CO-AMILOFRUSE 2.5MG/20MG TABLETS

Active substance: FUROSEMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Co-Amilofruse 2.5mg/20mg Tablets
Co-Amilofruse 5mg/40mg Tablets
Co-Amilofruse 10mg/80mg Tablets
Amiloride Hydrochloride and Furosemide

Read all of this leaflet carefully before
you start to take 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 pharmacist.
− This medicine has been prescribed for
you. Do not pass it on to 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.
In this leaflet:
1. What Co-Amilofruse Tablets are and
what they are used for
2. Before you take Co-Amilofruse Tablets
3. How to take Co-Amilofruse Tablets
4. Possible side effects
5. How to store Co-Amilofruse Tablets
6. Further information
1. What Co-Amilofruse Tablets are and
what they are used for
The name of your medicine is
Co-Amilofruse Tablets. This is a medicine
containing two active ingredients, amiloride
hydrochloride and furosemide. Amiloride
hydrochloride belongs to a group of
medicines called potassium sparing
diuretics which also remove excess water
and prevent a reduction in potassium
levels. Furosemide belongs to a group of
medicines called loop diuretics which
remove excess water from the body but can
cause a reduction of potassium levels.
Co-Amilofruse Tablets comes in three
strengths and is used in the treatment of:
• heart failure
• fluid retention in kidney disease
• fluid retention due to liver disease
• fluid retention due to treatment with
steroids or hormones (oestrogens).
2. Before you take Co-Amilofruse Tablets
You should not take Co-Amilofruse
Tablets if you:
• are allergic (hypersensitive) to
furosemide, amiloride hydrochloride or to
any of the other ingredients in
Co-Amilofruse Tablets (see section 6,
Further information)
• have high blood potassium levels
• have Addison’s disease (a disease of the
adrenal glands)
• have acute kidney failure or are unable to
pass water
• have severe, progressive kidney disease
• have liver failure or cirrhosis that is
affecting your level of consciousness
• have been told you have an imbalance of
salts in your blood
• are taking potassium supplements or
other potassium sparing diuretics
• are dehydrated
• have low blood pressure
• have digitalis intoxication
• are a woman who is breast-feeding
• are under 18 years.
Talk to your doctor before taking
Co-Amilofruse Tablets if you:
• if you are going to have, or have recently
had an X ray with contrast media (dye).
• if you are taking risperidone
• if you are taking medicine for asthma
(beta2-agonists)
• are elderly
• have or are likely to develop abnormal
blood chemistry with high or low salts or
acidosis
• are dehydrated
• have kidney problems
• have diabetes
• suffer from gout (a condition where too
much uric acid in the body causes joint
pains)
• have an enlarged prostate or have
problems passing water
• are vomiting and/or have diarrhoea
• have low blood pressure
• have liver failure
• have porphyria (a disease of blood
proteins that effects the skin, gut and
nervous system)
• have or have ever suffered from
pancreatitis (an inflammation of the
pancreas)
• have congestive heart failure
• have an excess of the hormone
aldosterone in the kidney, which could
lead to decreased levels of potassium in
the blood.
• are not producing enough parathyroid
hormone (PTH) from your parathyroid

