Fosinopril 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fosinopril sodium

Available from:

Zentiva Pharma UK Ltd

ATC code:

C09AA09

INN (International Name):

Fosinopril sodium

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 5012617014023

Patient Information leaflet

FOSINOPRIL SODIUM
20MG TABLETS
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, please 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 FOSINOPRIL SODIUM TABLETS ARE AND WHAT THEY ARE
USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL
SODIUM TABLETS
3.
HOW TO TAKE FOSINOPRIL SODIUM TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FOSINOPRIL SODIUM TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT FOSINOPRIL SODIUM TABLETS ARE AND WHAT
THEY ARE USED FOR
Each tablet contains the active ingredient fosinopril sodium
which is used to treat high blood pressure (hypertension) and
heart failure. Fosinopril Sodium Tablets belong to a group of
medicines called ACE inhibitors and make it easier for the
heart to pump blood around the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FOSINOPRIL SODIUM TABLETS
DO NOT TAKE FOSINOPRIL SODIUM TABLETS:
⋅
if you are ALLERGIC (hypersensitive) to fosinopril sodium,
other ACE inhibitors or any of the other ingredients of this
medicine (listed in section 6)
⋅
if you or a member of your family have PREVIOUSLY HAD
SWELLING of the legs, arms, face, mucous membranes or
tongue and/or throat (angioedema), with or without ACE
inhibitor treatment
⋅
if you have NARROWING OF THE BLOOD VESSELS IN one or both
KIDNEYS
⋅
if you are in SHOCK due to heart problems (cardiogenic shock)
⋅
if you are more than 3 months PREGNANT (it is also better to
avoid fosinopril sodium in early pregnancy - see
‘Pregnancy and breast feeding' section)
⋅
if you have diabetes or impaired kidney functio

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fosinopril Sodium 20mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg of Fosinopril sodium
Excipient(s) with known effect: Each tablet contains 108mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, circular, flat, uncoated 8mm tablets marked ‘FL
20’.
4.1.
THERAPEUTIC INDICATIONS
Hypertension:
Fosinopril Sodium 20mg Tablets are indicated in the treatment of
hypertension. Fosinopril Sodium 20mg Tablets may be used alone as
initial
therapy or in combination with other antihypertensive agents. The
antihypertensive effects of Fosinopril Sodium 20mg Tablets and
diuretics used
concomitantly are approximately additive.
Heart Failure:
Fosinopril Sodium 20mg Tablets are indicated for the treatment of
heart
failure in combination with a non-potassium sparing diuretic and where
appropriate, digitalis (see section 4.3, 4.4, 4.5, and 5.1). In these
patients,
Fosinopril Sodium 20mg Tablets improve symptoms and exercise
tolerance,
reduce severity of heart failure and decrease the frequency of
hospitalisation
for heart failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Fosinopril sodium should be administered orally in a single daily
dose. As
with all other medicinal products taken once daily, it should be taken
at
approximately the same time each day. The absorption of fosinopril
sodium is
not affected by food. The usual initial 10 mg dose has not been
studied in
patients with severe heart failure NYHA IV and in patients over 75
years
treated for heart failure (see section 4.4). The maintenance dose
should be
individualised according to patient profile and blood pressure
response (see
section 4.4). Hypertension Fosinopril sodium may be used as a
monotherapy
or in combination with other classes of antihypertensive medicinal
products
(see sections 4.3, 4.4, 4.5 and 5.1).
_Hypertensive patients not being treated with diuretics:_
Starting dose The initia