Skip to Content

UK Edition. Click here for US version.

SPIRONOLACTONE 50MG TABLETS

Active substance(s): SPIRONOLACTONE

View full screen / Print PDF » Download PDF ⇩
Transcript
TEVA UK Ref:

Version:

231-30-61263-Z LEA SPIRONOLACTONE A/S TABS TUK
SPIRONOLACTONE 25 mg,
50 mg AND 100 mg TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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 you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.

2

12 February 2016

Other important information you should
remember while taking Spironolactone
• If you see another doctor or go into hospital,
let him or the staff know what medicines you
are taking.
• Inform your doctor or dentist if you are taking
Spironolactone before undergoing surgery.
• Spironolactone may also cause problems if
you have a local or a general anaesthetic.

Other medicines and Spironolactone
Talk to your doctor if you are taking any of the
following:
• diuretics ('water tablets')
• potassium supplements
• ACE inhibitors (such as captopril or enalapril
maleate)
• antihypertensives (tablets for high blood
pressure)
• carbenoxolone (medicine used for treatment
of mouth and stomach ulcers)
WHAT IS IN THIS LEAFLET:
• noradrenaline (medicine used to treat
depression and hyperactivity)
1. What Spironolactone is and what it is used for
• aspirin, indometacin (non-steroidal
2. What you need to know before you take
anti-inflammatory drugs)
Spironolactone
• digoxin (medicine used to treat various heart
3. How to take Spironolactone
conditions)
4. Possible side effects
• trimethoprim and and
5. How to store Spironolactone
trimethoprim-sulfamethoxazole
6. Contents of the pack and other information
Please tell your doctor or pharmacist if you are
WHAT SPIRONOLACTONE IS AND
taking or have recently taken any other
WHAT IT IS USED FOR
medicines, including medicines obtained
without a prescription.
Spironolactone is a type of medicine called a
diuretic, which increases the amount of water
Pregnancy and breast-feeding
(urine) passed. Spironolactone is used to
Do not take Spironolactone if you are pregnant,
stimulate your kidneys to pass more urine, to
planning to become pregnant or breast-feeding.
get rid of excess water and salt which may be
Ask your doctor or pharmacist for advice before
causing problems.
taking any medicine.
Spironolactone Tablets are used for:
Driving and using machines
• treating build-up of fluid in the body (oedema) Spironolactone may cause drowsiness and
which may be caused by congestive heart
dizziness. If affected do not drive or operate
failure, liver cirrhosis, the kidney condition
machinery.
nephrotic syndrome (kidney damage which
Important information about some of the
results in large amounts of protein in the
ingredients of Spironolactone
urine) or ascites, a condition in which fluid
Patients who are intolerant to lactose should
collects in the abdomen
note that spironolactone tablets contain a small
• diagnosis and treatment of
amount of lactose. If your doctor has told you
hyperaldosteronism (overproduction of the
that you have an intolerance to some sugars,
hormone aldosterone).
contact your doctor before taking this medicine.

1

2

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE SPIRONOLACTONE

Do NOT take Spironolactone and talk to your
doctor if you:
• are allergic (hypersensitive) to spironolactone
or any of the other ingredients of this
medicine
• suffer from kidney failure, or significant
deterioration of kidney function
• have a high level of potassium in your blood
(hyperkalaemia)
• suffer from Addison's disease (an underactive
adrenal gland)
• are sometimes completely unable to pass
urine
• are pregnant or breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Spironolactone if you:
• suffer from or have a family history of liver
disease.
• suffer from kidney problems.
Concomitant administration of Spironolactone
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.

REG0068126

Version 2.7

Approved

3

HOW TO TAKE SPIRONOLACTONE

Always take spironolactone exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The spironolactone tablets should be swallowed
preferably with a glass of water and they
should be taken with food. The usual dose is:
Adults
The usual starting dose is 100 mg once daily.
This may then be adjusted by your doctor
according to your condition, up to a maximum
of 200 - 400 mg per day.
If spironolactone is being used by your doctor
to help in diagnosing your illness, a dose of
400 mg per day for up to four weeks may be
used. It may then be reduced, as appropriate.
Children
Your doctor will decide the correct dose for your
child based on their weight. This will be given in
divided doses and may be adjusted if necessary.
If a child has difficulty taking the tablets they
may be crushed and taken with food or drink.
The Elderly
Your doctor may begin your treatment with a
low dose, and then adjust it as appropriate,
particularly if you suffer from liver or kidney
problems.

