Package Insert: Information for the User

Famotidina Aristo 20 mg Tablets EFG

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

- Keep this package insert, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Famotidina Aristo

3. How to take Famotidina Aristo

4. Possible adverse effects

5. Storage of Famotidina Aristo

6. Contents of the package and additional information

Famotidina Aristo 20 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 containers containing 20 and 28 tablets.

Famotidina Aristo 20 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 to 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

The safety and efficacy of Famotidina administration in children have not been established.

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 posaconazole suspension (a medication used to prevent and treat certain fungal infections).

-Famotidina Aristo may reduce the effect of dasatinib, 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 blood alcohol levels 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 a certain sugar intolerance, 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 Aristo is 2 tablets (40 mg of famotidina) at night. It can also be administered 1 tablet (20 mg of famotidina) every 12 hours. Treatment should be maintained for 4 to 8 weeks, although it may 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 1 tablet (20 mg of famotidina) 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 2 tablets (40 mg of famotidina) daily at night. Treatment should be continued for 4 to 8 weeks, but may 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 1 tablet (20 mg of famotidina) administered at night, and may be administered for at least 1 year.

Esophagitis caused by gastroesophageal reflux:The recommended dosage for gastroesophageal reflux disease is 1 tablet (20 mg of famotidina) of Famotidina Aristo, twice a day.

For the treatment of esophagitis caused by gastroesophageal reflux, the recommended dose is 2 tablets (40 mg of famotidina), twice a day. 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 1 tablet (20 mg of famotidina) 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 per day have been used for 1 year without significant adverse effects. In patients with previous antisecretory treatment, the initial dose of famotidina should be higher than the recommended dose 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 Aristo 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 been used doses of up to 800 mg per day 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 Toxicology 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.

If you interrupt treatment with Famotidina Aristo

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them. The classification of adverse 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Famotidina Aristo 20 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 content of the packaging

Famotidina Aristo 20 mg tablets are round, white tablets.

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

Packaging with 20 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)

Spain

Last review date of this leaflet: July 2023

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