Furosemide 20mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Preparatomtale Preparatomtale (SPC)
21-10-2022

Aktiv ingrediens:

Furosemide

Tilgjengelig fra:

Ennogen Pharma Ltd

ATC-kode:

C03CA01

INN (International Name):

Furosemide

Dosering :

20mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02020200; GTIN: 05060313370646

Informasjon til brukeren

                                Furosemide 20mg Tablets
Furosemide 40mg Tablets
[FUROSEMIDE]
PACKAGE LEAFLET: INFORMATION 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 further questions, ask your doctor
or 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 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
1. WHAT FUROSEMIDE TABLETS ARE AND
WHAT THEY ARE USED FOR
Furosemide Tablets are one of a group of
medicines called diuretics (water tablets).
Your doctor has prescribed Furosemide Tablets to
treat a condition called oedema where there is too
much water in your body. This could be due to
problems with your heart, kidneys, liver, blood
vessels or high blood pressure. Furosemide helps
your kidneys to get rid of extra water that is not
needed in your body.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE FUROSEMIDE TABLETS
DO NOT TAKE FUROSEMIDE TABLETS IF YOU:
!
Are allergic to furosemide or any of the other
ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
the lips, face, throat or tongue
!
Are allergic to amiloride, sulfonamides or
sulphonamide derivatives, such as sulfadiazine
or cotrimoxazole
!
Have a low blood volume or are dehydrated
(with or without accompanying low blood
pressure)
!
Have too little potassium or sodium in your
blood (shown in blood test)
!
Have severe liver problems (cirrhosis)
!
Ha
                                
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Preparatomtale

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Furosemide Tablets BP 20mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
furosemide
BP
20mg.
Excipient(s) with known effect
Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Uncoated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Furosemide Tablets BP 20mg are recommended for use in all indications
when
a prompt and effective diuresis is required. They are indicated for
the
maintenance therapy of mild oedema of any origin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult_
_s:_
Initially 40mg in the morning; maintenance 20mg daily or 40mg on
alternate days, increasing in resistant oedema to 80mg daily.
_Elderl_
_y:_
Furosemide is generally eliminated more slowly in the elderly. The
dosage should be titrated until the required response is achieved.
_Paediatric population:_
1mg
to
3mg/kg
daily
up
to
maximum
total
dose
of
40mg/day.
Method of administration: Oral.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1.
•
Hypersensitivity to amiloride, sulphonamides or sulphonamide
derivatives.
•
Hypovolaemia or dehydration (with or without accompanying hypotension)
(see
section 4.4).
•
Severe hypokalaemia, severe hyponatraemia (see section 4.4).
•
Comatose or pre-comatose states associated with hepatic cirrhosis (see
section
4.4).
•
Anuria or renal failure with anuria not responding to furosemide,
renal failure as a
result of poisoning by nephrotoxic or hepatotoxic agents or renal
failure associated
with hepatic coma.
•
Impaired renal function with a creatinine clearance below 30ml/min per
1.73m
2
body surface area (see section 4.4).
•
Addison’s disease (see section 4.4).
•
Digitalis intoxication (see section 4.5).
•
Concomitant potassium supplements or potassium sparing diuretics (see
section
4.5).
•
Porphyria.
•
Breast-feeding women (see section 4.6).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR US
                                
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