Furosemide Tablets BP 40mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FUROSEMIDE

Available from:

Wockhardt UK Limited

ATC code:

C03CA01

INN (International Name):

FUROSEMIDE

Pharmaceutical form:

TABLET

Composition:

FUROSEMIDE 40 mg

Prescription type:

POM

Therapeutic area:

DIURETICS

Authorization status:

Authorised

Authorization date:

2006-08-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUROSEMIDE 20MG OR 40MG TABLETS
FUROSEMIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again while you are
receiving your treatment.
- If you have any further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it onto
others. It may harm them, even if their symptoms
are the same as yours.
- If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor
or pharmacist.
The name of your medicine is Furosemide 20mg or 40mg Tablets. In the
rest of this leaflet it is called Furosemide
Tablets.
IN THIS LEAFLET:
1.
What Furosemide Tablets are and what they are used for
2.
Before you take Furosemide Tablets
3.
How to take Furosemide Tablets
4.
Possible side effects
5.
How to store Furosemide Tablets
6.
Further 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’).
WHAT THIS MEDICINE DOES
Furosemide Tablets are used to get rid of excess fluid from the body,
to manage a condition called oliguria
where the body produces an abnormally small amount of urine due to
kidney disease, and in the treatment of
high blood pressure.
2. BEFORE YOU TAKE FUROSEMIDE TABLETS
DO NOT TAKE FUROSEMIDE TABLETS IF YOU:
• are allergic (hypersensitive) to furosemide or any of the other
ingredients of Furosemide Tablets (see section
6, Further information)
• you have been told you are allergic to certain antibiotics, called
suphonamides
• have kidney failure
• you have been told you have severe liver problems with cirrhosis
of the liver
• you are unable to pass urine (water)
• you have Digitalis intoxication (characterised by loss of
appetite, nausea and vomiting)
• you have Addison's disease (diseaseof the adrenal glands)
• you are breast-feeding.
TALK TO YOUR DOCTOR, IF ANY OF THE FOLLOWING APPLY TO YO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Furosemide 40mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide Tablets BP 40mg
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Oral - tablet
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Furosemide tablets are recommended for use in all indications when
prompt diuresis is
required.
Indications
include
cardiac,
pulmonary,
hepatic,
renal
and peripheral
oedema
and
oliguria due to chronic renal failure or insufficiency.
Furosemide may be effective in patients unresponsive to thiazide
diuretics.
Furosemide is also used in the treatment of hypertension, either alone
or with other
antihypertensive agents and in the urgent treatment of hypercalcaemia
to promote
urinary excretion following rehydration.
4.2
POSOLOGY AND METHOD FOR ADMINISTRATION
FOR ORAL ADMINISTRATION
OEDEMA
ADULTS & ELDERLY
Initially 40mg in the morning adjusted according to response;
maintenance 20mg daily
or 40mg on alternate days, increased in resistant oedema to 80mg or
more as one or two
doses daily or intermittently. Severe cases may require titration of
the furosemide
dosage up to 600mg daily.
CHILDREN
1-3mg/kg body weight daily up to a maximum of 40mg daily.
Page 2 of 12
OLIGURIA
ADULTS & ELDERLY
Initially 250mg daily; if necessary larger doses, increasing in steps
of 250mg, may be
given every 4-6 hours to a maximum of a single dose of 2g (rarely
used).
HYPERTENSION
ADULTS & ELDERLY
40-80mg daily by mouth alone or with other antihypertensive agents.
4.3
CONTRAINDICATIONS

Hypersensitivity to furosemide or any of the excipients,
sulphonamides,
sulphonamide derivatives/amiloride

Anuria and impaired renal function (creatinine clearance below
30mL/min per
1.73 m
2
body surface area) and renal failure resulting from poisoning by
nephrotoxic and/or hepatotoxic agents

Electrolyte disturbances (severe hyponatraemia: severe hypokalaemia),
dehydration and/or hypotension (see section 4.4)

Pre-coma/coma associated with hepatic cirrhosis

Addison’s di