ADIZEM-XL Prolonged Release Capsules 200 Milligram
Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Toote omadused
(SPC)
18-04-2024
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Toimeaine:
DILTIAZEM HYDROCHLORIDE
Saadav alates:
Napp Pharmaceuticals Limited
Annus:
200 Milligram
Ravimvorm:
Prolonged Release Capsules
Loa andmise kuupäev:
2002-04-19
Toote omadused
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adizem-XL 200 mg Prolonged Release Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg diltiazem hydrochloride.
Excipients: also contains soya lecithin, trace quantities per capsule.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsules, hard.
Size 1, hard gelatin capsules with brown body and brown cap marked ‘DCR 200’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
Management of angina pectoris.
2.
Treatment of mild to moderate hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
The capsules should be swallowed whole and not chewed.
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.
Children:
Not recommended for use in children.
Adizem XL should not be taken at the same time as an alcoholic beverage (refer to Section 4.5, Interactions with other
Medicinal Products and Other Forms of Interaction).
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 02/12/2010_
_CRN 2071630_
_page number: 1_
4.3 CONTRAINDICATIONS
Sick sinus syndrome not requiring pacemaker, second or third degree AV-block, bradycardia (less than 40 beats per
minute).
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