Adizem-SR 120 mg Prolonged Release Capsules

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Diltiazem hydrochloride

Disponible desde:

Mundipharma Pharmaceuticals Limited

Código ATC:

C08DB; C08DB01

Designación común internacional (DCI):

Diltiazem hydrochloride

Dosis:

120 milligram(s)

formulario farmacéutico:

Prolonged-release capsule, hard

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Benzothiazepine derivatives; diltiazem

Estado de Autorización:

Marketed

Fecha de autorización:

1995-04-20

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
_ADIZEM_
_®_
_-SR_ 90 MG,_ _120 MG AND 180 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-SR _
capsules are and what they are used for
2.
What you need to know before you take
_ADIZEM-SR_
capsules
3.
How to take
_ADIZEM-SR_
capsules
4.
Possible side effects
5.
How to store Adizem-SR capsules
6.
Contents of the pack and other information
1.
WHAT _ADIZEM-SR_ 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-SR_
capsules are listed in
section 6 of this leaflet.
_ADIZEM-SR_ CAPSULES ARE DESIGNED TO WORK PROPERLY OVER 12 HOURS. IF
THE CAPSULES ARE CRUSHED OR
CHEWED, THE ENTIRE 12 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-SR _CAPSULES
DO NOT TAKE _ADIZEM-SR _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 minute) or irregular heart
beat;
•

Ficha técnica

Health Products Regulatory Authority
25 May 2023
CRN00DKRF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adizem-SR 120 mg Prolonged Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 120 mg diltiazem hydrochloride.
Excipients: also contains sucrose 24.35 mg per capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsule, hard.
Size 3, hard gelatin, capsules with an opaque white body and an opaque
brown cap, printed '120 mg'.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of stable angina pectoris.
In the management of mild to moderate hypertension.
ADIZEM-SR capsules are indicated for use in adults only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
The usual initial dose is 90 mg twice daily. Dosage may be increased
gradually to 120 mg twice daily if required, or 180 mg
twice daily.
Elderly and patients with impaired renal or hepatic function
In the elderly dosage should commence at the lowest level of 90 mg
twice daily and be increased very slowly.
Dosage adjustments are not necessary in the presence of renal
dysfunction.
Paediatric population
Not recommended for use in children.
Route of administration
Oral.
To be taken at 12 hour intervals.
Dosage may be taken with or without food, and should be swallowed
whole and not chewed.
_ADIZEM-SR_ should not be taken at the same time as an alcoholic
beverage (see section 4.5).
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
25 May 2023
CRN00DKRF
Page 2 of 8
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.
Concurrent use with dantrolene infusion due to the risk of ventricular
fibrillation (see section 4.5).
Concurrent use with lomitapide (see section 4.5).
Pregnant women or women of child bearing potential.
Hypersensitivity to diltiazem or to any of the ex