OSMO - ADALAT 20 MG

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

NIFEDIPINE

Verfügbar ab:

BAYER ISRAEL LTD

ATC-Code:

C08CA05

Darreichungsform:

TABLETS PROLONGED RELEASE

Zusammensetzung:

NIFEDIPINE 20 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

BAYER PHARMA AG, GERMANY

Therapiegruppe:

NIFEDIPINE

Therapiebereich:

NIFEDIPINE

Anwendungsgebiete:

Chronic stable angina, hypertension.

Berechtigungsdatum:

2012-03-31

Fachinformation

1/14
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH
AND ITS CONTENT WAS
CHECKED AND APPROVED BY IT ON DECEMBER 2016.
1.
NAME OF THE MEDICINAL PRODUCT
Osmo-Adalat 20 mg
Osmo-Adalat 30 mg
Osmo-Adalat 60 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Osmo-Adalat 20
Each prolonged-release tablet contains 20 mg nifedipine.
Osmo-Adalat 30 mg
Each prolonged-release tablet contains 30 mg nifedipine.
Osmo-Adalat 60 mg
Each prolonged-release tablet contains 60 mg nifedipine.
Each tablet contains a 10% overage of nifedipine to deliver the label
claim
For excipients see Section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Osmo-Adalat 20 mg
Pink, round, convex prolonged-release tablet with a laser hole on one
side and marked with
Adalat 20.
Osmo-Adalat 30 mg
Pink, round, convex prolonged-release tablet, with a laser hole on one
side and marked with
Adalat 30.
Osmo-Adalat 60 mg
Pink round, convex prolonged-release tablet, with a laser hole on one
side and marked with
Adalat 60.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of chronic stable angina, and hypertension.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
_Dosage regimen _
As far as possible the treatment must be tailored to the needs of the
individual.
Depending on the clinical picture in each case, the basic dose must be
introduced gradually.
Unless otherwise prescribed, the following dosage guidelines are
recommended for adults:

For CHRONIC STABLE ANGINA PECTORIS (angina of effort):
1 Osmo-Adalat 20 mg tablet once daily (1 x 20 mg/day)
1 Osmo-Adalat 30 mg tablet once daily (1 x 30 mg/day)
1 Osmo-Adalat 60 mg tablet once daily (1 x 60 mg/day)

For hypertension:
1 Osmo-Adalat 20 mg tablet once daily (1 x 20 mg/day)
1 Osmo-Adalat 30 mg tablet once daily (1 x 30 mg/day)
1 Osmo-Adalat 60 mg tablet once daily (1 x 60 mg/day)
In general, for both indications, therapy should be initiated with 30
mg once daily.
Where registered a starting dose of 20 mg once daily may be considered
when medically