Fosinopril Aurobindo 20mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FOSINOPRIL SODIUM

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

C09AA09

INN (International Name):

FOSINOPRIL SODIUM 20 mg

Pharmaceutical form:

TABLET

Composition:

FOSINOPRIL SODIUM 20 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2013-01-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSINOPRIL AUROBINDO
10
MG
TABLETS
FOSINOPRIL AUROBINDO
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT ISIN THIS LEAFLET
:
1.
What Fosinopril Aurobindo is and what it is used for
2.
What you need to know before you take Fosinopril Aurobindo
3.
How to take Fosinopril Aurobindo
4.
Possible side effects
5.
How to store Fosinopril Aurobindo
6.
Contents of the pack and other information
1.
WHAT FOSINOPRIL SODIUM AUROBINDO IS AND WHAT IT IS USED FOR
Fosinopril belongs to a group of medicines known as ACE (angiotensin
converting enzyme) -
inhibitors. Fosinopril binds to the ACE in the body, thereby
inhibiting the formation of angiotensin II,
a substance which raises the blood pressure. Angiotensin II also has a
vasoconstricting effect which
narrows the blood vessels. By inhibiting this substance, there is a
decrease in pressure inside the blood
vessels and heart function can be improved.
Fosinopril Aurobindo is prescribed if you have high blood pressure, or
if the heart is not working
sufficiently, this is known as "heart failure".
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL SODIUM AUROBINDO
DO NOT TAKE FOSINOPRIL AUROBINDO
•
If you are allergic to fosinopril sodium or any of the other
ingredients of this medicine (listed in
section 6)
or to other angiotensin-converting enzyme (ACE) inhibitors.
•
If
you have ever experienced
hypersensitivity
reactions
in the past,
such as skin
reactions
and
sudden
fluid accumulation in
the
skin
and
muc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fosinopril Aurobindo 10 mg tablets
Fosinopril Aurobindo 20 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Fosinopril Aurobindo 10 mg tablet contains: 10 mg Fosinopril
sodium.
Excipient with known effect: Each tablet contains 68 mg of lactose.
Each Fosinopril Aurobindo 20 mg tablet contains: 20 mg Fosinopril
sodium.
Excipient with known effect: Each tablet contains 136 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
_ _
_Fosinopril Aurobindo 10 mg tablets:_
White to off-white, flat, capsule-shaped, uncoated tablets, with a
scoreline with notched sides on both
sides, debossed on one side of the tablet with 'X' and '77 ' on either
side of the scoreline, and plain on
the other side
The tablets can be divided into equal doses.
_ _
_Fosinopril Aurobindo 20 mg tablets: _
White to off white, round, biconvex, uncoated tablets with an "X" on
one side and "84" on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
Treatment of symptomatic 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).
In patients who are at particular risk of hypotension (since the
renine-angiotensin-aldosteron system
has been activated, See section 4.4), such as patients with severe
cardiac heart failure (NYHA IV),
patients over 75 years treated for heart failure, patients with severe
renal and /or severe hepatic
impairment, and patients treated with diuretics, it is however
recommended to initiate the treatment
with a reduced (5 mg) dose.
The maintainance do