DILTIAZEM sandoz

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

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Download Bijsluiter (PIL)
03-06-2024
Download Productkenmerken (SPC)
03-06-2024

Werkstoffen:

Diltiazem hydrochloride

Beschikbaar vanaf:

Sandoz Pty Ltd

klasse:

Medicine Registered

Bijsluiter

                                 
Diltiazem Sandoz
®
  
 
 
1 
 
DILTIAZEM SANDOZ
®
_ _
DILTIAZEM HYDROCHLORIDE TABLETS 
 
 
 
CONSUMER MEDICINE INFORMATION 
_ _
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about Diltiazem Sandoz.
 
 
It does not contain all the available information. It does not take
the place of talking to your doctor or 
pharmacist. 
 
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking this medicine 
against the benefits they expect it will have for you. 
 
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
WHAT DILTIAZEM SANDOZ IS USED FOR 
This medicine is used to prevent angina.  
Angina is a pain or uncomfortable feeling in the chest, often
spreading to the arms and neck, and 
sometimes the shoulders and back. This may be caused by too little
blood and oxygen getting to the heart. 
Angina is usually brought on by exercise or stress.  
 
It contains the active ingredient diltiazem hydrochloride. _  _
Diltiazem belongs to a group of medicines called calcium channel
blockers. _  _
 
It works by opening up blood vessels, thereby increasing the blood
flow and allowing more blood (and 
oxygen) to reach the heart. _ _
_ _
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU. 
Your doctor may have prescribed it for another reason. 
_ _
This medicine is not addictive. 
 
This medicine is available only with a doctor’s prescription. _ _
BEFORE YOU TAKE DILTIAZEM SANDOZ 
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: 
•  diltiazem hydrochloride, the active ingredient, or to any of
the other ingredients listed at the end of 
this leaflet under Product Description. 
 
Some of the symptoms of an allergic reaction may include: 
•  shortness of breath 
 
Diltiazem Sandoz
®
 
 
 
 
2 
 
•  wheezing or
                                
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Productkenmerken

                                 
1 
PRODUCT INFORMATION 
DILTIAZEM SANDOZ
®
 60MG FILM-COATED TABLETS 
 
 
NAME OF THE MEDICINE 
 
Chemical name: (2_S_,3_S_)-5-(2-dimethylaminoethyl)-2,3,4,5-tetrahydro-2-(4-methoxyphenyl)-
4-oxo-1,5-benzothiazepin-3-yl acetate hydrochloride. 
 
Generic name: diltiazem hydrochloride. 
 
 
 
 
CAS 33286-22-5  
 
 
 
MW: 450.98 
 
 
DESCRIPTION 
 
Diltiazem
hydrochloride is a white to off white crystalline powder with a bitter taste, soluble 
in water, methanol and chloroform. 
 
Composition 
Each tablet contains: 
_Active ingredient: _
Diltiazem Hydrochloride                    60.00mg 
 
_Inactive excipients: _
Hydrogenated Castor Oil, Lactose, Povidone 25, Macrogol 6000,
Microcrystalline Cellulose, 
Sodium Starch Glycollate,
Colloidal Anhydrous  Silica, Magnesium Stearate, Hypromellose, 
Stearic Acid, Titanium Dioxide. 
 
 
PHARMACOLOGY 
 
Diltiazem is a calcium ion influx inhibitor (slow channel
blocker or calcium antagonist). 
 
The therapeutic benefits achieved with Diltiazem
are believed to be related to its ability to 
inhibit the influx of calcium ions during membrane
depolarisation of cardiac and vascular 
smooth muscle. 
 
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_Mechanism of Action._  Although the precise mechanisms of its antianginal
actions are still 
being delineated, Diltiazem is believed to act
in the following ways: 
 
1. 
Vasospastic angina. Diltiazem has been shown to
be a potent dilator of coronary arteries 
both  epicardial and subendocardial.  Spontaneous and
ergometrine induced coronary 
artery spasm are inhibited by Diltiazem. 
 
2. 
Exertional angina. Diltiazem has been shown to
produce increases in exercise tolerance, 
probably due to its ability to reduce myocardial oxygen demand
and increase oxygen 
supply. This is accomplished via reductions in heart rate and
systemic blood pressure a
                                
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