Spironolactone 25mg & 100mg Tablets leaflet approved ... - Genesis

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRONOLACTONE
25 mg & 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 any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Spironolactone is for
2. Before you take Spironolactone
3. How to take Spironolactone
4. Possible side effects
5. How to store Spironolactone
6. Further information
1. WHAT SPIRONOLACTONE IS FOR
Spironolactone belongs to a group of medicines
called diuretics (water tablets).
Spironolactone can be used to stop the build up of
extra water in your body. It does this without loss of
potassium from your body. This extra water can be
due to:
congestive heart failure causing swollen ankles
or shortness of breath
nephrotic syndrome (a kidney disorder)
hepatic cirrhosis (liver disease) causing ascites
(build up of fluid in your abdomen) or oedema
(build up of fluid in your body causing swelling of
the arms, hands, legs or feet)
malignant ascites (a condition in which fluid
containing cancer cells collect in your abdomen)
primary aldosteronism (a condition in which your
adrenal glands release too much of the hormone
aldosterone)
hypertension (high blood pressure) due to
primary aldosteronism.
Spironolactone works by helping you to pass more
water (urine) than you usually do.
2. BEFORE YOU TAKE SPIRONOLACTONE
Do not take Spironolactone and tell your
doctor if you
are allergic to Spironolactone or any of the other
ingredients in the tablets (listed in section 6 of
this leaflet)
have Addison's disease. This is when your
adrenal glands are not working properly. It can
cause weakness, tiredness, weight loss and low
blood pressure
have severe kidney problems
have high blood levels of potassium
have low blood levels of sodium
are not passing any water (urine).
Take special care with Spironolactone
Tell your doctor before you take this medicine if you
have liver or kidneys problems
suffer from porphyria (an inherited iron disorder).
Regular blood and urine tests may be needed to
monitor your fluid and electrolyte (e.g. potassium
and sodium) levels, especially if you are elderly or
have liver or kidneys problems.
Taking other medicines
Tell your doctor or pharmacist if you are taking or
have recently taken, any other medicines, even
medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are
taking any of the following medicines, as they may
affect how Spironolactone tablets work:
Other diuretics such as Amiloride or Triamterene
Medicines or supplements containing potassium
(including table salt substitutes)
Medicines to treat heart failure or irregular
heartbeats such as Digoxin, Digitoxin or
Eplerenone
Medicines to treat high blood pressure such as
Captopril, Candesartan, Clonidine,
Guanethidine, Doxazosin, Atenolol, Amlodipine
or Sodium Nitroprusside. Your doctor may need
to change the dose of your medicine
Medicines to treat chest pain such as Glyceryl
Trinitrate
Medicines for depression or mental health
problems such as Lithium, Amisulpride,
Pimozide, Sertindole, Amitriptyline, Moclobemide
or Prochlorperazine
Medicines to calm you down or to help you sleep
such as Diazepam
Carbamazepine to treat epilepsy
Trilostane for Cushings syndrome or breast cancer
Ciclosporin or Tacrolimus to stop the rejection of
organs after transplants
Cisplatin to treat various types of cancer
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
such as Aspirin, Ibuprofen or Ketorolac for pain
and swelling
Chlorpropramide to treat diabetes
Steroids such as Hydrocortisone or
Prednisolone to treat inflammation and allergies
Oestrogens for contraception or hormone
replacement therapy.
Spironolactone does not cause loss of potassium
from your body as other water tablets do. Therefore,
it is not necessary for you to get extra potassium in
your diet or take supplements. Too much potassium
could even be harmful.
AVOID ALCOHOL whilst taking this medicine.
If you are going to have an operation where you will
be given an anaesthetic, tell the doctor in charge
that you are taking Spironolactone.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you
are pregnant, planning a pregnancy or are breastfeeding.
Make sure you follow your doctor's advice.
Driving and using machines
Spironolactone may cause drowsiness or dizziness.
If affected do not drive or operate machinery.

3. HOW TO TAKE SPIRONOLACTONE
Always take Spironolactone tablets exactly as
your doctor has told you. Take this medicine once
a day with a meal.
Dosage
Your doctor will decide your dose and length of
treatment, as it depends on your condition.
Adults:
The usual adult dose varies from 25-200 mg once
a day.
Elderly:
Your doctor may start you on a low starting dose
and gradually increase the dosage as needed to
obtain the desired effect.
Children:
Your doctor will work out the number of tablets that
you should give to your child, as it depends on your
child's weight. The tablets can be crushed and
taken with food or drink if necessary.
If you take more Spironolactone than you
should
Contact your doctor or go to a hospital immediately.
Take the package or container with you. Symptoms
of an overdose may include drowsiness, dizziness,
confusion, nausea, vomiting or diarrhoea.
If you forget to take Spironolactone
Don't worry, just take your next scheduled dose at
the correct time. Do not take a double dose to make
up for the one you have missed.
If you stop taking Spironolactone
DO NOT STOP taking Spironolactone until your
doctor tells you to. 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, Spironolactone tablets can cause
side effects, although not everybody gets them.
If you have an allergic reaction to
Spironolactone see a doctor straight away
An allergic reaction may include:
skin rash, redness, itching or hives
swelling of the face, lips, mouth or throat
difficulty in breathing or swallowing.
If you get any of the following side effects,
STOP TAKING Spironolactone and see your
doctor as soon as possible:
high blood levels of potassium, which can cause
muscle weakness, tiredness or irregular
heartbeats
low blood levels of sodium, which can cause
tiredness, confusion, muscle cramps, fits or coma
liver damage, which can cause yellowing of the
skin or whites of the eyes (jaundice)
kidney damage, which can cause dehydration,
loss of appetite, aches and pains in the stomach
area or blood in your urine
blood disorders, which can cause unexplained
bleeding, bruising, sore throat, general illness or
fever.
The side effects mentioned above may alter the
results of blood and urine tests.
Other side effects include:
headache, dizziness, tiredness or confusion
stomach upsets, nausea, vomiting or diarrhoea
breast enlargement in men (this usually goes
away when treatment is stopped)
inability to achieve or maintain an erection
(impotence)
menstrual problems in women
soft bones
increase in the number of times and the amount
of water (urine) you pass. This may be due to the
medicine.
If any of the side effects become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SPIRONOLACTONE
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original
package or container and keep the container tightly
closed.
Do not use these tablets after the expiry date, which
is stated on the package or container. 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
The active ingredient in Spironolactone 25 mg and
100 mg tablets is spironolactone. The other
ingredients are calcium sulphate dihydrate, maize
starch, crospovidone, povidone, pregelatinised
starch, magnesium stearate, peppermint flavour
(peppermint oil and starch) and quinoline yellow
(E104).
What Spironolactone tablets look like and
contents of the pack
The 25 mg tablets are pale yellow tablets with the
marking MP28 on one side. The 100 mg tablets are
pale yellow tablets with the marking MP29 on one
side. Both strengths have a peppermint odour.
The tablets come in blister packs and containers of
28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
Haupt Pharma Berlin GmbH, Gradestrasse 13,
Moosrosenstrasse 5 and Britzer Damm 120,
12347 Berlin, Germany
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last approved in 05/2009
SPL0028-29/0025&0100T/LEA005