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DONAFRUSE 40MG/5MG TABLETS

Active substance(s): AMILORIDE HYDROCHLORIDE / FUROSEMIDE

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Package Leaflet: Information for the user

Frumil® 40mg/5mg tablets
(furosemide/amiloride hydrochloride)

Read all of this leaflet carefully before you
start taking this medicine
ƒ
ƒ
ƒ

ƒ

Keep this leaflet. You may need to read it again.
If you have any further questions, 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.
2.
3.
4.
5.
6.

What Frumil Tablets are and what they are used for
Before you take Frumil Tablets
How to take Frumil Tablets
Possible side effects
How to store Frumil Tablets
Further information

1. What Frumil Tablets are and what they are
used for

You feel dizzy or dehydrated. This can happen if you have
lost a lot of water through being sick, having diarrhoea or
passing water very often. It can also happen if you are
having trouble drinking or eating
ƒ
You are going to have a glucose test
ƒ
You are taking any other water tablets
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Frumil Tablets.

Important information about some of the
ingredients of Frumil Tablets

Taking other medicines

3. How to take Frumil Tablets

ƒ

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines you
buy without a prescription, including herbal medicines. This is
because Frumil Tablets can affect the way some other medicines
work.
Also, some medicines can affect the way Frumil Tablets work.

Do not take this medicine, and tell your doctor, if
you are taking:
ƒ

The following medicines can affect the way Frumil
Tablets work and increase the chance of you getting
side effects:
ƒ

What Frumil Tablets are

The name of your medicine is Frumil 40mg/5mg Tablets (called
Frumil Tablets throughout this leaflet).
Frumil Tablets contain two different medicines called: furosemide
and amiloride hydrochloride.
Both belong to a group of medicines called diuretics (water
tablets).

What Frumil Tablets are used for

Frumil Tablets can be used to stop the build up of extra water in
your body. This extra water can cause swollen ankles, shortness
of breath and feeling more tired than usual.

How Frumil Tablets work

Frumil Tablets work by helping you to pass more water (urine)
than you usually do. If the extra water in your body is not
removed, it can put extra strain on the heart, blood vessels,
lungs, kidneys or liver.

2. Before you take Frumil Tablets
Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to furosemide, amiloride
hydrochloride or any of the other ingredients of Frumil
Tablets (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue
ƒ
You are allergic to sulphonamides such as sulfadiazine or cotrimoxazole
ƒ
You have severe problems with your kidneys
ƒ
You have severe liver problems
ƒ
Your doctor has told you that you have a low blood volume
or are dehydrated
ƒ
You are not passing any water (urine)
ƒ
You have too much or too little potassium or sodium in your
blood (shown in blood tests)
ƒ
You have an illness called ‘Addison’s Disease’. This can make
you feel tired and weak.
ƒ
You are breast-feeding (see “Pregnancy and breast-feeding”
section below)
ƒ
You are taking other medicines which change the amount of
potassium in your blood (see “Taking other medicines”
section below)
ƒ
If the person taking the medicine is under 18 years. Frumil
Tablets are not suitable for children
Do not take Frumil Tablets if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking
Frumil Tablets.
ƒ

Take special care with Frumil Tablets Check with
your doctor or pharmacist before taking your
medicine if:
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

You have difficulty in passing water (urine)
You are 65 years of age or older
You have liver or kidney problems
You are an elderly patient with dementia and are also taking
risperidone
You have diabetes
You have low blood pressure or feel dizzy when you stand up
You have prostate problems
You have gout

Medicines which change the amount of potassium in your
blood. These include potassium supplements such as
potassium chloride or certain water tablets (diuretics) such
as triamterene

ƒ
ƒ
ƒ
ƒ
ƒ

Medicines such as ramipril, enalapril, perindopril (called ‘ACE
inhibitors’) or losartan, candesartan, irbesartan (called
‘angiotensin II receptor antagonists’). Your doctor may need
to change the dose of your tablets or ask you to stop taking
them
Medicines for high blood pressure or heart problems. Your
doctor may need to change the dose of your medicine
Medicines used as a general anaesthetic for relaxing your
muscles during surgery
Medicines for diabetes. These may not work as well when
you are taking Frumil Tablets.
Theophylline - used for wheezing or difficulty in breathing
Phenytoin - used for epilepsy. This can lower the effect of
Frumil Tablets

The following medicines can increase the chance of
side effects when taken with Frumil Tablets:
ƒ

