DEXLANSOPRAZOLE TAKEDA 60 Milligram Capsules Modified Release

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

DEXLANSOPRAZOLE

Tilgjengelig fra:

Takeda Pharma A/S

INN (International Name):

DEXLANSOPRAZOLE

Dosering :

60 Milligram

Legemiddelform:

Capsules Modified Release

Resept typen:

Product subject to prescription which may be renewed (B)

Autorisasjon status:

Authorised

Autorisasjon dato:

0000-00-00

Informasjon til brukeren

 
Realized by:
QUALITY SYSTEM - ISO 9001:2008
ARTWORK
PDF 1.5
ISSUE DATE
24/03/2014
OPERATOR
RI007M
DRAFT
01
SEPARATIONS: 
( 
BLACK
 )
MEASURES (mm):  185X297
DECA CODE (mm):
(X=1,5mm /I=0,5mm/spazi=1 mm)

FONT TYPE: HELVETICA MEDIUM
Size: 9 PT
THIS ARTWORK IS PROPERTY OF:
TAKEDA
CLIENT APPROVAL
DATE                                            
          SIGNATURE
PRODUCT NAME: 
I-DEXLANSOPRAZOLO
30 MG - 60 MG
PRODUCT CODE:
ZTAK039
EURPACK GRAFIFARMA GRAFIFLEX - APRILIA (LT) tel. [phone]
 [e-mail] - ROBECCO S/N (MI) tel. [phone]
 [e-mail]
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FPO
FPO
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXLANSOPRAZOLE TAKEDA 30 MG MODIFIED‑RELEASE CAPSULES, HARD 
DEXLANSOPRAZOLE TAKEDA 60 MG MODIFIED‑RELEASE CAPSULES, HARD
Dexlansoprazole
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 effect

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexlansoprazole Takeda 60mg modified-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60 mg of dexlansoprazole.
Excipients with known effect:
Each 60 mg modified
-release capsule contains 76 mg of sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release capsule, hard
Each 60mg capsule (size 2) is opaque with a blue cap and body with ‘TAP’ imprinted on the cap and '60' on the body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexlansoprazole Takeda is indicated in adults for the following:
-
Treatment of erosive reflux oesophagitis
-
Maintenance of healed erosive reflux oesophagitis and maintenance of relief of heartburn
-
Short-term treatment of heartburn and acid regurgitation associated with symptomatic non-erosive gastro-
oesophageal reflux disease (GORD)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
-Treatment of erosive reflux oesophagitis
The recommended dose is 60 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.
- Maintenance of healed erosive reflux oesophagitis and maintenance of relief of heartburn.
The recommended dose is 30 mg once daily for up to 6 months in patients where prolonged acid suppression is needed.
-Symptomatic non-erosive gastro-oesophageal reflux disease (GORD)
The recommended dose is 30 mg once daily for up to 4 weeks.
Special populations
_Elderly_
Due to reduced clearance of dexlansoprazole in the elderly an adjustment of dose may be necessary based on individual
requirements. A daily dose of 60 mg should not be exceeded in the elderly unless there are compelling clinical
indications (see section 5.