Lansoprazole 15mg Orodispersible Tablet

Pays: Malte

Langue: anglais

Source: Malta Medicines Authority

Ingrédients actifs:

LANSOPRAZOLE

Disponible depuis:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Code ATC:

A02BC03

DCI (Dénomination commune internationale):

LANSOPRAZOLE 15 mg

forme pharmaceutique:

ORODISPERSIBLE TABLET

Composition:

LANSOPRAZOLE 15 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

DRUGS FOR ACID RELATED DISORDERS

Statut de autorisation:

Authorised

Date de l'autorisation:

2012-08-17

Notice patient

PAGE 1 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LANSOPRAZOLE 15 MG ORODISPERSIBLE TABLETS
LANSOPRAZOLE 30 MG ORODISPERSIBLE TABLETS
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 is and what it is used for.
2.
What you need to know before you take
Lansoprazole.
3.
How to take
Lansoprazole.
4.
Possible side effects.
5.
How to store Lansoprazole.
6.
Contents of the pack and other information.
1.
WHAT LANSOPRAZOLE IS AND WHAT IT IS USED FOR
The active ingredient in Lansoprazole 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 for the following:
-
Treatment of duodenal (gut) and stomach ulcers.
-
Treatment of inflammation in your food pipe (reflux oesophagitis).
-
Prevention of reflux oesophagitis.
-
Treatment of heartburn and acid regurgitation.
-
Treatment of infections caused by the bacteria
_Helicobacter pylori_
when given together with an
antibiotic.
-
Treatment or prevention of duodenal (gut) 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 to treat another
condition or with a dose different from
those written in this leaflet. Please follow your doctor’s
instructions for taking your medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LANSOPRAZOLE
DO NOT TAKE LANSOPRAZOLE
:
-
if you are a

Résumé des caractéristiques du produit

PAGE 1 OF 15
SUMMARY OF PRODUCT CHARACTERISTICS,
PAGE 2 OF 15
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 3 OF 15
1.
NAME OF THE MEDICINAL PRODUCT
Lansoprazole 15 mg Orodispersible Tablets
Lansoprazole 30 mg Orodispersible Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 15 mg of lansoprazole (as
gastro-resistant pellets)
Each orodispersible tablet contains 30 mg of lansoprazole (as
gastro-resistant pellets)
Excipients with known effect
Each orodispersible tablet contains 5.97 mg of aspartame (E951)
Each orodispersible tablet contains 11.93 mg of aspartame (E951)
Each orodispersible tablet contains 13.8 mg of sucrose
Each orodispersible tablet contains 27.6 mg of sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
White to yellowish white round, approximately 11 mm in diameter,
flat-faced beveled edged tablet
engraved with “LP1” on one side and “M” on other side with
orange to dark brown speckles.
White to yellowish white round, approximately 12.7 mm in diameter,
flat-faced beveled edged tablet
engraved with “LP2” on one side and “M” on other side with
orange to dark brown speckles.
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 non-steroidal anti-inflammatory drug (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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment of duodenal ulcer:
The recommended dose is 30 mg once daily for 2 weeks. In