Famotidine Clonmel 20 mg film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Famotidine

Tilgængelig fra:

Clonmel Healthcare Ltd

ATC-kode:

A02BA03

INN (International Name):

Famotidine

Dosering:

20 milligram(s)

Lægemiddelform:

Film-coated tablet

Terapeutisk område:

famotidine

Autorisation status:

Marketed

Autorisation dato:

2021-07-30

Indlægsseddel

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
FAMOTIDINE CLONMEL 20 MG FILM-COATED TABLETS
FAMOTIDINE CLONMEL 40 MG FILM-COATED TABLETS
famotidine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Famotidine Clonmel is and what it is used for
2.
What you need to know before you take Famotidine Clonmel
3.
How to take Famotidine Clonmel
4.
Possible side effects
5.
How to store Famotidine Clonmel
6.
Contents of the pack and other information
1. WHAT FAMOTIDINE CLONMEL IS AND WHAT IT IS USED FOR
Famotidine Clonmel works by reducing the amount of acid produced in
the stomach. It is used to treat
certain conditions caused by too much acid produced in the stomach. It
is a gastrointestinal medicine
that belongs to a group of medicine called Histamine H
2
-receptor antagonists.
Famotidine Clonmel is used for:
treatment of
•
symptoms of reflux disease (mild reflux oesophagitis), such as
heartburn (Famotidine Clonmel
20 mg)
•
mild to moderate inflammation of the oesophagus (food pipe)
(Famotidine Clonmel 40 mg)
•
benign gastric ulcer
•
duodenal ulcer
•
prevention of recurrent duodenal ulcers (only with Famotidine Clonmel
20 mg)
•
treatment of Zollinger-Ellison-Syndrome. This is a condition caused by
abnormal production of the
hormone gastrin that causes an overproduction of stomach acid.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FAMOTIDINE CLONMEL
DO NOT TAKE FAMOTIDINE CLONMEL
•
if you are allergic to the famotidine or any of the other ingredients
of this medicine (listed in section
6).

Produktets egenskaber

Health Products Regulatory Authority
04 October 2023
CRN00DRJK
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Famotidine Clonmel 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 20 mg of famotidine.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, biconvex, white film-coated tablets, engraved "20" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Prevention of recurrent duodenal ulcers

Duodenal ulcer

Benign gastric ulcer

Zollinger-Ellison-Syndrome

Symptomatic treatment of mild reflux oesophagitis
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Duodenal ulcers and benign gastric ulcers_
40 mg of famotidine once before going to sleep
_Prophylactic treatment for recurrent duodenal ulcers_
20 mg of famotidine in the evening
_Zollinger-Ellison syndrome_
Providing there has not been previous therapy with antisecretory
medications, Zollinger-Ellison syndrome therapy should start
by administering 20 mg of famotidine (corresponding to one film-coated
tablet of Famotidine Clonmel
®
20 mg) every 6 hours.
Depending on the acid secretion and the patient's clinical response, a
dosage titration should be performed as treatment
continues until the desired acid levels have been reached (e.g. < 10
mEq/h in the hour preceding the next dose of famotidine).
If the desired inhibition of acid secretion cannot be attained with a
daily dosage of 800 mg, alternative treatment should be
considered to regulate acid secretion, since no long-term experience
with dosages of more than 800 mg of famotidine/day
have been recorded.
Treatment should be continued for as long as clinically necessary.
Patients who have previously undergone H2 receptor antagonist
treatment can begin famotidine treatment at a higher dosage
than the initial dosage that is usually recommended. The dosage
depends on the severity of the disease and the dosage of
previous medications.
_Symptomatic treating