DILZEM XL
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
16-04-2024
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Virkt innihaldsefni:
DILTIAZEM HYDROCHLORIDE
Fáanlegur frá:
LTT Pharma Limited
Skammtar:
240 Milligram
Lyfjaform:
Prolonged Release Capsules
Leyfisdagur:
2010-11-12
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dilzem XL 240mg Prolonged-release Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Dilzem XL 240mg capsule contains diltiazem hydrochloride 240mg.
Excipients: Each capsule contains sucrose.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release capsules, hard
_Product imported from Germany_
White, hard gelatin capsules, printed with ‘D240 mg’ and containing roughly spherical white to off-white beads.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis and treatment of angina pectoris.
Treatment of mild to moderate hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral _use _only.
Adults:
Hypertension: The usual initial dose is one 180mg capsule per day (corresponding to 180mg of diltiazem
hydrochloride). Depending upon 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 upon clinical response the patient’s dosage may be increased stepwise to
360mg/day if required.
Elderly patients and those with renal or hepatic impairment:
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.
Children:
This product is not recommended for use in children.
4.3 CONTRAINDICATIONS
o
Use in women of child-bearing potential.
o
Concomitant administration of dantrolene infusion due to the risk of ventricular fibrillation.
o
Shock.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/04/2012_
_CRN 2111390_
_page numb
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