Lansoprazole 15 mg gastro-resistant capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lansoprazole

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

A02BC; A02BC03

INN (International Name):

Lansoprazole

Dosage:

15 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule, hard

Therapeutic area:

Proton pump inhibitors; lansoprazole

Authorization status:

Marketed

Authorization date:

2012-03-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LANSOPRAZOLE 15 MG GASTRO-RESISTANT CAPSULES, HARD
LANSOPRAZOLE 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
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Lansoprazole is and what it is used for
2.
What you need to know before you take Lansoprazole
3.
How to take Lansoprazole
4.
Possible side effects
5.
How to store Lansoprazole
6.
Contents of the pack and other information
1. WHAT LANSOPRAZOLE IS AND WHAT IT IS USED FOR
The active ingredient in Lansoprazole is lansoprazole, which is a
proton pump inhibitor. Proton
pump inhibitors reduce the amount of acid that your stomach makes.
Your doctor may prescribe Lansoprazole 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 against pain or inflammation)
−
Treatment of Zollinger-Ellison syndrome.
Your doctor may have prescribed Lansoprazole 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.
You must talk to a doctor if you do not feel bette

Summary of Product characteristics

Health Products Regulatory Authority
26 October 2023
CRN00DW2P
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lansoprazole 15 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 15 mg of lansoprazole
Excipients with known effect
Each 15 mg capsule contains 100.474 mg of sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Opaque yellow cap and body capsules. Each capsule contains white or
almost white spherical microgranules.
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 ulcers and duodenal ulcers in
patients at risk (see section 4.2) requiring continued
therapy
-Symptomatic gastroesophageal reflux disease
-Zollinger-Ellison syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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 two 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_
Health Products Regulatory Authority
26 October 2023
CRN00DW2P
Page 2 of 11
The recommended dose is 30 mg once daily for 4 weeks. In patients not
fully healed within this time, the treatment may be
continued at the same dose for another 4 weeks.
_Prophylaxis of reflux oesophagitis_
15 mg once daily. The dose may