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Active substance: SPIRONOLACTONE

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× You are not passing any water (urine)
× You have too much or too little potassium
or sodium in your blood (shown in blood
× 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)

Lasilactone 20mg/50mg
Furosemide 20mg
Spironolactone 50mg

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for help

Do not take Lasilactone Capsules if any of
the above apply to you. If you are not sure,
talk to your doctor or pharmacist before
taking Lasilactone Capsules.

Read all of this leaflet carefully before you
start taking this medicine
• 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. 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 gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or

Take special care with Lasilactone
Check with your doctor or pharmacist
before taking your medicine if:
▲ You have difficulty in passing water
▲ You are 65 years of age or older
▲ You have liver problems or kidney
▲ You have diabetes
▲ You are taking other medicines which
change the amount of potassium in
your blood (see “Taking other medicines”
section below)
▲ You are an elderly patient with
dementia and are also taking
▲ 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
▲ You rely on your voice to make a living.
Lasilactone Capsules can cause changes
to your voice

In this leaflet:
1. What Lasilactone Capsules are and what
they are used for
2. Before you take Lasilactone Capsules
3. How to take Lasilactone Capsules
4. Possible side effects
5. How to store Lasilactone Capsules
6. Further information
1. What Lasilactone Capsules are
and what they are used for
The name of your medicine is Lasilactone
20mg/50mg Capsules (called Lasilactone
Capsules throughout this leaflet).
Lasilactone Capsules contain two different
medicines called: furosemide and
spironolactone. Both belong to a group of
medicines called diuretics (water tablets).
Lasilactone Capsules 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.
Lasilactone Capsules 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.

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

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 Lasilactone
Capsules can affect the way some other
medicines work. Also, some medicines can
affect the way Lasilactone Capsules work.

2. Before you take Lasilactone Capsules
Do not take this medicine and tell
your doctor if:
× You are allergic (hypersensitive) to
furosemide, spironolactone or any of the
other ingredients of Lasilactone
Capsules (listed in Section 6 below)
Signs of an allergic reaction include:
a rash, swallowing or breathing problems,
swelling of your lips, face, throat or
× You are allergic to sulphonamides such
as sulfadiazine or co-trimoxazole
× You have severe problems with your
× You have severe liver problems
× Your doctor has told you that you have
a low blood volume or are dehydrated

In particular, tell your doctor if you are
taking any of the following:
The following medicines can affect the
way Lasilactone Capsules work and
increase the chance of you getting side
• 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 and amiloride


Scale 100%
LASILACTONE capsules - leaflet UK
148 x 315 mm/double - 4 pages
Code: 552256
Laetus: 1264
Color: 1
Pantone Reflex Blue CVC
Fonts: Ocean SansAV (min.10 pt)
Version nº 1
Plant Rzeszów
Date: 04.2014

• 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 capsules 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
• Medicines for diabetes. These may not
work as well when you are taking
Lasilactone Capsules
• Theophylline - used for wheezing or
difficulty in breathing
• Phenytoin - used for epilepsy. This can
lower the effect of Lasilactone Capsules

Taking Lasilactone Capsules with food
and drink
Lasilactone Capsules should be swallowed
with a full glass of water.
Pregnancy and breast-feeding
Do not take Lasilactone Capsules if you are
pregnant. Talk to your doctor before taking
this medicine if you are pregnant, might
become pregnant, or think you might be
Do not breast-feed if you are taking
Lasilactone Capsules. 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.

The following medicines can increase
the chance of side effects when taken
with Lasilactone Capsules:
• 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
• 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
• 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; if used
for a long time
• Amphotericin - used for fungal infections;
if used for a long time
• Corticosteroids used for inflammation
such as prednisolone
• Liquorice used in cough preparations;
if taken in large amounts
• Probenecid (used with another HIV
• Colestyramine - used for lowering
• Medicines for infection such as gentamicin,
tobramycin, vancomycin or high doses of
• Medicines used as injections before X-ray
• Medicines used for constipation
(laxatives) such as bisacodyl or senna;
if used for a long time
• 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

Driving and using machines
You may feel dizzy or unwell after taking
Lasilactone Capsules. If this happens, do
not drive or use any tools or machines.
Important information about some of
the ingredients of Lasilactone Capsules
This medicine contains:
• 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 Lasilactone Capsules
Always take Lasilactone Capsules exactly as
your doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the capsules whole with a drink
of water
• This medicine is not suitable for use in
• 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 Lasilactone Capsules to take
The usual dose is one to four capsules daily.
Your doctor will tell you how many capsules
to take. If you have to take your capsules
once each day, take with your breakfast. If
you have to take your capsules twice each
day, take with your breakfast and lunch.
Do not take your capsules in the evening,
as it could affect your sleep.
If you are taking sucralfate (a medicine
for stomach ulcers)
Do not take sucralfate at the same time as
Lasilactone Capsules. Take your dose at least
2 hours before or after Lasilactone Capsules.
This is because it can affect the way your
medicine works.


If you take more Lasilactone Capsules
than you should
If you think you may have taken more
Lasilactone Capsules than you should, or if
a child has swallowed any of your capsules,
tell your doctor or go 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.

• 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 your 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
• 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
• Pain before or after eating, black or
tar-like stools. This could be a sign of an
ulcer in your stomach or gut

If you forget to take Lasilactone Capsules
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 Lasilactone Capsules
Keep taking Lasilactone Capsules 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.

Tell your doctor or pharmacist if any of
the following side effects get serious or
last longer than a few days, or if you
notice any side effects not listed in this
• Feeling sick (nausea) or a general feeling
of being unwell, diarrhoea and being sick
(vomiting) and constipation
• Feeling confused, moving unsteadily or
• Breast swelling or growth sometimes with
nipple pain or sensitivity
• Difficulty in getting or maintaining an
erection, or in ejaculation
• Redness of the skin
• Hair grows more than normal on the
body or face
• Menstrual periods which are heavier or
last longer than usual
• Voice changes. For example hoarseness or
deepening of the voice in women and
changes in the pitch in men. This may
remain even after you stop taking these
• 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

4. Possible side effects
Like all medicines, Lasilactone Capsules 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’
• Brusing more easily, getting more
infections, feeling weak or tired more
than usual. Lasilactone Capsules 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 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.

Blood tests
Lasilactone Capsules can change the levels
of liver enzymes or body fats known as
cholesterol and triglycerides.


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 medicine.
5. How to store Lasilactone Capsules
• Keep out of the sight and reach of
• Do not take Lasilactone Capsules 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 25ºC. Keep the blister strip in
the outer carton in order to protect from
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 Lasilactone Capsules 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
• Each capsule contains the active
substances furosemide 20mg and
spironolactone 50mg
• The other ingredients are lactose
monohydrate, microcrystalline cellulose,
sodium starch glycolate, talc and
magnesium stearate. The capsule shell
contains gelatin, titanium dioxide (E171)
and indigotin (E132, FD&C Blue 2)
What Lasilactone Capsules look like and
contents of the pack
Lasilactone Capsules are hard, gelatin
capsules with a white body and a blue cap.
Your capsules are available in
blister packs of 28 and 50.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Marketing Authorisation Holder
One Onslow Street
Tel: 0845 372 7101
Sanofi-Aventis Sp. z o.o.
Drug Production and Distribution Plant
ul. Lubelska 52
35-233 Rzeszow
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
This leaflet was last revised in April 2014
© Sanofi, 1977 - 2014

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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.