OSENI FILM COATED TABLET 25MG 15MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ALOGLIPTIN BENZOATE; PIOGLITAZONE HCl

Available from:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC code:

A10BD09

Pharmaceutical form:

TABLET, FILM COATED

Composition:

ALOGLIPTIN BENZOATE 25 mg; PIOGLITAZONE HCl 15 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Takeda Pharmaceutical Company Limited, Osaka Plant

Authorization status:

ACTIVE

Authorization date:

2016-01-26

Patient Information leaflet

Page 1 of 7
PATIENT INFORMATION LEAFLET
OSENI 12.5 MG/15 MG FILM-COATED TABLETS
OSENI 12.5 MG/30 MG FILM-COATED TABLETS
OSENI 25 MG/15 MG FILM-COATED TABLETS
OSENI 25 MG/30MG FILM-COATED TABLETS
Alogliptin/Pioglitazone
Read this Patient Information Leaflet carefully before you start
taking OSENI and each
time you get a refill. There may be new information. This information
does not take the
place of talking with your doctor about your medical condition or your
treatment. If you
have any questions about OSENI, ask your doctor or pharmacist.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT OSENI?
OSENI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
1.
NEW OR WORSE HEART FAILURE: Pioglitazone, one of the medicines in
OSENI, can
cause your body to keep extra fluid (fluid retention), which leads to
swelling (edema)
and weight gain. Extra body fluid can make some heart problems worse
or lead to
heart failure. Heart failure means your heart does not pump blood well
enough.
•
Do not take OSENI if you have heart failure.
•
If you have heart failure with symptoms (such as shortness of breath
or swelling),
even if these symptoms are not severe, OSENI may not be right for you.
CALL YOUR DOCTOR RIGHT AWAY IF YOU HAVE ANY OF THE FOLLOWING:
•
swelling or fluid retention, especially in the ankles or legs
•
shortness of breath or trouble breathing, especially when you lie down
•
an unusually fast increase in weight
•
unusual tiredness
2.
INFLAMMATION OF THE PANCREAS (PANCREATITIS): Alogliptin, one of the
medicines in
OSENI, may cause pancreatitis, which may be severe.
Certain medical conditions make you more likely to get pancreatitis.
Page 2 of 7
BEFORE YOU START TAKING OSENI:
Tell your doctor if you have ever had:
•
pancreatitis
•
stones in your gallbladder
(gallstones)
•
a history of
alcoholism
•
kidney problems
•
liver problems
Stop taking OSENI and call your doctor right away if you have pain in
your stomach
area (abdomen) that is severe and will not go away. The pain may be
felt going from
your a

Summary of Product characteristics

Page 1 of 40
FULL PRESCRIBING INFORMATION
OSENI TABLETS 12.5MG/15MG
OSENI TABLETS 12.5MG/30MG
OSENI TABLETS 25MG/15MG
OSENI TABLETS 25MG/30MG
1
INDICATIONS AND USAGE
1.1
MONOTHERAPY AND COMBINATION THERAPY
OSENI is indicated as an adjunct to diet and exercise to improve
glycemic control in
adults with type 2 diabetes mellitus in multiple clinical settings
when treatment with both
alogliptin and pioglitazone is appropriate _[see Clinical Studies
(14)]. _
1.2
LIMITATION OF USE
OSENI should not be used in patients with type 1 diabetes mellitus or
for the treatment
of diabetic ketoacidosis, as it would not be effective in these
settings.
Use with caution in patients with liver disease _[see Warnings and
Precautions (5.4)]. _
_ _
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDATIONS FOR ALL PATIENTS
OSENI should be taken once daily and can be taken with or without
food. The tablets
must not be split before swallowing.
The recommended starting dose for OSENI (alogliptin and pioglitazone):
•
for patients inadequately controlled on diet and exercise is 25 mg/15
mg or 25
mg/30 mg,
•
for patients inadequately controlled on metformin monotherapy is 25
mg/15 mg or
25 mg/30 mg,
•
for patients on alogliptin who require additional glycemic control is
25 mg/15 mg or
25 mg/30 mg,
•
for patients on pioglitazone who require additional glycemic control
is 25 mg/15
mg, 25 mg/30 mg as appropriate based upon current therapy,
•
for patients switching from alogliptin coadministered with
pioglitazone, OSENI may
be initiated at the dose of alogliptin and pioglitazone based upon
current therapy,
After initiation of OSENI or with dose increase, monitor patients
carefully for adverse
reactions related to fluid retention as has been seen with
pioglitazone (e.g., weight gain,
Page 2 of 40
edema and signs and symptoms of congestive heart failure) _[see
Warnings and _
_Precautions (5.1)]_.
2.2
PATIENTS WITH RENAL IMPAIRMENT
No dose adjustment of OSENI is necessary for patients with mild renal
impairment
(creatinine clearance [CrCl] ≥60 mL/m