Skip to Content

UK Edition. Click here for US version.

DIURESAL (FUROSEMIDE) INJECTION 10MG/ML

Active substance(s): FUROSEMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

140313/1

Colours Used

Customer

Ennogen

Black

Description

Diuresal Injection Leaflet

Keyline

Market

UK

Language

English

Size

160 x 360 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

9

Date

22-12-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diuresal Injection 10mg/ml
Furosemide
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, 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 Injection is and what it is
used for
2. What you need to know before you are
given Diuresal Injection
3. How Diuresal Injection is given to you
4. Possible side effects
5. How to store Diuresal Injection
6. Contents of the pack and other information
1. WHAT DIURESAL INJECTION IS AND WHAT
IT IS USED FOR
Diuresal belongs to a group of medicines called
diuretics. Diuretics make you pass more water
(urine).
Excess fluid can build up in certain conditions
which affect the heart, lungs, kidneys or liver. It can
also be used for mild to moderate high blood
pressure as well as a condition in pregnancy called
toxaemia where there is high blood pressure and
protein in the urine.
Diuresal Injection is used to remove that fluid by
making you pass more water.
lt may also be used when your kidneys are not
functioning properly and not producing normal
amounts of urine.
2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN DIURESAL INJECTION
You should not be given Diuresal Injection if
you:
! Are hypersensitive (allergic) to furosemide,
other sulphonamide related drugs or any of the
other ingredients of Diuresal Injection (see
section 6)
! Have severe kidney failure
! Have very low levels of potassium, sodium or
other electrolytes in your blood (your doctor will
be able to advise you)
! Are not producing any urine
! Have porphyria (an inherited condition causing
skin blisters, abdominal pain and brain or
nervous system disorders)
! You have an altered level of consciousness and
coma as a result of liver disease
! Have Addisons disease (inadequate
functioning of the adrenal gland)
! Have severe dehydration (causing continuous
dry mouth and thirst) or are ill from having lost
a lot of body fluids
! Have digitalis poisoning (feeling or being
sick, high levels of potassium in the blood,
slow, fast or irregular heart beats)
! Are breastfeeding (see 'Pregnancy and
breastfeeding section).
Warnings and precautions:
Make sure you doctor is aware of these situations,
before you are given this medicine if you:! Are elderly, if you are on other medications
which cause the blood pressure to drop and if
you have other medical conditions that are risks
for the drop of blood pressure.
! Have low blood volume (hypovolaemia)
! Have low blood pressure (hypotension)
! Have liver or kidney problems
! Have diabetes. If you are taking insulin, your
doctor may need to adjust your insulin dosage
! Have had gout (severe joint pain)
! Metabolic acidosis (too much acid in the
body)
! Prostate trouble or difficulty passing urine
! Are an elderly patient with dementia and also
taking risperidone
! Are administering to a premature infant as
there could be possible formation of kidney

stones
Are prone to low levels of sodium, potassium or
other electrolytes in the blood and therefore
regular blood tests will be carried out by your
doctor to check this.
Your doctor may monitor you and take blood for
testing while you are on this treatment.

!

