Fosinopril 10mg tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Fosinopril sodium

Доступно од:

Viatris UK Healthcare 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: 5016695000749

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOSINOPRIL SODIUM
10 MG TABLETS
FOSINOPRIL SODIUM
20 MG TABLETS
Fosinopril sodium
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 Fosinopril is and what it is used for
2. What you need to know before you take Fosinopril
3. How to take Fosinopril
4. Possible side effects
5. How to store Fosinopril
6. Contents of the pack and other information.
1. WHAT FOSINOPRIL IS AND WHAT IS IT USED
FOR
Fosinopril belongs to the class of medicines called
Angiotensin Converting Enzyme (ACE) inhibitors that
act on the heart and blood vessels. You may have
been given Fosinopril to:
•
lower your blood pressure if it is too high (a
condition called hypertension)
•
help your heart pump blood around your body if
you have a condition known as heart failure and
are also being treated with diuretics (medicines
which help to remove excess fluid from the body).
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE FOSINOPRIL
DO NOT TAKE FOSINOPRIL:
•
if you are allergic to fosinopril or any other
ACE inhibitor, or any of the other ingredients
of this medicine (listed in section 6). An allergic
reaction may include rash, itching, swelling of
face, lips, tongue, hands and feet, or breathing
difficulties
•
if you know you have, or know that someone
in your close family has, a condition called
angioneurotic oedema where the face, lips, hands
or feet swell up, or you have breathing difficulties.
If you develop these symptoms during treatment
you should stop taking Fosinopril
•

Карактеристике производа

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