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SPIRONOLACTONE 25 MG FILM-COATED TABLETS

Active substance(s): SPIRONOLACTONE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Spironolacton

Market

UK-IE

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

1 (Page 1 of 2)

Date

07_12_15 (Spironolacton (ACC-UK-IE) PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Package leaflet: Information for the user

Spironolactone 25 mg
film-coated tablets
Spironolactone 50 mg
film-coated tablets
Spironolactone 100 mg
film-coated tablets
spironolactone

Read all of this leaflet carefully before you
start using 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 iftheir signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Spironolactone film-coated tablet is and
what it is used for
2. What you need to know before you take
Spironolactone film-coated tablets
3. How to take Spironolactone film-coated tablets
4. Possible side effects
5. How to store Spironolactone film-coated
tablets
6. Contents of the pack and other information

1. What Spironolactone
film-coated tablet is and what
it is used for
The active ingredient of the tablets is
Spironolactone. Spironolactone belongs to a
particular group of medicines, known as
aldosterone antagonists, which inhibit the action
of the hormone aldosterone. One of the functions
of aldosterone is to ensure that the body retains
sodium. It forms part of a system that regulates
the balance of fluids and salts in the body
(‘RAAS’, renin angiotensin aldosterone system).
Spironolactone promotes the excretion of urine in
patients in whom there is an accumulation of fluid
in the tissues (oedema) or in the abdominal
cavity (ascites) by increasing the amount of
sodium (salt) excreted in the urine. Potassium
loss as a possible consequence of using certain
diuretics is reduced. The antihypertensive effect
relies on the excretion of water and salt.
Spironolactone film-coated tablets may be
prescribed by your doctor for the treatment of:
• accumulation of fluid in the tissues as a result of
heart disorders;
• severe heart failure (NYHA III-IV)
• raised blood pressure as an adjunct to a
salt-free diet and diuretics;
• certain kidney disorders;
• accumulation of fluid in the tissues in the
abdominal cavity.
Spironolactone film-coated tablets may also be
used:
during medical investigations (diagnostics) to
confirm the presence of disorders in which too
high a level of aldosterone is produced in the
adrenal cortex (known as Conn’s disease) and
treatment.
Children should only be treated under guidance
of a paediatric specialist.

2. What you need to know before
you take Spironolactone
film-coated tablets
Do not take Spironolactone film-coated tablets
• if you are allergic to spironolactone or any of the
other ingredients of this medicine (listed in
section 6).
• if you suffer from severely impaired kidney
function or from a sudden or rapidly
deteriorating kidney disease, including cases in
which no urine, or very little urine, is being
produced.
• if you have low blood sodium levels
(hyponatraemia)
• if you have hyperkalaemia (raised blood
potassium levels) or any other conditions
associated with hyperkalaemia
• if you are are taking potassium-sparing diuretics
(including eplerenone) or potassium-supplements,
or dual-RAAS blockade with the combination of
an angiotensin converting enzyme (ACE) inhibitor
and an angiotensin receptor blocker (ARB).
Children
Children with moderate to severe kidney disease
must not take Spironolactone film-coated tablets.
Take special care with Spironolactone
film-coated tablets
• if you suffer from kidney disease especially
children with hypertension. Your doctor will
routinely assess you.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Spironolactone film-coated tablets
• if you need to use Spironolactone film-coated
tablets for a long time; your doctor should
perform regular follow-up checks (for example
on the levels of potassium and sodium in your
blood), especially if you are elderly.
• if you have a liver disorder; your doctor should
exercise caution when treating you;
• if you have a kidney disorder; your doctor
should exercise caution when treating you;
• if you have a raised level of potassium in the
blood or impaired kidney function;
administration of Spironacton Accord is not
advised (see also “Do not take Spironolactone
film-coated tablets”);
• if you have severe renal dysfunction which is
being simultaneously treated with potassium
supplements, since sever hyperkalaemia can

