TANATRIL 5MG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

IMIDAPRIL HYDROCHLORIDE

Available from:

Mitsubishi Tanabe Pharma Malaysia Sdn. Bhd.

INN (International Name):

IMIDAPRIL HYDROCHLORIDE

Units in package:

100 Tablet Tablets; 30 Tablet Tablets

Manufactured by:

PT Mitsubishi Tanabe Pharma Indonesia

Patient Information leaflet

TANATRIL
® TABLET
Imidapril Hydrochloride (5mg, 10mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Tanatril is used for
2.
How Tanatril works
3.
Before you use Tanatril
4.
How to use Tanatril
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Tanatril
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TANATRIL IS USED FOR
Tanatril is used to treat hypertension
which is a high blood pressure.
HOW TANATRIL WORKS
Tanatril contains imidapril hydrochloride
which is in a class of drugs called
angiotensin- converting enzyme (ACE)
inhibitors. ACE is an enzyme in a body
that is necessary in the formation of a
chemical called angiotensin II.
Angiotensin II causes the narrowing of
arteries, thereby increasing blood
pressure. ACE
inhibitors prevent the
formation of angiotensin II, hence
widening the blood vessels and helping
lower the blood pressure. Tanatril can be
used on its own or alongside other
medicines to help lower the blood
pressure.
BEFORE YOU USE TANATRIL
-
_When you must not use it _
You must not take this product when
you are:
•
having or ever had an allergic reaction
•
having
a
swelling
below
the
skin
surface, usually occurs around the eyes
and lips.
•
undergo hemodialysis.
•
pregnant or may possibly be pregnant.
-
_Before you start to use it _
Before you start to take this product,
make sure your doctor knows if you
are having any heart problem, kidney
problem, stroke and ischemia
(restriction of blood supply to the
brain).
_ _
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE TANATRIL
-
_How much to use _
_ _
The usual adult dosage for oral use is 5
mg to 10 mg of imidapril
hydrochloride once a day. The dosage
may be adjusted depending on the
patient’s age and symptom.
Follow all directions given to you by
your doctor and pharmacist carefully.
The

Summary of Product characteristics

SELECTIVE ANGIOTENSIN CONVERTING ENZYME INHIBITOR
TANATRIL
® TABLETS 5 MG
TANATRIL
® TABLETS 10 MG
(IMIDAPRIL HYDROCHLORIDE)
CONTRAINDICATIONS (TANATRIL IS CONTRAINDICATED IN THE FOLLOWING
PATIENTS.)
1)
Patients with a history of hypersensitivity to any of the ingredients
of the drug.
2)
Patients with a history of angioedema (Angioedema due to drug such as
angiotensin converting enzyme
(ACE) inhibitors, etc., hereditary angioedema, acquired angioedema,
idiopathic angioedema, etc.)
[Angioedema associated with dyspnea may occur.]
3)
Patients undergoing apheresis by an adsorber using dextran sulfate
immobilized cellulose, tryptophan
immobilized
polyvinyl
alcohol
or
polyethylene
terephthalate
[Shock
may
occur.]
(See
“Drug
Interactions" section.)
4)
Patients who undergo hemodialysis with acrylonitrile methallyl
sulfonate sodium membrane (AN69
®
)
[Anaphylactoid symptom may occur] (See PRECAUTIONS - Drug
Interactions.)
5)
Pregnant women or women who may possibly be pregnant. [See PRECAUTIONS
- Use during
Pregnancy, Delivery or Lactation]
6)
Patients with diabetes mellitus being treated with aliskiren fumarate
(excluding patients with markedly
uncontrolled blood pressure even after antihypertensive treatment with
other drugs) [Increased risk for
nonfatal stroke, renal impairment, hyperkalemia, and hypotension have
been reported] (See “Important
Precautions” section.)
7)
Patients receiving sacubitril valsartan sodium hydrate or patients
within 36 hours of discontinuation of
the drug [Angioedema may occur.] (See PRECAUTIONS – Drug
Interactions.)
DESCRIPTION
Brand name
TANATRIL
TANATRIL
Tablets 5 mg
Tablets 10 mg
Ingredient-
content
Imidapril hydrochloride
5 mg
per tablet
10 mg
per tablet
Dosage form
Plain tablets
Color
White
Appearance
Size
Diameter:
6.0 mm
Thickness:
2.53 mm (2.45-2.60 mm)
Diameter:
6.5 mm
Thickness:
2.55 mm (2.50-2.60 mm)
Weight
0.08 g
0.09 g
Identification code
TA 135
TA 136
Caution: Use only pursuant to the prescription or direction of a
physician, etc.
INDICATIONS
Treatment of essential hy