Captopril 12.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Captopril

Available from:

A A H Pharmaceuticals 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; GTIN: 5025903001928

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

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 captopril, 12.5mg.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat, beveled edged, uncoated tablet with
inscription ‘ BG ’
on one side and plain on 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.
Captopril can be used alone