Leaflet: Information for the User

Famotidina Normon 40 mg Film-Coated Tablets EFG

Famotidina

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, do 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.

Famotidina Normon belongs to a group of medicines called histamine H2receptor antagonists or H2blockers. Famotidina reduces the amount of acid produced in the stomach.

Famotidina is indicated for the treatment of duodenal ulcers, benign gastric ulcers, as well as the prevention of their recurrences. It is also used in other diseases in which the stomach produces excessive acid, such as Zollinger-Ellison syndrome, and in gastroesophageal reflux disease and esophagitis due to gastroesophageal reflux.

Famotidina Normon is indicated for adults.

Do not take Famotidina Normon

• If you are allergic (hypersensitive) to famotidine, other H2 receptor antagonists, or any of the other components of this medication (listed in section 6).

Warnings and precautions

• Your doctor must rule out the presence of other more serious diseases before starting treatment. Relief of stomach ulcer symptoms during treatment may delay diagnosis of these diseases.
• Do not stop treatment abruptly. Treatment discontinuation will always be done gradually and according to your doctor's instructions to avoid relapses.

Consult your doctor or pharmacist before starting to take Famotidina Normon:

• If you have moderate or severe kidney disease. Your doctor will indicate the lower frequency of administration or the lower dose you should take.
• If you are an elderly person, as you may have kidney problems.

Children and adolescents

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 case of moderate or severe renal insufficiency.

Taking Famotidina Normon with other medications

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

The treatment with famotidina is not recommended during pregnancy. Inform your doctor if you are pregnant or plan to become pregnant.

Famotidina has been detected in breast milk. Lactating mothers should discontinue treatment with famotidina or interrupt breastfeeding.

Driving and operating machinery

Although this is not expected, if you experience dizziness, do not drive or operate hazardous machinery.

Follow exactly the administration instructions of this medication contained in this leaflet or indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Treatment of duodenal ulcer:The recommended dose is 2 tablets (40 mg of famotidine) at night. It can also be administered 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 gastric or duodenal ulcer:It is recommended to take 1 tablet (20 mg of famotidine) 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 famotidine), twice a day. If there is no improvement after 4-8 weeks, consult your doctor.

Treatment of esophagitis due to 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: Normally treatment will start with a dose of 1 tablet (20 mg) every 6 hours. The doctor will subsequently adjust the dose according to the needs of each patient.

It is very important that you continue taking this medication for the time your doctor prescribes it because the pain usually disappears before the ulcer is completely healed.

Use in patients with moderate or severe renal insufficiency

The doctor will decide if a dose adjustment is necessary, either by reducing it to half or increasing the time between doses.

Only elderly patients need a dose adjustment in case of renal insufficiency.

Administration form

Take the tablets with water. You can take this medication with or without food.

The tablet can be divided into equal doses.

Your doctor will tell you how many tablets you should take per day and for how long. Do not stop treatment before. If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Famotidina Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested. If possible, bring this leaflet or the packaging and show it to the healthcare professional.

If you forgot to take Famotidina Normon

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may have adverse effects, although not everyone will experience them.

Frequent (may affect up to 1 in 10 people):

• Headache
• Dizziness
• Diarrhea
• Constipation

Infrequent (may affect up to 1 in 100 people):

• Loss of appetite
• Fatigue
• Nausea
• Vomiting
• Abdominal discomfort or distension
• Dry mouth
• Excessive intestinal gas
• Skin rash
• Itching
• Joint pain
• Muscle cramps
• Reversible psychiatric disorders, including depression, anxiety disorders, agitation, confusion, and hallucinations

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

• Cholestatic jaundice (yellowing of the skin and eyes due to bile secretion problems)
• Urticaria (skin patches)
• Anaphylaxis (unusual or excessive allergic reaction)
• Angioneuritic edema (severe allergic reaction with shortness of breath, urticaria, and facial, lip, tongue, throat, and limb inflammation, with difficulty swallowing or breathing)

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

• Hair loss
• Laboratory findings: Abnormal liver enzyme levels
• Toxic Epidermal Necrolysis (skin peeling)

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Famotidina Normon

• The active ingredient is famotidine. Each tablet contains 40 mg of famotidine
• The other components (excipients) are:
• • Tablet core: pregelatinized cornstarch, microcrystalline cellulose, talc, magnesium stearate, and iron oxide red (E-172).
  • Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 6000, and iron oxide red (E-172).

Appearance of the product and content of the packaging

Famotidina Normon 40 mg film-coated tablets are presented in aluminum/PVC blisters. Each package contains 14 or 28 film-coated tablets of pink color, round, biconvex, and scored.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

– 28760 Tres Cantos – Madrid

(SPAIN)

Last review date of this leaflet:August 2023

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