Lasoprol 30mg Capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LANSOPRAZOLE

Available from:

Delorbis Pharmaceuticals Limited 17 Athinon Str, Ergates Industrial Area, 2643 Ergates, PO Box 28629, 2081 Lefkosia, Cyprus

ATC code:

A02BC03

INN (International Name):

LANSOPRAZOLE 30 mg

Pharmaceutical form:

CAPSULE

Composition:

LANSOPRAZOLE 30 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2006-08-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LASOPROL 30 MG 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 Lasoprol is and what it is used for
2.
What you need to know before you take Lasoprol
3.
How to take Lasoprol
4.
Possible side effects
5.
How to store Lasoprol
6.
Contents of the pack and other information
1.
WHAT LASOPROL IS AND WHAT IT IS USED FOR
The active ingredient in Lasoprol is lansoprazole, which is a proton
pump inhibitor. Proton pump
inhibitors reduce the amount of acid that your stomach makes.
Your doctor may prescribe Lasoprol 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
treatment (NSAID treatment is used against pain or inflammation)
-
Treatment of Zollinger - Ellison syndrome.
Your doctor may have prescribed Lasoprol 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.
You must talk to a doctor if you do not feel better or if you feel
worse after 14 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LASOPROL
1
DO NOT TAKE LASOPROL:
-
if you are a

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lasoprol 30 mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lasoprol 30 mg capsule contains 30 mg of lansoprazole.
Excipient(s) with known effect
: each 30 mg capsule contains 26 mg of lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Red and white hard gelatin capsules containing white to off-white
pellets.
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.
Lasoprol is indicated in adults.
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 two weeks.
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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.
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 may be increased up to 30 mg daily as
necessary.
Eradication of
_Helicobacter pylori_
:
When selecting appropriate combination therapy consideration should be