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FRUMIL LS 20 MG/2.5 MG TABLETS

Active substance(s): AMILORIDE HYDROCHLORIDE / FUROSEMIDE

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62C0006

89029608

4/4

08-03-2016
IST FRUMIL LS 20/2,5MG
GB I02
Istruzione
89028842

89029608

PACK. ITEM:
3

1
-

4e1

11 pt su 12 pt

How Frumil LS Tablets work
Frumil LS 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.

167 x 304,8 DP

What Frumil LS Tablets are used for
Frumil LS 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.

1101010010

© Sanofi, 1990 - 2016

What Frumil LS Tablets are
The name of your medicine is Frumil LS
20mg/2.5mg Tablets (called Frumil LS Tablets
throughout this leaflet). Frumil LS Tablets
contain two different medicines called:
furosemide and amiloride hydrochloride.
Both belong to a group of medicines called
diuretics (water tablets).

GB: GREAT BRITAIN

This leaflet was last revised in 03/2016

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

Warnings and precautions
Talk to your doctor or pharmacist
before taking Frumil LS Tablets if:
ccYou have difficulty in passing water (urine)
ccYou are elderly (over 65 years of age)
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.

 Reflex Blue

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.

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

Sanofi S.p.A.

Manufacturer
Sanofi S.p.A.
Strada Statale 17, Km 22,
67019 Scoppito (L’Aquila),
Italy

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.

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com

Phone 0845 372 7101 for help

Arkhé S.n.c.

• Keep this medicine out of the sight and reach
of children.

What Frumil LS Tablets look like and contents
of the pack
Frumil LS Tablets are orange, evenly mottled
circular tablets with bevel edges and ‘LS’ printed
on one side.
Your tablets are available in blister packs of 28
and 56 tablets, or bottles containing 50, 100 or
500 tablets.
Not all pack sizes may be marketed.

Is this leaflet hard to see or
read?

Tel. 0862.404140
fax 0862.404140

5. How to store Frumil LS Tablets

What Frumil LS Tablets contain
One of the active ingredients in this medicine
is furosemide 20mg. This is the new name for
frusemide 20mg. The ingredient itself has not
changed
• The active substances are furosemide and
amiloride hydrochloride. Each tablet contains
20mg furosemide and 2.5mg 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

Furosemide 20mg
Amiloride Hydrochloride 2.5mg

Do not take Frumil LS 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 LS are not suitable for
children
Do not take Frumil LS if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Frumil LS.

3 - Modifica testo reg.

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.

6. Contents of the pack and other
information

Frumil LS 20mg/2.5mg
Tablets

2. What you need to know before you take
Frumil LS Tablets

2 - Modifica testo reg.

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

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.

PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

89029608 1/4

Tell a 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.
• 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)

• Do not take Frumil LS 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.

1 - Prima realizzazione

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

If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Frumil LS.

62C0006

89029608

2/4

08-03-2016
IST FRUMIL LS 20/2,5MG
GB I02
Istruzione
89028842
3
-

2e3

11 pt su 12 pt

If you have any further questions on
the use of this medicine, ask your doctor or
pharmacist.

2

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.

-

Frumil LS 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

167 x 304,8 DP

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

Sanofi S.p.A.

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

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

If you forget to take Frumil LS 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.

Arkhé S.n.c.

If you take more Frumil LS than you should
If you think you may have taken more Frumil
LS 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.

1101010010

If you are taking sucralfate (a medicine for
stomach ulcers)
Do not take sucralfate at the same time as
Frumil LS Tablets. Take your dose at least 2
hours before or after Frumil LS Tablets. This is
because it can affect the way your medicine
works.

GB: GREAT BRITAIN

How much Frumil LS 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.

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 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 LS 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, flulike 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 (caused by symptomatic
hypotension)

 Reflex Blue

89029608

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

PACK. ITEM:

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

Tel. 0862.404140
fax 0862.404140

Driving and using machines

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

3 - Modifica testo reg.

The following medicines can increase the
chance of side effects when taken with
Frumil LS:
• 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
indometacin
• Carbamazepine - used for epilepsy
• Aminoglutethimide - used for breast cancer
• Ciclosporin - used to stop the rejection of
organs after a transplant

Pregnancy and breast-feeding
Do not take Frumil LS 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 LS.
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.

Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.

89029608 3/4

The following medicines can affect the way
Frumil LS works 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
Frumil LS 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 LS.
• Theophylline - used for wheezing or
difficulty in breathing
• Phenytoin - used for epilepsy. This can lower
the effect of Frumil LS

4. Possible side effects

2 - Modifica testo reg.

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

3. How to take Frumil LS Tablets

1 - Prima realizzazione

Other medicines and Frumil LS Tablets
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 LS
can affect the way some other medicines
work. Also, some medicines can affect the way
Frumil LS works.

• 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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