Famotidine CINFA 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

famotidine cinfa 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

famotidine cinfa is a medicine that belongs to a group of drugs known as H2-receptor antagonists or H2 blockers. These medicines are used to treat conditions associated with stomach acid production.

famotidine cinfa is indicated for:

• Treatment and prevention of relapses of duodenal and gastric ulcers.
• Treatment of Zollinger-Ellison syndrome.
• Treatment of heartburn and acid regurgitation.
• Treatment of inflammation of the esophagus (reflux esophagitis).
• Prevention of gastroesophageal reflux esophagitis (irritation and inflammation of the esophagus).

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

Do not take famotidine cinfa

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

If you are unsure whether you should take famotidine, consult your doctor.

Warnings and precautions

Before starting treatment, your doctor must rule out the presence of more serious conditions. If your doctor has not ruled out the possibility of gastric neoplasia before initiating treatment with famotidine, relief of gastric ulcer symptoms during treatment does not exclude the presence of a malignant ulcer.

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

• If you have moderate or severe kidney or liver disease. Adverse reactions affecting the central nervous system (CNS) have been reported in patients with moderate or severe renal impairment. Your doctor will advise you to take the medicine less frequently or at a lower dose.
• If you are elderly, as you may have renal impairment.

If you have been taking famotidine for a long time, your doctor will likely perform regular check-ups. During visits to your doctor, you should report any new or unusual symptoms or circumstances.

Children

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

Elderly people

Dosage should be determined in consultation with your doctor; monitoring of kidney function may be helpful. Patients over 65 years of age only require dose adjustment in cases of moderate or severe renal impairment.

Other medicines and famotidine cinfa

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

• Calcium carbonate, when used to treat high blood phosphate levels (hyperphosphatemia) in dialysis patients.
• Famotidine may reduce the effect of oral posaconazole 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 famotidine cinfa with food and drink

Famotidine does not alter its absorption when administered with food.

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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding

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

Driving and using machines

Although effects in this regard are not expected, if dizziness occurs, you should not drive or operate dangerous machinery.

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.

famotidine cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take famotidine cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will prescribe the appropriate dose and duration depending on your condition. Take only the amount prescribed by your doctor.

Treatment of duodenal ulcer

The recommended dose is 2 tablets (40 mg of famotidine) at bedtime. Alternatively, 1 tablet (20 mg of famotidine) every 12 hours may be administered. 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 bedtime. Treatment should be maintained for 4 to 8 weeks.

Maintenance treatment of duodenal or gastric ulcer

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

Treatment of gastroesophageal reflux disease (GERD)

The recommended dose is 1 tablet (20 mg of famotidine) twice daily. 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 daily. If there is no improvement after 4–8 weeks, consult your doctor.

Zollinger-Ellison syndrome

Treatment is usually initiated with a dose of 1 tablet (20 mg of famotidine) every 6 hours. The doctor will subsequently adjust the dose according to individual patient needs.

Dose adjustment in patients with moderate or severe renal impairment

The doctor will decide whether dose adjustment is necessary, either by reducing the dose by half or by increasing the interval between doses to 36–48 hours, depending on your response.

Elderly patients require dose adjustment only in case of renal impairment.

If you think that the effect of famotidine cinfa is too strong or too weak, inform your doctor or pharmacist.

Method of administration

Swallow the tablet whole with a little water. Your doctor will indicate how many tablets to 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 those observed in normal clinical experience.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 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 a missed dose.

If you stop taking famotidine cinfa

Do not stop treatment abruptly or prematurely, even if symptoms have improved. Discontinuation of treatment should always be gradual and according to your doctor's instructions to avoid relapse.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Uncommon adverse 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 (abdominal swelling), dry mouth, excessive intestinal gas.
• Skin and subcutaneous tissue disorders: skin 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 adverse effects (may affect up to 1 in 1,000 people)

• General disorders and administration site conditions: anaphylaxis (unusual or exaggerated allergic reaction), angioneurotic oedema (severe allergic reaction with swelling of the face, lips, tongue, throat, and even limbs, causing difficulty in swallowing or breathing).
• Skin and subcutaneous tissue disorders: urticaria (skin rash).
• Hepatobiliary disorders: cholestatic jaundice (yellowing of the skin).

Very rare adverse 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 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 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of famotidine cinfa

• The active substance is famotidine. Each film-coated tablet contains 20 mg of famotidine.
• The other components are:
• Tablet core: croscarmellose sodium, talc, microcrystalline cellulose and magnesium stearate.
• Film coating: yellow iron oxide (E-172), red iron oxide (E-172) and Opadry-Y-1-7000 (titanium dioxide (E-171)/ hypromellose/ polyethylene glycol 400).

Appearance of the product and contents of the container

Film-coated tablets, beige-salmon in colour, cylindrical, biconvex, with the code “FA20” marked on one side.

Presented 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 the most recent review 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. 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