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FRUMIL TABLETS

Active substance(s): AMILORIDE HYDROCHLORIDE ANHYDROUS / FRUSEMIDE

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471 LEAFLET Frumil 20151006

PACKAGE LEAFLET: INFORMATION FOR THE USER

FRUMIL TABLETS

 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
 You are going to have a glucose test

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 or pharmacist



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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet:
1. What Frumil Tablets are and what they are used for
2. What you need to know before you take Frumil Tablets
3. How to take Frumil Tablets
4. Possible side effects
5. How to store Frumil Tablets
6. Contents of the pack and other information

 You are taking any other water tablets
 You have systemic lupus erythematosus
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Frumil Tablets.
Other medicines and Frumil Tablets
Please tell your doctor or pharmacist if you are taking or have
recently taken, or might take 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:


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



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.

1. WHAT FRUMIL TABLETS ARE AND WHAT THEY ARE USED
FOR
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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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:


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

Do not take Frumil Tablets if:
 You are allergic (hypersensitive) to furosemide, amiloride
hydrochloride or any of the other ingredients of this medicine
(listed in Section 6)



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

 You have an illness called ‘Addison’s Disease’. This can make
you feel tired and weak.



Liquorice - often used in cough medicines if taken in large
amounts

 You are breast-feeding (see “Pregnancy and breast-feeding”
section below)



Probenecid (used with another HIV medicine)



Medicines for infection such as gentamicin, amikacin,
neomycin, netilmicin, tobramycin, vancomycin or high doses of
cephalosporins

Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
 You are allergic to sulphonamides such as sulfadiazine or cotrimoxazole
 You have severe problems with your kidneys
 You have severe liver problems
 Your doctor has told you that you have a low blood volume or
are dehydrated
 You are not passing any water (urine)
 You have too much or too little potassium or sodium in your
blood (shown in blood tests)

 You are taking other medicines which change the amount of
potassium in your blood (see “Taking other medicines” section
below)



Medicines used as injections before X-ray examinations

 If the person taking the medicine is under 18 years. Frumil
Tablets are not suitable for children



Medicines used for constipation (laxatives) if used for a long
time such as bisacodyl or senna

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.



Medicines for asthma when given in high doses such as
salbutamol, terbutaline sulphate, salmeterol, formoterol or
bambuterol

Warnings and precautions



Other water tablets (diuretics) such as bendroflumethiazide.
Your doctor may need to change the dose of your medicine

Talk to your doctor or pharmacist before taking Frumil Tablets
if:
 You have difficulty in passing water (urine)
 You are 65 years of age or older

Pregnancy and breast-feeding
Do not take Frumil Tablets if you are pregnant.

 You have liver or kidney problems

Talk to your doctor before taking this medicine if you are pregnant,
might become pregnant, or think you might be pregnant.

 You are an elderly patient with dementia and are also taking
risperidone

Do not breast-feed if you are taking Frumil Tablets.

 You have diabetes
 You have low blood pressure or feel dizzy when you stand up
 You have prostate problems
 You have gout

This is because small amounts may pass into the mothers milk.
Talk to your doctor before taking this medicine if you are breastfeeding or planning to breast-feed. Ask your doctor or pharmacist
for advice before taking any medicine if you are pregnant or breastfeeding.
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.

This medicine contains:

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



A colour called ‘sunset yellow’ (E110). This may cause allergic
reactions.





Lactose. If you have been told by your doctor that you cannot
tolerate some sugars, talk to your doctor before taking this
medicine

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.

Frumil Tablets contain Sunset Yellow and Lactose

3. HOW TO TAKE FRUMIL TABLETS
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Taking this medicine


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



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
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


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.



Symptoms vary considerably between patients but the most
common are: joint aches and pains, swollen joints, headaches,
increased sensitivity to sunlight, skin rashes, kidney problems,
fatigue and weakness, mouth ulcers, hair loss, anxiety and
depression, fevers and night sweats, abdominal pain, chest
pain, shortness of breath, anaemia (Systemic lupus
erythematosus)
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.

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 medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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


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.

5. HOW TO STORE FRUMIL TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store the tablets in a dry place at a temperature not above
25°C. Protect from light.



Do not take the tablets after the expiry date shown on the pack.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep them
if your doctor tells you to.



If the tablets become discoloured or show any other signs of
deterioration, please seek the advice of the pharmacist.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Frumil Tablets contains


Each tablet contains two active ingredients: 40mg furosemide
and amiloride hydrochloride equivalent to 5mg anhydrous
amiloride hydrochloride.



The tablets also contain lactose, maize starch, microcrystalline
cellulose, sodium starch glycollate, Sunset Yellow dye (E110),
talc, colloidal anhydrous silica and magnesium stearate.