ƒ
ƒ
ƒ

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

ƒ
ƒ
ƒ

ƒ

Lithium - used for mental illnesses. To help stop side effects
your doctor may need to change the dose of your lithium
and check the amount of lithium in your blood.
Cisplatin - used for some cancers
Digoxin - used for heart problems. Your doctor may need to
change the dose of your medicine.
Non-steroidal anti-inflammatory drugs (NSAIDS) - used for
pain and inflammation such as aspirin, ibuprofen, ketoprofen
or indometacin
Carbamazepine - used for epilepsy
Aminoglutethimide - used for breast cancer
Ciclosporin - used to stop the rejection of organs after a
transplant
Methotrexate - used for cancers of the skin, joint or bowel
diseases
Carbenoxolone - used for ulcers of the food-pipe (gullet)
Reboxetine - used for depression
Amphotericin - used for fungal infections if used for a long
time
Corticosteroids - used for inflammation such as prednisolone
Liquorice - often used in cough medicines if taken in large
amounts
Probenecid (used with another HIV medicine)
Medicines for infection such as gentamicin, amikacin,
neomycin, netilmicin, tobramycin, vancomycin or high doses
of cephalosporins
Medicines used as injections before X-ray examinations
Medicines used for constipation (laxatives) if used for a long
time such as bisacodyl or senna
Medicines for asthma when given in high doses such as
salbutamol, terbutaline sulphate, salmeterol, formoterol or
bambuterol
Other water tablets (diuretics) such as bendroflumethiazide.
Your doctor may need to change the dose of your medicine

Pregnancy and breast-feeding

Do not take Frumil Tablets if you are pregnant. Talk to your
doctor before taking this medicine if you are pregnant, might
become pregnant, or think you might be pregnant.
Do not breast-feed if you are taking Frumil Tablets. This is
because small amounts may pass into the mother’s milk. Talk to
your doctor before taking this medicine if you are breast-feeding
or planning to breast-feed.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel dizzy or unwell after taking Frumil Tablets. If this
happens, do not drive or use any tools or machines.

Page 1 of 2

This medicine contains:
ƒ
A colour called ‘sunset yellow’ (E110). This may cause
allergic reactions.
ƒ
Lactose monohydrate. If you have been told by your doctor
that you cannot tolerate some sugars, talk to your doctor
before taking this medicine

Always take Frumil Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.

Taking this medicine
ƒ
ƒ
ƒ

Take this medicine by mouth
Swallow the tablets whole with a drink of water
If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your doctor

How much Frumil Tablets to take

The usual dose is one or two tablets first thing in the morning.
Your doctor will tell you how many tablets to take.

If you are taking sucralfate (a medicine for stomach
ulcers)

Do not take sucralfate at the same time as Frumil Tablets. Take
your dose at least 2 hours before or after Frumil Tablets. This is
because it can affect the way your medicine works.

If you take more Frumil Tablets than you should

If you think you may have taken more Frumil Tablets than you
should, or if a child has swallowed any of your tablets, tell your
doctor or got to your nearest hospital casualty department
straight away. Remember to take with you any medicine that is
left so the doctor knows what you have taken.
The following effects may happen: dry mouth, feeling thirsty,
muscle pain or cramps, feeling sick or being sick (vomiting), weak
or uneven heartbeat, feeling dizzy, weak or sleepy.

If you forget to take Frumil Tablets

If you forget a dose, take it as soon as you remember it. Then
continue the following morning as normal. Do not take a double
dose to make up for a forgotten dose.

If you stop taking Frumil Tablets

Keep taking Frumil Tablets until your doctor tells you to stop
taking it.

Blood tests

Your doctor may carry out blood tests to check that the levels of
some salts in the blood are at the correct levels.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Frumil Tablets can cause side effects, although
not everybody gets them.

Tell a doctor straight away if you notice any of the
following serious side effects – you may need
urgent medical treatment
ƒ

ƒ

ƒ
ƒ

ƒ

ƒ

ƒ

If you have an allergic reaction. The signs may include
inflammation of the kidney (nephritis), swollen ankles or
high blood pressure, skin rashes, change in skin colour,
severe blistering of the skin, being more sensitive to the sun
than usual, high temperature (fever), and itching
Severe allergic reactions. The signs may include shock such
as difficulty in breathing, cold clammy skin, pale skin colour
and racing heart beat
Severe stomach or back pain. These could be signs of
‘pancreatitis’
Bruising more easily, getting more infections, feeling weak
or tired more than usual. Frumil Tablets can affect the
number of blood cells, causing serious blood problems
Increased thirst, headache, feeling dizzy or light-headed,
fainting, confusion, muscle or joint pains or weakness,
cramps or spasms, stomach upsets or uneven heartbeats.
These could be signs of dehydration or changes in your
normal body chemicals. Severe dehydration can also lead to
blood clots or ‘gout’
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, fits, mood
changes 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.

