Denazox 60mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DILTIAZEM HYDROCHLORIDE

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, 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:

Authorised

Authorization date:

2007-11-22

Patient Information leaflet

page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DENAZOX 60 MG TABLETS
Diltiazem Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as 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.
WHAT IS IN THIS LEAFLET
1.
What Denazox is and what it is used for
2.
What you need to know before you take Denazox
3.
How to take Denazox
4.
Possible side effects
5.
How to store Denazox
6.
Contents of the pack and other information
1.
WHAT DENAZOX IS AND WHAT IT IS USED FOR
Denazox, belongs to the general category of calcium antagonists.
INDICATIONS:
Denazox is indicated
•
for the treatment of symptomatic coronary artery disease:
-
chronic stable angina (angulation of effort).
-
unstable angina (worsening angina, angina pectoris).
-
vasoconstriction angina (prinzmetal type, diverse angina).
•
in hypertension.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DENAZOX
DO NOT TAKE DENAZOX.
•
if you are allergic to diltiazem hydrochloride or any of the other
ingredients of this
medicine (listed in section 6).
•
if you have AV block of 2
nd
and 3
rd
grade.
•
if you have diseased phlegm syndrome.
•
if you have 2
nd
and 3
rd
degree focal fibrosarcoma.
•
if you have shock.
page 2 of 6
•
if you have acute, complicated myocardial infarction (bradycardia,
severe hypotension,
left ventricular failure).
•
if you have established heart failure.
•
if you have atrial fibrillation/fluttering and simultaneous existence
of Wolff-Parkinson-
White syndrome (increased risk of ventricular tachycardia).
•
if you have bradycardia (heart rate, less than 50 contractions/min).
•
if you are a w

Summary of Product characteristics

page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Denazox 60 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg diltiazem hydrochloride.
Excipient(s) with known effect
This product contains 175 mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, round, flat, scored tablets.
The score line is only there to help you break the tablet if you have
difficulty swallowing
it whole.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Denazox is indicated
•
for the treatment of symptomatic coronary artery disease:
-
chronic stable angina (angulation of effort).
-
unstable angina (worsening angina, angina pectoris).
-
vasoconstriction angina (prinzmetal type, diverse angina).
•
in hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The following dosages are recommended for adults.
_Coronary heart disease _
The daily dose is one Denazox tablet three times a day (equivalent to
3x60 mg diltiazem
hydrochloride). When necessary, the daily dose may be increased at 360
mg. For cases
of long-term treatment and direct therapeutic effect, it is
recommended to examine the
possibility of reducing the dose every 2-3 months.
page 2 of 8
_Hypertension _
The daily dose is one Denazox tablet three times a day (equivalent to
3x60 mg diltiazem
hydrochloride). Depending on the patient's response, the daily dose
can be increased up
to 360 mg. When stabilization of the antihypertensive action is
achieved, the possibility
to reduce the dose should be checked. Denazox should be administered
with caution in
patients with hepatic and/or severe renal disorder, as well as in
elderly patients.
GENERAL
_Coronary heart disease and hypertension _
The tablets must be swallowed unchewed with a little water, after
eating. Denazox
treatment is usually long-term. Stopping or changing the dose, should
only be done with
adviced by a doctor. Discontinuation of treatment with Denazox, should
be done
gradually, not abruptly, especially in pa