Approved By
Quality Assurance

occur which can result in cardiac arrest
(sometimes fatal).
• if you use certain diuretics, called
potassium-sparing diuretics (such as amiloride
and triamterene); concomitant use with
Spironolactone film-coated tablet is
contra-indicated, because the risk of
excessively high levels of potassium in the
blood (hyperkalaemia) is increased.
• in the case of long-term treatment of young
patients with Spironolactone film-coated tablets,
your doctor should weigh the advantages
carefully against the long-term disadvantages.
Tell your doctor if one of the above warnings
applies to you, or has done so in the past.
Other medicines and Spironolactone
film-coated tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription, your doctor may wish to alter your
dose of Spironolactone film-coated tablets if you
are taking any of the following.
• medicines for high blood pressure including
ACE inhibitors, ganglion-blocking drugs
• other diuretics
• non-steroidal anti-inflammatory drug (NSAID)
such as aspirin or ibuprofen
• potassium supplements
• heparin or low molecular weight heparin
(medicines used to prevent blood clots)
• drugs that inhibit blood coagulation
(anticoagulants, ‘blood thinners’)noradrenaline
(an agent with a stimulant effect on a particular
part of the nervous system (sympathomimetic))
• lithium (used to treat depression)
• digoxin (used in the treatment of various heart
conditions)
• alcohol, barbiturates or narcotics
• medicines known to cause hyperkalaemia
(raised blood potassium levels)
• Cholestyramine (used for reducing cholesterol
levels in the blood)
• Corticosteroids, ACTH (prescribed for different
epileptic conditions)
• ammonium chloride (e.g. in liquorice)
• Ciclosporin
Spironolactone film-coated tablets with food
The action of Spironolactone is not affected by
food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Sprinonolactone should not be used during
pregnancy.
Sprinonolactone should only be used during
breast-feeding if clearly needed.
You should discuss the use of Sprinonolactone
with your doctor, who will advise you to consider
an alternative method of feeding your baby while
you are taking this medicine.
Spironolactone may induce impotence and
menstrual irregularities.
Driving and using machines
Side effects such as dizziness, headache and
confusion can sometimes occur while you are
using Spironolactone film-coated tablets. In this
case, do not drive a vehicle or use machines.
Spironolactone film-coated tablets contains
lactose
This medicine contains lactose. If you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking
this medicinal product.

3. How to take Spironolactone
film-coated tablets
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 recommended dose is:
Adults
The recommended dosage is 100 mg daily,
administered as one or several doses. The adult
dose varies from 25mg to 400mg spironolactone
a day. If you are not sure how much to take, ask
your doctor or pharmacist.
You should take the tablets with meals. If the total
dose is more than 100 mg per day, the dose must
be administered in divided doses spread
throughout the day.
Use in children
The recommended dose is 3 mg per kg body
weight daily, in several divided doses. In order to
make it easier for children to take, the tablets
may first be ground or crushed and then
suspended in a glass of water by stirring.
The elderly
It is recommended that elderly patients should be
started on the lowest possible dose, increasing
this gradually until the desired effect is achieved.
Caution and regular medical checks are advised,
especially in the event of renal impairment.
Remember to take your medicine. Taking your
tablets at the same time each day gives the best
effect. It also helps you remember when you
should take the tablets.
If you take more Spironolactone film-coated
tablets than you should
If you have taken too much Spironolactone
film-coated tablets, contact your doctor or
pharmacist immediately. Keep the pack so that
the doctor can see what medicine you have
taken.
Symptoms of overdose can include nause and
vomiting, and (more rarely) drowsiness,
confusion, skin rash or diarrhoea. Disturbance of
the fluid and salt balance and dehydration may
occur.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Spironolacton

Market

UK-IE

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

1 (Page 2 of 2)

Date

07_12_15 (Spironolacton (ACC-UK-IE) PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

If you forget to take Spironolactone
film-coated tablets
If you have forgotten to take a dose, take it as
soon as possible unless it is almost time to take
the next dose, in which case you should not take
the forgotten dose, but continue according to the
schedule prescribed. Do not take a double dose
to make up for a forgotten dose. Ask your doctor
or pharmacist if you are not sure.
If you stop taking Spironolactone film-coated
tablets
If you stop using Spironolactone film-coated
tablets, the original symptoms may return. Always
contact your doctor if you want to stop using the
medicine.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The side effects depend on the dose and the
duration of treatment.
The most common side effects are
hyperkalaemia, reproductive system and breast
disorders, including gynaecomastia.
Gynaecomastia appears to be related to both
dosage level and duration of therapy and is
usually reversible as soon as the treatment is
discontinued. Other very common undesirable
side effects are headache, digestive
disturbances, diarrhoea, fatigue and drowsiness.
Very common: may affect more than 1 in 10
people
• Hyperkalaemia in patients with severe renal
dysfunction who are receiving concomitant
treatment with potassium supplements
• Headache
• Indigestion, diarrhoea
• Men: reduced libido, erectile dysfunction,
impotence, enlargement of the mammary
glands (gynaecomastia);
• Women: breast disorders, tenderness of the
breasts, menstrual disorders, deepening of the
voice (in many cases irreversible)
• Fatigue, drowsiness
Common: may affect up to 1 in 10 people
• Hyponatraemia (in particular during combined
intensive therapy with thiazide diuretics),
hyperkalaemia in (1) patients with severe renal
dysfunction, (2) patients receiving treatment
with ACE inhibitors or potassium chloride, (3)
the elderly, and (4) diabetic patients
• Nausea and vomiting
• Women: changes in vaginal secretions, reduced
libido, absence of periods (amenorrhoea),
post-menopausal bleeding
• Weakness, somnolence (lethargy) in patients
with cirrhosis, sensations of tickling, itching or
tingling for which there is no cause
(paraesthesia)
• General weakness
Uncommon: may affect up to 1 in 100 people
• Acidity of the blood (acidosis) in patients with
liver problems
• Confusion
• Skin rash, urticaria, erythema, chloasma,
generalised itchiness
• Muscle spasms
• Leg cramps
• Elevated serum creatinine levels
Rare: may affect up to 1 in 1,000 people
• Very severe blood abnormalities (deficiency of
white blood cells) accompanied by sudden high
fever, severe throat pain and mouth ulcers
(agranulocytosis), blood abnormality (platelet
deficiency) accompanied by bruises and
tendency to bleed (thrombocytopenia),
• Allergic reactions
• Insufficient fluid in the tissues (dehydration),
porphyria, temporary increase in nitrogen levels
in the blood and urine, elevated uric acid levels
in the blood (hyperuricemia), This can in
susceptible patients lead to gout attacks.
• Paralysis, paraplegia of the limbs due to
hyperkalaemia
Very rare: may affect up to 1 in 10,000 people
• Breast cancer
• Inflammation of the vessel walls (vasculitis)
• Gastric inflammation, gastric ulcers,
gastrointestinal haemorrhage, cramps
• Hepatitis
• Alopecia, eczema, erythema annulare
centrifugum (EAC)
• Systemic lupus erythematosus (SLE)
• Acute renal failure
• Excessive hair growth (hypertrichosis)
• Bone softening (osteomalacia)
Not known: frequency cannot be estimated
from the available data
• Slight androgenic effects, including hirsutism.
• Reversible hyperchloraemic metabolic acidosis
– usually accompanied by hyperkalaemia – has
been reported in some patients with
decompensated hepatic cirrhosis, even where
renal function was normal.
• Dizziness, ataxia
• Mild hypotension
• Itchiness and blistering of the skin around the
lips and the rest of the body (Stevens-Johnson
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)
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via
For UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
For Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2