Other medicines and Diuresal Injection:
Please inform your doctor or pharmacist if you are
taking or have recently taken any other medicines,
even those not prescribed.
In particular tell your doctor if you are taking any of
the following:
! Drugs to lower blood pressure, such as ACE
inhibitors e.g ramipril, enalapril. Your doctor
may need to change the dose or ask you to
stop taking them
! Medicines for high blood pressure or heart
problems such as calcium channel blockers,
beta blockers, clonidine, moxonidine,
amiodarone
! Non-steroidal anti-inflammatory drugs
(NSAIDs) or aspirin for pain
! Digoxin used to treat heart failure
! Alprostadil, moxisylyte used to treat erectile
dysfunction (impotence)
! Antidepressants tricyclics, monoamino
oxidase inhibitors (MAOIs), reboxetine or
phenothiozines, and anxiolytics eg barbiturates
! Antifungals such as amphotericin if used for a
long time
! Medicines used as general anaesthetics and
medicines for relaxing your muscles during
surgery such as baclofen, tizanidine,
tubocurarine
! Carbamazepine to control epilepsy
! Corticosteroids used to treat allergic reactions
! Laxatives used over a long period of time e.g
bisacodyl or senna
! Other diuretics such as acetazolamide
! Carbenoxolone, sucralfate to treat ulcers
! Drugs for asthma such as theophylline,
salbutamol, terbutaline
! Antibiotics that affect your kidneys or ears (e.g
gentamicin, neomycin) or high doses of
cephalosporins
! Lithium used for mental illnesses
! Medicine to control diabetes such as insulin
or glucocorticoid tablets
! Liquorice often used in cough medicines if
taken in large amounts
! Risperidone used to treat schizophrenia
! Phenytoin used for epilepsy
! Cisplatin used for some cancers
! Aminoglutethimide used for breast cancer
! Ciclosporin used to stop rejection of organs
after a transplant
! Methotrexate used for cancers of the skin, joint
or bowel
! Probenecid used for treatment of gout
! Medicines for Parkinsonism e.g levodopa
! Medicines for kidney cancer e.g aldesleukin.
Pregnancy and breastfeeding:
Do not have Diuresal Injection if you are pregnant.
Talk to your doctor before having this medicine if
you are pregnant, might become pregnant or think
you might be pregnant.
Do not breastfeed if you are being given Diuresal
Injection. This is because small amounts may pass
into the mother's milk. Talk to your doctor before
having this medicine if you are breast feeding or
planning to breastfeed.
Ask your doctor or nurse for advice before taking
any medicine if you are pregnant or breastfeeding.
Driving and using machines:
Diuresal may cause some patients to be less alert
which can interfere with the ability to drive or
operate machines.
Diuresal Injection contains sodium:
This medicinal product contains less than 1mmol
sodium (23mg) per dose i.e. essentially 'sodium
free'.
3. HOW DIURESAL INJECTION IS GIVEN TO
YOU
Diuresal Injection will always be given to you by a
doctor or nurse. It may be given by injecting the
solution into a muscle or by injecting it slowly into
a vein.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

140313/1

Colours Used

Customer

Ennogen

Black

Description

Diuresal Injection Leaflet

Keyline

Market

UK

Language

English

Size

160 x 360 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

9

Date

22-12-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

The usual dose:
This is given by intravenous infusion or
intramuscular injection.
Adults:
Intravenous injections must be given slowly,
lnitially a dose of 2ml to 4ml (20mg to 40mg) is
given intramuscularly or intravenously.
Elderly:
The dose may be reduced in this age group.
Children:
Doses for children are in the range of 0.5mg to
1.5mg per kg body weight.
If you think you have been given more Diuresal
Injection than you should have
As the injection will be administered by a doctor, it
is unlikely that you will be given more than is
necessary. However, if you think you have been
given too much, tell your doctor immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Diuresal Injection can cause
side effects, although not everyone gets them.
If you experience any of the following reactions
you should report them to your doctor
immediately.
! Allergic reactions. The signs may include
inflammation of the kidney (nephritis) swollen
ankles, skin rashes, being more sensitive to the
sun than usual, high temperature (fever) or
inflammation of the blood vessels causing pain
in the joints and red and purple discoloration of
the skin
! Severe allergic reactions. The signs may
include shock such as difficulty in breathing,
cold clammy skin, pale skin colour and racing
heart beats
! Severe stomach or back pain. These could be
signs of pancreatitis
! Increased thirst, headache, muscle weakness,
confusion or irregular heartbeats. These could
be signs of dehydration or changes in your
normal body chemicals. Severe hydration can
lead to blood clots
! You notice yellowing of your skin or eyes and
your urine becomes darker in colour. These
could be signs of a liver problem, in patients
who already have liver problems, a more
serious liver problem known as liver
encephalopathy may occur. Symptoms include
forgetfulness, irritability, fits and coma
! Blistering or peeling of the skin around the lips,
eyes mouth, nose and genitals, flu-like
symptoms and fever. This could be a condition
called Stevens-Johnson syndrome. In a more
severe form of the condition called Toxic
Epidermal Necrolysis, layers of the skin may
peel off to leave large areas of raw exposed
skin all over the body
! A rash with pustule formation, this could be a
condition called acute genralised
exanthematous pusutulosis (AGEP)
! A fever and wide spread skin rash. This may be
the symptoms of a condition called DRESS
syndrome (Drug rash with eosinophilia and
systemic symptoms).
Tell your doctor if you notice any of the
following side effects:
Uncommon (affects less than 1 in 100 people)
! Deafness (sometimes irreversible).
Rare (affects less than 1 in 1,000 people)
! Bruising more easily, getting infections, feeling
weak or tired more than usual
! Diuresal Injection can affect the number of
blood cells, causing serious blood problems.
This could lead to withdrawal of treatment
! Tingling or feeling numb on the skin
! Problems hearing or ringing in the ears
(tinnitus). This especially affects people who
already have problem with their kidneys.
Very rare (affect less than 1 in 10,000 people)
Muscle cramps, spasm of the hands and feet
(due to very low calcium levels in the blood).