Tell a doctor as soon as possible if you have any of
the following side effects:
ƒ

ƒ
ƒ
ƒ
ƒ

Problems hearing or ringing in the ears (tinnitus). This
especially affects people who already have problems with
their kidneys
Deafness
Tingling or feeling numb on the skin
Small changes in your mood such as feeling agitated or
anxious.
Headaches, feeling dizzy or light-headed when standing up
quickly. Also loss of concentration, slower reactions, feeling
sleepy or weak, problems with your sight, dry mouth. This
could be due to low blood pressure

This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Leaflet issue and revision date (Ref): 07.08.14
Frumil® is a registered trademark of Sanofi.

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts longer
than a few days, or if you notice any side effects not
listed in this leaflet
ƒ
ƒ

ƒ
ƒ

Feeling sick (nausea) or a general feeling of being unwell,
diarrhoea and being sick (vomiting) and constipation
People with bladder and prostate problems may notice pain
when passing water. This is due to an increase in the
amount of water passed
If you have diabetes you may be less able to control the
levels of glucose in your blood
Passing more water (urine) than you usually do. This
normally happens 1 or 2 hours after taking this medicine.

Blood tests

Frumil Tablets can change the levels of liver enzymes or body fats
known as cholesterol and triglycerides shown up on blood tests.

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 Frumil Tablets
ƒ
ƒ

ƒ
ƒ
ƒ

ƒ

ƒ

Keep out of the sight and reach of children.
Do not take Frumil Tablets after the expiry date which is
stated on the carton and blister pack after EXP. The expiry
date refers to the last day of that month
Do not store above 25°C.
Store in the original package to protect from light.
If your doctor decides to stop the treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to.
If your medicine appears to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you further.
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 to
protect the environment.

6. Further Information
What Frumil Tablets contain

The active ingredients are furosemide and
amiloride hydrochloride.
ƒ
Each tablet contains 40mg furosemide and 5mg
amiloride hydrochloride.
ƒ
The other ingredients are lactose monohydrate,
maize starch, microcrystalline cellulose,
sodium starch glycollate, talc, sunset yellow dye (E110),
colloidal anhydrous silica and magnesium stearate.

What Frumil Tablets look like and contents of the
pack
Frumil Tablets are orange, circular, uncoated tablets with a
breakline on one side and 'FRUMIL' on the reverse.
Frumil Tablets are available in blister packs of 28 and 56.

Manufacturer

Manufactured by: Sanofi-Aventis S.p.A,
Strada Statale 17, Km 22, 67019 Scoppito (L'Aquila), Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0629

POM

Page 2 of 2

Package Leaflet: Information for the user

Co-Amilofruse 40mg/5mg tablets
(furosemide/amiloride hydrochloride)

Read all of this leaflet carefully before you
start taking this medicine
ƒ
ƒ
ƒ

ƒ

Keep this leaflet. You may need to read it again.
If you have any further questions, 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.
2.
3.
4.
5.
6.

What Co-Amilofruse Tablets are and what they are used for
Before you take Co-Amilofruse Tablets
How to take Co-Amilofruse Tablets
Possible side effects
How to store Co-Amilofruse Tablets
Further information

1. What Co-Amilofruse Tablets are and what
they are used for

You feel dizzy or dehydrated. This can happen if you have
lost a lot of water through being sick, having diarrhoea or
passing water very often. It can also happen if you are
having trouble drinking or eating
ƒ
You are going to have a glucose test
ƒ
You are taking any other water tablets
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Co-Amilofruse Tablets.

Important information about some of the
ingredients of Co-Amilofruse Tablets

Taking other medicines

3. How to take Co-Amilofruse Tablets

ƒ

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines you
buy without a prescription, including herbal medicines. This is
because Co-Amilofruse Tablets can affect the way some other
medicines work.
Also, some medicines can affect the way Co-Amilofruse Tablets
work.

