FAMOTIDINE CINFA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

famotidine cinfa 20 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is famotidine cinfa and what is it used for.
2. What you need to know before you take famotidine cinfa.
3. How to take famotidine cinfa.
4. Possible side effects.
5. Storing famotidine cinfa.
6. Contents of the pack and other information.

1. What is famotidine cinfa and what is it used for

famotidine cinfa is a medicine that belongs to a group of medicines called H2 receptor antagonists or H2 blockers. These medicines are used to treat diseases associated with stomach acid.

famotidine cinfa is indicated in:

• Treatment and relapse of duodenal and gastric ulcers.
• Treatment of Zollinger-Ellison syndrome.
• Treatment of heartburn and acid reflux.
• Treatment of esophageal inflammation (reflux esophagitis).
• Prevention of reflux esophagitis (irritation and inflammation of the esophagus).

2. What you need to know before you take famotidine cinfa

Do not take famotidina cinfa

• If you are allergic to famotidine or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other H2 receptor antagonists.

If you are not sure if you should take famotidine, consult your doctor.

Warnings and precautions

Before starting treatment, your doctor should rule out the existence of other more serious diseases. If your doctor has not ruled out the existence of gastric neoplasia before starting treatment with famotidine. Relief of gastric ulcer symptoms during treatment does not rule out the presence of a malignant ulcer.

Consult your doctor or pharmacist before starting to take famotidine cinfa and in the following cases:

• If you have any kidney or liver disease, moderate or severe. Adverse reactions on the CNS have been reported in patients with moderate or severe renal insufficiency. Your doctor will indicate the lowest administration frequency or the lowest dose you should take.
• If you are an elderly person because you may have renal insufficiency.

If you have been taking famotidine for a long time, your doctor will probably have regular check-ups. During visits to your doctor, you should inform him of any new or unusual symptoms and circumstances.

Children

Safety and efficacy have not been established in the pediatric population.

Elderly

Consult your doctor for dose selection, and it may be useful to monitor kidney function. Patients over 65 years old only need a dose adjustment in case of moderate or severe renal insufficiency.

Other medicines and famotidine cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Calcium carbonate, when used to treat high blood phosphorus levels (hyperphosphatemia) 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 famotidine cinfa with food and drinks

Famotidine does not modify its absorption when administered with meals.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Treatment with famotidine is not recommended during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding

Famotidine is excreted in human milk. Breastfeeding mothers should discontinue treatment with famotidine or stop breastfeeding.

Driving and using machines

Although they are not expected, if dizziness occurs, do not drive or use hazardous machinery.

Interference with analytical tests

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

famotidine cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take famotidine cinfa

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will prescribe the appropriate dose and for how long, depending on your condition. Take only the amount that the doctor prescribes.

Treatment of duodenal ulcer

The recommended 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 ulcer

The recommended dose is 2 tablets (40 mg of famotidine) at night. Treatment should be maintained for 4 to 8 weeks.

Maintenance treatment of duodenal or gastric ulcer

The recommended dose to prevent the recurrence of peptic ulcers is 1 tablet (20 mg of famotidine) administered at night. Your doctor will indicate for how long you should take the medicine.

Treatment of gastroesophageal reflux disease (GERD)

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 ulcer associated with gastroesophageal 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 insufficiency

The doctor will decide if a dose adjustment is necessary, either by reducing it by half or increasing the time between doses to 36-48 hours according to your response.

Elderly patients only need a dose adjustment in case of renal insufficiency.

If you think the action of famotidine is too strong or too weak, tell your doctor or pharmacist.

Method of administration

Swallow the tablet whole with a little water. Your doctor will indicate how many tablets you should take per day and for how long.

If you take more famotidine cinfa than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take famotidine cinfa

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

If you stop taking famotidine cinfa

Do not stop treatment abruptly, or before time because the symptoms have improved. The suspension of treatment is always done gradually and according to the indications of your doctor to avoid relapses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• Nervous system disorders: headache, dizziness.
• Gastrointestinal disorders: constipation, diarrhea.

Uncommon side effects (may affect up to 1 in 100 people)

• General disorders and administration site conditions: persistent loss of appetite, fatigue.
• Gastrointestinal disorders: nausea, vomiting, abdominal discomfort or distension (inflammation of the abdomen), dry mouth, excess gas.
• Skin and subcutaneous tissue disorders: rash, pruritus (itching or skin irritation).
• Musculoskeletal and connective tissue disorders: joint pain, muscle cramps.
• Psychiatric disorders: reversible mental disorders including depression, anxiety disorders, agitation, confusion, and hallucinations.

Rare side effects (may affect up to 1 in 1,000 people)

• General disorders and administration site conditions: anaphylaxis (unusual or exaggerated allergic reaction), angioedema (severe allergic reaction with inflammation of the face, lips, tongue, throat, and possibly extremities with difficulty swallowing or breathing).
• Skin and subcutaneous tissue disorders: urticaria (skin patches).
• Hepatobiliary disorders: cholestatic jaundice (yellowing of the skin).

Very rare side effects (may affect up to 1 in 10,000 people)

• Skin and subcutaneous tissue disorders: toxic epidermal necrolysis (skin peeling) and hair loss.
• Investigations: abnormalities in liver enzymes.

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing famotidine cinfa

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of famotidine cinfa

• The active substance is famotidine. Each film-coated tablet contains 20 mg of famotidine.
• The other ingredients are:
• Core of the tablet: croscarmellose sodium, talc, microcrystalline cellulose, and magnesium stearate.
• Coating of the tablet: yellow iron oxide (E-172), red iron oxide (E-172), and Opadry-Y-1-7000 (titanium dioxide (E-171)/hypromellose/macrogol 400).

Appearance and packaging

Beige-salmon colored film-coated tablets, cylindrical, biconvex, and with the code "FA20" on one face.

They come in PVC/Aluminum blisters. Each pack contains 20 or 28 film-coated tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra)-Spain

Date of last revision of this leaflet:August 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63319/P_63319.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63319/P_63319.html