Dilzem XL 120mg Prolonged-release hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diltiazem hydrochloride

Available from:

Cephalon UK Limited

ATC code:

C08DB; C08DB01

INN (International Name):

Diltiazem hydrochloride

Dosage:

120 milligram(s)

Pharmaceutical form:

Prolonged-release capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Benzothiazepine derivatives; diltiazem

Authorization status:

Marketed

Authorization date:

1990-07-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DILZEM XL 120 MG, 180 MG, 240 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 XL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DILZEM XL
3. HOW TO TAKE DILZEM XL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DILZEM XL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DILZEM XL IS AND WHAT IT IS USED FOR
DILZEM XL 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 XL 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 XL 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 XL
DO NOT TAKE DILZEM XL IF YOU:
-
are allergic to diltiazem hydrochloride or any of the other
ingredients of this medicine (see
section 6)
-
are a woman of a child-bearing potential and are not using
contraception (see “Pregnancy,
breast-feeding and fertility”)
-
are pregnant, think you may be pregnant or are breast-feeding (see
“Pregnancy, breast-
feeding and fertility”)
-
are currently in shock (reduced bl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dilzem XL 120mg Prolonged-release hard capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Dilzem XL 120mg capsule contains diltiazem hydrochloride 120mg.
Excipients with known effect: Each capsule contains 25.2mg sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
White, hard gelatin capsules, printed with ‘e120’ and containing
roughly spherical white to off-white beads.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dilzem XL is indicated in adults for:
prophylaxis and treatment of angina pectoris;
treatment of mild to moderate hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS:_
_Hypertension:_
The usual initial dose is one 180mg capsule per day (corresponding to
180 mg of diltiazem
hydrochloride once daily).
Depending upon the clinical response the patient’s dosage may be
increased stepwise to
360mg/day if required.
_Angina Pectoris:_
The usual
initial
dose is
one 180mg capsule per
day (corresponding to 180mg of
diltiazem
hydrochloride once daily).
Depending on the clinical
response the patient’s dosage may be increased stepwise to
360mg/day if required.
_ELDERLY:_
Dosage should commence at the lower level of 120mg once-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 minute. See section
4.4.
_PAEDIATRIC POPULATION:_
This product is not recommended for use in children.
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