Spironolactone 50mg tablets

Main information

  • Trade name:
  • Spironolactone 50mg tablets
  • Dosage:
  • 50mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Spironolactone 50mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02020300

Status

  • Source:
  • eMC
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

TEVA UK Ref:

231-30-61263-Z

LEA SPIRONOLACTONE A/S TABS TUK <DEB

12 February 2016

Version:

2

WHAT IS IN THIS LEAFLET:

PACKAGE LEAFLET:

INFORMATION FOR THE USER

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)

noradrenaline (medicine used to treat

depression and hyperactivity)

aspirin, indometacin (non-steroidal

anti-inflammatory drugs)

digoxin (medicine used to treat various heart

conditions)

trimethoprim and and

trimethoprim-sulfamethoxazole

Please tell your doctor or pharmacist if you are

taking or have recently taken any other

medicines, including medicines obtained

without a prescription.

Pregnancy and breast-feeding

Do not take Spironolactone if you are pregnant,

planning to become pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before

taking any medicine.

Driving and using machines

Spironolactone may cause drowsiness and

dizziness. If affected do not drive or operate

machinery.

Important information about some of the

ingredients of Spironolactone

Patients who are intolerant to lactose should

note that spironolactone tablets contain a small

amount of lactose. If your doctor has told you

that you have an intolerance to some sugars,

contact your doctor before taking this medicine.

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.

SPIRONOLACTONE 25 mg,

50 mg AND 100 mg TABLETS

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.

1.

What Spironolactone is and what it is used for

2. What you need to know before you take

Spironolactone

3. How to take Spironolactone

4. Possible side effects

5. How to store Spironolactone

6. Contents of the pack and other information

WHAT SPIRONOLACTONE IS AND

WHAT IT IS USED FOR

Spironolactone is a type of medicine called a

diuretic, which increases the amount of water

(urine) passed. Spironolactone is used to

stimulate your kidneys to pass more urine, to

get rid of excess water and salt which may be

causing problems.

Spironolactone Tablets are used for:

treating build-up of fluid in the body (oedema)

which may be caused by congestive heart

failure, liver cirrhosis, the kidney condition

nephrotic syndrome (kidney damage which

results in large amounts of protein in the

urine) or ascites, a condition in which fluid

collects in the abdomen

diagnosis and treatment of

hyperaldosteronism (overproduction of the

hormone aldosterone).

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.

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TEVA UK Ref:

231-30-61263-Z

LEA SPIRONOLACTONE A/S TABS TUK <DEB

12 February 2016

Version:

2

61263-Z

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.

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).

Rare (may affect up to 1 in 1,000 people)

breast enlargement in men may occur, but this

is usually reversible on stopping treatment.

Not known (frequency cannot be estimated

from the available data)

change in sex drive for both men and women

(libido)

disturbances in body electrolytes

reduced number of cells that fight infection -

white cells (leukopenia), reduced number of

cells that help with clotting

(thrombocytopenia)

excessive growth of breast tissue in men

(gynaecomastia)

skin rash, generalised itchiness

skin allergy with development of itchiness and

weals (urticaria), excessive hair growth

(hypertrichosis)

hair loss

general weakness, muscle cramps

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.

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.

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

strength tablets are also available in a pack size

of 500 tablets. See outer packaging or the

pharmacy label for contents i.e. the number of

tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and

Manufacturer

Marketing Authorisation holder and company

responsible for manufacture: TEVA UK Limited,

Eastbourne, BN22 9AG

This leaflet was last revised: January 2016

PL 00289/0071-72, PL00289/0136

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