Do not take this medicine, and tell your doctor, if
you are taking:
ƒ

The following medicines can affect the way
Co-Amilofruse Tablets work and increase the
chance of you getting side effects:
ƒ

What Co-Amilofruse Tablets are

The name of your medicine is Co-Amilofruse 40mg/5mg Tablets
(called Co-Amilofruse Tablets throughout this leaflet).
Co-Amilofruse Tablets contain two different medicines called:
furosemide and amiloride hydrochloride.
Both belong to a group of medicines called diuretics (water
tablets).

What Co-Amilofruse Tablets are used for

Co-Amilofruse Tablets can be used to stop the build up of extra
water in your body. This extra water can cause swollen ankles,
shortness of breath and feeling more tired than usual.

How Co-Amilofruse Tablets work

Co-Amilofruse Tablets work by helping you to pass more water
(urine) than you usually do. If the extra water in your body is not
removed, it can put extra strain on the heart, blood vessels,
lungs, kidneys or liver.

2. Before you take Co-Amilofruse Tablets
Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to furosemide, amiloride
hydrochloride or any of the other ingredients of
Co-Amilofruse Tablets (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue
ƒ
You are allergic to sulphonamides such as sulfadiazine or cotrimoxazole
ƒ
You have severe problems with your kidneys
ƒ
You have severe liver problems
ƒ
Your doctor has told you that you have a low blood volume
or are dehydrated
ƒ
You are not passing any water (urine)
ƒ
You have too much or too little potassium or sodium in your
blood (shown in blood tests)
ƒ
You have an illness called ‘Addison’s Disease’. This can make
you feel tired and weak.
ƒ
You are breast-feeding (see “Pregnancy and breast-feeding”
section below)
ƒ
You are taking other medicines which change the amount of
potassium in your blood (see “Taking other medicines”
section below)
ƒ
If the person taking the medicine is under 18 years.
Co-Amilofruse Tablets are not suitable for children
Do not take Co-Amilofruse Tablets if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist before
taking Co-Amilofruse Tablets.

ƒ
ƒ
ƒ
ƒ
ƒ

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

You have difficulty in passing water (urine)
You are 65 years of age or older
You have liver or kidney problems
You are an elderly patient with dementia and are also taking
risperidone
You have diabetes
You have low blood pressure or feel dizzy when you stand up
You have prostate problems
You have gout

Medicines such as ramipril, enalapril, perindopril (called ‘ACE
inhibitors’) or losartan, candesartan, irbesartan (called
‘angiotensin II receptor antagonists’). Your doctor may need
to change the dose of your tablets or ask you to stop taking
them.
Medicines for high blood pressure or heart problems. Your
doctor may need to change the dose of your medicine
Medicines used as a general anaesthetic for relaxing your
muscles during surgery
Medicines for diabetes. These may not work as well when
you are taking Co-Amilofruse Tablets.
Theophylline - used for wheezing or difficulty in breathing
Phenytoin - used for epilepsy. This can lower the effect of
Co-Amilofruse Tablets

The following medicines can increase the chance of
side effects when taken with Co-Amilofruse Tablets:
ƒ

ƒ
ƒ
ƒ

ƒ

Take special care with Co-Amilofruse Tablets Check
with your doctor or pharmacist before taking your
medicine if:

Medicines which change the amount of potassium in your
blood. These include potassium supplements such as
potassium chloride or certain water tablets (diuretics) such
as triamterene

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

ƒ
ƒ
ƒ

ƒ

Lithium - used for mental illnesses. To help stop side effects
your doctor may need to change the dose of your lithium
and check the amount of lithium in your blood.
Cisplatin - used for some cancers
Digoxin - used for heart problems. Your doctor may need to
change the dose of your medicine.
Non-steroidal anti-inflammatory drugs (NSAIDS) - used for
pain and inflammation such as aspirin, ibuprofen, ketoprofen
or indometacin
Carbamazepine - used for epilepsy
Aminoglutethimide - used for breast cancer
Ciclosporin - used to stop the rejection of organs after a
transplant
Methotrexate - used for cancers of the skin, joint or bowel
diseases
Carbenoxolone - used for ulcers of the food-pipe (gullet)
Reboxetine - used for depression
Amphotericin - used for fungal infections if used for a long
time
Corticosteroids - used for inflammation such as prednisolone
Liquorice - often used in cough medicines if taken in large
amounts
Probenecid (used with another HIV medicine)
Medicines for infection such as gentamicin, amikacin,
neomycin, netilmicin, tobramycin, vancomycin or high doses
of cephalosporins
Medicines used as injections before X-ray examinations
Medicines used for constipation (laxatives) if used for a long
time such as bisacodyl or senna
Medicines for asthma when given in high doses such as
salbutamol, terbutaline sulphate, salmeterol, formoterol or
bambuterol
Other water tablets (diuretics) such as bendroflumethiazide.
Your doctor may need to change the dose of your medicine

This medicine contains:
ƒ
A colour called ‘sunset yellow’ (E110). This may cause
allergic reactions.
ƒ
Lactose monohydrate. If you have been told by your doctor
that you cannot tolerate some sugars, talk to your doctor
before taking this medicine

Always take Co-Amilofruse Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are
not sure.

