ADIZEM CD 180

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

DILTIAZEM HYDROCHLORIDE

Disponibil de la:

RAFA LABORATORIES LTD

Codul ATC:

C08DB

Forma farmaceutică:

CAPSULES CONTROLLED RELEASE

Compoziție:

DILTIAZEM HYDROCHLORIDE 180 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

RAFA LABORATORIES LTD, JERUSALEM

Grupul Terapeutică:

BENZOTHIAZEPINE DERIVATIVES

Indicații terapeutice:

Calcium channel blocker that is indicated for the treatment of hypertension and angina.

Data de autorizare:

2021-10-31

Prospect

page 1 of 5
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor's prescription only
ADIZEM CD 120
ADIZEM CD 180
ADIZEM CD 240
CONTROLLED RELEASE CAPSULES
ACTIVE INGREDIENT:
Each capsule of
ADIZEM CD 120
contains 120 mg diltiazem hydrochloride.
Each capsule of
ADIZEM CD 180
contains 180 mg diltiazem hydrochloride.
Each capsule of
ADIZEM CD 240
contains 240 mg diltiazem hydrochloride.
For a list of the other ingredients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
This medicine has been prescribed for treatment of your illness. Do
not pass it on to
others. It may harm them, even if it seems to you that their illness
is similar to yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of hypertension and angina.
THERAPEUTIC GROUP
: Calcium channel blocker
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to the active ingredient, or to any of
the other
ingredients this medicine contains (for a list of the other
ingredients, please see
section 6).

You suffer from heart rhythm disorders (such as slow or irregular
heartbeat).

You suffer from heart failure.

You are pregnant, planning to become pregnant or breastfeeding. See
section
'Pregnancy and breastfeeding'.

You are receiving concomitant dantrolene injections (a medicine used
for
treatment in cases of severe hyperthermia or severe muscle spasms).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:

Adizem capsules have a controlled release mechanism which enables the
active
ingredient to be gradually released over 24 hours.
Do not chew or crush the capsule or its contents, since this may cause
rapid
release of the active ingredient (overdose) and severe problems. See
section 'If
you have accidently taken a higher dose'.

Do not tak

Caracteristicilor produsului

דומע
1
ךותמ
10
3
0
-
23
20
-
November
-
02
-
SPC
-
®
CD
Adizem
-
DL
_ _
Summary of product characteristics
1
NAME OF THE MEDICINAL PRODUCT
ADIZEM CD
®
120
ADIZEM CD
®
180
ADIZEM CD
®
240
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
ADIZEM CD
®
120_ _
capsule contains
_ _
diltiazem hydrochloride 120 mg.
_ _
Each
ADIZEM CD
®
180_ _
capsule contains
_ _
diltiazem hydrochloride 180 mg.
_ _
Each
ADIZEM CD
®
240_ _
capsule contains
_ _
diltiazem hydrochloride 240 mg.
_ _
_ _
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Controlled release capsules containing white to off white spherical
pellets.
ADIZEM CD
®
120
- yellow-red capsules.
ADIZEM CD
®
180_ _
- blue-red capsules.
ADIZEM CD
®
240
- purple-red capsules.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Calcium channel blocker that is indicated for the treatment of
hypertension and
angina.
4.2
Posology and method of administration
ADIZEM CD
®
capsules are indicated for use in adults only.
Posology
Dosage requirements may differ between patients with angina and
patients with
hypertension. In addition, individual patients’ responses may vary
necessitating
careful titration. This range of capsule strengths facilitates
titration to the optimal
dose.
דומע
2
ךותמ
10
_Adults: _
For patients new to diltiazem therapy the usual starting dose is one
240 mg capsule
daily.
Patients currently receiving a total daily dose of 180 mg diltiazem
(as 90 mg b.d. or
60 mg t.i.d.) and transferring to
ADIZEM CD
®
capsules should be given the 240 mg
capsule (o.d.). A patient receiving 240 mg/day of diltiazem (as 120 mg
b.d.) should
commence treatment on the 240 mg capsule (o.d.).
_Elderly and patients with impaired hepatic and renal function: _
For patients new to diltiazem therapy, the usual starting dose is one
120 mg capsule
daily. If necessary the dose may be gradually increased but careful
monitoring of this
group of patients is advised.
Elderly patients transferring to
ADIZEM CD
®
capsules should receive the same total
d