FAMOTIDINE NORMON 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Famotidine Normon 20 mg Film-Coated Tablets

Famotidine

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 package leaflet:

1. What is Famotidine Normon and what is it used for
2. What you need to know before you take Famotidine Normon
3. How to take Famotidine Normon
4. Possible side effects
5. Storage of Famotidine Normon
6. Contents of the pack and further information

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

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

Famotidine is indicated for the treatment of duodenal ulcer, benign gastric ulcer, as well as for the prevention of their relapses. 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 in adults.

2. What you need to know before you take 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 ingredients of this medicine (listed in section 6).

Warnings and precautions

• Before starting treatment, your doctor must 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. Discontinuation of treatment will always be gradual and according to your doctor's instructions to avoid relapses.

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 medicine in children have not been established.

Use in people over 65 years

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

Taking Famotidine Normon with other medicines

Tell your doctor 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 Normon may decrease the effect of the oral suspension of posaconazole (a medicine used to prevent and treat some fungal infections).
• Famotidine Normon may decrease the effect of dasatinib, erlotinib, gefitinib or pazopanib (medicines used to treat cancer).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 stop 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.

3. How to take Famotidine Normon

Follow exactly the administration instructions of this medicine contained in this leaflet or as 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: 1 tablet (20 mg of famotidine) is recommended at night. 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 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 medicine during 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 by half or by increasing the time between doses.

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

Method of administration

Take the tablets with water. You can take Famotidine Normon 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 beforehand. If you think the effect of this medicine is too strong or too weak, tell 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, telephone 915 620 420, indicating the medicine and the amount taken. If possible, take this leaflet or the packaging with you 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.

If you have any further questions on 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 (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 wheezing, urticaria and swelling of the face, lips, tongue, throat and even limbs with difficulty swallowing or breathing)

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

• Hair loss
• Laboratory findings: Liver enzyme abnormalities
• Toxic Epidermal Necrolysis (skin peeling)

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Famotidine Normon

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging after ‘EXP’. The expiry date refers to the last day of the month shown.

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 further information

Composition of Famotidine Normon

• The active substance is famotidine. Each tablet contains 20 mg of famotidine
• The other ingredients (excipients) are:

• Core of the tablet: pregelatinized maize starch, microcrystalline cellulose, talc, magnesium stearate
• Coating of the tablet: hypromellose, titanium dioxide (E-171), macrogol 6000 and yellow iron oxide (E-172).

Appearance of the product and pack contents

Famotidine Normon 20 mg film-coated tablets are presented in aluminum/PVC blisters. Each pack contains 28 film-coated tablets of yellow 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 last revision of this leaflet:August 2023

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