Zomel 15 mg gastro-resistant capsule, hard

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Lansoprazole

Beschikbaar vanaf:

Clonmel Healthcare Ltd

ATC-code:

A02BC; A02BC03

INN (Algemene Internationale Benaming):

Lansoprazole

Dosering:

15 milligram(s)

farmaceutische vorm:

Gastro-resistant capsule, hard

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Proton pump inhibitors; lansoprazole

Autorisatie-status:

Marketed

Autorisatie datum:

2005-08-26

Bijsluiter

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOMEL 15 MG GASTRO-RESISTANT CAPSULES, HARD
ZOMEL 30 MG GASTRO-RESISTANT CAPSULES, HARD
LANSOPRAZOLE
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
included any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Zomel is and what it is used for
2.
What you need to know before you take Zomel
3.
How to take Zomel
4.
Possible side effects
5.
How to store Zomel
6.
Contents of the pack and other information
1. WHAT ZOMEL IS AND WHAT IT IS USED FOR
The active ingredient in Zomel is lansoprazole, which is a proton pump
inhibitor. Proton pump
inhibitors reduce the amount of acid that your stomach makes.
Your doctor may prescribe Zomel for the following indications:
•
treatment of duodenal and stomach ulcer
•
treatment of inflammation in your oesophagus (reflux oesophagitis)
•
prevention of reflux oesophagitis
•
treatment of heartburn and acid regurgitation
•
treatment of infections caused by the bacteria
_Helicobacter pylori_
when given in combination with
antibiotic therapy
•
treatment or prevention of duodenal or stomach ulcer in patients
requiring continued NSAID
treatment (NSAID treatment is used for pain or inflammation)
•
treatment of Zollinger-Ellison syndrome.
Your doctor may have prescribed Zomel for another indication or with a
dose different from that
which is written in this information leaflet. Please follow your
doctor’s instructions for taking your
medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOMEL
DO NOT TAKE ZOMEL:
•
If you are allergic to lansoprazole or any of the oth

Productkenmerken

Health Products Regulatory Authority
11 August 2023
CRN00DC2P
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zomel 15 mg gastro-resistant capsule, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 15 mg of lansoprazole.
Excipient(s) with known effect:
Each 15 mg capsule contains 95.07 – 108.73 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Opaque, yellow hard-gelatine capsules, containing pellets with enteric
coating.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

treatment of duodenal and gastric ulcer.

treatment of reflux oesophagitis.

prophylaxis of reflux oesophagitis.

eradication of _Helicobacter pylori_ (_H. _pylori) concurrently given
with appropriate antibiotic therapy for treatment of
_H. pylori _associated ulcers.

treatment of NSAID-associated benign gastric and duodenal ulcers in
patients requiring continued NSAID
treatment.

prophylaxis of NSAID-associated gastric and duodenal ulcers in
patients at risk (see section 4.2) requiring
continued therapy.

symptomatic gastro-oesophageal reflux disease.

zollinger-Ellison syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For optimal effect, Zomel should be taken once daily in the morning,
except when used for _H. pylori _eradication when
treatment should be twice a day, once in the morning and once in the
evening.
_Treatment of duodenal ulcer:_
The recommended dose is 30 mg once daily for 2 weeks. In patients not
fully healed within this time, the medication is
continued at the same dose for another 2 weeks.
_Treatment of gastric ulcer:_
The recommended dose is 30 mg once daily for 4 weeks. The ulcer
usually heals within 4 weeks, but in patients not fully healed
within this time, the medication may be continued at the same dose for
another 4 weeks.
_Reflux oesophagitis:_
The recommended dose is 30 mg once daily for 4 weeks. In patients not
fully healed within this time, the treatment may be
c