Fosinopril 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fosinopril sodium

Available from:

Waymade Healthcare Plc

ATC code:

C09AA09

INN (International Name):

Fosinopril sodium

Dosage:

10mg

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

FOSINOPRIL SODIUM
10MG 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 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg fosinopril sodium
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white rectangular shaped tablet with “G” scoreline
“G” on one
side and “FS” scoreline “10” on the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Fosinopril is indicated in adults for the treatment of hypertension.
Fosinopril may be
used alone as initial therapy or in combination with other
antihypertensive agents (see
sections 4.3, 4.4, 4.5 and 5.1). The antihypertensive effects of
fosinopril and diuretics
used concomitantly are approximately additive.
Heart Failure
Fosinopril is indicated for adults for the treatment of heart failure
in
combination with a non-potassium sparing diuretic and where
appropriate,
digitalis. In these patients, fosinopril improves symptoms and
exercise
tolerance, reduces severity of heart failure and decreases the
frequency of
hospitalisation for heart failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertensive patients not being treated with diuretics:
The dose range is 10 to 40 mg per day administered in a single dose
and
without regard to meals. The normal starting dose for patients is 10
mg once a
day. Dosage may need to be adjusted after approximately 4 weeks
according
to blood pressure response. No additional blood pressure lowering is
achieved
with doses greater than 40 mg daily. If blood pressure is not
adequately
controlled with fosinopril alone, a diuretic can be added.
Hypertensive patients being treated with concomitant diuretic therapy:
The diuretic should preferably be discontinued for several days prior
to
beginning therapy with fosinopril to reduce the risk of an excessive
hypotensive response. If blood pressure is inadequately controll