HERBESSER TABLET 30MG

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

DILTIAZEM HYDROCHLORIDE

Verfügbar ab:

Mitsubishi Tanabe Pharma Malaysia Sdn. Bhd.

INN (Internationale Bezeichnung):

DILTIAZEM HYDROCHLORIDE

Einheiten im Paket:

100Tablet Tablets; 1000Tablet Tablets; 600 Tablet Tablets; 30 Tablet Tablets

Hergestellt von:

PT Mitsubishi Tanabe Pharma Indonesia

Gebrauchsinformation

HERBESSER
® TABLETS
Diltiazem Hydrochloride (30mg, 60mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Herbesser is used for
2.
How Herbesser works
3.
Before you use Herbesser
4.
How to use Herbesser
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Herbesser
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT HERBESSER IS USED FOR
Herbesser is used to treat hypertension
and angina. Hypertension is high blood
pressure. Angina is a severe chest pain
which occurs when the heart muscles do
not receive enough oxygen.
HOW HERBESSER WORKS
Herbesser works by relaxing and opening
up the blood vessel. This allows blood to
circulate more freely around the body,
lowering blood pressure and helping
more oxygen to reach the heart.
BEFORE YOU USE HERBESSER
-
_When you must not use it _
Do not use this product if you have
any heart problem known, like heart
block.
Do not use this product if you are
allergic to Diltiazem Hydrochloride, or
any other ingredients in this
medication.
_Pregnancy and lactation _
_ _
Do not take Herbesser if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Herbesser if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start to use it _
Before you start to take this
medication, let your doctor know if
you have:
-
any other medical condition,
especially any heart related disease.
-
have undergo, or is planning to take
any sort of operation, minor or major.
-
_Taking other medicines _
_ _
Some medications will cause
complications when taken together
with Herbesser. This medication
includes:
-
asunaprevir-containing product
-
ivabradine hydrochloride
-
lomitapide mesylate
-
antihypertensive agents
*
effect of antihypertensive agent is
enhanced
-
beta-blocking agents or rauwolfia
preparations
*
lower heart rate might occur
-any other heart medications.
Tell your doctor if you are taking any
other medicines, i

Fachinformation

*
Date of Revision: June 2023
Ca-antagonist
HERBESSER
®
TABLET 30MG
HERBESSER
®
60 TABLET
(Diltiazem hydrochloride)
DESCRIPTION
Product Name
HERBESSER
TABLET 30MG
HERBESSER 60
TABLET
Active Ingredient
(per tablet)
Diltiazem hydrochloride
30 mg
60 mg
Description
White tablets with
mark TA 120 on one
side and blank on
other side
White tablets with
mark TA 125 on one
side and mark 60 on
other side
Diameter
8.0 mm
8.0 mm
Thickness
3.45 mm
3.45 mm
Weight
0.19 g
0.185 g
Tablet Code
TA 120
TA 125
INDICATIONS
-
Angina pectoris, variant angina pectoris
-
Essential hypertension (mild to moderate)
DOSAGE AND ADMINISTRATION
-
Angina pectoris, variant angina pectoris
The usual adult dosage for oral use is 30 mg of diltiazem
hydrochloride three times a day (90
mg/day). The dosage may be increased to 60 mg three times a day (180
mg/day), if necessary.
-
Essential hypertension (mild to moderate)
The usual adult dosage for oral used is 30 to 60 mg of diltiazem
hydrochloride three times a day
(90 – 180 mg/day). The dosage may be adjusted depending on the
patient’s age and symptoms.
CONTRAINDICATIONS (HERBESSER IS CONTRAINDICATED IN THE FOLLOWING
PATIENTS.)
(1)
Patients with severe congestive cardiac failure [Symptoms of cardiac
failure may be
aggravated].
(2)
Patients with second or third degree atrioventricular block or sick
sinus syndrome
(persistent sinus bradycardia) (less than 50 beats/ minute), sinus
arrest, sinoatrial block,
etc.) [Depression of cardiac stimulation and cardiac conduction may
occur excessively].
(3)
Patients with a history of hypersensitivity to any of the ingredients
of this product.
(4)
Pregnant women and women who may possibly be pregnant [See "Use during
Pregnancy,
Delivery or Lactation" section].
(5)
Patients receiving asunaprevir-containing product, ivabradine
hydrochloride, or lomitapide
mesylate [See “Drug Interactions” section].
PRECAUTIONS
1.
CAREFUL ADMINISTRATION (HERBESSER SHOULD BE ADMINISTERED WITH CARE IN
THE FOLLOWING
PATIENTS.)
1)
Patients
with
congestive
cardiac
failure.
[Symptom