Taking this medicine
ƒ
ƒ
ƒ

How much Co-Amilofruse Tablets to take

The usual dose is one or two tablets first thing in the morning.
Your doctor will tell you how many tablets to take.

If you are taking sucralfate (a medicine for stomach
ulcers)

Do not take sucralfate at the same time as Co-Amilofruse Tablets.
Take your dose at least 2 hours before or after Co-Amilofruse
Tablets. This is because it can affect the way your medicine
works.

If you take more Co-Amilofruse Tablets than you
should

If you think you may have taken more Co-Amilofruse Tablets than
you should, or if a child has swallowed any of your tablets, tell
your doctor or got to your nearest hospital casualty department
straight away. Remember to take with you any medicine that is
left so the doctor knows what you have taken.
The following effects may happen: dry mouth, feeling thirsty,
muscle pain or cramps, feeling sick or being sick (vomiting), weak
or uneven heartbeat, feeling dizzy, weak or sleepy.

If you forget to take Co-AmilofruseTablets

If you forget a dose, take it as soon as you remember it. Then
continue the following morning as normal. Do not take a double
dose to make up for a forgotten dose.

If you stop taking Co-Amilofruse Tablets

Keep taking Co-Amilofruse Tablets until your doctor tells you to
stop taking it.

Blood tests

Your doctor may carry out blood tests to check that the levels of
some salts in the blood are at the correct levels.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Co-Amilofruse Tablets can cause side effects,
although not everybody gets them.

Tell a doctor straight away if you notice any of the
following serious side effects – you may need
urgent medical treatment
ƒ

ƒ

ƒ
ƒ

Pregnancy and breast-feeding

Do not take Co-Amilofruse Tablets if you are pregnant. Talk to
your doctor before taking this medicine if you are pregnant, might
become pregnant, or think you might be pregnant.
Do not breast-feed if you are taking Co-Amilofruse Tablets. This is
because small amounts may pass into the mother’s milk. Talk to
your doctor before taking this medicine if you are breast-feeding
or planning to breast-feed.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel dizzy or unwell after taking Co-Amilofruse Tablets. If
this happens, do not drive or use any tools or machines.

Page 1 of 2

Take this medicine by mouth
Swallow the tablets whole with a drink of water
If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your doctor

ƒ

If you have an allergic reaction. The signs may include
inflammation of the kidney (nephritis), swollen ankles or
high blood pressure, skin rashes, change in skin colour,
severe blistering of the skin, being more sensitive to the sun
than usual, high temperature (fever), and itching.
Severe allergic reactions. The signs may include shock such
as difficulty in breathing, cold clammy skin, pale skin colour
and racing heart beat.
Severe stomach or back pain. These could be signs of
‘pancreatitis’
Bruising more easily, getting more infections, feeling weak
or tired more than usual. Co-Amilofruse Tablets can affect
the number of blood cells, causing serious blood problems
Increased thirst, headache, feeling dizzy or light-headed,
fainting, confusion, muscle or joint pains or weakness,
cramps or spasms, stomach upsets or uneven heartbeats.
These could be signs of dehydration or changes in your
normal body chemicals. Severe dehydration can also lead to
blood clots or ‘gout’.

ƒ

ƒ

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, fits, mood
changes 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.

Tell a doctor as soon as possible if you have any of
the following side effects:
ƒ

ƒ
ƒ
ƒ
ƒ

Problems hearing or ringing in the ears (tinnitus). This
especially affects people who already have problems with
their kidneys.
Deafness
Tingling or feeling numb on the skin
Small changes in your mood such as feeling agitated or
anxious.
Headaches, feeling dizzy or light-headed when standing up
quickly. Also loss of concentration, slower reactions, feeling
sleepy or weak, problems with your sight, dry mouth. This
could be due to low blood pressure.

