DEXILANT DELAYED RELEASE CAPSULE 60mg

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Dexlansoprazole

Fáanlegur frá:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC númer:

A02BC06

Skammtar:

60mg

Lyfjaform:

CAPSULE, DELAYED RELEASE

Samsetning:

Dexlansoprazole 60mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

Takeda Pharmaceutical Company Limited,Osaka Plant

Leyfisstaða:

ACTIVE

Leyfisdagur:

2014-01-16

Upplýsingar fylgiseðill

DEXILANT DEXLANSOPRAZOLE
PATIENT INFORMATION LEAFLET
Your doctor has recommended DEXILANT for you.
This booklet will provide answers to some common questions about this
medicine, to better understand how DEXILANT can help you cope with
gastroesophageal reflux disease. It does not contain all the available
information
and does not take the place of talking with your doctor.
All medicines have risks and benefits. Your doctor has more
information about
this medicine than is contained in this leaflet. Also, your doctor has
had the
benefit of taking a full and detailed history from you and is in the
best position
to make an expert judgement to meet your individual needs.
Dexilant is available only with a doctor’s prescription.
If you have any concerns about taking this medicine, talk to your
doctor or
pharmacist. Keep this leaflet with this medicine. You may need to read
it again.
Before you take DEXILANT, tell your doctor if you:
• Have been told that you have low magnesium levels in your blood.
• Have liver problems.
• Have any other medical conditions.
• Are pregnant or plan to become pregnant. It is not known if
DEXILANT will
harm your unborn baby.
• Are breastfeeding or planning to breastfeed.
It is not known if DEXILANT passes into your breast milk. You and your
doctor should decide if you will take DEXILANT or breastfeed.
You should not do both. Talk to your doctor about the best way to feed
your
baby if you take DEXILANT.
I. NAME OF PRODUCT
DEXILANT (dexlansoprazole) delayed-release capsules 30 mg or DEXILANT
(dexlansoprazole) delayed-release capsules 60 mg
II. DESCRIPTION OF PRODUCT
DEXILANT delayed-release capsules, 30 mg, are opaque, blue and gray
with
TAP and “30” imprinted on the capsule. Each capsule contains 30mg
of the
active ingredient called dexlansoprazole.
DEXILANT delayed-release capsules, 60 mg, are opaque, blue with TAP
and
“60” imprinted on the capsule. Each capsule contains 60mg of the
active
ingredient called dexlansoprazole.
The capsule also contains the following inactiv

Vara einkenni

DEXILANT DELAYED RELEASE CAPSULE 30mg
DEXILANT DELAYED RELEASE CAPSULE 60mg
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
Dexlansoprazole is indicated in adults and in adolescents 12 to 17
years of age for the following:
1.1
HEALING OF EROSIVE ESOPHAGITIS
DEXILANT is indicated for healing of all grades of erosive esophagitis
(EE) for up to 8 weeks.
1.2
MAINTENANCE OF HEALED EROSIVE ESOPHAGITIS
DEXILANT is indicated to maintain healing of EE and relief of
heartburn for up to 6 months.
1.3
SYMPTOMATIC NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
DEXILANT is indicated for the treatment of heartburn and acid
regurgitation associated with symptomatic non-erosive gastroesophageal
reflux disease
(GERD) for 4 weeks.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSE
DEXILANT is available as capsules in 30 mg and 60 mg strengths for
adults and in adolescents 12 to 17 years of age. Directions for use in
each
indication are summarized in Table 1._ _
TABLE 1: DEXILANT DOSING RECOMMENDATIONS
INDICATION
RECOMMENDED DOSE
FREQUENCY
Healing of EE
60 mg
Once daily for up to 8 weeks
Maintenance of Healed EE
and relief of heartburn
30 mg
Once daily*
Treatment of heartburn
and acid regurgitation
associated with
Symptomatic Non-Erosive
GERD
30 mg
Once daily for 4 weeks
*Controlled studies did not extend beyond 6 months in adults and 4
months in 12 to 17 year olds.
2.2
SPECIAL PATIENT POPULATIONS
ELDERLY PATIENTS
No dosage adjustment is necessary for elderly patients.
PEDIATRIC PATIENTS
The safety and efficacy of dexlansoprazole in children under 12 years
of age have not been established.
IMPAIRED RENAL FUNCTION
No dosage adjustment is necessary for patients with renal impairment
_[see Clinical Pharmacology (11.3]_
.
HEPATIC IMPAIRMENT
No adjustment for DEXILANT is necessary for patients with mild hepatic
impairment (Child-Pugh Class A). Consider a maximum daily dose of 30
mg for
patients with moderate hepatic impairment (Child-Pugh Class B). No
studies have been conducted in patients with severe hepatic impairment
(Child-Pugh Clas