Skip to Content

UK Edition. Click here for US version.

SPIRONOLACTONE TABLETS BP 100MG

Active substance(s): SPIRONOLACTONE

View full screen / Print PDF » Download PDF ⇩
Transcript
Spironolactone 25mg, 50mg
and 100mg 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.

Index
1 What Spironolactone tablets are and what
they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1 What Spironolactone tablets are and what they are

used for

Spironolactone tablets belong to a group of medicines called potassiumsparing diuretics (water tablets), which help you lose excess fluid from your
body. They may be used for:
• congestive heart failure
• nephrotic syndrome (a kidney disorder)
• liver cirrhosis with fluid retention (oedema) and swelling of the abdomen
(ascites)
• a cancerous disease with swelling of the abdomen (malignant ascites)
• diagnosis and treatment of primary aldosteronism (a condition where
excess hormone is produced).

2 Before you take

• 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription. Especially:
• blood pressure lowering medicines (antihypertensives) such as ACE
inhibitors (e.g. captopril or enalapril) and angiotensin-II receptor
antagonists (such as valsartan or losartan)
• chlorpropamide (used in diabetes)
• digoxin (used in some heart conditions)
• ciclosporin or tacrolimus (used to prevent organ transplant rejection,
treat rheumatoid arthritis, eczema or psoriasis)
• fludrocortisone (a corticosteroid)
• warfarin (used to thin the blood)
• other potassium-sparing diuretics (water tablets)
• lithium (used for some mental illnesses)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as indometacin and
mefenamic acid
• aspirin to reduce, pain, inflammation and high temperature
• potassium supplements (potassium salts)
• noradrenaline (norepinephrine) (used for low blood pressure or heart
problems)
• an anaesthetic
• carbenoxolone (an ulcer healing drug)
• trimethoprim and trimethoprim-sulfamethoxazole.

Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant, speak to your doctor
before taking this medicine. Spironolactone tablets should not be taken if
you are breast-feeding.

Do not take Spironolactone tablets and tell your doctor if you:
• are allergic (hypersensitive) to spironolactone or any of the other
ingredients in Spironolactone tablets (see section 6)
• have diabetes with or without kidney problems
• have Addison’s disease (weakness, loss of energy, low blood pressure
and dark pigmentation of the skin)
• have kidney problems which may be severe or worsening
• have high blood levels of potassium
• are not passing urine.

Driving and using machines

Check with your doctor or pharmacist before taking Spironolactone
tablets if you have:
• a diet high in potassium
• low blood levels of sodium
• liver cirrhosis
• been passing small amounts of urine
• a severe illness
• or have ever had too much acid in the body
• an inherited disorder of the red blood pigment haemoglobin causing
skin blisters, abdominal pain and nervous system disorders (porphyria)
• abnormal periods or swollen breasts

Your doctor may want to carry out tests to monitor the levels of fluid and
chemicals in your body, especially if you are elderly or have impaired liver
or kidney function.

Spironolactone tablets may cause dizziness or drowsiness. Make sure you
are not affected before you drive or operate machinery.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact
your doctor before taking this medicine, as it contains a type of sugar
called lactose.

Tests

Diabetic and liver function tests

If you are to have liver function tests, you are to be tested for diabetes or
need to have other tests related to diabetes, tell your doctor that you are
taking Spironolactone tablets. Spironolactone tablets may need to be
stopped at least three days before a diabetes test.

Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Spironolactone 25mg, 50mg & 100mg 28 Tablets PIL - UK
item no: AAAI8124

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 25.02.16

min pt size: 7

1. Black
2.

revision date: 01.03.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Spironolactone Tablets 25, 50 &
100mg x 28’s (UK)
JDE No.:

50889830

4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 4170

3.

6.

originated by: S.Anson
approved for print/date

colours/plates:

Non Printing Colours
1.
2.
3.

Date Sent:
16/02/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

3 How to take

Always take Spironolactone tablets exactly as your doctor has told you. If you are
not sure, check with your doctor or pharmacist.
Swallow the tablets with water and preferably with food.
Doses:
•A
 dults
-C
 ongestive heart failure – 100mg a day. The maintenance dose is 25-200mg
a day. In difficult or severe cases, up to a maximum of 400mg a day may be
taken.
-N
 ephrotic syndrome – 100-200mg a day.
- L iver cirrhosis with fluid retention and swelling of the abdomen –
100-400mg a day. Your doctor will decide on the best maintenance dose for
you.
-A
 cancerous disease with swelling of the abdomen – 100-200mg a day.
Your doctor will decide on the best maintenance dose for you. In severe cases,
up to a maximum of 400mg a day may be taken.
- P rimary aldosteronism diagnosis –
Long test: 400mg a day for 3-4 weeks.
Short test: 400mg a day for 4 days.
- P rimary aldosteronism treatment – 100-400mg a day in preparation for
surgery. If surgery is not to be carried out, your doctor will decide on the best
maintenance dose for you.
• E lderly
Your doctor will decide on the best dose for you. If you have severely impaired
liver or kidney function, your doctor may prescribe a different dose.
•C
 hildren
Usual starting dose is 3mg per kg of bodyweight a day, to be taken in divided
doses. Your doctor will adjust the dose depending on the response to
treatment. If necessary, the tablets may be crushed and dispersed in food or
drink.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you
think a child may have swallowed any, contact your nearest hospital casualty
department or tell your doctor immediately. Symptoms of an overdose include
drowsiness, mental confusion, feeling or being sick, dizziness, diarrhoea,
decreased blood levels of sodium, increased blood levels of potassium
(symptoms include ‘pins and needles’ or tingling, unusual tiredness or weakness,
muscular weakness, paralysis with a loss of muscle tone, muscle spasm).

