Esomeprazole Clonmel 40 mg gastro-resistant capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Esomeprazole

Available from:

Clonmel Healthcare Ltd

ATC code:

A02BC; A02BC05

INN (International Name):

Esomeprazole

Dosage:

40 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; esomeprazole

Authorization status:

Marketed

Authorization date:

2010-11-12

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESOMEPRAZOLE CLONMEL 20MG GASTRO-RESISTANT CAPSULES, HARD
ESOMEPRAZOLE CLONMEL 40MG GASTRO-RESISTANT CAPSULES, HARD
Active substance: Esomeprazole
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 Esomeprazole Clonmel is and what it is used for
2.
What you need to know before you take Esomeprazole Clonmel
3.
How to take Esomeprazole Clonmel
4.
Possible side effects
5.
How to store Esomeprazole Clonmel
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOLE CLONMEL IS AND WHAT IS IT USED FOR
Esomeprazole Clonmel contains a medicine called esomeprazole. This
belongs to a group of
medicines called ‘proton pump inhibitors’. They work by reducing
the amount of acid that your
stomach produces.
Esomeprazole Clonmel is used to treat the following conditions:
Adults
-
‘Gastro-oesophageal reflux disease’ (GORD). This is where acid
from the stomach escapes into
the gullet (the tube which connects your throat to your stomach)
causing pain, inflammation and
heartburn.
-
Ulcers in the stomach or upper part of the gut (intestine) that are
infected with bacteria called
‘Helicobacter pylori’. If you have this condition, your doctor may
also prescribe antibiotics to
treat the infection and allow the ulcer to heal.
-
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Esomeprazole Clonmel can also be used to stop stomach ulcers from
forming if you are taking
NSAIDs.
-
Too much acid in the stomach cause

Summary of Product characteristics

Health Products Regulatory Authority
20 July 2021
CRN00CD3Z
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Clonmel 40 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg of esomeprazole (as magnesium dihydrate).
Excipient(s) with known effect
Each capsule contains 16.09 mg sucrose, 3.65micrograms
methyl-p-hydroxybenzoate (E218) and 1.1 micrograms of
propyl-p-hydroxybenzoate (E216).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Capsule with an opaque yellow cap and an opaque yellow body imprinted
in black with “40 mg” both on the cap and on the
body. The capsule contains off-white to greyish spherical
microgranules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole Clonmel capsules are indicated in adults for:
Gastro-oesophageal Reflux Disease (GORD)

treatment of erosive reflux oesophagitis

long-term management of patients with healed oesophagitis to prevent
relapse

symptomatic treatment of gastro-oesophageal reflux disease (GORD)
In combination with appropriate antibacterial therapeutic regimens for
the eradication of _Helicobacter pylori _and

healing of Helicobacter pylori associated duodenal ulcer and

prevention of relapse of peptic ulcers in patients with Helicobacter
pylori associated ulcers
Patients requiring continued NSAID therapy
Healing of gastric ulcers associated with NSAID therapy.
Prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients at risk.
Prolonged treatment after IV induced prevention of rebleeding of
peptic ulcers.
Treatment of Zollinger Ellison Syndrome
ESOMEPRAZOLE CLONMEL CAPSULES ARE INDICATED IN ADOLESCENTS FROM THE
AGE OF 12 YEARS FOR:
Gastro-oesophageal Reflux Disease (GORD)

treatment of erosive reflux oesophagitis

long-term management of patients with healed oesophagitis to prevent
relapse

symptomatic treatment of gastro-oesophageal reflux disease (GORD