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ALDACTIDE 50 TABLETS

Active substance(s): HYDROFLUMETHIAZIDE / SPIRONOLACTONE

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Package leaflet: Information for the patient

®
Aldactide
50mg and 25mg Tablets
(spironolactone and hydroflumethiazide)

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

1. What Aldactide is and what it is
used for
Aldactide is a diuretic medicine
(“water tablet”) used for the treatment of
Congestive Heart Failure.
You may have gone to your doctor because
of symptoms like swollen ankles and
breathlessness. This can happen when your
heart's pumping action has become weak
because of too much fluid in your body. This is
called 'congestive heart failure'. Pushing extra
fluid around your body means your heart has
to work harder. This may lead to weakness.
Your doctor has given you Aldactide to help
you lose the extra fluid from your body. This
will mean your heart has to do less work. You
lose the extra fluid as urine, so you may need
to go to the toilet more often while you are
taking Aldactide.
You must talk to a doctor if you do not feel
better or if you feel worse.

2. What you need to know before
you take Aldactide
Do not take Aldactide if:
you have had an unusual or allergic
reaction to spironolactone, thiazide,
diuretics or sulfonamides (a type of
antibiotic) in the past
you are allergic to any of the other
ingredients of this medicine (listed in
section 6)
you have Addison’s disease (a hormone
deficiency characterised by extreme
weakness, loss of weight and low blood
pressure)
you have hyperkalaemia (raised blood
potassium levels)
you have hypercalcaemia (raised blood
calcium levels)
you cannot pass urine
you have severe kidney disease
you are taking other potassium conserving
diuretics or potassium supplements,
which may induce hyperkalaemia

FPO

Warnings and precautions
Talk to your doctor or pharmacist before
taking Aldactide if:
you suffer from liver disease
you are pregnant
you have diabetes, gout, systemic lupus
erythematosus (lupus), or high blood fats,
(such as high cholesterol)
you are taking loop diuretics,
glucocorticoids or adrenocorticotropic
hormones (ACTH) as this may lead to
profound diuresis and hypokalaemia
(reduced blood potassium levels)
you are taking other diuretics, which may
cause hyponatraemia (reduced blood
sodium levels)
you have kidney problems
you need your blood potassium levels
to be monitored because you are taking
other medicines which could cause you to
lose too much body fluid
your eyesight changes or becomes painful
Other medicines and Aldactide
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicines
obtained without prescription. Your doctor
may wish to alter your dose of Aldactide if
you are taking any of the following:
digoxin, quinidine or other heart medicines
lithium or carbenoxolone
lipid-lowering medicines such as
colestyramine and colestipol
medicines for high blood pressure such
as angiotensin-converting enzyme (ACE)
inhibitors or angiotensin II antagonists
other diuretics

non-steroidal anti-inflammatory drug
(NSAIDs) such as aspirin, indometacin,
mefenamic acid or ibuprofen
mineral or vitamin supplements such as
potassium, calcium or vitamin D
medicines known to cause hyperkalaemia
(raised blood potassium levels), such as
aldosterone blockers
medicines used to prevent blood clots
such as heparin and low molecular
weight heparin
noradrenaline
medicines to treat diabetes such as insulin
corticosteroids
medicines to treat gout, such as
allopurinol and probenecid
If you are going to have an operation
where you will be given an anaesthetic, tell
the doctor in charge that you are taking
Aldactide.
Aldactide with food or drink
No food or drink interactions have been
described.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be
pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before
taking this medicine.
Aldactide should not be used if you are
breast-feeding.
You should discuss the use of Aldactide with
your doctor, who will advise you to consider
an alternative method of feeding your baby
while you are taking this medicine.
Driving and using machines
Take care if you drive or operate machinery.
The treatment may affect your ability to drive
or operate machinery safely.