!

Not known: frequency cannot be estimated
from the data available:
! Loss of concentration, slower reactions, feeling
sleepy or weak. This could be due to low blood
pressure
! Problems with your eyesight
! Feeling sick (nausea) or a general feeling of
being unwell, diarrhoea and being sick
(vomiting), constipation or dry mouth

Quality Control (QC)

Production

Pass more water (urine) than you
usually do People with bladder and
prostate problems may notice pain
when passing urine. This is due to
retention of urine
! If you have diabetes you may be less
able to control the levels of glucose in
your blood
! Elevated uric acid levels
(hyperuricaemia) which may lead to
gout causing a swollen painful joint or
joints
! Pain at the site of injection (in the muscles)
! Allergic reactions such as skin rashes, increase
in skin reactions due to light, inflammation of
the blood vessels, fever, shock and/or
experience kidney problems. If any of these
reactions occur, the treatment should be
withdrawn.
Deposits of calcium salts in the kidneys or heart
defects such as cardiac rhythm disorders and
patent ductus arteriosus have been reported in
premature babies following treatment with
Furosemide.
! Acute generalised exanthematous pustulosis
(AGEP) (acute febrile drug eruption)
! Dizziness, fainting and loss of consciousness
(caused by symptomatic hypotension).
!

Blood tests:
! During treatment with Diuresal Injection the
blood levels of some fats (cholesterol and
triglycerides) may rise
! Diuresal Injection may lead to transitory
increase in blood creatinine and urea levels
! Diuresal Injection may increase the levels of
liver enzymes.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE DIURESAL INJECTION
Do not use this medicine after the expiry date
printed on the ampoule or carton.
Do not store above 25°C.
Do not refrigerate or freeze.
Keep the container in the outer carton in order to
protect from light.
If only part used, discard the remaining solution.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures help to protect the environment.
Keep out of the sight and reach of children
6. FURTHER INFORMATION
What Diuresal Injection contains:
Diuresal Injection contains the active ingredient
furosemide. Each 1ml of solution contains 10mg of
furosemide.
Other ingredients are: sodium-chloride, sodium
hydroxide and water.
What Diuresal Injection looks like and contents
of the pack
Diuresal Injection is a clear, colourless or almost
colourless sterile solution.
Diuresal is available in:
2ml amber glass ampoules in packs of 10 or 25
5ml amber glass ampoules in packs of 5.
Marketing Authorisation Holder:
Ennogen Pharma Limited,
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford,DA1 5BS, UK
Manufacturer:
Rorer Healthcare Limited
Brampton Road, Hampden Park, Eastbourne
East Sussex, BN22 9AG
This leaflet was last revised in December 2015.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide