Dazil 30

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DILTIAZEM HYDROCHLORIDE

Available from:

Delorbis Pharmaceuticals Limited 17 Athinon Str, Ergates Industrial Area, 2643 Ergates, PO Box 28629, 2081 Lefkosia, Cyprus

ATC code:

C08DB01

INN (International Name):

DILTIAZEM HYDROCHLORIDE 30 mg

Pharmaceutical form:

TABLET

Composition:

DILTIAZEM HYDROCHLORIDE 30 mg

Prescription type:

POM

Therapeutic area:

CALCIUM CHANNEL BLOCKERS

Authorization status:

Withdrawn

Authorization date:

2006-08-29

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET 

Before you start taking this medicine, please read carefully this
patient information leaflet.  

ƒ  Keep this patient information leaflet. You may need to read
it again.   
ƒ  If you have questions or if you do not understand something,
ask your doctor or pharmacist.   
ƒ  This medicine was given to you and you should not give any of
this medicine to anybody else. 
It might harm them even if they have the same symptoms like yours. 

DAZIL 30 TABLETS 
DAZIL 60 TABLETS 
DAZIL 90 TABLETS 
The active ingredient is diltiazem hydrochloride. 
The other ingredients are ethanol, lactose, magnesium stearate,
polyvidone, sterotex and talc. 
DAZIL 30 are white, flat, round tablets, scored on one side. 
DAZIL 60 are white, concave, round tablets, scored on one side. 
DAZIL 90 are white, concave, round tablets, scored on one side. 

Product License Holder and Manufacturer:  
Aegis Ltd., P.O.Box 28629, 2081 Nicosia, Cyprus, Europe. 

WHAT IS DAZIL AND WHAT IS ITS USE 

Diltiazem belongs to a group of medicines called calcium
antagonists.  They help more blood to reach 
the heart and they also reduce blood pressure. 
DAZIL is indicated in the management of angina pectoris (chest pain
caused by a reduction of oxygen 
to the heart muscle) and hypertension (high blood pressure). 

Ask your doctor why you have to take this medicine. 

WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAZIL 

DO NOT TAKE DAZIL 
ƒ  In case of hypersensitivity (allergy) to diltiazem or to any
other ingredient.  
ƒ  If you are pregnant or breast feeding or a woman of child
bearing age. 

2
ƒ  If you have slow heart beat. 
ƒ  In case of heart problems, other than angina or hypertension. 
ƒ  If you have porphyria (a rare disease of blood pigments). 
ƒ  In case of severe liver or kidney disease. 

BE CAUTIOUS WITH DAZIL  
ƒ  In case of reduced left ventricular function. 
ƒ  If you have mild bradycar

Summary of Product characteristics

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS  

1.  TRADE NAME OF THE MEDICAL PRODUCT 

DAZIL 30 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Diltiazem hydrochloride 30mg 

3.   PHARMACEUTICAL FORM:  

Tablets 

4.   CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS   
_ _
_ _
Dazil is indicated for the management of Angina pectoris and
treatment of mild to moderate 
hypertension. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
_ _
_Adults: _The usual dose is 60 mg, three times daily. However,
patient responses may vary and dosage 
requirements can differ significantly between individual patients. If
necessary the dosage may be 
increased to 360 mg/day. Higher doses up to 480 mg/day have been
used with benefit in some patients 
especially in unstable angina. There is no evidence of any decrease
in efficacy at these high doses.  
_ _
_Elderly and patients with impaired hepatic or renal function: _The
recommended starting dose is 60 mg, 
twice daily. The heart rate should be measured regularly in these
groups of patients and the dose should 
not be increased if the heart rate falls below 50 beats per minute.

_ _
_Children:_ Safety and efficacy in children have not been
established.  

4.3 CONTRAINDICATIONS 

DAZIL is contra-indicated in pregnancy and in women of child-bearing
potential.  

DAZIL depresses atrioventricular node conduction and is therefore
contra-indicated in patients with 
marked bradycardia, sick sinus syndrome, left ventricular failure
with stasis, or second or third degree 
AV block except in the presence of a functioning pacemaker.  
DAZIL, like any calcium antagonist, should not be administered
concurrently with dantrolene infusion 
because of the risk of ventricular fibrillation.  

Page 2 of 5 
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

DAZIL should be used with caution in patients with reduced left
ventricular function. Patients with 
mild bradycardia, first degree AV b