Page 1 of 3

TEVA UK Ref:

231-30-61263-Z LEA SPIRONOLACTONE A/S TABS TUK
If you take more Spironolactone than you
should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately. An overdose is likely to
cause drowsiness, mental confusion, nausea,
vomiting, dizziness, or diarrhoea. Weakness or
muscle spasm may occur. Please take this
leaflet, any remaining tablets and the container
with you to the hospital or doctor so that they
know which tablets were consumed.
If you forget to take Spironolactone
If you forget to take a tablet, take one as soon
as you remember, unless it is nearly time to take
the next one. Do not take a double dose to make
up for a forgotten dose. Take the remaining
doses at the correct time.
If you stop taking Spironolactone
You should continue to take these tablets for as
long as your doctor tells you to.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Spironolactone can cause
side effects, although not everybody gets them.
If the following happens, stop taking the tablets
and tell your doctor immediately or go to the
casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face
or neck leading to severe difficulty in
breathing; skin rash or nettle rash).
This is a very serious but rare side effect. You
may need urgent medical attention or
hospitalisation.
Common (affects less than 1 in 10 people)
The following common side effects have been
reported:
• nausea and vomiting
• abdominal pain, diarrhoea or constipation
• drowsiness and lethargy
• headache
• mental confusion
• loss of co-ordination
• fever
• rashes
• breast soreness
• irregularities with your periods
• temporary impotence
• mild masculinisation effects (e.g. a deepening
of the voice in women)
• elevated levels of potassium in blood
(hyperkalaemia)
• liver problems (hepatotoxicity).

Version:

2

• sudden kidney failure
• pemphigoid (condition presenting with
fluid-filled blisters on the skin)
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 SPIRONOLACTONE

Keep this medicine out of the sight and reach
of children.
These tablets should be stored below 25°C,
protected from light, in the package or
container supplied. Do not transfer them to
another container. Do not use spironolactone
Tablets after the expiry date that is stated on
the outer packaging. The expiry date refers to
the last day of that month. 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 Spironolactone Tablets contain:
• The active ingredient is spironolactone 25 mg,
50 mg or 100 mg.
• The other ingredients are colloidal anhydrous
silica, sodium laurilsulfate, lactose
monohydrate, microcrystalline cellulose
(E460), rice starch, povidone (E1201),
peppermint oil, magnesium stearate,
hypromellose (E464), polyethylene glycol and
the colours titanium dioxide (E171) and iron
oxide (E172).
In addition to these ingredients the 25 mg
tablets contain agar (E460) and talc (E553b),
the 50 mg tablets contain agar (E460), and the
100 mg tablets contain sodium starch
glycolate, menthol and talc (E553b)
What Spironolactone looks like and contents
of the pack:
• The 25 mg tablet is a buff coloured biconvex
film-coated tablet marked "APS" or plain on
one side and "25 0705" on the reverse.
• The 50 mg tablet is a buff coloured biconvex
film-coated tablet marked “APS” or plain on
one side and “50 0707” on the reverse.
• The 100 mg tablet is a buff coloured biconvex
film-coated tablet marked "APS" or plain on
one side and "100 0706" on the reverse.

The product is available in pack sizes of 7, 10,
14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120,
150, 160 and 168 tablets. The 25 mg and 50 mg
• breast enlargement in men may occur, but this strength tablets are also available in a pack size
is usually reversible on stopping treatment.
of 500 tablets. See outer packaging or the
pharmacy label for contents i.e. the number of
Not known (frequency cannot be estimated
tablets.
from the available data)
Not all pack sizes may be marketed.
• change in sex drive for both men and women
Marketing Authorisation Holder and
(libido)
Manufacturer
• disturbances in body electrolytes
Marketing Authorisation holder and company
• reduced number of cells that fight infection responsible for manufacture: TEVA UK Limited,
white cells (leukopenia), reduced number of
Eastbourne, BN22 9AG
cells that help with clotting
(thrombocytopenia)
This leaflet was last revised: January 2016
• excessive growth of breast tissue in men
PL 00289/0071-72, PL00289/0136
(gynaecomastia)
• skin rash, generalised itchiness
• skin allergy with development of itchiness and
weals (urticaria), excessive hair growth
(hypertrichosis)
• hair loss
61263-Z
• general weakness, muscle cramps
Rare (may affect up to 1 in 1,000 people)

REG0068126

Version 2.7

Approved

Page 2 of 3

12 February 2016

Expand view ⇕

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.

Hide