Manufacturer

Manufactured by: Sanofi-Aventis S.p.A,
Strada Statale 17, Km 22, 67019 Scoppito (L'Aquila), Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0629

POM

This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Leaflet issue and revision date (Ref): 07.08.14

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts longer
than a few days, or if you notice any side effects not
listed in this leaflet
ƒ
ƒ

ƒ
ƒ

Feeling sick (nausea) or a general feeling of being unwell,
diarrhoea and being sick (vomiting) and constipation
People with bladder and prostate problems may notice pain
when passing water. This is due to an increase in the
amount of water passed
If you have diabetes you may be less able to control the
levels of glucose in your blood
Passing more water (urine) than you usually do. This
normally happens 1 or 2 hours after taking this medicine.

Blood tests

Co-Amilofruse Tablets can change the levels of liver enzymes or
body fats known as cholesterol and triglycerides shown up on
blood tests.

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 Co-Amilofruse Tablets
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Keep out of the sight and reach of children.
Do not take Co-Amilofruse Tablets after the expiry date
which is stated on the carton and blister pack after EXP. The
expiry date refers to the last day of that month
Do not store above 25°C.
Store in the original package to protect from light.
If your doctor decides to stop the treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to.
If your medicine appears to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you further.
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 to
protect the environment.

6. Further Information
What Co-AmilofruseTablets contain

The active ingredients are furosemide and
amiloride hydrochloride.
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Each tablet contains 40mg furosemide and
5mg amiloride hydrochloride.
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The other ingredients are lactose monohydrate,
maize starch, microcrystalline cellulose,
sodium starch glycollate, talc, sunset yellow dye (E110),
colloidal anhydrous silica and magnesium stearate.

What Co-Amilofruse Tablets look like and contents
of the pack

Co-Amilofruse Tablets are orange, circular, uncoated tablets with
a breakline on one side and 'FRUMIL' on the reverse.
Co-Amilofruse Tablets are available in blister packs of 28 and 56.

Page 2 of 2

Package Leaflet: Information for the user

Donafruse 40mg/5mg tablets
(furosemide/amiloride hydrochloride)

Read all of this leaflet carefully before you
start taking this medicine
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Keep this leaflet. You may need to read it again.
If you have any further questions, 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.
2.
3.
4.
5.
6.

What Donafruse Tablets are and what they are used for
Before you take Donafruse Tablets
How to take Donafruse Tablets
Possible side effects
How to store Donafruse Tablets
Further information

1. What Donafruse Tablets are and what they
are used for

You have prostate problems.
You have gout.
You feel dizzy or dehydrated. This can happen if you have
lost a lot of water through being sick, having diarrhoea or
passing water very often. It can also happen if you are
having trouble drinking or eating.
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You are going to have a glucose test.
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You are taking any other water tablets.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Donafruse Tablets.
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Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines you
buy without a prescription, including herbal medicines. This is
because Donafruse Tablets can affect the way some other
medicines work. Also, some medicines can affect the way
Donafruse Tablets work.

Do not take this medicine, and tell your doctor, if
you are taking:
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The following medicines can affect the way
Donafruse Tablets work and increase the chance of
you getting side effects:
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What Donafruse Tablets are

The name of your medicine is Donafruse 40mg/5mg Tablets
(called Donafruse Tablets throughout this leaflet). Donafruse
Tablets contain two different medicines called: furosemide and
amiloride hydrochloride.
Both belong to a group of medicines called diuretics (water
tablets).

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What Donafruse Tablets are used for

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Donafruse Tablets can be used to stop the build up of extra water
in your body. This extra water can cause swollen ankles,
shortness of breath and feeling more tired than usual.

How Donafruse Tablets work

Donafruse Tablets work by helping you to pass more water (urine)
than you usually do. If the extra water in your body is not
removed, it can put extra strain on the heart, blood vessels,
lungs, kidneys or liver.

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Do not take this medicine and tell your doctor if:

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You are allergic (hypersensitive) to furosemide, amiloride
hydrochloride or any of the other ingredients of Donafruse
Tablets (listed in Section 6 below). Signs of an allergic
reaction include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.
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You are allergic to sulphonamides such as sulfadiazine or cotrimoxazole.
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You have severe problems with your kidneys.
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You have severe liver problems.
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Your doctor has told you that you have a low blood volume
or are dehydrated.
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You are not passing any water (urine).
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You have too much or too little potassium or sodium in your
blood (shown in blood tests).
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You have an illness called ‘Addison’s Disease’. This can make
you feel tired and weak.
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You are breast-feeding (see “Pregnancy and breast-feeding”
section below).
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You are taking other medicines which change the amount of
potassium in your blood (see “Taking other medicines”
section below).
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If the person taking the medicine is under 18 years.
Donafruse Tablets are not suitable for children.
Do not take Donafruse Tablets if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking
Donafruse Tablets.

