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Spiractin

contains the active ingredient spironolactone
CONSUMER MEDICINE INFORMATION

Buy Spiractin Spironolactone 25mg Tablets (Pack of 100).

What is in this leaflet

This leaflet answers some common questions about Spiractin.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Spiractin against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Spiractin is used for

Spiractin is used:

to treat essential hypertension (high blood pressure with an unknown cause)
to treat oedematous disorders (swelling with fluid), including congestive cardiac failure
to help bring potassium levels in the blood back to normal when the levels become too low
to treat hyperaldosteronism (a hormone disorder causing fluid retention)
as add on therapy in malignant hypertension (a very serious form of high blood pressure)
treat excess facial or body hair in women.

Your doctor may have prescribed Spiractin for another purpose. Ask your doctor if you have any questions about why Spiractin has been prescribed for you.

Spiractin is available only with a doctor`s prescription.

There is no evidence that Spiractin is addictive.

How Spiractin works

In fluid build-up and high blood pressure

Spiractin is a fluid tablet or diuretic. It helps reduce the amount of excess fluid in the body by increasing the amount of urine produced. This also helps to lower blood pressure.

In hyperaldosteronism and low potassium levels in the blood

In hyperaldosteronism, the adrenal glands produce too much of a hormone called aldosterone. Spiractin works by stopping the effects of aldosterone.

By stopping the effects of aldosterone, Spiractin also helps to maintain normal levels of potassium in the blood by retaining potassium in the body.

In women with excess hair

All women produce small amounts of the male sex hormone, testosterone. Women with excess facial or body hair tend to be especially sensitive to the action of testosterone on hair growth. Spiractin reduces the growth of hair by stopping the effects of testosterone.

Before you take Spiractin

When you must not take it

Do not take Spiractin if you are allergic to medicines containing spironolactone or any of the ingredients listed at the end of this leaflet.
Some of the 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.
Do not take Spiractin if you have any of the following medical conditions:
high potassium levels in your blood (hyperkalaemia)
severe kidney disease or are not passing urine.
Addison`s disease (a condition where the adrenal glands do not work properly).
Do not take Spiractin if you are pregnant.
Spiractin can affect your developing baby if you take it during pregnancy.
Do not take Spiractin if you are breastfeeding.
Spiractin passes into breast milk and may affect your baby.
Do not take Spiractin if the expiry date (Exp.) printed on the pack has passed.
Do not take Spiractin if the packaging shows signs of tampering or the tablets do not look quite right.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.
Tell your doctor if you have any medical conditions, especially the following:

liver problems
kidney problems.

Tell your doctor if you plan to become pregnant or breastfeed.
Tell your doctor if you plan to have surgery.
If you have not told your doctor about any of the above, tell them before you start taking Spiractin.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by Spiractin or may affect how well it works. These include:

other medicines used to treat high blood pressure, including ACE inhibitors
diuretics, which are fluid removing medicines also known as water tablets
digoxin, a medicine used to treat heart conditions
potassium supplements or potassium-containing salt substitutes
cholestyramine, a medicine used to lower cholesterol levels in the blood
ammonium chloride, which is contained in some cough and cold medicines
aspirin
non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis (e.g. indomethacin and mefenamic acid)
carbenoxolone, a medicine used to treat mouth ulcers
regional or general anaesthetics.

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

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Spiractin.

How to take Spiractin

How much to take

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.

Follow all directions given to you by your doctor and pharmacist carefully.

How to take Spiractin

Swallow the tablets with a glass of water.
Take Spiractin with or immediately after food.

If you forget to take Spiractin

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.

How long to take Spiractin for

The length of treatment will depend on your condition. Spiractin is usually taken long term.

Keep taking Spiractin for as long as your doctor recommends.

If you take too much Spiractin (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital if you think you or anyone else may have taken too much Spiractin. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much Spiractin, you may feel drowsy, weak, confused or sick, vomit, have diarrhoea or pins and needles of the hands or feet.

