FAMOTIDINE NORMON 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Famotidine Normon 40 mg Film-Coated Tablets

Famotidine

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet:

1. What is Famotidine Normon and what is it used for
2. What you need to know before taking Famotidine Normon
3. How to take Famotidine Normon
4. Possible side effects
5. Storage of Famotidine Normon
6. Package Contents and Additional Information

1. What is Famotidine Normon and what is it used for

Famotidine Normon belongs to a group of medications called histamine H2 receptor antagonists or H2 blockers. Famotidine reduces the amount of acid produced in the stomach.

Famotidine is indicated for the treatment of duodenal ulcers, benign gastric ulcers, as well as for the prevention of their recurrence. It is also used in other diseases where the stomach produces too much acid, such as Zollinger-Ellison syndrome, and in gastroesophageal reflux disease and gastroesophageal reflux esophagitis.

Famotidine Normon is indicated for adults.

2. What you need to know before taking Famotidine Normon

Do not take Famotidine Normon

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

Warnings and Precautions

• Before starting treatment, your doctor should rule out the existence of more serious diseases. Relief of gastric ulcer symptoms during treatment may delay the diagnosis of these diseases.
• Do not stop treatment abruptly. Treatment discontinuation should always be gradual and according to your doctor's instructions to avoid recurrence.

Consult your doctor or pharmacist before taking Famotidine Normon:

• If you have moderate or severe kidney disease. Your doctor will indicate the lowest administration frequency or the lowest 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 People Over 65 Years

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

Taking Famotidine Normon with Other Medications

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

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

Pregnancy and Breastfeeding

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

Treatment with famotidine is not recommended during pregnancy. You should inform your doctor if you are pregnant or plan to become pregnant.

Famotidine has been detected in breast milk. Breastfeeding mothers should discontinue treatment with famotidine or stop breastfeeding.

Driving and Using Machines

Although no effects are expected, if dizziness occurs, you should not drive or use hazardous machinery.

3. How to Take Famotidine Normon

Follow the administration instructions for this medication exactly as described in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Treatment of duodenal ulcers: 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 ulcers: 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 ulcers: 1 tablet (20 mg of famotidine) is recommended at night. Your doctor will indicate 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 gastroesophageal reflux esophagitis: 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) every 6 hours. The doctor will then 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, as the pain usually disappears before the ulcer is completely healed.

Use in Patients with Moderate or Severe Renal Impairment

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

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

Method of Administration

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

If You Take More Famotidine Normon Than You Should

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

If You Forget to Take Famotidine Normon

Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

Like all medications, this medication can have side effects, although not everyone experiences them.

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

• Headache
• Dizziness
• Diarrhea
• Constipation

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

• Lack of appetite
• Fatigue
• Nausea
• Vomiting
• Abdominal discomfort or distension
• Dry mouth
• Excess gas
• Rash
• Itching
• Joint pain
• Muscle cramps
• Reversible mental 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 exaggerated allergic reaction)
• Angioedema (severe allergic reaction with shortness of breath, urticaria, and swelling of the face, lips, tongue, throat, and possibly limbs, with difficulty swallowing or breathing)

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

• Hair loss
• Laboratory findings: Abnormalities in liver enzymes
• Toxic Epidermal Necrolysis (skin peeling)

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting Side Effects:

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

5. Storage of Famotidine Normon

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging, after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Famotidine Normon

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

Appearance of the Product and Package Contents

Famotidine 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.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

• 28760 Tres Cantos – Madrid

(SPAIN)

Date of the Last Revision of this Package Leaflet:August 2023

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