What Frumil Tablets looks like and contents of the pack
Frumil Tablets are orange round tablets marked FRUMIL on one
side and with a scoreline on the other.
The calendar blister packs contain either 28 or 56 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex HA0 1DX, England.
Manufacturer
This product is manufactured by Sanofi-Aventis SpA, Scoppito,
Italy.
POM

PL No. 08747/0471

Leaflet revision date: 06 October 2015
Frumil is a registered trade mark of Rorer Health Care Ltd, UK.
471 LEAFLET Frumil 20151006

471 LEAFLET Co-amilofruse 20151006

PACKAGE LEAFLET: INFORMATION FOR THE USER

CO-AMILOFRUSE 40mg/5mg TABLETS
These tablets are known as Co-Amilofruse 40mg/5mg Tablets but
will usually be referred to as Co-Amilofruse Tablets in this leaflet.
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 or pharmacist



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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet:
1. What Co-Amilofruse Tablets are and what they are used for
2. What you need to know before you take Co-Amilofruse Tablets
3. How to take Co-Amilofruse Tablets
4. Possible side effects
5. How to store Co-Amilofruse Tablets

 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
 You are going to have a glucose test
 You are taking any other water tablets
 You have systemic lupus erythematosus
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Co-Amilofruse Tablets.
Other medicines and Co-Amilofruse Tablets
Please tell your doctor or pharmacist if you are taking or have
recently taken, or might take 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:


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

6. Contents of the pack and other information



1. WHAT CO-AMILOFRUSE TABLETS ARE AND WHAT THEY
ARE USED FOR

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 CoAmilofruse Tablets

What Co-Amilofruse Tablets are
The name of your medicine is Frumil 40mg/5mg Tablets (called CoAmilofruse 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

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


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

 You are allergic to sulphonamides such as sulfadiazine or cotrimoxazole



Methotrexate - used for cancers of the skin, joint or bowel
diseases

 You have severe problems with your kidneys



Carbenoxolone - used for ulcers of the food-pipe (gullet)

 You have severe liver problems



Reboxetine - used for depression

 Your doctor has told you that you have a low blood volume or
are dehydrated



Amphotericin - used for fungal infections if used for a long time



Corticosteroids - used for inflammation such as prednisolone

 You are not passing any water (urine)



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

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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COAMILOFRUSE TABLETS
Do not take Co-Amilofruse Tablets if:
 You are allergic (hypersensitive) to furosemide, amiloride
hydrochloride 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 your lips, face, throat or tongue

 You have too much or too little potassium or sodium in your
blood (shown in blood tests)
 You have an illness called ‘Addison’s Disease’. This can make
you feel tired and weak.
 You are breast-feeding (see “Pregnancy and breast-feeding”
section below)
 You are taking other medicines which change the amount of
potassium in your blood (see “Taking other medicines” section
below)
 If the person taking the medicine is under 18 years. CoAmilofruse 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.
Warnings and precautions

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking Co-Amilofruse
Tablets if:

Do not take Co-Amilofruse Tablets if you are pregnant.

 You have difficulty in passing water (urine)

Talk to your doctor before taking this medicine if you are pregnant,
might become pregnant, or think you might be pregnant.

 You are 65 years of age or older

Do not breast-feed if you are taking Co-Amilofruse Tablets.

 You have liver or kidney problems

 You have diabetes

This is because small amounts may pass into the mothers milk.
Talk to your doctor before taking this medicine if you are breastfeeding or planning to breast-feed. Ask your doctor or pharmacist
for advice before taking any medicine if you are pregnant or breastfeeding.

 You have low blood pressure or feel dizzy when you stand up

Driving and using machines

 You have prostate problems

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

 You are an elderly patient with dementia and are also taking
risperidone

 You have gout

Co-Amilofruse Tablets contain Sunset Yellow and Lactose
This medicine contains:


A colour called ‘sunset yellow’ (E110). This may cause allergic
reactions.



Lactose. 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 CO-AMILOFRUSE TABLETS
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Taking this medicine


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 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-Amilofruse 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 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 medicine, ask
your doctor or pharmacist.

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


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
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


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.



Symptoms vary considerably between patients but the most
common are: joint aches and pains, swollen joints, headaches,
increased sensitivity to sunlight, skin rashes, kidney problems,
fatigue and weakness, mouth ulcers, hair loss, anxiety and
depression, fevers and night sweats, abdominal pain, chest
pain, shortness of breath, anaemia (Systemic lupus
erythematosus)
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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store the tablets in a dry place at a temperature not above
25°C. Protect from light.

Like all medicines, this medicine 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



Do not take the tablets after the expiry date shown on the pack.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep them
if your doctor tells you to.



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



If the tablets become discoloured or show any other signs of
deterioration, please seek the advice of the pharmacist.



Severe allergic reactions. The signs may include shock such as
difficulty in breathing, cold clammy skin, pale skin colour and
racing heart beat

4. POSSIBLE SIDE EFFECTS



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’





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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-Amilofruse Tablets contains


Each tablet contains two active ingredients: 40mg furosemide
and amiloride hydrochloride equivalent to 5mg anhydrous
amiloride hydrochloride.



The tablets also contain lactose, maize starch, microcrystalline
cellulose, sodium starch glycollate, Sunset Yellow dye (E110),
talc, colloidal anhydrous silica and magnesium stearate.

What Co-Amilofruse Tablets looks like and contents of the
pack
Co-Amilofruse Tablets are orange round tablets marked FRUMIL on
one side and with a scoreline on the other.
The calendar blister packs contain either 28 or 56 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex HA0 1DX, England.
Manufacturer
This product is manufactured by Sanofi-Aventis SpA, Scoppito,
Italy.
POM

PL No. 08747/0471

Leaflet revision date: 06 October 2015
471 LEAFLET Co-amilofruse 20151006

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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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