Frusol 50mg/5ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Furosemide

Available from:

Rosemont Pharmaceuticals Ltd

ATC code:

C03CA01

INN (International Name):

Furosemide

Dosage:

10mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020200; GTIN: 5016119094897

Patient Information leaflet

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JOB INFORMATION
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PREFLIGHT
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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
50mg/5ml
BLACK
7474
PANTONE
PANTONE
265
KEYLINE
BRAILLE
UKL460
365
150 x 500mm
N/A
150 x 33mm
1
8pt
(horizontally
condensed to 90%)
Yes
150ml
150ml
N/A
C3PD1RBJ2
C3PD1RBJ1
N/A
1 of 2
Frusol® 50mg/5ml Oral Solution (furosemide)
31/08/17
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DH
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3
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APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
Signature:
Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
n
Keep this leaflet. You may need to read it again.
n
If you have any further questions, ask your doctor or pharmacist.
n
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.
n
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Frusol is and what is it used for
2.
What you need to know before you take Frusol
3.
How to take Frusol
4.
Possible side effects
5.
How to store Frusol
6.
Contents of the pack and other information
1. WHAT FRUSOL IS AND WHAT IS IT USED FOR
The name of your medicine is Frusol 50mg/5ml Oral Solution (called
Frusol in this leaflet). It contains furosemide.
This belongs to a group of medicines called diuretics, or water
tablets.
Furosemide can be used to remove the levels of excess water in the
body caused by heart, lung, kidney, liver or
blood vessel problems.
2. WHAT YOU NEED TO KN

Summary of Product characteristics

OBJECT 1
FRUSOL 50MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 17-Nov-2017 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Frusol 50mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml contains 50 milligrams Furosemide
Excipient(s) with known effect:
Each 5ml Oral Solution contains 0.5ml ethanol and 2.5g liquid
maltitol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
A clear, colourless to straw coloured liquid (Oral Solution)
4. Clinical particulars
4.1 Therapeutic indications
Furosemide is indicated in all conditions requiring prompt diuresis,
including cardiac, pulmonary, hepatic
and renal oedema, peripheral oedema due to mechanical obstruction or
venous insufficiency and
hypertension.
It is also indicated for the maintenance therapy of mild oedema of any
origin.
4.2 Posology and method of administration
Posology
_Adults_
The usual initial daily dose is 40mg. This may be adjusted until an
effective dose is achieved.
_Paediatric population_
1 to 3mg/Kg body weight daily up to a maximum total dose of 40mg/day.
_Elderly_
In the elderly, Furosemide is generally eliminated more slowly. Dosage
should be titrated until the
required response is achieved.
Method of administration
For oral use.
Suitable for administration via nasogastric (NG) or percutaneous
endoscopic gastrostomy (PEG) tubes.
For further instructions see section 6.6.
The medication should be administered in the morning to avoid
nocturnal diuresis.
4.3 Contraindications
CONTRA-INDICATED CONDITIONS
SEE ALSO
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1 or sulphonamides, sulphonamide derivatives.
Hypovolaemia and dehydration (with or without accompanying
hypotension)
Section 4.4
Severe hypokalaemia: severe hyponatraemia
Section 4.4
Comatose or pre-comatose states associated with hepatic cirrhosis or
encephalopathy Section 4.4
Anuria or renal failure with anuria not responding to furosemide,
renal failure as a
result of poisoni