FAMOTIDINE ARISTO 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Famotidine Aristo 40 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Contents of the package leaflet:

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

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

Famotidine Aristo 40 mg tablets is an anti-ulcer medicine that belongs to a group called H2 antihistamines, with prolonged action.

Famotidine Aristo is available as tablets and comes in packs containing 10, 14, and 28 tablets.

Famotidine Aristo 40 mg tablets is indicated for duodenal ulcer, benign gastric ulcer, hypersecretory syndromes such as Zollinger-Ellison syndrome, and for maintenance therapy to reduce the recurrence of duodenal and benign gastric ulcers. Symptomatic treatment of reflux disease that has not responded to hygienic-dietary measures and antacids. Esophagitis due to esophageal reflux.

2. What you need to know before you take Famotidine Aristo

Do not take Famotidine Aristo:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Famotidine Aristo.

• If your doctor has not ruled out the existence of gastric neoplasia before starting treatment with Famotidine. Symptomatic relief of gastric ulcer during treatment does not rule out the presence of a malignant gastric ulcer.
• It should be used with caution in patients with moderate or severe hepatic or renal dysfunction. Adverse reactions on the central nervous system (CNS) have been reported in patients with moderate and severe renal insufficiency, and it may be necessary to extend the dosing interval or reduce the dose.
• Treatment discontinuation should always be gradual and under medical criteria to avoid relapses.

Children and adolescents

There was no increase in the incidence or changes in the types of side effects when Famotidine was administered to the elderly. No dose adjustment was required based on age. It may be necessary to adjust the dose in case of moderate or severe renal damage.

Elderly patients

There was no increase in the incidence or changes in the types of side effects when Famotidine was administered to the elderly. No dose adjustment was required based on age. It may be necessary to adjust the dose in case of moderate or severe renal damage.

Other medicines and Famotidine Aristo

Tell your doctor or pharmacist 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 Aristo may decrease the effect of the oral suspension of posaconazole (a medicine used to prevent and treat some fungal infections).

- Famotidine Aristo may decrease the effect of dasatinib, erlotinib, gefitinib, or pazopanib (medicines used to treat cancer).

No interactions with other drugs have been established. The studies carried out demonstrate that there are no significant interferences with the metabolism of compounds at the level of hepatic microsomal enzymes. In humans, it is unlikely that interactions will occur with warfarin, propranolol, theophylline, and diazepam. Additionally, studies with Famotidine have not shown increases in expected blood alcohol levels resulting from alcohol ingestion.

Pregnancy and breastfeeding

Pregnancy

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, it should only be prescribed if clearly necessary. Before using Famotidine in pregnant women, the potential benefits should be weighed against the possible risks.

Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

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

Driving and using machines

It is unlikely that Famotidine will affect your ability to drive or use machines. However, it is recommended to exercise caution until the response to therapy is well established.

Famotidine Aristo contains lactose and sodium

Famotidine Aristo contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Famotidine Aristo

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take Famotidine Aristo. Do not stop treatment before.

Famotidine Aristo is administered orally with the help of a little water. If you have difficulty taking the tablets, inform your doctor or pharmacist.

The recommended dose is:

Duodenal ulcer:The recommended daily dose of famotidine is 1 tablet (40 mg of famotidine) at night. It can also be administered as 20 mg every 12 hours. Treatment should be maintained for 4 to 8 weeks, although it may be shortened if endoscopy reveals that the ulcer is healed. In most cases of duodenal ulcer, healing occurs within 4 weeks. If during this period the ulcer does not heal, treatment should be continued for another 4 weeks.

Maintenance therapy: To reduce the recurrence of duodenal ulcers, it is recommended to continue with a daily dose of 20 mg at night. However, it should be taken into account that no controlled studies have been conducted for periods longer than 1 year.

Benign gastric ulcer:The recommended dose is 1 tablet (40 mg of famotidine) daily, at night. Treatment should be continued for 4 to 8 weeks, but may be shortened if endoscopy reveals that the ulcer is healed.

Maintenance therapy: For the prevention of recurrences of benign gastric ulcers, the recommended dose is 20 mg administered at night, and it can be administered for at least one year.

Gastroesophageal reflux disease:The recommended dosage for gastroesophageal reflux disease is 20 mg of famotidine orally, twice a day.

For the treatment of esophagitis due to gastroesophageal reflux, the recommended dose is 1 tablet (40 mg of famotidine) twice a day, orally. If no response is obtained after 4-8 weeks of treatment, it is advisable to perform endoscopic diagnosis.

Zollinger-Ellison syndrome:Treatment should be started in patients without previous antisecretory treatment at a dose of 20 mg every 6 hours. This dose should be adjusted to the individual needs of the patient and should be maintained for as long as clinically required. Doses of up to 800 mg daily have been used for 1 year without significant adverse effects or tachyphylaxis. In patients with previous antisecretory treatment, the initial dose of famotidine should be higher than that recommended for initial cases, depending on the severity of the clinical picture and the dose of H2 antagonist used previously.

Dose adjustment in patients with moderate or severe renal insufficiency:In adult patients with moderate or severe renal insufficiency, the dose of Famotidine may be reduced to half or the dosing interval extended to 36-48 hours according to their response.

If you think that the action of Famotidine Aristo is too strong or too weak, tell your doctor or pharmacist.

If you take more Famotidine Aristo than you should

There is no experience of overdoses. Patients with hypersecretory syndromes have used doses of up to 800 mg daily without serious adverse effects. In case of accidental overdose, the usual measures should be used to remove the unabsorbed medicine from the gastrointestinal tract, the patient should be closely monitored, and supportive treatment should be used.

Contact your doctor or pharmacist or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Famotidine Aristo

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The classification of side effects is based on the following frequencies:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

Frequency not known: frequency cannot be estimated from the available data

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
• Rash
• Itching
• Joint pain
• Muscle cramps
• Reversible mental disorders including depression, anxiety disorders, agitation, confusion, and hallucinations
• Excess gas

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):

• Toxic epidermal necrolysis (skin peeling)
• Laboratory findings: liver enzyme abnormalities
• Hair loss

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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 Aristo

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 carton after EXP. The expiry date is 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 Aristo 40 mg

• The active ingredient is famotidine.
• The other excipients are: povidone, sodium croscarmellose, corn starch, magnesium stearate, lactose, colloidal silicon dioxide, microcrystalline cellulose.

Appearance of the product and pack contents

Famotidine Aristo 40 mg tablets are white, round, and smooth.

They come in aluminum/aluminum blisters inserted in cardboard boxes.

Packs of 10, 14, and 28 tablets.

Clinical pack of 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Medinsa (Laboratorios Medicamentos Internacionales S.A.)

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Or

TEDEC-MEIJI FARMA, S.A.

Carretera M-300, Km 30,500

28802 Alcala de Henares (Madrid)

Date of the last revision of this leaflet: July 2023

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