glands, which could lead to decreased
levels of calcium in the blood
• suffer from systemic lupus erythematosus
(a disease were the immune system
attacks the tissues of the body)
• are due to take a glucose tolerance test
(this medicine should be discontinued for
at least three days before).
This medicine may cause falsely high
reading in blood test for kidney function
(creatinine). Cholesterol levels may also
rise during the first 6 months of treatment,
but usually return to normal thereafter.
Electrolyte levels such as sodium,
potassium and blood urea nitrogen levels,
require monitoring. Regular monitoring of
the blood, liver, and for rare side effects are
required.
In infants, there is a risk of Patent Ductus
Aretiosus (PDA). Renal function must be
monitored as there is also a risk of raised
calcium levels within the kidneys, and
kidney stones.
The renal function of patients with diabetes
mellitus should be assessed prior to the
start of treatment.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription. The following
medicines can affect or be affected by
treatment with Co-Amilofruse Tablets:
• medicines used to treat high blood
pressure (e.g. beta-blockers,
calcium-channel blockers, hydralazine,
alpha-blockers, such as prazosin, ACE
inhibitors, such as captopril, and
angiotensin II antagonists, such as
losartan)
• amphotericin used to treat fungal
infections
• anaesthetics
• aldesleukin, used to treat cancer of the
kidney
• carbamazepine and phenytoin used to
treat epilepsy
• nitrates, used to treat angina
• Nephrotoxic drugs, or drugs which have a
toxic effect on the kidneys
• quinidine, flecainide, amiodarone,
disopyramine, sotaolol, mexilitine and
lidocaine, used to treat abnormal heart
rhythms
• anion-exchange resins used to reduce
cholesterol (e.g. colestyramine and
colestipol)
• Levodopa, used to treat Parkinson's
disease
• medicines used in chemotherapy (e.g.
cisplatin, methotrexate)
• phenothiazines and risperidone,
medicines used to treat mental illness
• medicines used to treat depression (e.g.
tricyclic antidepressants and monoamine
oxidase inhibitors [MAOIs])
• medicines used to suppress the immune
system following organ transplant (e.g.
ciclosporin and tacrolimus)
• medicines used to treat inflammation
such as indometacin, keterolac,
acetylsalicylic acid
• carbenoxolone, sucralfate and ranitidine,
used to treat stomach ulcers
• medicines called muscle relaxants, such
as tizanidine or baclofen, used to treat
muscle pain, spasms and twitching
• triostane, used to treat hormone
disturbances
• diuretics, used to treat water retention
(e.g. metolazone)
• laxatives
• medicines used to treat bacterial
infections
• medicines used to treat diabetes, such as
chlorpropamide
• lithium, a medicine used to treat manic
depression/bipolar disorder
• aprostadil, a medicine used to treat
impotence
• probenecid, a medicine used to prevent
gout
• theophylline, used in the treatment of
respiratory conditions such as COPD or
asthma
• asthma or COPD ‘reliever’ inhalers such
as salbutamol, terbutaline
• terfenadine, used to treat allergic
conditions
• steroids or potassium supplements
• Warfarin, used to thin the blood.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
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Taking Co-Amilofruse Tablets with food
and drink
If you feel dizzy while taking this medicine
then alcohol may make the effects worse. It
is also advised to avoid smoking while you
take this medicine as nicotine can reduce
the effectiveness of Co-Amilofruse Tablets.

• psychiatric disturbance
• inflammation of the kidneys
• blood salt imbalances. Symptoms include
dry mouth, thirst, headache, low blood
pressure, drowsiness, stomach upsets,
feeling confused, muscle cramps, muscle

