LASILACTONE CAPSULES

Active substance: SPIRONOLACTONE

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Ref: 0149/120514/1/F

®

Lasilactone Capsules / Lasilacton Capsules
Patient Information Leaflet
In particular, tell your doctor if you are taking any of the following:
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 gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist
Your medicine is called Lasilactone Capsules / Lasilacton Capsules but will
be called Lasilactone throughout this leaflet.
In this leaflet:
1

What Lasilactone is and what they are used for

2

Before you take Lasilactone

3

How to take Lasilactone

4

Possible side effects

5

How to store Lasilactone

6

Further information

1

What Lasilactone is and what is it used for

Lasilactone contains two different medicines called: furosemide and
spironolactone. Both belong to a group of medicines called diuretics (water
tablets). Lasilactone 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 works 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

Before you take Lasilactone

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 (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)
Do not take Lasilactone if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Lasilactone.
Take special care with Lasilactone

The following medicines can affect the way Lasilactone work and
increase the chance of you getting side effects:
* 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
surgery
* Medicines for diabetes. These may not work as well when you are taking
Lasilactone.
* Theophylline - used for wheezing or difficulty in breathing
* Phenytoin - used for epilepsy. This can lower the effect of Lasilactone.
The following medicines can increase the chance of side effects when
taken with Lasilactone:
* 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
* 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 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) 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 bambuterol)
* Other water tablets (diuretics) such as bendroflumethiazide. Your doctor
may need to change the dose of your medicine.
Taking Lasilactone with food and drink
Lasilactone should be swallowed with a full glass of water.
Pregnancy and breast-feeding
Do not take Lasilactone 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 Lasilactone. 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.

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 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 can cause
changes to your voice

Ask your doctor or pharmacist for advice before taking any medicine if you
are pregnant or breast-feeding.

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

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 children
* If you feel the effect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor

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

Driving and using machines
You may feel dizzy or unwell after taking Lasilactone. If this happens, do not
drive or use any tools or machines.
Important information about some of the ingredients of Lasilactone
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

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

How much Lasilactone 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.

Ref: 0149/120514/1/B

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Lasilactone Capsules / Lasilacton Capsules
Patient Information Leaflet (continued)
If you are taking sucralfate (a medicine for stomach ulcers)
Do not take sucralfate at the same time as Lasilactone. Take your dose at
least 2 hours before or after Lasilactone. This is because it can affect the
way your medicine works.
If you take more Lasilactone than you should
If you think you may have taken more Lasilactone than you should, or if a
child has swallowed any of your capsules, tell your doctor or go to you
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.

Blood tests
Lasilactone 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
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

If you forget to take Lasilactone
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
Keep taking Lasilactone 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.

4

Possible side effects

Like all medicines, Lasilactone 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 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.
* 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 kidneys
* 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.
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 leaflet
* Feeling sick (nausea) or a general feeling of being unwell, diarrhoea and
being sick (vomiting) and constipation
* Feeling confused, moving unsteadily or staggering
* 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 capsules.
* 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.

How to store Lasilactone

5

*
*
*

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
Store at ambient temperature protected from light
Store in original packaging

Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused
capsules to your pharmacist (chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to.
If your capsules become discoloured or show any other signs of
deterioration, consult your pharmacist (chemist) who will tell you what to do.
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 this medicine contains:
Each capsule contains 20mg of Furosemide and 50mg of Spironolactone as
the active ingredients.
Your medicine also contains the following inactive ingredients:
microcrystalline cellulose, lactose, talc, magnesium stearate, sodium
amylopectin glycolate, indigotin (FD&C Blue 2) (E132), titanium dioxide
(E171) and gelatin
What this medicine looks like and contents of the pack
Lasilactone are hard gelatine capsules with a white opaque body and blue
cap with no markings and are available in packs of 20, 30 or 50 capsules.
Manufacturer and Licence Holder
Your medicine is manufactured by Sanofi-Aventis Sp. z.o.o ul. Lubelska 52,
35-233 Rzeszow, Poland and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/0149

Lasilactone is a registered trademark of Aventis Pharma Deutschland GmbH.
Revision date: 12/05/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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