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• 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
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:
By reporting side effects you can help provide
more information on the safety of this

• Keep this medicine 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
• Store below 25°C. Keep the blister strip in the
outer carton in order to protect from light and
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. Contents of the pack and other
What Frumil Tablets contain
One of the active ingredients in this medicine
is furosemide 40mg. This is the new name for
frusemide 40mg. The ingredient itself has not
• The active substances are furosemide and
amiloride hydrochloride. Each tablet contains
40mg furosemide and 5mg amiloride
hydrochloride (as anhydrous)
• The other ingredients are lactose, maize
starch, microcrystalline cellulose, sodium
starch glycollate, talc, sunset yellow dye (E110),
colloidal anhydrous silica and magnesium
What Frumil Tablets look like and
contents of the pack
Frumil Tablets are orange, evenly mottled
circular tablets with bevel edges and ‘FRUMIL’
embossed on one side, with a breakline on the
other side.
Your tablets are available in blister packs of 4, 7,
28, 56 and 1400 tablets or bottles containing 50,
100 or 500 tablets.
Not all pack sizes may be marketed.

Sanofi S.p.A.
Strada Statale 17, Km 22,
67019 Scoppito (L’Aquila),
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.
This leaflet was last revised in 07/2016
© Sanofi, 1983 - 2016


Frumil 40mg/5mg
Furosemide 40mg
Amiloride Hydrochloride 5mg

Is this leaflet hard to see or

Phone 0845 372 7101 for help
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
• 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
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
Do not take Frumil Tablets if:
²²You 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
²²You are allergic to sulphonamides such as
sulfadiazine or co-trimoxazole
²²You have severe problems with your kidneys
²²You have severe liver problems
²²Your doctor has told you that you have a low
blood volume or are dehydrated
²²You are not passing any water (urine)
²²You have too much or too little potassium or
sodium in your blood (shown in blood tests)
²²You have an illness called ‘Addison’s Disease’.
This can make you feel tired and weak.
²²You are breast-feeding (see “Pregnancy and
breast-feeding” section below)
²²You are taking other medicines which change
the amount of potassium in your blood (see
“Taking other medicines” section below)
²²If the person taking the medicine is under
18 years. Frumil Tablets are not suitable for
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.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Frumil Tablets if:
ccYou have difficulty in passing water (urine)
ccYou are 65 years of age or older
ccYou have liver or kidney problems
ccYou are an elderly patient with dementia and
are also taking risperidone
ccYou have diabetes
ccYou have low blood pressure or feel dizzy
when you stand up
ccYou have prostate problems
ccYou have gout
ccYou 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
ccYou are going to have a glucose test
ccYou are taking any other water tablets
ccYou have systemic lupus erythematosus
ccYou are elderly, or you are on other
medications which can cause the drop of the
blood pressure and you have
other medical conditions that are
risks for the drop of blood pressure.
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Frumil Tablets.

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5. How to store Frumil Tablets

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Marketing Authorisation Holder
One Onslow Street
Tel: 0845 372 7101

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.

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.
• Theophylline - used for wheezing or difficulty
in breathing
• Phenytoin - used for epilepsy. This can lower
the effect of Frumil Tablets

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.

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
• Non-steroidal anti-inflammatory drugs
(NSAIDS) - used for pain and inflammation
such as aspirin, ibuprofen, ketoprofen or
• 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 foodpipe (gullet)
• Reboxetine - used for depression
• Amphotericin - used for fungal infections if
used for a long time
• Corticosteroids - used for inflammation such as

Frumil Tablets contain Sunset Yellow and
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

Do not breast-feed if you are taking Frumil
This is because small amounts may pass into
the mothers 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.

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
• 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
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
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 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
Frequency not known (cannot be estimated
from the available data
• 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
• 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
• 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.
• Acute generalised exanthematous pustulosis
(AGEP) (acute febrile drug eruption), symptoms
include the skin becoming red with swollen
areas covered in numerous small pustules
• Dizziness, fainting and loss of consciousness
Tell a doctor as soon as possible if you have
any of the following side effects:
Uncommon (may affect up to 1 in 100 people)
• Deafness (sometimes irreversible)
Frequency not known (cannot be estimated
from the available data)
• Problems hearing or ringing in the ears
(tinnitus). This especially affects people who
already have problems with their kidneys
• 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
Frequency not known (cannot be estimated
from the available data)
• 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.

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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

• 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
• Medicines used for constipation (laxatives)
if used for a long time such as bisacodyl or
• Medicines for asthma when given in high
doses such as salbutamol, terbutaline
sulphate, salmeterol, formoterol or
• Other water tablets (diuretics) such as
bendroflumethiazide. Your doctor may need
to change the dose of your medicine

+ Expand Transcript

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.