BYLANS 15 Milligram Capsules Gastro-Resistant

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

LANSOPRAZOLE

Commercializzato da:

Teva Pharma B.V.

INN (Nome Internazionale):

LANSOPRAZOLE

Dosaggio:

15 Milligram

Forma farmaceutica:

Capsules Gastro-Resistant

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2014-01-20

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
BYLANS 15MG GASTRO-RESISTANT CAPSULES  
BYLANS 30MG GASTRO-RESISTANT CAPSULES 
(LANSOPRAZOLE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•  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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•  If any of the side effects gets serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Bylans Gastro-resistant Capsules are
and what they are used for
2. Before you take Bylans Gastro-resistant
Capsules
3. How to take Bylans Gastro-resistant Capsules
4. Possible side effects
5. How to store Bylans Gastro-resistant
Capsules
6. Further information
1. WHAT BYLANS GASTRO-RESISTANT 
CAPSULES ARE AND WHAT THEY ARE 
USED FOR
Lansoprazole belongs to a group of medicines
called proton pump inhibitors. Proton pump
inhibitors like lansoprazole, reduce the amount
of acid that your stomach makes.
You have been given lansoprazole, because
you have a condition caused by stomach acid.
Your doctor may prescribe Lansoprazole for:
•  Treatment of ulcers in your stomach or
duodenum
•  Treatment or prevention of inflammation in
your oesophagus (gullet). This is called
Gastroesophageal Reflux Disease
•  Treatment of infection caused by the
bacteria _Helicobacter pylori_ together with
suitable antibiotics in the treatment of
ulcers in the stomach or duodenum
(eradication therapy)
•  Relieving you from the unpleasant symptoms
that often occur with these conditions
•  Stopping these conditions coming back.
•  Treatment or prevention of ulcers in stomach
or duodenum in patients requiring continued
NSAID treatment (NSAID treatment is used
against pain or inflammation).
•  Treatment of heartburn and acid regurgitation.
•  Lansoprazole is sometimes given t

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ByLans 15 mg Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains lansoprazole, 15 mg
Excipients:
Each capsule contains 64.8 mg sucrose (in sugar spheres)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Size 3, white cap marked with ‘L’ and white body marked with ‘15’, containing white to beige gastro-resistant
micropellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of duodenal and/or benign gastric ulcer
Treatment and prophylaxis of reflux oesophagitis
Symptomatic Gastroesophageal Reflux Disease (GORD).
Treatment and prophylaxis of NSAID-associated benign gastric ulcers, duodenal ulcers and relief of symptoms in
patients requiring continued NSAID treatment.
Treatment of Zollinger-Ellison syndrome.
Eradication of _Helicobacter pylori _concurrently given with appropriate antibiotic therapy and prevention of relapse of
peptic ulcers in patients with _H.pylori _associated ulcers
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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. Lansoprazole should be taken at
least 30 minutes before food (see section 5.2). Capsules should be swallowed whole with liquid.
The capsules should be swallowed whole. Do not crush or chew.
Dosage:
Treatment of duodenal ulcer: the recommended dose is lansoprazole 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 benign gastric ulcer: the recommended dose is lansoprazole 30 mg once daily