Captor 12.5mg Tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Captopril

から入手可能:

Rowex Ltd

ATCコード:

C09AA; C09AA01

INN（国際名）:

Captopril

投薬量:

12.5 milligram(s)

医薬品形態:

Tablet

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

ACE inhibitors, plain; captopril

認証ステータス:

Not marketed

承認日:

1996-02-16

情報リーフレット

Package leaflet: Information for the user
CAPTOR 12.5MG, 25MG & 50MG TABLETS
CAPTOPRIL
________________________________________________________
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Captor is and what it is used for
2.
What you need to know before you take Captor
3.
How to take Captor
4.
Possible side effects
5.
How to store Captor
6.
Contents of the pack and other information
1 WHAT CAPTOR IS AND WHAT IT IS USED FOR
Captor is used to treat:

HIGH BLOOD PRESSURE

HEART FAILURE

RECOVERING HEART ATTACK PATIENTS

KIDNEY DISEASE resulting from diabetes
Captopril belongs to the ACE inhibitor medicine group
(angiotensin-converting enzyme
inhibitors). Captopril expands your blood vessels. This reduces your
blood pressure and
makes it easier for your heart to pump blood to all body parts.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPTOR
DO NOT TAKE CAPTOR:
-
if you are ALLERGIC to captopril or any of the other ingredients of
this medicine (listed in
section 6) or other ACE inhibitors

if you or a family member had a reaction including SWELLING OF THE
FACE, LIPS, TONGUE
and/or THROAT with difficulty swallowing or breathing
-
to previous use of ACE inhibitors
-
without a known cause

if you suffer from NARROWING OF THE AORTIC VALVE (aortic stenosis) or
other forms of a
heart problem called outflow tract obstruction

if you suffer from NARROWING OF THE ARTERIES TO YOUR KIDNEYS (renal
artery stenosis)

if you are MORE THAN 3 MONTHS PREGNANT. (It is also better to avoid
Captor

製品の特徴

Health Products Regulatory Authority
24 November 2019
CRN008X7G
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Captor 12.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Captopril 12.5 mg
Excipient(s) with known effect: Each tablet contains 25mg lactose
monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White, round tablet with a score notch on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Captor is indicated for the treatment of hypertension.
Heart Failure:
Captor is indicated for the treatment of chronic heart failure with
reduction of systolic ventricular function, in combination with
diuretics and when appropriate, digitalis and beta-blockers (see
sections 4.3, 4.4, 4.5 and 5.1).
Myocardial Infarction:
-Short -term (4 weeks) treatment: Captor is indicated in any
clinically stable patients within the first 24 hours of an infarction.
-Long term prevention of symptomatic heart failure: Captor is
indicated in clinically stable patients with asymptomatic left
ventricular dysfunction (ejection fraction ≤ 40%).
Type I Diabetic Nephropathy:
Captor is indicated for the treatment of macroproteinuric diabetic
nephropathy in patients with type I diabetes. (See section
5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dose should be individualised according to patient's profile (see
section 4.4) and blood pressure response. The recommended
maximum daily dose is 150 mg.
Captor may be taken before, during and after meals.
Hypertension:
The recommended starting dose is 25-50 mg daily in two divided doses.
The dose may be increased incrementally, with
intervals of at least 2 weeks, to 100-150 mg/day in two divided doses
as needed to reach target blood pressure. Captopril may
be used alone or with other antihypertensive agents, especially
thiazide diuretics (see sections 4.3, 4.4, 4.5 and 5.1).
A once-daily dosing regimen may be appropriate when concomita