Take special care with Donafruse Tablets Check
with your doctor or pharmacist before taking your
medicine if:
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You have difficulty in passing water (urine).
You are 65 years of age or older.
You have liver or kidney problems.
You are an elderly patient with dementia and are also taking
risperidone.
You have diabetes.
You have low blood pressure or feel dizzy when you stand
up.

Medicines such as ramipril, enalapril, perindopril (called ‘ACE
inhibitors’) or losartan, candesartan, irbesartan (called
‘angiotensin II receptor antagonists’). Your doctor may need
to change the dose of your tablets or ask you to stop taking
them
Medicines for high blood pressure or heart problems. Your
doctor may need to change the dose of your medicine
Medicines used as a general anaesthetic for relaxing your
muscles during surgery
Medicines for diabetes. These may not work as well when
you are taking Donafruse Tablets.
Theophylline - used for wheezing or difficulty in breathing
Phenytoin - used for epilepsy. This can lower the effect of
Donafruse Tablets.

The following medicines can increase the chance of
side effects when taken with Donafruse Tablets:

2. Before you take Donafruse Tablets
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Medicines which change the amount of potassium in your
blood. These include potassium supplements such as
potassium chloride or certain water tablets (diuretics) such
as triamterene.

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Lithium - used for mental illnesses. To help stop side effects
your doctor may need to change the dose of your lithium
and check the amount of lithium in your blood.
Cisplatin - used for some cancers.
Digoxin - used for heart problems. Your doctor may need to
change the dose of your medicine.
Non-steroidal anti-inflammatory drugs (NSAIDS) - used for
pain and inflammation such as aspirin, ibuprofen, ketoprofen
or indometacin.
Carbamazepine - used for epilepsy.
Aminoglutethimide - used for breast cancer.
Ciclosporin - used to stop the rejection of organs after a
transplant.
Methotrexate - used for cancers of the skin, joint or bowel
diseases.
Carbenoxolone - used for ulcers of the food-pipe (gullet).
Reboxetine - used for depression.
Amphotericin - used for fungal infections if used for a long
time.
Corticosteroids - used for inflammation such as
prednisolone.
Liquorice - often used in cough medicines if taken in large
amounts.
Probenecid (used with another HIV medicine).
Medicines for infection such as gentamicin, amikacin,
neomycin, netilmicin, tobramycin, vancomycin or high doses
of cephalosporins.
Medicines used as injections before X-ray examinations.
Medicines used for constipation (laxatives) if used for a long
time such as bisacodyl or senna.
Medicines for asthma when given in high doses such as
salbutamol, terbutaline sulphate, salmeterol, formoterol or
bambuterol.
Other water tablets (diuretics) such as bendroflumethiazide.
Your doctor may need to change the dose of your medicine.

Driving and using machines

You may feel dizzy or unwell after taking Donafruse Tablets. If
this happens, do not drive or use any tools or machines.

Important information about some of the
ingredients of Donafruse Tablets

This medicine contains:
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A colour called ‘sunset yellow’ (E110). This may cause
allergic reactions.
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Lactose monohydrate. If you have been told by your doctor
that you cannot tolerate some sugars, talk to your doctor
before taking this medicine

3. How to take Donafruse Tablets
Always take Donafruse Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are
not sure.

Taking this medicine
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How much Donafruse Tablets to take

The usual dose is one or two tablets first thing in the morning.
Your doctor will tell you how many tablets to take.

If you are taking sucralfate (a medicine for stomach
ulcers)

Do not take sucralfate at the same time as Donafruse Tablets.
Take your dose at least 2 hours before or after Donafruse Tablets.
This is because it can affect the way your medicine works.

If you take more Donafruse Tablets than you should

If you think you may have taken more Donafruse Tablets than you
should, or if a child has swallowed any of your tablets, tell your
doctor or got to your nearest hospital casualty department
straight away. Remember to take with you any medicine that is
left so the doctor knows what you have taken.
The following effects may happen: dry mouth, feeling thirsty,
muscle pain or cramps, feeling sick or being sick (vomiting), weak
or uneven heartbeat, feeling dizzy, weak or sleepy.

If you forget to take Donafruse Tablets

If you forget a dose, take it as soon as you remember it. Then
continue the following morning as normal. Do not take a double
dose to make up for a forgotten dose.

