Lansoprazole Teva Pharma 30 mg gastro-resistant capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lansoprazole

Available from:

Teva B.V.

ATC code:

A02BC; A02BC03

INN (International Name):

Lansoprazole

Dosage:

30 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; lansoprazole

Authorization status:

Marketed

Authorization date:

2015-02-27

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LANSOPRAZOLE TEVA PHARMA 15 MG GASTRO-RESISTANT CAPSULES, HARD LANSOPRAZOLE TEVA PHARMA 30MG 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 Teva Pharma is and what it is used for
2.
What you need to know before you take Lansoprazole Teva Pharma
3.
How to take Lansoprazole Teva Pharma
4.
Possible side effects
5.
How to store Lansoprazole Teva Pharma
6.
Contents of the pack and other information
1.
WHAT LANSOPRAZOLE TEVA PHARMA IS AND WHAT IT IS USED FOR
The active ingredient in Lansoprazole Teva Pharma 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 Teva Pharma for the following
indications in adults:
•
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
(nonsteroidal anti-inflammatory drugs) treatment (NSAID treatment is
used against pain or
inflammation)
•
Treatment of Zollinger-Ellison syndrome.
Your doctor may have prescribed Lansoprazole Teva Pharma for another
indication or with a dose
different from that which is

Summary of Product characteristics

Health Products Regulatory Authority
08 February 2024
CRN00F06K
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lansoprazole Teva Pharma 30 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg lansoprazole.
Excipient(s) with known effect:
Each 30 mg capsule contains 120.03 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
A hard gelatin size 1 capsule with an opaque white cap and opaque
white body, filled with white to beige micropellets. The
capsules have been marked using black ink with the letter “L” on
the cap and the number “30” on the body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lansoprazole Teva Pharma capsules is indicated in adults.

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 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.
Treatment of reflux oesophagitis
The recommended dose is 30 mg once daily for 4 weeks. In patients not
fully healed within this t