Captopril 25mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Captopril

Dostępny od:

Tillomed Laboratories Ltd

Kod ATC:

C09AA01

INN (International Nazwa):

Captopril

Dawkowanie:

25mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 02050501; GTIN: 5024655000371 5024655000388

Ulotka dla pacjenta

WHAT THIS MEDICINE IS AND
WHAT IT IS USED FOR
1
Captopril belongs to a group of medicines called
Angiotensin Converting Enzyme (ACE) Inhibitors.
These 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 the following:
ƒ Mild to moderately high blood pressure
(hypertension)
ƒ Severely high blood pressure (hypertension) where
standard treatment is ineffective or unsuitable
ƒ Treatment or prevention of heart failure
ƒ Short-term (4 weeks) treatment within the first
24 hours of a heart attack
ƒ Kidney problems caused by diabetes
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE CAPTOPRIL
2
DO NOT TAKE CAPTOPRIL IF:
ƒ You are allergic to Captopril, ACE Inhibitors or any
of the other ingredients of this medicine (listed in
Section 6)
ƒ You are more than 3 months pregnant (it is also
better to avoid Captopril in early pregnancy - see
"Pregnancy and breast-feeding" section)
ƒ You have a history of suffering from swelling of the
deeper layers of the skin caused by a build-up of
fluid relating to previous treatment with an ACE
Inhibitor (angioedema)
ƒ You suffer from an inherited swelling of the deeper
layers of the skin caused by a build-up of fluid or
without an identifiable cause (hereditary or
idiopathic angioedema)
ƒ If you are breast-feeding (see "Pregnancy and
breast-feeding" section)
ƒ If you have diabetes or impaired kidney function
and you are treated with a blood pressure lowering
medicine containing aliskiren
WARNINGS AND PRECAUTIONS
If you are taking any of the following medicines used
to treat high blood pressure:
ƒ An angiotensin II receptor blocker (ARBs)
(also known as sartans - for example valsartan,
telmisartan, irbesartan), in particular if you have
diabetes-related kidney problems
ƒ Aliskiren
Your doctor may check your kidney function,
blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also information under the heading "Do not take
Captopril"
TALK TO YOUR DOCTO

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Captopril 25mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg captopril
Excipients
with known effect
: Each tablet contains 50 mg lactose (as lactose
monohydrate)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Round, white tablets of diameter 8.0 -8.2mm with facet and a
crossed
break line on
each side
The score line is only to facilitate breaking for the ease of
swallowing and not to
divide into equal doses
4
CLINICAL PARTICULARS
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 and symptomatic 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