If you stop taking Donafruse Tablets

Keep taking Donafruse Tablets until your doctor tells you to stop
taking it.

Blood tests

Your doctor may carry out blood tests to check that the levels of
some salts in the blood are at the correct levels.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Donafruse Tablets can cause side effects,
although not everybody gets them.

Tell a doctor straight away if you notice any of the
following serious side effects – you may need
urgent medical treatment
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Pregnancy and breast-feeding

Do not take Donafruse Tablets if you are pregnant. Talk to your
doctor before taking this medicine if you are pregnant, might
become pregnant, or think you might be pregnant.
Do not breast-feed if you are taking Donafruse Tablets. This is
because small amounts may pass into the mother’s milk. Talk to
your doctor before taking this medicine if you are breast-feeding
or planning to breast-feed.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.

Page 1 of 2

Take this medicine by mouth
Swallow the tablets whole with a drink of water
If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your doctor

ƒ

If you have an allergic reaction. The signs may include
inflammation of the kidney (nephritis), swollen ankles or
high blood pressure, skin rashes, change in skin colour,
severe blistering of the skin, being more sensitive to the sun
than usual, high temperature (fever), and itching.
Severe allergic reactions. The signs may include shock such
as difficulty in breathing, cold clammy skin, pale skin colour
and racing heart beat.
Severe stomach or back pain. These could be signs of
‘pancreatitis’.
Bruising more easily, getting more infections, feeling weak
or tired more than usual. Donafruse Tablets can affect the
number of blood cells, causing serious blood problems.
Increased thirst, headache, feeling dizzy or light-headed,
fainting, confusion, muscle or joint pains or weakness,
cramps or spasms, stomach upsets or uneven heartbeats.
These could be signs of dehydration or changes in your
normal body chemicals. Severe dehydration can also lead to
blood clots or ‘gout’.

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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, fits, mood
changes 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.

Tell a doctor as soon as possible if you have any of
the following side effects:
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Problems hearing or ringing in the ears (tinnitus). This
especially affects people who already have problems with
their kidneys.
Deafness
Tingling or feeling numb on the skin.
Small changes in your mood such as feeling agitated or
anxious.
Headaches, feeling dizzy or light-headed when standing up
quickly. Also loss of concentration, slower reactions, feeling
sleepy or weak, problems with your sight, dry mouth. This
could be due to low blood pressure.

Manufacturer

Manufactured by: Sanofi-Aventis S.p.A,
Strada Statale 17, Km 22, 67019 Scoppito (L'Aquila), Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0629

POM

This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Leaflet issue and revision date (Ref): 07.08.14

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts longer
than a few days, or if you notice any side effects not
listed in this leaflet
ƒ
ƒ

ƒ
ƒ

Feeling sick (nausea) or a general feeling of being unwell,
diarrhoea and being sick (vomiting) and constipation.
People with bladder and prostate problems may notice pain
when passing water. This is due to an increase in the
amount of water passed.
If you have diabetes you may be less able to control the
levels of glucose in your blood.
Passing more water (urine) than you usually do. This
normally happens 1 or 2 hours after taking this medicine.

Blood tests

Donafruse Tablets can change the levels of liver enzymes or body
fats known as cholesterol and triglycerides shown up on blood
tests.

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 Donafruse Tablets
ƒ
ƒ

ƒ
ƒ
ƒ

ƒ

ƒ

Keep out of the sight and reach of children.
Do not take Donafruse Tablets after the expiry date which is
stated on the carton and blister pack after EXP. The expiry
date refers to the last day of that month
Do not store above 25°C.
Store in the original package to protect from light.
If your doctor decides to stop the treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to.
If your medicine appears to be discoloured or show any
other signs of deterioration, please return to your
pharmacist who will advise you further.
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 to
protect the environment.

6. Further Information
What Donafruse Tablets contain

The active ingredients are furosemide and
amiloride hydrochloride.
ƒ
Each tablet contains 40mg furosemide and
5mg amiloride hydrochloride.
ƒ
The other ingredients are lactose monohydrate,
maize starch, microcrystalline cellulose,
sodium starch glycollate, talc, sunset yellow dye (E110),
colloidal anhydrous silica and magnesium stearate.

What Donafruse Tablets look like and contents of
the pack
Donfruse Tablets are orange, circular, uncoated tablets with a
breakline on one side and 'FRUMIL' on the reverse.
Donafruse Tablets are available in blister packs of 28 and 56.

Page 2 of 2

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.

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