Fosinopril 10mg tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Fosinopril sodium

Доступно од:

Teva UK Ltd

АТЦ код:

C09AA09

INN (Међународно име):

Fosinopril sodium

Дозирање:

10mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 02050501; GTIN: 5017007014812

Информативни летак

BBBA5707
FOSINOPRIL SODIUM
10MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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, 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)
•

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fosinopril Sodium 10mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of Fosinopril sodium
Excipient(s) with known effect: Each tablet contains 118mg 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
10’.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hypertension:
Fosinopril Sodium 10mg Tablets are indicated in the treatment of
hypertension. Fosinopril Sodium 10mg Tablets may be used alone as
initial
therapy or in combination with other antihypertensive agents. The
antihypertensive effects of Fosinopril Sodium 10mg Tablets and
diuretics used
concomitantly are approximately additive.
Heart Failure:
Fosinopril Sodium 10mg 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 10mg 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:_
S