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember it and then take the
next dose at the right time. Do not take a double dose to make up for a forgotten
dose.

4 Possible side effects

Like all medicines, Spironolactone tablets can cause side effects, although not
everybody gets them.
Stop taking Spironolactone and contact your doctor at once if you develop
high blood levels of potassium (muscle twitching or weakness, irregular heart
beat, unusual tiredness or weakness, paralysis with or without loss of muscle
tone, circulatory failure), especially if you have impaired kidney function or a diet
high in potassium.
Contact your doctor immediately if you experience the following:
• a n allergic reaction (hypersensitivity) such as swelling of the face, lips, tongue
or throat, difficulty breathing or swallowing, shock, collapse, skin rash or itching.
• severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson
syndrome)
• severe rash involving reddening, peeling and swelling of the skin that
resembles severe burns (toxic epidermal necrolysis)
• severe skin rash involving fever and swelling
Tell your doctor or pharmacist if you notice any of the following side effects,
they get worse or if you notice anything not listed.
•B
 lood: increase in blood levels of nitrogen or urea especially in those with
impaired kidney function, altered numbers and types of blood cells. If you
notice increased bruising, nosebleeds, sore throats or infections, you should tell
your doctor who may want you to have a blood test.

•M
 etabolism and nutrition: low blood levels of sodium, changes in the levels
of chemicals in the body.
•N
 ervous system: lack of muscle control or coordination, drowsiness, dizziness,
headache, clumsiness.
• P sychiatric: tiredness, confusion.
• L iver: impaired liver function, a poisonous effect on the liver.
• Stomach and intestines: stomach upset, inflammation of the stomach
lining, bleeding in the stomach, stomach or intestinal ulcers, stomach cramps,
diarrhoea, feeling or being sick.
• Skin: skin rashes including pale or red irregular raised patches with severe
itching (hives), hair loss, excessive hair growth, itching, rash, pemphigoid
(condition presenting with fluid-filled blisters on the skin).
•M
 uscle and bone: bone softening due to vitamin D deficiency, leg cramps.
•K
 idneys: acute kidney failure particularly in those who already have impaired
kidney function.
•R
 eproductive system: enlarged breasts in men, changes in voice pitch,
reduced sexual potency in men, decreased sexual ability/drive, breast
tenderness, breast lumps and increased hair growth in females, irregular
periods, sweating.
•O
 ther: feeling of general discomfort and illness
Tell your doctor or pharmacist if you notice any of the above side effects,
they get worse or if you notice anything not listed.

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 tablets

Keep out of the reach and sight of children.
Do not store above 25 ºC.
Store in the original package.
Keep container in the outer carton.
Do not use Spironolactone tablets after the expiry date which is stated on the
label/carton/bottle. 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 Further information
What Spironolactone tablets contain

• T he active substance (the ingredient that makes the tablets work)
is spironolactone. Each tablet contains either 25mg, 50mg or
100mg of the active substance.
• T he other ingredients are lactose, magnesium stearate, maize
starch, microcrystalline cellulose, peppermint flavour, polyvidone,
sodium starch glycollate, purified water, iron oxide red (E172), iron
oxide yellow (E172), methylhydroxypropylcellulose (E5) (E464),
propylene glycol, titanium dioxide (E171).

What Spironolactone tablets look like and contents
of the pack
Spironolactone tablets are buff, circular, biconvex film-coated
tablets.
Pack size is 28.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in February 2016

If you would like a leaflet with larger
text, please contact
01271 385257.

Continued top of next column
50889830 AAAI8124

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Spironolactone 25mg, 50mg & 100mg 28 Tablets PIL - UK
item no: AAAI8124

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 25.02.16

min pt size: 7

1. Black
2.

revision date: 01.03.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Spironolactone Tablets 25, 50 &
100mg x 28’s (UK)
JDE No.:

50889830

4.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.

Pharmacode: 4170

3.

6.

originated by: S.Anson
approved for print/date

colours/plates:

Non Printing Colours
1.
2.
3.

Date Sent:
16/02/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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