While you are taking Spiractin

Things you must do

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Spiractin.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Spiractin.

This is especially important if you are going to receive an anaesthetic agent while being treated with Spiractin.

If you become pregnant while taking Spiractin, tell your doctor immediately.

If it is possible for you to become pregnant, you should use adequate contraception while you are taking Spiractin. Examples of adequate contraception are oral contraceptives (“the Pill”) or intra-uterine devices (IUDs). Stop taking Spiractin if you become pregnant or you think you may be pregnant.

If you are about to have any blood tests, tell your doctor that you are taking Spiractin.

Spiractin may affect the results of some tests.
Visit your doctor regularly for a check-up.

Your doctor may ask you to have blood tests to check your sodium and potassium levels and see how your kidneys are working.

Things you must not do

Do not take potassium supplements or use salt substitutes that contain potassium.
Do not consume a diet rich in potassium.

Dried fruit, bananas and oranges are some foods that contain high amounts of potassium. Consuming some of these foods is usually safe but do not consume excessive amounts.

If you are taking Spiractin, too much potassium can cause serious problems, such as disturbances to the heart rhythm.

Do not stop taking Spiractin, or lower the dose, without checking with your doctor.
Do not use Spiractin to treat any other conditions unless advised by your doctor.
Do not give Spiractin to anyone else, even if they have the same condition as you.

Things to be careful with

Be careful driving or operating machinery until you know how Spiractin affects you.

Spiractin may cause drowsiness or confusion in some people. If either of these occurs, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

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

Like all other medicines, Spiractin may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.
Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Possible side effects of Spiractin include:

feeling sick, vomiting
stomach cramps or pain, diarrhoea
stomach bleeding, ulcers or gastritis (inflammation of the stomach)
headache
drowsiness, lethargy or generally feeling unwell
mental confusion or dizziness
skin rash or itchiness
fever
unsteadiness when walking
leg cramps
irregular periods or no periods
post-menopausal bleeding
breast pain
change in sex drive
impotence (inability to get or maintain an erection in men)
unusual hair loss or thinning
excessive hair growth.

A few cases of agranulocytosis (lack of white blood cells) have been reported in patients taking Spiractin. Signs of agranulocytosis include frequent infection such as fever, severe chills, sore throat or mouth ulcers and should be reported to your doctor immediately.

Breast enlargement may occur in men taking Spiractin. This normally goes away when Spiractin is stopped. In rare instances some breast enlargement may persist.

Breast lumps and breast cancer have been reported in patients taking Spiractin although Spiractin has not been shown to cause breast cancer.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some patients.

After using Spiractin

Storage

Keep Spiractin where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep your tablets in a cool dry place where the temperature stays below 30 degrees C.
Do not store Spiractin or any other medicine in the bathroom or near a sink.
Do not leave Spiractin in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Spiractin, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Spiractin comes in 2 strengths of tablets:

Spiractin 25 – round, pale orange, peppermint flavoured tablet, marked SP/1 and a Greek alpha symbol
Spiractin 100 – round, pale orange, peppermint flavoured tablet, marked SP/2 and a Greek alpha symbol.

Each bottle contains 100 tablets.

Ingredients

The active ingredient in Spiractin is spironolactone

each Spiractin 25 tablet contains 25 mg of spironolactone
each Spiractin 100 tablet contains 100 mg of spironolactone.

The tablets also contain:

lactose
microcrystalline cellulose
maize starch
sodium starch glycollate
purified talc
magnesium stearate
polysorbate 80
povidone
quinoline yellow (104)
erythrosine (127)
sunset yellow FCF (110)
peppermint oil.

The tablets are gluten free.

Manufacturer

Spiractin is made in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Chase Building 2
Wentworth Park Road
Glebe NSW 2037
Phone: (02) 9298 3999
www.alphapharm.com.au
Medical Information
Phone: 1800 028 365
Australian registration numbers:
Spiractin 25 – Aust R 46689
Spiractin 100 – Aust R 46691
This leaflet was prepared on 22 May 2006

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