Quinapril 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Quinapril hydrochloride

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

C09AA06

INN (International Name):

Quinapril hydrochloride

Dosage:

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

1
_Version 4, 02/2016 _
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUINAPRIL 5MG, 10MG, 20MG AND 40MG TABLETS
QUINAPRIL HYDROCHLORIDE
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 Quinapril tablets are and what they are used for.
2.
What you need to know before you take Quinapril tablets.
3.
How to take Quinapril tablets.
4.
Possible side effects
5.
How to store Quinapril tablets.
6.
Contents of the pack and other information.
1.
WHAT QUINAPRIL TABLETS IS AND WHAT IT IS USED FOR
THE ACTIVE INGREDIENT
in Quinapril Tablets is quinapril (present as quinapril
hydrochloride). This
belongs to a group of medicines called angiotensin converting enzyme
(ACE) inhibitors. ACE
inihibitors work by widening blood vessels in the body, which can
reduce the pressure in the vessels.
FOR THE OTHER INGREDIENTS IN QUINAPRIL TABLETS, (SEE SECTION 6.)
Quinapril is an ACE inhibitor used to treat high blood pressure
(hypertension) and to help treat heart
failure.
Quinapril
is
effective
alone
or
together
with
water
tablets
(diuretics)
in
patients
with
hypertension. Quinapril can also be used for the treatment of heart
failure when given together with a
diuretic and/or cardiac glycoside such as digoxin.
Treatment of heart failure with quinapril should always be started
under close medical supervision.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUINAPRIL TABLETS
DO NOT TAKE QUINAPRIL TABLETS IF:
• you are allergic to quinapril, any other ACE inhibitor or any of
the other ingredients (listed in
section 6)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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NAME OF THE MEDICINAL PRODUCT
Quinapril 5 mg Tablets
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg tablet contains quinapril hydrochloride 5.416 mg equivalent
to 5
mg Quinapril
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated Tablet
Quinapril Tablets 5mg are Yellow coloured, Oval shaped, film-coated
tablets
debossed with ‘5’ on one side and score line on the other side.
The tablet can be divided into equal halves.
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CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
For the treatment of all grades of essential hypertension. Quinapril
Tablet is effective
as monotherapy or concomitantly with diuretics in patients with
hypertension.
CONGESTIVE HEART FAILURE
For the treatment of congestive heart failure when given concomitantly
with a diuretic
and/or cardiac glycoside. Treatment of congestive heart failure with
Quinapril Tablets
should always be initiated under close medical supervision.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
ADULTS
HYPERTENSION
Monotherapy: The recommended initial dosage is 10 mg once daily in
uncomplicated hypertension. Depending upon clinical response,
patient's
dosage may be titrated (by doubling the dose allowing adequate time
for
dosage adjustment) to a maintenance dosage of 20 to 40 mg/day given as
a
single dose or divided into 2 doses. Long-term control is maintained
in most
patients with a single daily dosage regimen. Patients have been
treated with
dosages up to 80 mg/day.
Concomitant Diuretics: In order to determine if excess hypotension
will occur,
an initial dosage of 2.5 mg of Quinapril Tablets is recommended in
patients
who are being treated with a diuretic. After this the dosage of
Quinapril
Tablets should be titrated (as described above) to the optimal
response.
CONGESTIVE HEART FAILURE
In order to closely monitor patients for symptomatic hypotension, a
single 2.5
mg initial dosage is recommended. After this, patients should be
titrated to an
effective dose: (up to 40 mg/day) g