Famotidine Aristo 20 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Famotidina Aristo 20 mg Tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Famotidina Aristo is and what it is used for
- What you need to know before taking Famotidina Aristo
- How to take Famotidina Aristo
- Possible adverse effects
- How to store Famotidina Aristo
- Contents of the pack and other information
1. What Famotidine Aristo is and what it is used for
Famotidine Aristo 20 mg tablets is an antiulcer medication belonging to the group known as H2 antihistamines, with prolonged action.
Famotidine Aristo is presented as tablets and is available in packaging containing 20 and 28 tablets.
Famotidine Aristo 20 mg tablets is indicated for duodenal ulcer, benign gastric ulcer, hypersecretory conditions such as Zollinger-Ellison syndrome, and for maintenance therapy to reduce recurrence of duodenal and benign gastric ulcers. Symptomatic treatment of reflux disease that has not responded to hygienic-dietary measures and antacids. Reflux esophagitis.
2. What you need to know before starting Famotidina Aristo
Do not take Famotidina Aristo:
If you are allergic to famotidine or to any of the other ingredients of this medicine (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 ulcer during treatment does not exclude the possibility of a malignant gastric ulcer.
- Should be used with caution in patients with moderate or severe hepatic or renal dysfunction. Central nervous system (CNS) adverse reactions have been reported in patients with moderate and severe renal impairment, and it may be necessary to extend the dosing interval or reduce the dose.
- Discontinuation of treatment should always be done gradually and under medical supervision to avoid relapse.
Children and adolescents
The safety and efficacy of Famotidine have not been established in pediatric administration.
Elderly patients
There was no increase in the incidence or changes in the types of adverse effects when Famotidine was administered to elderly patients. Dose adjustment based on age is not required. However, dose adjustment may be necessary in cases of moderate or severe renal impairment.
Other medicines and Famotidina Aristo
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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Calcium carbonate, when used to treat elevated blood phosphate levels (hyperphosphatemia) in dialysis patients.
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Famotidina Aristo may reduce the effect of oral posaconazole suspension (an oral medication used to prevent and treat certain fungal infections).
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Famotidina Aristo may reduce the effect of dasatinib, gefitinib, or pazopanib (medicines used to treat cancer).
No interactions with other drugs have been established. Studies performed show no significant interference with the metabolism of compounds via hepatic microsomal enzymes. In humans, interactions with warfarin, propranolol, theophylline, and diazepam are unlikely. Additionally, studies with famotidine have not shown increases in expected blood alcohol levels following alcohol ingestion.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Treatment with Famotidine is not recommended during pregnancy and should only be prescribed if clearly necessary. The potential benefits should be weighed against the possible risks before using Famotidine in pregnant women.
Breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Famotidine has been detected in breast milk. Breastfeeding mothers should either discontinue treatment with Famotidine or stop breastfeeding.
Driving and using machines
It is unlikely that Famotidine affects the ability to drive vehicles or operate machinery. Nevertheless, caution is advised until the response to therapy is well established.
Famotidina Aristo contains lactose and sodium
Famotidina Aristo contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially "sodium-free".
3. How to take Famotidina Aristo
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will tell you how long your treatment with Famotidina Aristo should last. Do not stop treatment early.
Famotidina Aristo is administered orally with a little water. If you have difficulty swallowing the tablets, inform your doctor or pharmacist.
The recommended dose is:
Duodenal ulcer: The recommended daily dose of Famotidina Aristo is 2 tablets (40 mg of famotidine) at night. Alternatively, 1 tablet (20 mg of famotidine) every 12 hours may be administered. Treatment should continue for 4 to 8 weeks, although it may be shortened if endoscopy shows that the ulcer has healed. In most cases of duodenal ulcer, healing occurs within 4 weeks. If the ulcer has not healed during this period, treatment should be continued for another 4 weeks.
Maintenance therapy: To reduce recurrences of duodenal ulcer, it is recommended to continue daily with a dose of 1 tablet (20 mg of famotidine) at night. However, it should be noted that controlled studies have not been conducted for periods exceeding 1 year.
Benign gastric ulcer: The recommended dose is 2 tablets (40 mg of famotidine) daily, taken at night. Treatment should continue for 4 to 8 weeks, but may be shortened if endoscopy shows that the ulcer has healed.
Maintenance therapy: For prevention of recurrences of benign gastric ulcer, the recommended dose is 1 tablet (20 mg of famotidine) administered at night, which may be given for at least one year.
Gastroesophageal reflux disease: The recommended dosage for gastroesophageal reflux disease is 1 tablet (20 mg of famotidine) of Famotidina Aristo twice daily.
For the treatment of reflux esophagitis, the recommended dose is 2 tablets (40 mg of famotidine) twice daily. If no response is obtained after 4–8 weeks of treatment, an endoscopic diagnosis is advisable.
Zollinger-Ellison syndrome: Treatment should be initiated in patients without prior antisecretory treatment at a dose of 1 tablet (20 mg of famotidine) every 6 hours. This dose should be adjusted according to the individual needs of the patient and should be maintained as long as clinically required. Doses of up to 800 mg daily have been used for 1 year without significant adverse effects. In patients with prior antisecretory treatment, the initial dose of famotidine should be higher than that recommended for initial cases, depending on the severity of the clinical condition and the dose of H2 antagonist previously used.
Dosage adjustment in patients with moderate or severe renal impairment: In adult patients with moderate or severe renal impairment, the dose of famotidine may be reduced by half or the dosing interval may be extended to 36–48 hours, depending on the patient's response.
If you feel that the effect of Famotidina Aristo is too strong or too weak, inform your doctor or pharmacist.
If you take more Famotidina Aristo than you should
There is no experience with overdosage. Patients with hypersecretory conditions have received doses up to 800 mg daily without serious adverse effects. In case of accidental overdose, standard measures should be used to remove the unabsorbed drug from the gastrointestinal tract, the patient should be closely monitored, and supportive treatment should be provided.
Contact your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Famotidina Aristo
Do not take a double dose to make up for missed doses. Consult your doctor.
If you stop treatment with Famotidina Aristo
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause 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 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):
- Loss of appetite
- Fatigue
- Nausea
- Vomiting
- Abdominal discomfort or bloating
- 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 problems with bile secretion)
- Urticaria (skin rash)
- Anaphylaxis (unusual or exaggerated allergic reaction)
- Angioedema (severe allergic reaction with wheezing, urticaria, and swelling of the face, lips, tongue, throat, and even limbs, causing difficulty in swallowing or breathing)
Very rare (may affect up to 1 in 10,000 people):
- Toxic epidermal necrolysis (skin peeling)
- Laboratory findings: abnormalities in liver enzymes
- Hair loss
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Famotidine Aristo
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Famotidine Aristo 20 mg
- The active substance is famotidine.
- The other excipients are: povidone, sodium croscarmellose, corn starch, magnesium stearate, lactose, colloidal anhydrous silica, microcrystalline cellulose.
Appearance of the product and contents of the pack
Famotidine Aristo 20 mg tablets are round, white tablets.
They are presented in aluminum/aluminum blisters contained in cardboard boxes.
Pack sizes of 20 and 28 tablets.
Hospital pack of 500 tablets.
Only some 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
Date of the most recent revision of this leaflet: July 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.