Package Leaflet: Information for the User

Famotidina Aristo 40 mg Tablets EFG

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

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

2. What you need to know before you start taking Famotidina Aristo

3. How to take Famotidina Aristo

4. Possible side effects

5. Storage of Famotidina Aristo

6. Contents of the pack and additional information

Famotidina Aristo 40 mg tablets is an antiulcer medication that belongs to the group called H2 antihistamines, with prolonged action.

Famotidina Aristo are tablets and are presented in packaging containing 10, 14, and 28 tablets.

Famotidina Aristo 40 mg tablets is indicated for duodenal ulcer, benign gastric ulcer, hypersecretory syndromes such as Zollinger-Ellison syndrome, and in maintenance therapy to reduce the recurrence of benign duodenal and gastric ulcers. Symptomatic treatment of non-responsive gastroesophageal reflux disease with hygienic-dietary measures and antacids. Esophagitis due to gastroesophageal reflux.

Do not take Famotidina Aristo:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Famotidina Aristo.

- If your doctor has not ruled out the presence of gastric neoplasia before starting treatment with Famotidina. Symptomatic relief of gastric ulcers during treatment does not rule out the presence of a malignant gastric ulcer.

- Use 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 will always be done gradually and under medical supervision to avoid relapses.

Children and adolescents

No increase in the incidence or changes in the types of adverse effects were observed when Famotidina was administered to the elderly. No dose adjustment was required based on age. Dose adjustment may be necessary in case of moderate or severe renal damage.

Older adults

No increase in the incidence or changes in the types of adverse effects were observed when Famotidina was administered to the elderly. No dose adjustment was required based on age. Dose adjustment may be necessary in case of moderate or severe renal damage.

Other medications and Famotidina Aristo

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 undergoing dialysis.

-Famotidina Aristo may reduce the effect of oral suspension of posaconazole (a medication used to prevent and treat certain fungal infections).

-Famotidina Aristo may reduce the effect of dasatinib, erlotinib, gefitinib, or pazopanib (medications used to treat cancer).

No interactions with other medications have been established. Studies have shown 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 Famotidina have not shown increases in the expected levels of alcohol in the blood resulting from alcohol consumption.

Pregnancy and lactation

Pregnancy

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

Treatment with Famotidina is not recommended during pregnancy, and it should only be prescribed if clearly necessary. Before using Famotidina in pregnant women, the potential benefits must be weighed against the possible risks.

Lactation

Consult your doctor or pharmacist before taking a medication.

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

Driving and operating machinery

It is unlikely that Famotidina will have any effect on the ability to drive vehicles or operate machinery. However, caution is recommended until the response to therapy is well established.

Famotidina Aristo contains lactose and sodium

Famotidina Aristo contains lactose If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Famotidina Aristo. Do not discontinue treatment beforehand.

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

The recommended dose is:

Peptic ulcer:The recommended daily dose of famotidina is 1 tablet (40 mg of famotidina) at night. It can also be administered 20 mg every 12 hours. Treatment should be maintained for 4 to 8 weeks, although it can be shortened if endoscopy reveals that the ulcer is cured. In most cases of peptic 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 peptic ulcer, it is recommended to continue daily with a dose of 20 mg at night. However, it should be noted that no controlled studies have been conducted for periods exceeding 1 year.

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

Maintenance therapy: For the prevention of recurrences of benign gastric ulcer, the recommended dose is 20 mg administered at night, and can be administered for at least 1 year.

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

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

Zollinger-Ellison syndrome:Treatment should be initiated 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 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 famotidina should be higher than that recommended for initial cases, depending on the severity of the clinical condition 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 Famotidina can be reduced to half or the dosing interval can be extended to 36-48 hours according to their response.

If you estimate that the action of Famotidina Edigen is too strong or too weak, inform your doctor or pharmacist.

If you take more Famotidina Aristo than you should:

No experience of overdosing is available. Patients with hypersecretory syndromes have used doses of up to 800 mg daily without serious adverse effects. In case of accidental overdosing, the usual measures should be taken to remove the non-absorbed medication from the gastrointestinal tract, the patient should be closely monitored, and supportive treatment should be used.

Contact your doctor or pharmacist or call the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Famotidina Aristo:

No take a double dose to compensate for the missed doses. Consult your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The classification of side effects is based on the following frequencies:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

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

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

Unknown frequency: the frequency cannot be estimated from available data

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

- Headache

- Dizziness

- Diarrhea

- Constipation

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

- Loss of appetite

- Fatigue

- Nausea

- Vomiting

- Abdominal discomfort or distension

- Dry mouth

- Skin rash

- Itching

- Joint pain

- Muscle cramps

- Reversible psychiatric disorders including depression, anxiety disorders, agitation, confusion, and hallucinations

- Excessive intestinal 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 excessive allergic reaction)

- Angioneurotic edema (severe allergic reaction with shortness of breath, urticaria, and facial, lip, tongue, throat, and extremity inflammation, 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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.

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 unused medications at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Famotidina Aristo 40 mg

- The active ingredient is famotidine.

- The other excipients are: povidone, sodium croscarmellose, cornstarch, magnesium stearate, lactose, colloidal silica, microcrystalline cellulose.

Appearance of the product and contents of the packaging

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

They are presented in aluminum/aluminum blisters introduced into cardboard boxes.

Packaging with 10, 14, and 28 tablets.

Clinical packaging of 500 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid- Spain

Responsible for manufacturing

Medinsa (Laboratorios Medicamentos Internacionales S.A.)

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

O

TEDEC-MEIJI FARMA, S.A.

Carretera M-300, Km 30,500

28802 Alcala de Henares (Madrid)

Last review date of this leaflet: July 2023

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