Famotidine Aristo 40 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
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.
|
Package leaflet:
- 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 side effects
- How to store Famotidina Aristo
- Contents of the pack and other information
1. What Famotidina Aristo is and what it is used for
Famotidina Aristo 40 mg tablets is an antiulcer medication belonging to the group known as H2 antihistamines, with prolonged action.
Famotidina Aristo comes in tablet form and is available in packages containing 10, 14, and 28 tablets.
Famotidina Aristo 40 mg tablets are 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 taking 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
Talk to your doctor or pharmacist before taking 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 presence 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
There was no increase in the incidence or changes in the types of adverse effects when Famotidina was administered to elderly patients. Dosage adjustment based on age was not required. Dose adjustment may be necessary in cases of moderate or severe renal impairment.
Elderly patients
There was no increase in the incidence or changes in the types of adverse effects when Famotidina was administered to elderly patients. Dosage adjustment based on age was not required. Dose adjustment may be necessary in cases of moderate or severe renal impairment.
Other medicines and Famotidina Aristo
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
-
Calcium carbonate, when used to treat elevated blood phosphate levels (hyperphosphatemia) in patients on dialysis.
-
Famotidina Aristo may reduce the effect of oral posaconazole suspension (a medication taken 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 drugs have been established. Studies conducted show no significant interference with the metabolism of compounds by 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 are planning 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 will affect your ability to drive or operate machinery. However, caution is advised until your 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 them 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 given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will determine the duration of your treatment with Famotidina Aristo. Do not stop treatment prematurely.
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 famotidine is 1 tablet (40 mg famotidine) at night. Alternatively, 20 mg 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 with a daily dose of 20 mg 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 1 tablet (40 mg famotidine) daily 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 20 mg administered at night, which may be given for at least 1 year.
Gastroesophageal reflux disease: The recommended dosage for gastroesophageal reflux disease is 20 mg of famotidine orally, twice daily.
For the treatment of reflux esophagitis, the recommended dose is 1 tablet (40 mg famotidine) twice daily, orally. If there is no response after 4–8 weeks of treatment, endoscopic diagnosis is advisable.
Zollinger-Ellison syndrome: Treatment should be initiated in patients without prior antisecretory treatment at a dose of 20 mg every 6 hours. This dose should be adjusted according to individual patient needs and maintained as long as clinically required. Doses up to 800 mg daily have been used for 1 year without significant adverse effects or tachyphylaxis. In patients previously treated with antisecretory agents, 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 Famotidina may be reduced by half or the dosing interval extended to 36–48 hours, depending on the patient's response.
If you think that the effect of Famotidina Edigen is too strong or too weak, inform your doctor or pharmacist.
The score line should not be used to divide the tablet.
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 taken to remove the unabsorbed drug from the gastrointestinal tract. The patient should be closely monitored and supportive treatment should be administered.
Contact your doctor or pharmacist or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Famotidina Aristo
D o not take a double dose to make up for missed doses. Consult your doctor.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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
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 breathing difficulty, urticaria, and swelling of the face, lips, tongue, throat, and even limbs, possibly 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 Medicines: 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 the 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 empty containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Famotidine Aristo 40 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 medicinal product and contents of the pack
Famotidine Aristo 40 mg tablets are white, round tablets with a score line on one side.
They are supplied in aluminum/aluminum blisters placed in cardboard boxes.
Pack sizes of 10, 14 and 28 tablets.
Hospital pack of 500 tablets.
Only some pack sizes may be commercially available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 review of this leaflet: July 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.