Lanzol 15 mg hard gastro-resistant capsules

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Lansoprazole

Beszerezhető a:

Rowex Ltd

ATC-kód:

A02BC; A02BC03

INN (nemzetközi neve):

Lansoprazole

Adagolás:

15 milligram(s)

Gyógyszerészeti forma:

Gastro-resistant capsule, hard

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Proton pump inhibitors; lansoprazole

Engedélyezési státusz:

Marketed

Engedély dátuma:

2005-03-11

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LANZOL 15 MG HARD GASTRO-RESISTANT CAPSULES
LANZOL 30 MG HARD GASTRO-RESISTANT CAPSULES
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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lanzol is and what it is used for
2.
What you need to know before you take Lanzol
3.
How to take Lanzol
4.
Possible side effects
5.
How to store Lanzol
6.
Contents of the pack and other information
1
WHAT LANZOL IS AND WHAT IT IS USED FOR
The active substance in Lanzol is lansoprazole, which is a proton pump
inhibitor. Proton pump
inhibitors reduce the amount of acid that your stomach makes.
Your doctor may prescribe Lanzol 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.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANZOL
DO NOT TAKE LANZOL:
•
if you are allergic to lansoprazole or any of the other ingredients of
this medicine (listed in section
6.1).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Lanzol if you have serious liver
disease. The doctor may have to
adjust your dose.
Your doctor may perform or

Termékjellemzők

Health Products Regulatory Authority
13 January 2023
CRN00DCCR
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lanzol 15 mg hard gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gastro-resistant capsule contains 15 mg of lansoprazole.
Excipient(s) with known effect
Each hard gastro-resistant capsule contains up to 108.7 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard Gastro-resistant capsule.
Opaque, yellow hard gelatine capsule, containing white to almost white
pellets with enteric coating.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lanzol gastro-resistant capsules are indicated :
o Treatment of duodenal and gastric ulcer.
o Treatment of reflux oesophagitis
o Prophylaxis of reflux oesophagitis
o Eradication of _Helicobacter pylori (H. pylori) _concurrently given
with appropriate antibiotic therapy for treatment of
_H.pylori_-associated ulcers
o Treatment of NSAID-associated benign gastric and duodenal ulcers in
patients requiring continued NSAID-treatment
o Prophylaxis of NSAID-associated gastric and duodenal ulcers in
patients at risk (see section 4.2) requiring continued therapy
o Symptomatic gastro-oesophageal reflux disease
o 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 medicinal product 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
medicinal product 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
continued at the same dose for another 4 weeks.
PROPHYLAXIS OF REFLUX OESOPHAGITIS
15 mg once daily. The dose m