ADALAT LA
Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Toote omadused
(SPC)
03-05-2024
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Toimeaine:
NIFEDIPINE
Saadav alates:
LTT Pharma Limited
Annus:
20 Milligram
Ravimvorm:
Tablet Prolonged Release
Loa andmise kuupäev:
2010-11-26
Toote omadused
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adalat LA 20 mg Prolonged-Release Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 20 mg nifedipine.
Excipients: Sodium
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release film-coated tablet.
_Product imported from the UK:_
Pink, circular convex tablets with Adalat 20 marked on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of mild to moderate hypertension.
For the management of chronic stable angina pectoris either as monotherapy or in combination with a beta-blocker.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration, the tablets should be swallowed whole with a glass of water, independently of meals. The
tablets should be taken at approximately 24-hour intervals, i.e. at the same time each day, preferably during the
morning. Adalat LA tablets must be swallowed whole; under no circumstances should they be bitten, chewed or
broken up.
In mild to moderate hypertension, the recommended initial dose is one 20 mg tablet once-daily. If necessary, the
dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily.
For the management of angina pectoris, the recommended initial dose is one 30 mg tablet once-daily. The dosage can
be increased according to individual requirements up to a maximum of 90 mg once-daily.
Patients in whom hypertension or anginal symptoms are controlled on Adalat capsules or Adalat retard may be safely
switched to Adalat LA. Prophylactic anti-anginal efficacy is maintained when patients are switched from other calcium
antagonists such as diltiazem or verapamil to Adalat LA. Patients switched from other calcium antagonists should
initiate therapy at the
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