SPIROTONE

Spironolactone 25mg and 100mg Tablets

What is in this leaflet

This leaflet answers some common questions about SPIROTONE. It does not
contain all the information available on this medicine. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks and
benefits. Your doctor has weighed the risks of using SPIROTONE against the
benefits expected it will have for you. If you have any concerns about using
this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may want to read it again.

What SPIROTONE is used for and how it works

Your SPIROTONE tablets contain the active ingredient spironolactone. It
belongs to a group of medicines known as diuretics.

SPIROTONE is used to lower high blood pressure, also called hypertension. It
treats fluid build-up in the body which can occur in some heart, liver or kidney
conditions. It helps bring potassium levels in the blood back to normal when the
levels become too low. It also treats a condition called hyperaldosteronism and
excess facial or body hair in women.

Your doctor may, however, prescribe SPIROTONE for another reason. Ask your
doctor if you have any questions about why SPIROTONE has been prescribed for
you.

There is no evidence that SPIROTONE is addictive.

SPIROTONE is available on prescription from your doctor.

Before you take SPIROTONE

When you must not take it

Do not take SPIROTONE if:

• You are allergic to spironolactone or any other ingredients listed at
  the end of this leaflet
• You have kidney problems
• You have high potassium levels in your blood
• You are not producing or passing urine

Symptoms of an allergic reaction may include shortness of breath, wheezing or
difficulty breathing, swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.

Before you take it

Tell your doctor:

• If you have kidney or liver problems
• If you are pregnant or planning to become pregnant
• If you are breastfeeding or planning to breastfeed

Taking other medicines

If you are taking any other medicines, including any you get without a
prescription from a pharmacy, supermarket or health food shop, tell your doctor
or pharmacist.

Medicines that may interfere with SPIROTONE include:

• Medicines used to treat high blood pressure and some other heart
  conditions
• Certain other fluid tablets or diuretics
• Digoxin, a medicine used to treat heart failure
• Tablets, preparations or supplements which contain potassium
• Salt substitutes which contain potassium
• Non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve
  pain, swelling and other symptoms of inflammation, including arthritis
• Carbenoxolone, a medicine used to treat mouth ulcers

These medicines may be affected by SPIROTONE or may affect how well SPIROTONE
works. You may need different amounts of your medicines or you may need to take
different medicines.

Your doctor or pharmacist has more information on medicines to be careful
with or avoid while taking SPIROTONE.

How to take SPIROTONE properly

How much to take

Your doctor will tell you how much SPIROTONE you need to take. It is
important that you take SPIROTONE as directed by your doctor. Do not take more
than the recommended dose.

The usual dose for adults with high blood pressure is 50mg to 100mg per day
which may be gradually increased at two weekly intervals up to 200 mg per day.
The daily dose may be given either in divided doses or as a single daily dose.
Treatment should be continued for at least two weeks since an adequate response
may not occur before this time.

For other conditions, your doctor will tell you how many tablets you need to
take each day and when to take them. This depends on your condition and whether
or not you are taking other medicines.

How long to take it

Continue taking SPIROTONE for as long as your doctor tells you to.

Taking your medicine at the same time each day may help you to remember to
take it regularly. If you have trouble remembering to take your medicine, ask
your pharmacist for some hints.

While you are taking SPIROTONE

Tell all doctors, dentists and pharmacists who are treating you that you are
taking SPIROTONE.

Tell your doctor or pharmacist that you are taking SPIROTONE before you start
any new medicine.

Tell your doctor if you develop a skin rash or hives, or you become pregnant
while taking SPIROTONE.

If you are going to have surgery, tell the surgeon or anaesthetist that you
are taking SPIROTONE.

If you are going to have any blood tests, tell your doctor that you are
taking SPIROTONE.

Do not take SPIROTONE to treat any other complaints unless your doctor tells
you to.

Do not stop taking SPIROTONE or lower the dose without first checking with
your doctor.

Do not give this medicine to anyone else, even if their symptoms seem similar
to yours.

SPIROTONE may cause drowsiness or confusion in some people. Be careful when
driving, operating machinery or performing jobs that need you to be alert, until
you are certain that SPIROTONE does not affect your performance.

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well
while you are taking SPIROTONE.

All medicines can have some unwanted effects. Sometimes they are serious,
most of the time they are not. You may need medical treatment if you get some of
the side effects.

Tell your doctor or pharmacist if you notice any of the following and they
worry you:

• Feeling sick, vomiting
• Stomach cramps or pain, diarrhoea
• Headache
• Drowsiness, lack of energy
• Menstrual period changes in women
• Breast enlargement in men
• Sexual problems in men

These are the more common side effects of spironolactone.

Tell your doctor as soon as possible if you notice any of the following:

• Lumps in the breasts
• Confusion
• Skin rash or hives
• Unsteadiness when walking
• Signs of infrequent infections such as fever, chills, sore throat or mouth
  ulcers

Tell your doctor immediately if you experience any of the following:

• Vomiting blood or material that looks like coffee grounds
• Bleeding from the back passage, black sticky bowel motions (stools) or
  bloody diarrhoea

The list of side effects mentioned above is not complete. If you should
suffer from any of these side effects or any other undesired effect please tell
your doctor or pharmacist.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

In case of overdose

You should only take the number of tablets that you have been told.

Immediately contact your doctor or the National Poisons Information Centre
(0800 POISON or 0800 764 766) or go to the Emergency department at your nearest
hospital, if you think that you may have taken too much, or if anyone else has
taken any SPIROTONE by mistake. Do this even if there are no signs of discomfort
or poisoning. You may need urgent medical attention. Take the container of
SPIROTONE with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Do not take this medicine after the expiry date shown on the label or if the
packaging shows signs of tampering.

Keep your SPIROTONE tablets in the container until it is time to take them.

Store below 30°C and out of reach of children. Avoid exposure to heat, light
and moisture.

Do not store SPIROTONE, or any other medicine, in the bathroom or near a
sink.

Disposal

If your doctor tells you to stop taking SPIROTONE or if the tablets have
passed the expiry date, ask your pharmacist what to do with the remaining
medicine.

Product Description

What SPIROTONE tablets look like

SPIROTONE 25mg tablets are pale orange round tablets, marked with α on one side and	SP	on the other.
	1
SPIROTONE 100mg tablets are pale orange round tablets, marked with α on one side and	SP	on the other.
	2

Each SPIROTONE tablet contains the active ingredient, spironolactone.

Each SPIROTONE tablet also contains quinoline yellow, sunset yellow,
erythrosine, polysorbate, peppermint oil, povidone, microcrystalline cellulose,
maize starch, sodium starch glycollate, talc, magnesium stearate and lactose.