3. How to take Aldactide
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure. The label on the pack also explains this
information. This medicine should be taken
once a day with food.
Adults
The recommended adult dose is 100mg
once daily. However the dosage will be
adjusted by your doctor as necessary and
may range from 25mg to 200mg a day.
If you are not sure how much to take, ask
your doctor or pharmacist.
Elderly
Your doctor will start you on a low starting
dose and gradually increase the dosage as
needed to obtain the desired effect.
Use in children and adolescents
If you are giving Aldactide to a child, the
number of tablets you give will depend on the
child's weight. Your doctor will work out the
number of tablets that you should give.
If you take more Aldactide than you should
If you accidentally take too many tablets,
contact your doctor or nearest hospital
accident department immediately. The
symptoms of an overdose are feeling drowsy
and dizzy. You may also feel or be sick or
may suffer from diarrhoea.
If you forget to take Aldactide
If you forget to take your tablet, take it as
soon as you remember, unless it is almost
time for your next dose. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Aldactide
Do not stop taking your tablets or alter the
dose you are currently taking without seeing
you doctor first, even if you start to feel better.
If you stop taking the tablets too soon, your
condition may get worse.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

FPO

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.

4. Possible side effects
Like all medicines, this medicine can cause
side effects although not everybody gets
them.
Tell your doctor immediately if you
experience any of the following symptoms
after taking this medicine. Although they are
very rare, the symptoms can be severe.
Irregular heartbeat, tingling sensation,
paralysis or difficulty in breathing, which
may be symptoms of raised potassium
levels in your blood. Your doctor will
conduct regular blood tests to monitor
potassium and other electrolyte levels.
He or she may stop your treatment if
necessary
Itchiness and blistering of the skin around
the lips and the rest of the body (StevensJohnson syndrome)
Detachment of the top layer of skin from
the lower layers of skin, all over the body
(toxic epidermal necrolysis)
Skin rash, fever and swelling (which could
be symptoms of something more serious,
drug rash and eosinophilia and systemic
symptoms)
Yellow skin and eyes (jaundice), Aldactide
can cause impairment of liver function
Decreased urine output with puffy eyes
(acute renal failure)
Black discoloration of your extremities
caused by necrotising vasculitis (gangrene
caused by poor circulation)
Other side effects of Aldactide
Feeling faint on standing (postural
hypotension), dizziness, vertigo
Indigestion, stomach pain, sickness, acute
pancreatitis
Confusion, numbness of parts of the body
(paraesthesia), feeling restless
Menstrual problems in women (heavy or
irregular menstrual flow)
Change in sex drive for both men and
women (impotence)
Disturbances in body electrolytes (high
blood calcium)
Decrease in blood platelets or red or white
blood cells (anaemia, leucopenia, or other
blood disorders)
Visual disturbances, abnormal colour
vision (xanthopsia), nearsightedness
(myopia), red eye, blurred vision, eye pain
Breast enlargement in men
(gynaecomastia), this goes away when
treatment is stopped
Breast lumps or tumour (benign breast
neoplasm), breast pain
Women develop deep voices
Skin rash, photosensitivity (a skin reaction
caused by exposure to sunlight)
Hair loss
General weakness, muscle cramps
Headaches
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.

5. How to store Aldactide
Keep this medicine out of the sight and
reach of children
Keep your tablets in a dry place, below 30°C
Do not use this medicine after the ‘expiry’
date which is stated on the pack after
‘EXP’. The expiry date refers to the last
day of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Aldactide contains
The active substances are spironolactone and
hydroflumethiazide. Each Aldactide 50 tablet
contains 50mg of spironolactone and 50mg
of hydroflumethiazide. Each Aldactide
25 tablet contains 25mg of spironolactone
and 25mg of hydroflumethiazide.
The other ingredients are calcium sulfate
dihydrate, corn starch, polyvinylpyrrolidone,
magnesium stearate, felcofix peppermint,
hypromellose, polyethylene glycol and
opaspray yellow (E171 and E172).

What Aldactide looks like and the contents
of the pack
The Aldactide 50 tablets are buff coloured,
film coated tablets engraved with
“SEARLE 180” on one side.
The Aldactide 25 tablets are buff coloured,
film coated tablets engraved with
“SEARLE 101” on one side.
Both Aldactide 50 and 25 tablets come in
packs of 100 and 500 tablets. Aldactide
50 tablets also come in calendar packs
of 28 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Pfizer Limited,
Ramsgate Road,
Sandwich,
Kent,
CT13 9NJ
United Kingdom
Manufacturer
Piramal Healthcare UK Limited,
Morpeth,
Northumberland,
NE61 3YA
United Kingdom
Company Contact address
For further information on this medicine,
please contact Medical Information at
Pfizer Limited, Walton Oaks, Tadworth,
Surrey, KT20 7NS, United Kingdom,
Tel: +44 1304 616161
This leaflet was last revised in 03/2015
Ref: AD 8_3

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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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