Aldactone 25mg Film-coated Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Spironolactone
Available from:
Imbat Limited
ATC code:
C03DA; C03DA01
INN (International Name):
Spironolactone
Dosage:
25 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Aldosterone antagonists; spironolactone
Authorization status:
Authorised
Authorization number:
PPA1151/197/001
Authorization date:
2014-08-01

Page 1 of 2

PACKAGE LEAFLET:

INFORMATION FOR THE PATIENT

Aldactone

®

25mg Film-coated Tablets

(spironolactone)

Your medicine is available using the name Aldactone 25mg

Film-coated Tablets but will be referred to as Aldactone

throughout this leaflet.

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.

What is in this leaflet:

What Aldactone is and what it is used for

What you need to know before you take Aldactone

How to take Aldactone

Possible side effects

How to store Aldactone

Contents of the pack and other information

1.

What Aldactone is and what it is used for

Aldactone belongs to a group of medicines called ‘diuretics’ -

you may know these as ‘water’ tablets. You may have gone to

your doctor because you had swollen ankles or were short of

breath. 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. Your

doctor has given you Aldactone 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 Aldactone.

Your doctor may also give you Aldactone if your blood

pressure is higher than it should be. This is called

‘hypertension’. High blood pressure occurs when there is

increased pressure of blood within the walls of your blood

vessels. By taking fluid from within your blood vessels,

Aldactone reduces the pressure on the walls of the blood

vessels and so lowers your blood pressure.

You can also take Aldactone for the following illnesses:

'Nephrotic syndrome' - a kidney disorder that causes too

much fluid in your body

'Ascites' - too much fluid in your abdomen and ‘Oedema’

- accumulation of fluid beneath skin or in one or more

cavities of the body that produces swelling, for example

caused by cirrhosis of the liver

‘Malignant ascites’ - fluid containing cancer cells that

collect in the abdomen

'Primary aldosteronism' - extra fluid in your body caused

by too much of a hormone called 'aldosterone'.

If you have these illnesses, Aldactone will help your body to

get rid of the extra fluid.

You must talk to a doctor if you do not feel better or if you

feel worse.

Children should only be treated under guidance of a

paediatric specialist.

2.

What you need to know before you take

Aldactone

Do not take Aldactone:

if you are allergic to spironolactone or any of the other

ingredients of this medicine (listed in section 6)

if you have Addison’s disease (a hormone deficiency

characterised by extreme weakness, loss of weight and

low blood pressure)

if you have hyperkalemia (raised blood potassium

levels) or any other conditions associated with

hyperkalemia

if you cannot pass urine

if you have severe kidney disease

if you are already taking another similar use drug known

as eplerenone

if you are taking water tablets (potassium sparing

diuretics) or any potassium supplements

if you are breast feeding.

Children with moderate to severe kidney disease must not

take Aldactone.

Warnings and precautions

Talk to your doctor or pharmacist before taking Aldactone:

if you suffer from kidney disease especially children with

hypertension or liver disease

if you are an elderly patient or

if you have difficulty passing urine, or

if you

have a disease that can result in electrolyte

balance disturbance in your blood

if you suffer from any increase or decrease of

electrolytes in your blood such as potassium or sodium

if you have severe heart failure

if you experience reduced kidney function or kidney

failure you may have severe increases in the levels of

potassium in your blood. This can affect the way your

heart functions and in extreme cases this can be fatal

if you are taking any other water tablets (diuretics) in

combination with Aldactone which may cause low

sodium levels (hyponatraemia) in the blood

if you are pregnant

Concomitant administration of Aldactone with certain

medicines, potassium supplements and food rich in potassium

may lead to severe hyperkalemia (increased potassium blood

level). The symptoms of severe hyperkalemia might include

muscle cramps, irregular heart rhythm, diarrhoea, nausea,

dizziness or headache.

Other medicines and Aldactone

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines. The use of

Aldactone with high potassium salt diet and salt substitutes

containing potassium may lead to increased levels of

potassium in your blood. Your doctor may wish to alter your

dose of Aldactone if you are taking any of the following:

ACE inhibitors, digoxin or other anti-arrhythmic

medicines

lithium, antipyrine, colestyramine, ammonium chloride

or carbenoxolone

medicines for high blood pressure including angiotensin-

converting enzyme (ACE) inhibitors

other diuretics

non-steroidal anti-inflammatory drugs (NSAIDs) such as

aspirin, ibuprofen or mefenamic acid

potassium supplements

noradrenaline

cardiac glycosides, used in the treatment of heart failure

regional or general anaesthesia

anti-pyrines, used to reduce fever

heparin (a medicine preventing blood clots forming)

medicines known to cause hyperkalemia (raised blood

potassium levels)

trimethoprim and trimethoprim-sulfamethoxazole

If you are going to have an operation where you will be given

an anaesthetic, tell the doctor in charge that you are taking

Aldactone.

Aldactone with food and drink

This medicine should be taken with food (see section 3 ‘How

to take Aldactone’).

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.

Aldactone should not be used if you are breast-feeding. You

should discuss the use of Aldactone 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. Drowsiness and

dizziness have been associated with Aldactone treatment and

this may affect your ability to drive or operate machinery

safely.

Page 2 of 2

3.

How to take Aldactone

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 pharmacist's label on the

pack also gives this information. The number of tablets you

need to take depends on your illness.

The recommended dose is once a day with food.

