NIFEDIPINE 5 STADA NIFEDIPINE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-05-2024
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Active ingredient:
NIFEDIPINE
Available from:
Stada Arzneimittel AG
Dosage:
5 Milligram
Pharmaceutical form:
Capsule
Authorization date:
1997-04-04
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nifedipine 5 mg STADA Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg Nifedipine
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Soft capsule.
Brown capsule, oval, content consists of a yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(i) Chronic stable angina.
(ii) mild to moderate hypertension.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
4.2.1 DOSAGE
Adults / Elderly:
The recommended dose is 5 to 10 mg three times a day.
The maximum daily dose should not exceed 20 mg three times
a day. Patients with hepatic dysfunction should commence therapy
at 5 mg three times a day. No dosage adjustment is
normally required in patients with renal dysfunction.
Therapy may be indefinitely continued.
Children:
Not recommended.
4.2.2 ADMINISTRATION
For oral administration only.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to the active ingredient.
Use in patients with cardiogenic shock.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 29/09/2005_
_CRN 2012633_
_page number: 1_
Unstable angina pectoris.
Acute myocardial infarction (within the first 4 weeks).
Use in women capable of child-bearing or to nursing mothers.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
The use of nifedipine in diabetic patients may
require adjustment of their control.
Nifedipine should be used with caution in patients with
poor cardiac reserve or severe hypotension. Deterioration of
heart failure has occasionally been observed with nifedipine.
The introduction of nifedipine therapy may
induce attacks of ischaemic pain in some patients with
angina pectoris
commonly within 30 minutes of taking nifedipine. Should
this occur treatment should be stopped.
Patients should be
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