ADIZEM-XL 180mg prolonged release capsules

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Diltiazem hydrochloride

Verfügbar ab:

Mundipharma Pharmaceuticals Limited

ATC-Code:

C08DB; C08DB01

INN (Internationale Bezeichnung):

Diltiazem hydrochloride

Dosierung:

180 milligram(s)

Darreichungsform:

Prolonged-release capsule, hard

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Benzothiazepine derivatives; diltiazem

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1994-12-16

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ADIZEM_
_®_
_-XL _120 MG, 180 MG, 240 MG AND 300 MG PROLONGED-RELEASE_ _CAPSULES
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 any 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 of the side effects talk to your doctor. This includes
any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What
_ADIZEM-XL _
capsules are and what they are used for
2.
What you need to know before you take
_ADIZEM-XL_
capsules
3.
How to take
_ADIZEM-XL_
capsules
4.
Possible side effects
5.
How to store
_ADIZEM-XL _
capsules
6.
Contents of the pack and other information
1.
WHAT _ADIZEM-XL_ CAPSULES ARE AND WHAT THEY ARE USED FOR
These capsules have been prescribed for you to treat angina (chest
pain caused by a reduction of oxygen to
the heart muscle) or high blood pressure (hypertension). They contain
the active ingredient diltiazem.
Diltiazem belongs to a group of medicines called calcium antagonists.
Calcium antagonists help more blood
to reach the heart and reduce blood pressure. The other ingredients of
_ADIZEM-XL _
capsules are listed in
section 6 of this leaflet.
_ADIZEM-XL _CAPSULES ARE DESIGNED TO WORK PROPERLY OVER 24 HOURS. IF
THE CAPSULES ARE CRUSHED OR
CHEWED, THE ENTIRE 24 HOUR DOSE MAY BE ABSORBED RAPIDLY INTO YOUR
BODY. THIS CAN BE DANGEROUS,
CAUSING SERIOUS PROBLEMS SUCH AS AN OVERDOSE.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE_ ADIZEM-XL _CAPSULES
DO NOT TAKE _ADIZEM-XL _CAPSULES_ _IF YOU:
•
are allergic (hypersensitive) to diltiazem or any of the other
ingredients of the capsules (see section 6
‘Further Information’);
•
have a very slow (less than 40 beats per minutes) or irregular hear

Fachinformation

Health Products Regulatory Authority
25 May 2023
CRN00DKRF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ADIZEM-XL 180mg prolonged release capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release capsule contains 180 mg diltiazem hydrochloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsules, hard.
Size 3 hard gelatin capsules approximately 18mm long with a dark pink
body and royal blue cap, marked DCR 180.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Management of angina pectoris.
2. Treatment of mild to moderate hypertension.
ADIZEM-XL capsules are indicated for use in adults only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
The usual starting dose is one 240 mg capsule daily. However,
patients' responses may vary and dosage requirements can
differ significantly between individual patients. There is no evidence
of any decrease in efficacy at higher doses. If necessary
the dose may be gradually increased to 300 mg or 360 mg per day. Doses
of 480 mg/day have been used with benefit in some
angina patients.
Elderly:
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.
Paediatric population:
Not recommended for use in children.
Route of administration
Oral.
To be taken at 24 hour intervals.
The capsules should be swallowed whole and not chewed.
ADIZEM-XL should not be taken at the same time as an alcoholic
beverage (see section 4.5).
4.3 CONTRAINDICATIONS
Patients with severe bradycardia (less than 40 beats per minute),
second or third degree heart block, or sick sinus syndrome,
decompensated cardiac failure or left ventricular failure with
pulmonary congestion.
Health Products Regulatory Authority
25 May 2023
CRN00DKRF
Page 2 of 8
Concurrent use with dantrolene infusion due to the risk of ventricular
fibrillation (see section 4.5).
Concurrent use with lomitapide (see section 4.5).
Pre