Captopril 50mg 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:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 5025903001911

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPTOPRIL 25 MG/50 MG TABLETS
ACTIVE SUBSTANCE: 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 Captopril is and what it is used for
2. What you need to know before you take Captopril
3. How to take Captopril
4. Possible side effects
5. How to store Captopril
6. Contents of the pack and other information
1. WHAT CAPTOPRIL IS AND WHAT IT IS USED FOR
Captopril belongs to the group of medicines known as ACE inhibitors
(i.e. inhibitors of the enzyme that
converts angiotensin), which are used in the treatment of diseases of
the heart and blood vessels.
Captopril reduces blood pressure by widening the blood vessels and
increases the elimination of fluid and
salt from the body. The widening of the blood vessels also causes a
reduced workload on the heart in
heart failure.
YOUR DOCTOR HAS PRESCRIBED CAPTOPRIL FOR ONE OF THE FOLLOWING REASONS:
• You have high blood pressure (hypertension)
• You have a heart condition known as heart failure (cardiac
insufficiency). This is where your heart is not
working as well as it used to, in order to pump blood around your
body, leading to tiredness after mild
exercise, breathlessness and swelling of the ankles and legs
• You have had a heart attack (myocardial infarction). Captopril can
improve survival after a heart attack
and reduce further heart problems
• You have insulin-dependent Type I diabetes kidney disease
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BEFORE YOU TAKE CAPTOPRIL
DO NOT TAKE CAPTOPRIL
-
i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Captopril 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg captopril
Excipients
with known effect: Each tablet contains 100 mg lactose (as lactose
monohydrate)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Round, white tablets of diameter 10.0 -10.2mm 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: Captopril 50 mg tablets are indicated for the first line
treatment
of mild to moderate hypertension. In severe hypertension it should be
used
where standard therapy is ineffective or inappropriate.
Congestive
heart
failure:
Captopril
50 mg
tablets
are
indicated
for
the
treatment of congestive heart failure. The drug should be used
together with
diuretics, and where appropriate, digitalis.
Myocardial infarction:
- _ short-term (4 weeks) treatment:_ Captopril 50 mg tablet is
indicated in any
clinically stable patient within the first 24 hours of an infarction.
_-_ _long-term prevention of symptomatic heart failure:_ Captopril 50
mg tablets
are indicated in clinically stable patients with asymptomatic and
symptomatic
left
ventricular
dysfunction
to
improve
survival,
delay
the
onset
of
symptomatic heart failure, reduce hospitalisations for heart failure,
and reduce
recurrent myocardial infarction and coronary revascularisation
procedures.
Determination
of
cardiac
function
by
radionuclide
ventriculography
or
echocardiography
should
be
undertaken
prior
to
initiation
of
preventive
treatment with captopril in post myocardial infarction patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
_Mild to moderate hypertension:_
Initial dose 12.5 mg twice daily. The usual m