Irbel Tablets 150 mg

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

IRBESARTAN

Доступна з:

RANBAXY (MALAYSIA) SDN. BHD.

ІПН (Міжнародна Ім'я):

IRBESARTAN

Одиниць в упаковці:

2x14 Tablets

Виробник:

Sun Pharmaceutical Industries Limited

інформаційний буклет

IRBEL TABLETS
Irbesartan Tablets (150 and 300 mg)
_Consumer Medication Information Leaflet (RiMUP)_
Irbesartan Tablets
Page | 1
What is in this leaflet
1. What
IRBEL TABLETS
are used
for
2. How
IRBEL TABLETS
work
3. Before you use
IRBEL TABLETS
4. How to use
IRBEL TABLETS
5. While you are using
IRBEL
TABLETS
6. Side Effects
7. Storage and disposal of
IRBEL
TABLETS
8. Product description
9. Manufacture
10. Product registration holder
11. Date of Revision
WHAT IRBEL TABLETS
IS USED FOR
IRBEL
TABLETS
contain
a
medicine
called
irbesartan.
Irbesartan
belongs to a group of medicines known
as
angiotensin-II
receptor
blocker.
Angiotensin-II is a substance produced
in the body which binds to receptors in
blood
vessels
causing
narrowing
of
blood vessels. This results in an
increase in blood pressure.
IRBEL TABLETS
are used in adult
patients:
• to treat high blood pressure
• to protect the kidney in patients
with
high
blood
pressure,
type
2
diabetes and laboratory evidence of
impaired kidney function
(Nephropathy
in
type
2
diabetic
patients).
HOW IRBEL TABLETS
WORKS
IRBEL TABLETS
prevent the binding
of
angiotensin-II
to
angiotensin-II
receptors, causing the blood vessels to
relax and the blood pressure to lower.
Irbesartan slows the decrease of kidney
function
in
patients
with
high
blood
pressure and type 2 diabetes.
Your
doctor
may
give
you
other
medicines as well as Irbel Tablets to
help treat your condition.
BEFORE YOU USE IRBEL TABLETS
WHEN YOU MUST NOT TAKE IT
Do not take
IRBEL TABLETS
if:
• you are allergic to irbesartan or any
of the other ingredients of this
medicine.
An
allergic
reaction
may
include rash, itching, swelling of face,
lips,
or
hands/feet,
or
breathing
difficulties.
• you are more than 3 months
pregnant.
(It
is
also
better
to
avoid
Irbesartan
in
early
pregnancy-see
pregnancy section)
• you are breast feeding.
If you are not sure whether you should
start taking this medicine talk to your
doctor.
BEFORE YOU START TO TAKE IT
Tell your doctor if you have or have had
any
of
the
following
medical
c

Характеристики продукта

-
_Body as a Whole:_ fever, chills, facial oedema, upper
extremity oedema
-
_Cardiovascular:_
hypertension,
cardiac
murmur,
m y o c a r d i a l
i n f a r c t i o n ,
a n g i n a
p e c t o r i s ,
arrhythmic/conduction
disorder,
cardio-respiratory
arrest,
heart
failure,
hypertensive
crisis,
sinus
abnormality, syncope
-
_Dermatologic:_
pruritus,
dermatitis,
ecchymosis,
erythema face,
-
_Endocrine/Metabolic/Electrolyte Imbalances:,_ gout
-
_Gastrointestinal:_
constipation,
oral
lesion,
gastroenteritis, flatulence, abdominal distention
-
_Musculoskeletal/Connective _
_Tissue:_
extremity
swelling, arthritis, , joint stiffness, bursitis, muscle
weakness
-
_Nervous _
_System:_
sleep
disturbance,
numbness,
somnolence,
emotional
disturbance,
depression,
paresthesia,
tremor,
transient
ischemic
attack,
cerebrovascular accident, anxiety/nervousness
-
_Renal/Genitourinary:_
abnormal
urination,
prostate
disorder, urinary tract infection
-
_Respiratory:_ epistaxis, tracheobronchitis, congestion,
pulmonary congestion, dyspnea, wheezing, influenza,
pharyngitis, rhinitis
-
_Special _
_Senses:_
vision
disturbance,
hearing
abnormality, ear infection, ear pain, conjunctivitis, other
eye disturbance, eyelid abnormality, ear abnormality
_Laboratory Test Findings_
-
Minor increases in blood urea nitrogen (BUN) have
been reported in patients with essential hypertension
receiving irbesartan.
-
Mean decreases in neutropenia (<1000 cells/mm3)
have been reported in patients receiving irbesartan
Rare cases of rhabdomyolysis have been reported in patients
receiving angiotension II receptor blockers.
USE IN SPECIAL POPULATIONS
Ÿ
PREGNANCY
USE IN PREGNANCY
THE
USE
OF
ANGIOTENSIN
II
RECEPTOR
ANTAGONISTS
(AIIRAS) IS NOT RECOMMENDED DURING THE FIRST TRIMESTER
OF PREGNANCY (SEE WARNINGS AND PRECAUTIONS).
THE
USE
OF AIIRAS
IS
CONTRAINDICATED
DURING
THE
SECOND
AND
THIRD
TRIMESTERS
OF
PREGNANCY
(SEE
CONTRAINDICATIONS
AND
WARNINGS
AND
PRECAUTIONS).
The use of Angiotensin II Receptor Antagonists (AIIRAs) is
not recommended during the first trimester of