LANSOPRAZOLE MYLAN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LANSOPRAZOLE

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

A02BC03

INN (International Name):

LANSOPRAZOLE

Dosage:

15 Milligram

Pharmaceutical form:

Capsules Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

lansoprazole

Authorization status:

Not Marketed

Authorization date:

2011-08-12

Patient Information leaflet

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LANSOPRAZOLE MYLAN 15 MG GASTRO-RESISTANT CAPSULES
LANSOPRAZOLE MYLAN 30 MG 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 Lansoprazole Mylan is and what it is used for
2.
What you need to know before you take Lansoprazole Mylan
3.
How to take Lansoprazole Mylan
4.
Possible side effects
5.
How to store Lansoprazole Mylan
6.
Contents of the pack and other information
1.
WHAT LANSOPRAZOLE MYLAN 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.
_ _
YOUR DOCTOR MAY PRESCRIBE LANSOPRAZOLE MYLAN FOR THE FOLLOWING
CONDITIONS:
-
Treatment of duodenal and stomach ulcers
-
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 Mylan 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.
2.
WHAT YOU NE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lansoprazole Mylan 15 mg Gastro-resistant capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 15 mg of lansoprazole
Excipients with known effect:
Each 15 mg capsule contains 70.5 mg of sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsules, hard
white to off-white coloured pellets filled in hard gelatin capsule of
size 2 with white opaque cap and white opaque body
imprinted axially with ‘MYLAN’ over ‘LN 15’ on both cap and
body in black ink.
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
For optimal effect, Lansoprazole 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.
Adults
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.
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