Diuresal 500mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Furosemide

Tilgjengelig fra:

Ennogen Pharma Ltd

ATC-kode:

C03CA01

INN (International Name):

Furosemide

Dosering :

500mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02020200; GTIN: 05060313370639

Informasjon til brukeren

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
200917/1
Ennogen
Diuresal 500mg Leaflet
UK
English
160 x 500 mm
9 pt
1 of 1
4
08-02-17
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
DIURESAL 500MG 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 DIURESAL TABLETS ARE AND WHAT THEY ARE
USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DIURESAL TABLETS
3.
HOW TO TAKE DIURESAL TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DIURESAL TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
Diuresal Tablets are one of a group of medicines
called diuretics (water tablets).
They are used to treat the abnormally low
production of urine caused by kidney disorders.
DO NOT TAKE DIURESAL 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)
Have already taken furosemide in the past to

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diuresal 500mg Tablets
Furosemide Tablets BP 500mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains furosemide BP 500 mg.
Excipient(s) with known effect
Lactose
Certolake tartrazine
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Yellow, flat bevelled edge tablets with 13mm diameter, “F3”
debossed on one
side and score line on reverse side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated in oliguria due to renal failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _
Initially 250mg daily; if necessary larger doses increasing in steps
of 250mg
may be given every 4 to 6 hours to a maximum of a single dose of 2g.
_Elderly: _
Furosemide is generally eliminated more slowly in the elderly. The
dosage
should be titrated until the required response is achieved.
_Children: _
No recommended dose.
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).
•
Children and adolescents under 18 years of age (safety in this age
group has not been established)
•
Digitalis intoxication (see section 4.5).
•
Concomitant potassium supplements or potassium sparing diuretics
(see section 4.