Use in adults

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.

Use in the 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 Aldactone 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 Aldactone than you should

If you accidentally take too many tablets, contact your doctor

or nearest hospital accident and emergency department

immediately. The symptoms of an overdose are feeling

drowsy, dizzy, feeling dehydrated and you may feel confused.

You may also feel or be sick, suffer from diarrhoea and may

have skin rashes that will appear as flat red areas of skin with

overlapping small raised bumps. Changes in your blood

sodium and potassium levels may leave you feeling weak and

suffering from tingling, prickling or numbness of the skin

and/or muscle spasms but these symptoms are unlikely to be

associated with severe over dosage.

If you forget to take Aldactone

Do not take a double dose to make up for a forgotten tablet.

If you forget to take your tablet, take it as soon as you

remember, unless it is almost time for your next dose.

If you stop taking Aldactone

It is important to keep taking Aldactone until your doctor tells

you to stop, 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.

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.

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)

Yellow skin and eyes (jaundice; Aldactone can cause

impairment of liver function)

Irregular heartbeat that can be fatal, tingling sensation,

paralysis (loss of muscle function) 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.

Other side effects of Aldactone

Nausea, stomach upset, fever

Confusion, dizziness, drowsiness, headache, feeling

generally unwell

Menstrual problems in women, temporary impotence in

Change in sex drive for both men and women (libido)

Disturbances in body electrolytes such as high blood

calcium

Reduced number of cells that fight infection - white cells

(leukopenia), reduced number of cells carrying oxygen

(anaemia) or that help with clotting (thrombocytopenia)

or increased eosinophil count in the blood (eosinophilia).

This may cause you to bruise more easily or cause

purple spots on the skin (purpura)

Breast enlargement in men (gynaecomastia, this goes

away when treatment is stopped), breast lumps, breast

pain

Skin rash, generalised itchiness

Skin allergy with development of itchiness and weals

(urticaria), excessive hair growth (hypertrichosis),

skin condition presenting with fluid-filled blisters

(pemphigoid)

Hair loss

General weakness or lethargy, headaches, muscle or leg

cramps and problems coordinating muscle movements

(ataxia)

Kidney failure or abnormal function

Raised potassium in the blood (hyperkalemia).

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

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

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 Aldactone

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated

on the blister and carton after Exp. The expiry date refers to

the last day of that month.

Do not store above 30°C. Keep the blisters in the outer

carton.

If your doctor decides to stop the treatment, return any

leftover medicine to the pharmacist. Only keep it if your

doctor tells you to.

If your medicine appears to be discoloured or shows any

other signs of deterioration, please return to your pharmacist

who will advise you further.

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

information

What Aldactone contains

The active substance is spironolactone.

Each film-coated tablet contains 25mg of spironolactone.

The other ingredients are: calcium sulphate dihydrate,

corn starch, povidone, peppermint flavour and

magnesium stearate.

Coating: hydroxypropylmethylcellulose, polyethylene glycol

and Opaspray M-1-7111 B (white).

What Aldactone looks like and contents of the pack

Aldactone are white, round, biconvex tablets, marked with

‘SEARLE 39’ on one side and scored on the other.

Your tablets are available in packs of 100 tablets.

Manufacturer

Manufactured by:

Farmasierra Manufacturing, S.L., Carretera de Irún, Km.

26,200, 28700 San Sebastián de los Reyes (Madrid), Spain.

Procured from within the EU by the PPA holder:

Imbat Ltd., Unit L2, North Ring Business Park, Santry,

Dublin 9.

Repackaged by: Doncaster Pharmaceuticals Group Ltd.,

Kirk Sandall, Doncaster, South Yorkshire, DN3 1QR, UK.

Distributed by: Eurodrug Ltd., Santry, Dublin 9.

PPA No: 1151/197/1

Leaflet revision and issue date (ref): 27.04.16

Aldactone

is a registered trademark of G.D. Searle LLC.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Aldactone 25mg Film-coated Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 25 mg of spironolactone.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated Tablet

Product imported from Spain:

White, round, biconvex tablets, marked with ‘SEARLE 39’ on one side and scored on the other.

4 CLINICAL PARTICULARS

As per PA0822/110/001

5 PHARMACOLOGICAL PROPERTIES

As per PA0822/110/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium sulphate dihydrate

Corn starch

Povidone

Peppermint flavour

Magnesium stearate

Coating:

Hyproxypropylmethylcellulose

Polyethylene glycol

Opaspray M-1-7111 B (white)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life expiry date of this product shall be the date shown on the blister strips and outer carton of the product as

marked in the country of origin.

6.4 Special precautions for storage

Do not store above 30°C. Keep the blisters in the outer carton.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

4

/

0

6

/

2

0

1

5

C

R

N

2

1

6

0

4

5

7

p

a

g

e

n

u

m

b

e

r

:

1

6.5 Nature and contents of container

Outer carton containing blister strips

Pack size: 100 tablets (4 x 25 tablets)

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Imbat Limited

Unit L2,

North Ring Business Park,

Santry,

Dublin 9,

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1151/197/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1

August 2014

10 DATE OF REVISION OF THE TEXT

June 2015

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

4

/

0

6

/

2

0

1

5

C

R

N

2

1

6

0

4

5

7

p

a

g

e

n

u

m

b

e

r

:

2

Similar products

Search alerts related to this product

View documents history

Share this information