DILZEM SR 90 Milligram Prolonged Release Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
17-12-2015
Summary of Product characteristics
(SPC)
13-12-2016
Active ingredient:
DILTIAZEM HYDROCHLORIDE
Available from:
Cephalon UK Limited
ATC code:
C08DB01
INN (International Name):
DILTIAZEM HYDROCHLORIDE
Dosage:
90 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Benzothiazepine derivatives
Authorization status:
Authorised
Authorization date:
2010-11-19
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
DILZEM SR 60 MG, 90 MG, 120 MG
PROLONGED-RELEASE HARD 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 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 DILZEM SR IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DILZEM SR
3.
HOW TO TAKE DILZEM SR
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DILZEM SR
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DILZEM SR IS AND WHAT IT IS USED FOR
DILZEM SR contains the active
ingredient, diltiazem hydrochloride.
Diltiazem belongs to a group of medicines called calcium channel blockers. These medicines work to
lower blood pressure and ease anginal chest pain
by preventing the narrowing of blood vessels.
DILZEM SR is used to treat and control MILD TO MODERATELY HIGH BLOOD PRESSURE and to prevent and
treat CHEST PAIN due to the narrowing of blood vessels
in the heart. DILZEM SR is designed to release the
active ingredient, diltiazem, in a controlled manner throughout the whole day so that blood pressure and
angina are treated for a full 24 hour period.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DILZEM SR
DO NOT TAKE DILZEM SR IF Y
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dilzem SR 90 mg Prolonged-release hard capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Dilzem SR 90 mg capsule contains diltiazem hydrochloride 90 mg.
Excipients with known effect: Each capsule contains 18.9mg sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsules, hard
Buff coloured hard gelatin capsules, printed with ‘90 mg’ and containing roughly spherical white to off-white beads.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dilzem SR is indicated in adults for:
treatment of angina pectoris including Prinzmentals angina;
treatment of mild to moderate hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS:_
Hypertension: The usual initial dose is 90 mg twice daily (corresponding to 180 mg of diltiazem hydrochloride).
Depending upon clinical response the patient’s dosage may be increased to 180 mg twice daily if required.
Angina Pectoris: The usual initial dose is 90 mg twice daily (corresponding to 180 mg of diltiazem
hydrochloride). Depending upon clinical response the patient’s dosage may be increased to 180 mg twice daily
if required.
_ELDERLY:_
Dosage should commence at the lower level of 60 mg twice daily and be increased slowly. Do not increase the
dose if the heart rate falls below 50 beats per minute.
_PATIENTS WITH HEPATIC IMPAIRMENT:_
Dosage should commence at the lower level of 60 mg twice daily and be increased slowly. Do not increase the
dose if the heart rate falls below 50 beats per minute. See section 4.4.
_PATIENTS WITH RENAL IMPAIRMENT:_
Dosage should commence at the lower level of 60 mg twice daily and be increased slowly. Do not increase the
dose if the heart rate falls below 50 beats per
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