Leaflet: information for the user

famotidine cinfa 40 mg film-coated tablets

Read this 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 must not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take famotidine cinfa.

4.Possible side effects.

5.Storage of famotidine cinfa.

6.Contents of the pack and additional information.

famotidine cinfa is a medication that belongs to the group of drugs known as H2 receptor antagonists or H2 blockers.2. These medications are used to treat diseases associated with acid produced by the stomach.

famotidine cinfa is indicated for:

-Treatment and relapses of duodenal and gastric ulcers.

-Treatment of Zollinger Ellison syndrome.

-Treatment of stomach burning and acid regurgitation.

-Treatment of esophagus inflammation (esophagitis caused by reflux).

-Prevention of esophagitis caused by gastroesophageal reflux (irritation and inflammation of the esophagus).

Do not take famotidine cinfa

-If you are allergic to famotidine or any of the other components of this medication (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 other more serious diseases. If your doctor has not ruled out the presence of gastric neoplasia before starting treatment with famotidine. The 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 moderate or severe kidney or liver disease. Adverse reactions on the CNS have been reported in patients with moderate or severe renal insufficiency. Your doctor will indicate the lesser frequency of administration or the lower 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 make regular checks. At your doctor's visits, you must inform him of any new symptoms and abnormal circumstances.

Children

The safety and efficacy have not been established in pediatric populations.

Elderly

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

Other medications and famotidine cinfa

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

• Calcium carbonate, when used to treat elevated blood phosphate levels (hyperphosphatemia) in patients on dialysis.
• Famotidine may decrease the effect of oral suspension posaconazole (a medication used to drink to prevent and treat some fungal infections).
• Famotidine may decrease the effect of dasatinib, erlotinib, gefitinib, or pazopanib (medications 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 medication.

Pregnancy

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

Breastfeeding

Famotidine is excreted in human milk. Lactating mothers should discontinue treatment with famotidine or interrupt breastfeeding.

Driving and operating machinery

Although such effects are not expected, if you experience dizziness, do not drive or use hazardous machinery.

Interference with diagnostic tests

Inform your doctor if you are using this medication, as it may alter test results.

famotidine cinfa contains sodium

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

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

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

Ulcer duodenal treatment

The recommended dose is 1 tablet (40 mg of famotidine) at night. It can also be administered with half a tablet (20 mg of famotidine) every 12 hours. Treatment should be maintained for 4 to 8 weeks..

Benign gastric ulcer treatment

The recommended dose is 1 tablet (40 mg of famotidine) at night. Treatment should be maintained for 4 to 8 weeks.

Maintenance treatment of duodenal or gastric ulcers

The recommended dose to prevent peptic ulcers from recurring is half a tablet (20 mg of famotidine) administered at night. Your doctor will indicate for how long you should take the medication.

Gastroesophageal reflux disease (GERD) treatment

The recommended dose is half a tablet (20 mg of famotidine) twice a day. If there is no improvement after 4-8 weeks, consult your doctor.

Ulcer healing associated with gastroesophageal reflux

The recommended dose is 1 tablet (40 mg of famotidine) 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 of famotidine) every 6 hours. Your doctor will then adjust the dose according to each patient's needs.

Dose adjustment in patients with moderate or severe renal insufficiency

Your 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.

Only patients of advanced age need dose adjustment in case of renal insufficiency.

If you consider that the action of famotidine is too strong or too weak, inform your doctor or pharmacist.

Administration form

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

The groove is only for breaking the tablet if it is difficult for you to swallow it whole.

If you take more famotidine cinfa than you should

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

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

If you forgot to take famotidina cinfa

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 compensate for the missed doses.

If you interrupt the treatment with famotidina cinfa

You should not stop treatment abruptly, nor before time because the symptoms have improved. Treatment suspension is always done gradually and according to your doctor's indications to avoid relapses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

-Nervous system disorders: headache, dizziness.

-Gastrointestinal disorders: constipation, diarrhea.

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

-General disorders and administration site conditions: persistent lack of appetite, fatigue.

-Gastrointestinal disorders: nausea, vomiting, abdominal pain or distension (inflammation of the abdomen), 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 psychiatric 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 excessive allergic reaction), angioneurotic edema (severe allergic reaction with inflammation of the face, lips, tongue, throat, and even extremities with difficulty swallowing or breathing).

-Skin and subcutaneous tissue disorders: urticaria (skin patches).

-Hepatobiliary disorders: cholestatic jaundice (yellow discoloration 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.

-Complementary examinations: abnormalities in liver enzymes.

Reporting of side effects

If you experience any of these side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Do not use this medication 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. Dispose of 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. By doing so, you will help protect the environment.

Famotidine cinfa composition

- The active ingredient is famotidine. Each film-coated tablet contains 40 mg of famotidine.

- The other components are:

- Tablet core: sodium croscarmellose, talc, microcrystalline cellulose, and magnesium stearate.

- Tablet coating: yellow iron oxide (E-172), red iron oxide (E-172), and Opadry-Y-1-7000 (titanium dioxide (E-171), hypromellose, and macrogol 400).

Product appearance and packaging content

Orange-brown film-coated tablets, cylindrical, biconvex, scored on one side, and with the code “FA40” on the other side.

Presented in PVC/Aluminum blisters. Each package contains 10, 14, or 28 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: August 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http:// /w w w.aemps.gob.es

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63317/P_63317.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63317/P_63317.html