FRUMIL 40 MG/5 MG TABLETS

Active substance: FUROSEMIDE

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

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• Keep out of the reach and sight 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
moisture.
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
One of the active ingredients in this medicine
is furosemide 40mg. This is the new name for
frusemide 40mg. The ingredient itself has not
changed
• 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 stearate

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 01483 505515
Fax: 01483 535432
Email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi-aventis S.p.A.
Strada Statale 17, Km 22,
67019 Scoppito (L’Aquila),
Italy
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 04/2012.
 Sanofi, 1983 - 2012

2. Before you take Frumil Tablets

Is this leaflet hard to see
or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you
start taking this medicine
• 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. What Frumil Tablets are and what they are
used for
2. Before you take Frumil Tablets
3. How to take Frumil Tablets
4. Possible side effects
5. How to store Frumil Tablets
6. Further 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.

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
××You are allergic to sulphonamides such as
sulfadiazine or co-trimoxazole
××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 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. 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 .
Take special care with Frumil Tablets
Check with your doctor or pharmacist
before taking your medicine if:
 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
 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
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

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.

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 Frumil Tablets can
affect the way some other medicines work.
Also, some medicines can affect the way
Frumil Tablets work.

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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
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

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 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.
Important information about some of the
ingredients of Frumil Tablets
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 Frumil Tablets

4. Possible side effects

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

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
• 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:
• 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

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
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.

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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

• 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 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

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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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