Approved By
Quality Assurance

Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Spironolactone
film-coated tablets
• Keep this medicine out of the sight and reach of
children.
• This medicinal product does not require any
special temperature storage conditions. Store in
the original package in order to protect from light.
• Do not use this medicine after the expiry date
which is stated on the carton and blister 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 protect
the environment.

6. Contents of the pack and
other information
What Spironolactone film-coated tablets
contains
The active substance is spironolactone.
Spironolactone film-coated tablets contains 25 mg,
50 mg or 100 mg spironolactone.
The other ingredients are:
Core of the tablet
Lactose monohydrate, pregelatinised corn starch ,
calcium hydrogen phosphate, anhydrous,
povidone K25, peppermint oil, purified talc, silica,
colloidal anhydrous, magnesium stearate (E470b).
Film coating
Hypromellose, macrogol, titanium dioxide (E171).
What Spironolactone film-coated tablets
looks like and contents of the pack
Spironolactone 25 mg, film-coated tablets are
white to pale white, round, biconvex tablets
printed with ‘AD’ on one side and no imprint on
the other side. 25mg tablet diameter is
approximately 8.1 mm.
Spironolactone 50 mg, film-coated tablets are
white to pale white, round, biconvex tablets
printed with ‘AE’ on one side and no imprint on
the other side. 50mg tablet diameter is
approximately 10.1 mm.
Spironolactone 100 mg, film-coated tablets are
white to pale white, round, biconvex tablets
printed with ‘AF’ on one side and no imprint on
the other side. 100mg tablet diameter is
approximately 11.2 mm.
Spironolactone film-coated tablets are packaged
in blister strips with 10 tablets. The carton
contains 20, 30, 50, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF,
United Kingdom.
This medicinal product is authorised in the
member states of the EEA under the following
names:
Country
The Natherland

Invented Name
Spironolacton Accord 25mg/
50 mg/100 mg filmomhulde
tabletten
Bulgaria
Spironolactone Accord 25 mg/
50 mg/100 mg филмирани
таблетки
Cyprus
Spironolactone Accord 25 mg/
100 mg Επικαλυμμένα με
λεπτό υμένιο δισκία
Germany
Spironolacton Accord 25 mg/
50 mg/100 mg Filmtabletten
Denmark
Spironolactone Accord 25 mg/
50 mg/100 mg filmovertrukne
tabletter
Estonia
Spironolactone Accord
Spain
Spironolactone Accord 25 mg/
100 mg comprimidos
recubiertos con película
Ireland
Spironolactone 25 mg/50 mg/
100 mg film-coated tablets
Lithuania
Spironolactone Accord 25 mg/
50 mg/100 mg plėvele dengtos
tabletės
Latvia
Spironolactone Accord 25 mg/
50 mg/100 mg apvalkotās
abletes
Malta
Spironolactone 25 mg/100 mg
film-coated tablets
Poland
Ismian
Sweden
Spironolactone Accord 25 mg/
50 mg/100 mg filmdragerad
tablet
Slovakia
Spironolactone Accord 25 mg/
50 mg/100 mg filmom obalené
tablety
United Kingdom Spironolactone 25 mg/50 mg/
100 mg film-coated tablets
This leaflet was last revised in 12/2015.

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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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