Nexazole 40 mg hard gastro-resistant capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Esomeprazole

Available from:

Pinewood Laboratories 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:

2010-02-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEXAZOLE 20 MG HARD GASTRO-RESISTANT CAPSULES
NEXAZOLE 40 MG HARD GASTRO-RESISTANT CAPSULES
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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Nexazole is and what it is used for
2.
What you need to know before you take Nexazole
3.
How to take Nexazole
4.
Possible side effects
5.
How to store Nexazole
6.
Contents of the pack and other information
1.
WHAT NEXAZOLE IS AND WHAT IT IS USED FOR
Nexazole 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.
Nexazole is used for:
Adults
-
"Gastroesophageal reflux disease" (GERD). 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. This medicine is given to:
-
heal your gullet if it has become damaged or inflamed
-
stop these conditions coming back
-
give you relief from the unpleasant symptoms that often occur with
these conditions
-
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 this
medicine in combination with certain antibiotics to:
-
heal duodenal ulcers associated with bacteria
_Helicobacter pylori_
-
prevent the recurrence of ulcers associated with this bacteria
-
Stomach ulcers caused by medicines called NSAIDs (Non-Ster

Summary of Product characteristics

Health Products Regulatory Authority
15 February 2024
CRN00DD62
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nexazole 40 mg hard gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gastro-resistant capsule contains 40 mg esomeprazole (as
magnesium dihydrate).
Excipient (s) with known effect:
40 mg gastro-resistant capsules
sucrose
56,928-65,111 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard gastro-resistant capsule
The body and the cap of the capsule are off-pink. The content of
capsules are white to almost white pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nexazole capsules are indicated in adults for:
GASTROESOPHAGEAL REFLUX DISEASE (GERD):

Treatment of erosive reflux esophagitis

Long-term management of patients with healed esophagitis to prevent
relapse

Symptomatic treatment of gastroesophageal reflux disease (GERD)
IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR
THE ERADICATION OF _HELICOBACTER PYLORI_:

Healing of _Helicobacter pylori_ associated duodenal ulcer

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 I.V. INDUCED PREVENTION OF REBLEEDING OF
PEPTIC ULCERS
TREATMENT OF ZOLLINGER ELLISON SYNDROME
Nexazole capsules are indicated in adolescents from the age of 12
years for:
GASTROESOPHAGEAL REFLUX DISEASE (GERD)

treatment of erosive reflux esophagitis

long-term management of patients with healed esophagitis to prevent
relapse

symptomatic treatment of gastroesophageal reflux disease (GERD)
IN COMBINATION WITH ANTIBIOTICS IN TREATMENT OF DUODENAL ULCER CAUSED
BY _HELICOBACTER PYLORI_
Health Products Regulatory Authority
15 February 2024
CRN00DD62
Page 2 of 14
4.2 POSOLOGY AND