued gradually and under medical supervision to avoid recurrences.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy:

Treatment with Famotidina is not recommended during pregnancy. You should 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 stop treatment with Famotidina or stop breastfeeding.

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Driving and using machines:

It is unlikely that Famotidine will affect your ability to drive or use machines. However, precautions are recommended during the first few months of treatment.

Interference with laboratory tests:

If you are going to have any diagnostic tests, tell your doctor that you are using this medicine, as it may affect the results.

Important information about some of the ingredients of FAMOTIDINA MABO 20 mg:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

3. HOW TO TAKE FAMOTIDINA MABO 20 mg tablets

Follow exactly the administration instructions of FAMOTIDINA MABO 20 mg given by your doctor.

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

If you think that the action of this medicine is too strong or too weak, talk to 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 medicine.

Treatment of duodenal ulcers:The normal dose is 2 tablets (40 mg of Famotidine) at night. It can also be administered as 1 tablet (20 mg of Famotidine) every 12 hours. Treatment should be maintained for 4 to 8 weeks.

Treatment of benign gastric ulcers:The normal dose is 2 tablets (40 mg of Famotidine) at night. Treatment should be maintained for 4 to 8 weeks.

Maintenance treatment of gastric or duodenal ulcers:1 tablet (20 mg of Famotidine) is recommended at night. Your doctor will tell you how long you should take the medicine.

Treatment of gastro-oesophageal reflux disease (GORD):The recommended dose is 1 tablet (20 mg of Famotidine) twice a day. If there is no improvement after 4-8 weeks, consult your doctor.

Healing of ulcers associated with gastro-oesophageal reflux:the recommended dose is 2 tablets (40 mg of Famotidine) twice a day. If there is no improvement after 4-8 weeks, consult your doctor.

Zollinger-Ellison syndrome:treatment usually starts with a dose of 1 tablet (20 mg of Famotidine) every 6 hours. The doctor will then adjust the dose according to the needs of each patient.

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 to half or the dosing interval extended to 36-48 hours according to the response.

If you take more FAMOTIDINA MABO 20 mg tablets than you should

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 call the Toxicology Information Service. Telephone 91 562 04 20. If possible, take this leaflet or the packaging with you and show it to the healthcare professional.

If you forget to take FAMOTIDINA MABO 20 mg tablets

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

If you stop taking FAMOTIDINA MABO 20 mg

Do not stop treatment before time, even if your symptoms have improved. It is possible that your condition has not been completely cured and may recur if you do not finish the entire treatment.

4. Possible side effects

Like all medicines, FAMOTIDINE MABO 20 mg tablets can cause side effects, although not everybody gets them.

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

Other, even rarer side effects included: fatigue, dry mouth, nausea and vomiting, abdominal discomfort or distension, excess gas, loss of appetite, skin rash, itching, urticaria, changes in liver enzymes, cholestatic jaundice, anaphylaxis, angioedema and arthralgia. Hair loss and toxic epidermal necrolysis have been very rarely reported with H2 receptor antagonists.

However, it cannot be excluded at present that other side effects of the type seen with other H2 antagonists may occur.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing FAMOTIDINE MABO 20 mg tablets

Keep out of the sight and reach of children.

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

Expiry date

Do not use FAMOTIDINE MABO 20 mg after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

Composition of FAMOTIDINE MABO 20 mg tablets

• The active substance is famotidine. Each tablet contains 20 mg of famotidine.
• The other ingredients (excipients) are: lactose, microcrystalline cellulose, maize starch, povidone, sodium croscarmellose and magnesium stearate.

Appearance of the finished product and packaging contents

FAMOTIDINA MABO 20 mg tablets are presented in tablet form. Each pack contains 28 tablets.

Marketing authorisation 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 approved in August 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/