Lansoprazole Pinewood 15mg Gastro-resistant Capsules, Hard

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Lansoprazole

Beschikbaar vanaf:

Pinewood Laboratories 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:

2013-11-25

Bijsluiter

PACKAGE LEAFLET
For medicinal products available on prescription
PACKAGE LEAFLET: INFORMATION FOR THE USER
LANSOPRAZOLE PINEWOOD 15 MG GASTRO-RESISTANT HARD CAPSULES
LANSOPRAZOLE PINEWOOD 30 MG GASTRO-RESISTANT HARD 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 Lansoprazole Pinewood is and what it is used for
2. What you need to know before you take Lansoprazole Pinewood
3. How to take Lansoprazole Pinewood
4. Possible side effects
5. How to store Lansoprazole Pinewood
6. Contents of the pack and other information
1. WHAT LANSOPRAZOLE PINEWOOD IS AND WHAT IT IS USED FOR
The active ingredient in Lansoprazole Pinewood 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 Pinewood 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 Pinewood for another
indication or with a dose
different from that which is written in this information

Productkenmerken

Health Products Regulatory Authority
26 January 2023
CRN00D9Q3
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lansoprazole Pinewood 15mg Gastro-resistant Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 15 mg of lansoprazole
Excipient(s) 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
Lansopraozle Pinewood 15 mg gastro-resistant capsules, hard are 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
For optimal effect, Lansoprazole Pinewood 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.
Lansoprazole Pinewood should be taken at least 30 minutes before food
(see section 5.2). Capsules should be swallowed whole
with liquid.
The peelable blisters are opened as described following foil opening
instructions:
- Remove one blister by tearing down perforations
- Carefully peel back corner of foil to reveal capsule
(CAPSULE CANNOT BE PUSHED THROUGH FOIL)
The non peelable blisters are opened by pushing through the aluminium
foil.
Treatment of duodenal ulcer:
The recommended dose is 30