Dazil 60

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 60 mg

Pharmaceutical form:

TABLET

Composition:

DILTIAZEM HYDROCHLORIDE 60 mg

Prescription type:

POM

Therapeutic area:

CALCIUM CHANNEL BLOCKERS

Authorization status:

Withdrawn

Authorization date:

2006-08-29

Patient Information leaflet

PATIENT INFORMATION LEAFLET
Before you start taking this medicine, please read carefully this
patient information leaflet.

Keep this patient information leaflet. You may need to read it again.

If you have questions or if you do not understand something, ask your
doctor or pharmacist.

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.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
DAZIL 60 TABLETS
The active ingredient is diltiazem hydrochloride.
The other ingredients are ethanol, lactose, magnesium stearate,
polyvidone, hydrogenated vegetable oil
and talc.
Dazil 60 mg are white, concave, round tablets, scored on one side.
Product License Holder and Manufacturer:
Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial
Area, 2643 Ergates, P.O.Box 28629,
2081 Lefkosia, Cyprus, European Union.
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
1
DO NOT TAKE DAZIL

In case of hypersensitivity (allergy) to diltiazem or to any other
ingredient.

If you are pregnant or breast feeding or a woman of child bearing age.

If you have slow heart beat.

In case of heart problems, other than angina or hypertension.

If you have porphyria (a rare disease of blood pigments).

In case of severe liver or kidney disease.
BE CAUTIOUS WITH DAZIL

In case of reduced left ventricular function.

If you have mild bradycardia, first degree atrioventricular block or
prolonged PR internal you
should be und

Summary of Product characteristics

1.
NAME OF THE MEDICAL PRODUCT
Dazil 60 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg Diltiazem hydrochloride.
Excipient(s) with known effect: contains 300 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
White, concave, round tablets, scored on one side.
4. CLINICAL INFORMATION
4.1
THERAPEUTIC INDICATIONS
Diltiazem is a calcium antagonist. It selectively reduces calcium
entry through voltage-
dependent calcium channels into vascular smooth muscle cells and
myocardial cells. This
lowers the concentration of intracellular calcium that is available to
activate contractile
proteins. This action of diltiazem results in dilation of coronary
arteries causing an increase
in myocardial oxygen supply. It reduces cardiac work by moderating the
heart rate and
reducing systemic vascular resistance thus reducing oxygen demand.
Diltiazem also causes
mild peripheral vasodilatation.
When Dazil is given alone or with a beta-blocking agent only slight
negative inotropic
effects have been reported in patients with preserved ventricular
function.
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_ _
_Indication_
: 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
CONTRAINDIC