ADIZEM-XL Prolonged Release Capsules 200 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-03-2023
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Active ingredient:
DILTIAZEM HYDROCHLORIDE
Available from:
Napp Pharmaceuticals Limited
Dosage:
200 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Authorization date:
2002-04-19
Summary of Product characteristics
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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
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