Captopril 12.5mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-04-2017
Summary of Product characteristics
(SPC)
08-12-2017
Active ingredient:
Captopril
Available from:
Sandoz Ltd
ATC code:
C09AA01
INN (International Name):
Captopril
Dosage:
12.5mg
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
Package leaflet: Information for the patient
Captopril 12.5mg Tablets
Captopril 25mg Tablets
Captopril 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, pharmacist or nurse.
•
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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Captopril Tablets are and what
they are used for
2. What you need to know before you
take Captopril Tablets
3. How to take Captopril Tablets
4. Possible side effects
5. How to store Captopril Tablets
6. Contents of the pack and other
information 1. WHAT CAPTOPRIL TABLETS ARE AND
WHAT THEY ARE USED FOR
Captopril belongs to a group of
medicines called Angiotensin Converting
Enzyme (ACE) inhibitors.
ACE inhibitors work by helping to widen
your blood vessels, which then make it
easier for your heart to pump blood
through them.
Captopril is used to treat high blood
pressure (hypertension), congestive heart
failure, kidney problems caused by diabetes,
and to improve survival after a heart attack. 2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CAPTOPRIL TABLETS
DO NOT TAKE CAPTOPRIL TABLETS:
•
If you are allergic (hypersensitive) to
captopril, any of the other ingredients
in these tablets or other ACE inhibitors
(_see Section 6 and end of Section 2_).
•
If you have ever had a reaction which
included swelling of the hands, lips face
or tongue where the cause was unknown.
•
If you have diabetes or impaired
kidney function and you are treated
with a blood pressure lowering
medicine containing aliskiren
•
If you are more than 3 months
pregnant. (It is also better to avoid
Captopril tablets in early pregnancy
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Captopril 12.5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 12.5 mg of Captopril.
Excipient with known effect: Also contains 12.5mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
For 12.5mg tablets:
White to almost white, round, biconvex, uncoated tablets with
“12.5” embossed on
one 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 transpla
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