Razolager 30 mg hard gastro-resistant capsules

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Lansoprazole

Beschikbaar vanaf:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-code:

A02BC; A02BC03

INN (Algemene Internationale Benaming):

Lansoprazole

Dosering:

30 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:

Not marketed

Autorisatie datum:

2005-04-08

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAZOLAGER 15 MG HARD GASTRO-RESISTANT CAPSULES
RAZOLAGER 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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Razolager
is and what it is used for
2.
What you need to know before you take Razolager
3.
How to take Razolager
4.
Possible side effects
5.
How to store Razolager
6.
Contents of the pack and other information
1.
WHAT RAZOLAGER IS AND WHAT IT IS USED FOR
The active ingredient in your medicine is lansoprazole, which is a
proton pump inhibitor. Proton pump
inhibitors reduce the amount of acid that your stomach makes.
_ _
Razolager is used to treat adults.
Your doctor may prescribe Razolager for the following conditions:
-
Treatment of ulcers in the upper part of the intestine (duodenal
ulcer) or stomach (gastric ulcer)
-
Treatment of inflammation in your oesophagus (reflux oesophagitis)
-
Prevention of reflux oesophagitis
-
Treatment of Gastro-oesophageal reflux disease causing heartburn and
acid regurgitation
-
Treatment of infections caused by the bacteria
_Helicobacter pylori_
when given in combination with
antibiotic therapy
-
Treatment or prevention of ulcers in the upper part of the intestine
(duodenal ulcer) or stomach (gastric
ulcer) in patients requiring continued NSAID treatment (NSAID
treatment is used against pain or
inflammation)
-
Treatment of Zollinger-Ellison syndrome (a growth in the pancreas
causing too much acid in the
stomach).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAZOLAGER
DO

Productkenmerken

Health Products Regulatory Authority
11 August 2023
CRN00DP3D
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Razolager 30 mg hard gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of lansoprazole
Excipients with known effect
Each 30 mg capsule contains 200.95 mg of sucrose (as in sugar
spheres).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard gastro-resistant capsule
Size 1 (approx. 19 mm), opaque white hard gelatin capsule containing
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 gastro-oesophageal reflux disease
• Zollinger-Ellison syndrome.
Razolager is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For optimal effect, Razolager 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 treatment 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 treatment maybe continued at the same dose for
another 4 weeks.
Treatment of reflux oesophagitis:
The recommended dose is 30 mg once