Captopril 25mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-11-2014
Summary of Product characteristics
(SPC)
08-12-2017
Active ingredient:
Captopril
Available from:
Actavis UK Ltd
ATC code:
C09AA01
INN (International Name):
Captopril
Dosage:
25mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02050501
Patient Information leaflet
PATIENT INFORMATION LEAFLET
ECOPACE 12.5MG, 25MG AND 50MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
•
If any of the side effects gets serious, or you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
•
The name of your medicine is Ecopace 12.5mg, 25mg and 50mg Tablets,
but will be referred to
as ‘Ecopace Tablets’ throughout the remainder of the Leaflet.
IN THIS LEAFLET:
1.
What Ecopace Tablets are and what they are used for
2.
Before you take Ecopace Tablets
3.
How to take Ecopace Tablets
4.
Possible side effects
5.
Storing Ecopace Tablets
6.
Further information
1.
WHAT ECOPACE TABLETS ARE AND WHAT THEY ARE USED FOR
Ecopace Tablets belong to a group of medicines known as ACE inhibitors
(Angiotensin Converting
Enzyme Inhibitors).
Captopril works by making your blood vessels wider. This helps your
blood pressure to fall. It also
makes it easier for your heart to pump blood around your body.
ECOPACE TABLETS CAN BE USED TO TREAT
•
High blood pressure – also called hypertension
•
Heart failure - where the heart has difficulty pumping blood around
your body.
•
Heart attack (Myocardial infarction) - where the heart has difficulty
pumping blood around your
body.
2.
BEFORE YOU TAKE ECOPACE TABLETS
DO NOT TAKE ECOPACE TABLETS IF:
•
You are PREGNANT, planning to become pregnant or are breast-feeding.
•
You have ever had an allergic (hypersensitivity) reaction to
Captopril, any other ACE inhibitor
medicine, or any of the ingredients in these tablets (see Section 6:
Further Information).
Signs of an allergic reaction include: rash, swallowing or breathing
problems, swelling of your lips,
face, throat or tongue.
If you are not sure about taking Captopril, talk
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Summary of Product characteristics
1.
NAME OF THE MEDICINAL PRODUCT
Captopril 25mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of Captopril.
Excipient with known effect: Also contains 25mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
White to almost white, round, flat, bevelled edged, uncoated tablets
with score line on
one side and “25” embossed on the other side.
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION: The management of mild to moderate hypertension. In
severe hypertension it
should be used where standard therapy is ineffective or inappropriate.
CONGESTIVE HEART FAILURE: Captopril is indicated for the treatment of
congestive heart failure. The
drug should be used together with diuretics and, when appropriate,
digitalis and beta-blockers. In
patients on doses of over 100 mg daily plus or minus a diuretic, in
those with severe renal
impairment or those with severe congestive heart failure use of
captopril should be under
specialist supervision.
MYOCARDIAL INFARCTION:
-
_Short-term (4 weeks) treatment_: Captopril is indicated in any
clinically stable patient
within the first 24 hours of an infarction.
-
_Long-term prevention of symptomatic heart failure:_ Captopril is
indicated in
clinically stable patients with asymptomatic left ventricular
dysfunction (ejection
fraction
≤
40%) following myocardial infarction to improve survival, delay the
onset
of symptomatic heart failure, reduce hospitalisations for heart
failure and reduce
recurrent myocardial infarction and coronary revascularisation
procedures.
Before starting therapy, cardiac function should be determined by
radionuclide
ventriculography or echocardiography.
TYPE I DIABETIC NEPHROPATHY:
Captopril is indicated in insulin dependent diabetics for the
treatment of macroproteinuric diabetic
nephropathy (microalbuminuria greater than 30 mg/day) (See Section
5.1). Captopril may prevent
the progression of the renal disease and reduce associated clinical
events e.g. dialysis, renal
transplantation and death.
C
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