Furosemide Bristol 40 mg Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Furosemide

Verfügbar ab:

Bristol Laboratories Limited

ATC-Code:

C03CA; C03CA01

INN (Internationale Bezeichnung):

Furosemide

Dosierung:

40 milligram(s)

Darreichungsform:

Tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Sulfonamides, plain; furosemide

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2006-05-26

Gebrauchsinformation

1
PACKAGE LEAFLET: NFORMATION FOR THE USER
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 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
1.
WHAT FUROSEMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Furosemide belongs to a group of medicines called diuretics, which
increase the amount of urine
passed by the kidneys, helping to remove excess fluids from the body.
Diuretics are also known as
‘water tablets’.
Furosemide tablets are used in the treatment of oedema (fluid
retention) caused by disorders of the
heart, kidneys or liver alone or in combination with other
anti-hypertensive agents. The tablets
may also be used to treat pulmonary oedema (build up of fluid in the
lungs) and mild to moderate
hypertension (high blood pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE FUROSEMIDE TABLETS
DO NOT TAKE FUROSEMIDE TABLETS IF: FUROSEMIDE 20MG TABLETS FUROSEMIDE 40MG TABLETS
(FUROSEMIDE)
WHAT IS IN THIS LEAFLET:
1.
What Furosemide tablets are and what they are used for
2.
What you need to know before you take Furosemide tablets
3.
How to take Furosemide Tablets
4.
Possible Side Effects
5.
How to store Furosemide Tablets
6.
Contents of the pack and other information
2

you are allergic(hypersensitive) to Furosemide or any of the other
ingredients in the
tablets (these are listed in section 6,) . Signs of an allergic
reaction include: a rash,
swallowing or breathing problems, swelling of your lips, face, throat
or tongue.

you are allergic to amiloride, sulfonamides or sulphonamide
derivatives, such as
sulfadiazine or co-trimoxazole.

you have been told that you have a low blood vo

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide Bristol 40 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg of Furosemide.
Excipient(s):
Each tablet contains 105 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, white to off-white tablet embossed ‘F 40’ on one side
(‘F’and ‘40’ separated by scoreline) and ‘’BL’’ 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
Furosemide is a potent diuretic with rapid action.
Furosemide tablets are indicated for:
1) The treatment of fluid retention associated with heart failure,
including left ventricular failure, cirrhosis of the liver
and renal disease, including nephrotic syndrome.
2) The treatment of mild to moderate hypertension (alone, or in
combination with other antihypertensive agents in the
treatment of more severe cases).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that Furosemide tablets are taken on an empty
stomach, and with plenty of liquid.
Adults: The initial adult dose is 40mg daily, reduced to 20mg daily or
40mg on alternative days. In some patients daily
doses of 80mg or higher (given in divided doses) may be required.
Children:
Contra-indicated (see section 4.3)
Elderly:
Caution is advised as furosemide is eliminated more slowly in elderly
patients.Treatment should be started
with 20mg and titrated upwards as required (see section 4.4).
Method of Administration:
For oral administration
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___