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× 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

Is this leaflet hard to
see or read?
Phone 0845 372 7101
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.
Warnings and precautions

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
side effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1. What Lasilactone Capsules are and what
they are used for
2. What you need to know before you take
Lasilactone Capsules
3. How to take Lasilactone Capsules
4. Possible side effects
5. How to store Lasilactone Capsules
6. Contents of the pack and other information

Talk to your doctor or pharmacist before
taking Lasilactone Capsules if:
▲ You have difficulty in passing water
▲ You are 65 years of age or older
▲ You have liver problems or kidney problems
▲ 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 risperidone
▲ 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
▲ You have systemic lupus erythematosus
▲ You 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.
▲ Concomitant administration of Lasilactone
Capsules with certain medicines, potassium
supplements and food rich in potassium
may lead to severe hyperkalaemia (increased potassium blood level). The symptoms
of severe hyperkalaemia might include
muscle cramps, irregular heart rhythm,
diarrhoea, nausea, dizziness or headache.

1. What Lasilactone Capsules are
and what they are used for
The name of your medicine is Lasilacton
20mg/50mg Capsules (called Lasilactone
Capsules throughout this leaflet).
Lasilactone Capsules contain two different
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.
2. What you need to know before you
take Lasilactone Capsules

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

Do not take Lasilactone Capsules
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 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)

Other medicines and Lasilactone
Tell your doctor or pharmacist if you are
taking, haven recently taken or might take
other medicines.
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.


Scale 100%
LASILACTONE capsules - leaflet UK
148 x 315 mm/double - 4 pages
Code: 652327
Laetus: 1264
Color: 1
Pantone Reflex Blue CVC
Fonts: Ocean SansAV (min.10 pt)
Version nº 03
Plant Rzeszów
Date: 09.2016

In particular, tell your doctor if you
aretaking any of the following:

• 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
Lasilactone Capsules with food and drink
Lasilactone Capsules should be swallowed
with a full glass of water and preferably
with food.

The following medicines can affect
theway 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
• 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
• Trimethoprim and trimethoprim-sulfamethoxazole

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.
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.

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 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
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 cholesterol
• 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)
such as bisacodyl or senna; if used for a long

Lasilactone Capsules contain 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 medicinefor 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 Capsulesthan 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 medicinethat 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.
• 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

If you forget to take Lasilactone Capsules
If you forget a dose, take it as soon as you
remember it. Then continue the followingmorning as normal. Do not take a doubledose to make up for a forgotten dose.

Tell your 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)

If you stop taking Lasilactone Capsules
Keep taking Lasilactone Capsules until your
doctor tells you to stop taking it.

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

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.
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

Tell your doctor or pharmacist if any of the
known (Cannot be following side effects get serious or last
longer than a few days, or if you notice any
estimated from the available data)
• If you have an allergic reaction. The signs side effects not listed in this leaflet
may include inflammation of the kidney
(nephritis) or kidney failure, swollen ankles Frequency not known (cannot be estimated
or high blood pressure, skin rashes, change from the available data)
in skin colour, severe blistering of the skin, • Feeling sick (nausea) or a general feeling of
being unwell, diarrhoea and being sick
being more sensitive to the sun than usual,
(vomiting) and constipation
high temperature (fever), and itching
• Severe allergic reactions. The signs may • Feeling confused, moving unsteadily or
include shock such as difficulty in
staggering (ataxia)
breathing, cold clammy skin, pale skin • Lack of energy
colour and racing heart beat
• Feeling drowsy or sleepy (somnolence)
• Severe stomach or back pain. These could
• Headache
be signs of ‘pancreatitis’
• Brusing more easily, getting more • Breast swelling or growth sometimes with
nipple pain or sensitivity
infections, feeling weak or tired more than
usual. Lasilactone Capsules can affect the • Enlargement of breasts in men. This may go
number of blood cells, causing serious
away after you stop taking these capsules.
blood problems.
• Difficulty in getting or maintaining an
• Increased thirst, headache, feeling dizzy or
erection, or in ejaculation
light-headed, fainting, confusion, muscle • Redness of the skin
or joint pains or weakness, cramps or • Hair grows more than normal on the body or
spasms, stomach upsets or uneven heartface
• Menstrual periods which are heavier or last
These could be signs of dehydration or
longer than usual
changes in your normal body chemicals. • Lack/absence of menstrual periods
Severe dehydration can lead to blood clots
or ‘gout’
• Voice changes. For example hoarseness or
• You notice yellowing of your skin or eyes
deepening of the voice in women and
and your urine becomes darker in colour.
changes in the pitch in men. This may
These could be signs of a liver problem such
even after you stop taking these
as jaundice or hepatitis. 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.

Marketing Authorisation Holder and

• People with bladder and prostate problems
may notice pain when passing water. This is
due to an increase in the amount of water
• 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

Marketing Authorisation Holder
One Onslow Street
UKTel: 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
sureabout anything, ask your doctor or

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

This leaflet was last revised in September

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.

© Sanofi, 1977 - 2016

5. How to store Lasilactone Capsules
• Keep this medicine out of the sight and
reach of children
• 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. Contents of the pack and other
What Lasilactone Capsules contain
One of the active ingredients in this medicineis 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.

+ 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.