Rybelsus 7mg Tablet

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

SEMAGLUTIDE

Available from:

NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.

INN (International Name):

SEMAGLUTIDE

Units in package:

30 Tablets; 60 Tablets; 90 Tablets

Manufactured by:

NOVO NORDISK A/S

Patient Information leaflet

RYBELSUS
® TABLET
_ _
Semaglutide (3 mg, 7 mg, 14 mg)
_ _
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What Rybelsus
®
is used for
2.
How Rybelsus
®
works
3.
Before you use Rybelsus
®
4.
How to use Rybelsus
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Rybelsus
®
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT RYBELSUS
® IS USED FOR
Rybelsus
®
is used to treat adults (aged
18
years
and
older)
with
type
2
diabetes when diet and exercise is not
enough:

on its own – when you cannot use
metformin
(another
diabetes
medicine) or

with other medicines for diabetes
– when the other medicines are
not enough to control your blood
sugar
levels.
These
may
be
medicines you take by mouth or
inject such as insulin.
It is important that you continue with
your diet and exercise plan as agreed
with your doctor, pharmacist or nurse.
2. HOW RYBELSUS
® WORKS
Rybelsus
®
contains
the
active
substance
semaglutide.
It
is
a
medicine that is used to lower blood
sugar levels.
3. BEFORE YOU USE RYBELSUS
®
_ _
_- WHEN YOU MUST NOT USE IT _
Do not take Rybelsus
®

If you are allergic to semaglutide
or any of the other ingredients of
this medicine (listed in section 8.
Product Description’).
_- BEFORE YOU START TO USE IT _
Talk to your doctor, pharmacist or
nurse before using Rybelsus
®
.
WARNINGS AND PRECAUTIONS
This
medicine
is
not
the
same
as
insulin and you should not use it if:

you have type 1 diabetes (your
body
does
not
produce
any
insulin)

you
develop
diabetic
ketoacidosis.
This
is
a
complication
of
diabetes
with
high
blood
sugar,
breathing
difficulty,
confusion,
excessive
thirst, a sweet smell to the breath
or a sweet or metallic taste in the
mouth.
STOMACH
AND
GUT
PROBLEMS
AND
DEHYDRATION
During treatment with this medicine,
you may feel sick (nausea) or be sick
(vomiting), or have diarrhoea. These
side
effects
can
cause
dehydration
(loss of fluids). It is important that you
drink
enough

Summary of Product characteristics

Rybelsus
®
Professional leaflet EN-Aug-2022_8-0503-00-004-1_Version 3.0
Based on EU text: 20220401_EN_08274_RYB_4-0
1
1.
NAME OF THE MEDICINAL PRODUCT
RYBELSUS
® 3 MG TABLETS
RYBELSUS
® 7 MG TABLETS
RYBELSUS
® 14 MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rybelsus
®
3 mg tablets
Each tablet contains 3 mg semaglutide*.
Rybelsus
®
7 mg tablets
Each tablet contains 7 mg semaglutide*.
Rybelsus
®
14 mg tablets
Each tablet contains 14 mg semaglutide*.
*human glucagon-like peptide-1 (GLP-1) analogue produced in
_Saccharomyces cerevisiae_
cells by
recombinant DNA technology.
Excipient with known effect
Each tablet, regardless of semaglutide strength, contains 23 mg
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Rybelsus
®
3 mg tablets
White to light yellow, oval shaped tablet (7.5 mm x 13.5 mm) debossed
with ‘3’ on one side and
‘novo’ on the other side.
Rybelsus
®
7 mg tablets
White to light yellow, oval shaped tablet (7.5 mm x 13.5 mm) debossed
with ‘7’ on one side and
‘novo’ on the other side.
Rybelsus
®
14 mg tablets
White to light yellow, oval shaped tablet (7.5 mm x 13.5 mm) debossed
with ‘14’ on one side and
‘novo’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rybelsus
®
is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes
mellitus to improve glycaemic control as an adjunct to diet and
exercise
•
as monotherapy when metformin is considered inappropriate due to
intolerance or
contraindications
•
in combination with other medicinal products for the treatment of
diabetes.
Rybelsus
®
Professional leaflet EN-Aug-2022_8-0503-00-004-1_Version 3.0
Based on EU text: 20220401_EN_08274_RYB_4-0
2
For study results with respect to combinations, effects on glycaemic
control and cardiovascular events,
and the populations studied, see sections 4.4, 4.5 and 5.1.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The starting dose of semaglutide is 3 mg once daily for one month.