Pregnancy and breast-feeding
You should not take this medicine if you are
pregnant or breast feeding unless your
doctor specifically recommends it.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machinery
This medicine can make you feel dizzy,
reduce alertness or impair your vision. Do
not drive or operate machinery if affected.
Important information about some of the
ingredients in Co-Amilofruse Tablets
This medicine contains lactose, if you have
been told by your doctor that you have an
intolerance to some sugars contact your
doctor before taking this medicine. This
medicine also contains a food dye called
Sunset Yellow FCF Lake (E110) which may
cause allergic reactions.
3. How to take Co-Amilofruse Tablets
Always take Co-Amilofruse Tablets as your
doctor has told you. Your doctor will decide
the right dose for you. This will be on the
pharmacist’s label. This medicine should be
swallowed whole.
Adults
• The starting dose is usually 5mg/40mg
taken in the morning; this can be adjusted
by your doctor according to your
response to treatment.
While you are taking this medicine your
doctor may want to monitor your salt levels
with regular blood tests, especially if you
are elderly or unwell, to check for any
possible imbalances.
Children
• This medicine is not recommended for
use in children under the age of 18.
If you take more Co-Amilofruse Tablets
than you should
If you (or anybody else, including a child),
takes more Co-Amilofruse Tablets than you
should then you should contact your
nearest hospital casualty department or
doctor immediately. Always take the
container and this leaflet with you.
If you forget to take Co-Amilofruse
Tablets
If you forget a dose, take another as soon
as you remember. If it is almost time for
your next dose, then do not take the missed
dose at all. NEVER take a double dose to
make up for the one missed.
4. Possible side effects
Like all medicines, Co-Amilofruse Tablets
can cause side effects, although not
everybody gets them. As can happen with
any medicine, a few people may develop an
allergic reaction. If you experience any of
the following, seek medical help
immediately:
• inflammation of the pancreas
(pancreatitis) which causes severe pain in
the abdomen and back (may be
associated with nausea, vomiting or
fever). If you notice these symptoms talk
to your doctor as soon as possible
• yellowing of the skin or whites of the eyes
caused by liver or blood problems
(jaundice). If you notice these symptoms
talk to your doctor as soon as possible
• rash, itching, difficulty breathing.
Side effects that have been reported with
Co-Amilofruse Tablets are:
• rises in blood urea levels
• cough
• shortness of breath
• nausea
• vomiting
• sensitivity to light
• stomach upsets
• stomach pains
• diarrhoea
• constipation
• dizziness
• fainting
• ringing in the ears
• deafness
• blurred vision, visual changes
• yellow vision, a condition where
everything you see appears to have a
yellowish tinge
• skin rashes
• muscle twitching
• skin blistering
• bruising
• vitamin B1 deficiency
• gout, a condition that causes pain,
inflammation and swelling of your joints
• high blood sugar (hyperglycaemia).
Symptoms include feeling thirsty, needing
to pass water frequently, feeling tired and
getting infections such as thrush more
often than usual
• Skin: rash, itching, hair loss

twitching and an abnormal heartbeat
angina
palpitations
general feeling of being unwell
aggravation of diabetes
low blood pressure on standing
inflammation of blood vessels
problems with bone formation
reduced sex drive, erectile dysfunction
disturbance in liver function (seen in
blood tests)
• problems with bone marrow and blood
cell production.










If you experience any side effects or feel
that the medicine is affecting you badly tell
your doctor or pharmacist immediately.
5. How to store Co-Amilofruse Tablets
Keep out the reach and sight of children.
• Co-Amilofruse Tablets should not be
stored above 25°C. Store in the original
container and do not transfer to another
container.
• Co-Amilofruse Tablets should not be
taken after the expiry date on the pack;
the expiry date refers to the last day of
the month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
protect the environment.
6. Further information
What Co-Amilofruse Tablets contains
The active ingredients are: amiloride
hydrochloride and furosemide. The other
ingredients are: lactose powder,
microcrystalline cellulose, dispersed sunset
yellow FCF Lake (E110), povidone K30,
sodium starch glycollate, magnesium
stearate, purified water.
Each Co-Amilofruse 2.5mg/20mg tablet
contains 2.84mg of amiloride hydrochloride
equivalent to 2.5 mg of amiloride and 20mg
of furosemide.
Each Co-Amilofruse 5mg/40mg tablet
contains 5.68mg of amiloride hydrochloride
equivalent to 5mg of amiloride and 40mg of
furosemide.
Each Co-Amilofruse 10mg/80mg tablet
contains 11.36mg of amiloride
hydrochloride equivalent to 10mg of
amiloride and 80mg of furosemide.
What Co-Amilofruse Tablets looks like
and the contents of the pack
Co-Amilofruse tablets are supplied in
opaque white blister packs (containing 28,
30, 56 or 60 tablets) or in polyethylene
plastic containers of 500 tablets.
Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer:
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following
information:
Product name

Reference
number

Co-Amilofruse
2.5mg/20mg Tablets

PL 29831/0039

Co-Amilofruse
5mg/40mg Tablets

PL 29831/0040

Co-Amilofruse
10mg/80mg Tablets

PL 29831/0038

This is a service provided by the Royal
National Institute of Blind People.
Leaflet Prepared: September 2012

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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.

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