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CHOLSTAT®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
CHOLSTAT contains the active ingredient pravastatin sodium. CHOLSTAT is used to lower
cholesterol levels in your blood and helps to protect you in other ways heart attack
or stroke. It is more effective if it is taken with a diet low in fat.
For more information, see Section 1. Why am I taking CHOLSTAT? in the full CMI.
Do not take if you have ever had an allergic reaction to pravastatin sodium or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take CHOLSTAT? in the full CMI.
Some medicines may interfere with CHOLSTAT and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
CHOLSTAT should only be taken as directed by your doctor.
Your doctor will decide on the dose, this will depend on many factors including your
cholesterol level.
More instructions can be found in Section 4. How do I take CHOLSTAT? in the full CMI.
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Things you should do
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Tell your doctor, dentist or pharmacist you visit that you are taking CHOLSTAT.
Call your doctor straight away if you suffer from an allergic reaction to PRAVACHOL,
tell your doctor if you develop a skin rash or itchiness, fever, joint pain or shortness
of breath.
Call your doctor straight way if you have or have had myasthenia (a disease with general
muscle weakness including in some cases muscles used when breathing), or ocular myasthenia
(a disease causing eye muscle weakness) as statins may sometimes aggravate the condition
or lead to the occurrence of myasthenia.
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Things you should not do
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Do not stop taking this medicine suddenly without checking with your doctor.
Do not take CHOLSTAT to treat any other conditions or give CHOLSTAT to anyone else.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how CHOLSTAT
affects you.
CHOLSTAT may cause dizziness in some people. It generally does not interfere with
your ability to drive or operate machinery, however some people do experience dizziness.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your tablets in a cool dry place where the temperature stays below 25°C.
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For more information, see Section 5. What should I know while taking CHOLSTAT? in the full CMI.
There are a number of side effects associated with PRAVACHOL. It is important to be
aware of them so that you can identify any symptoms if they occur. For more information,
including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
CHOLSTAT®
Active ingredient:
pravastatin sodium
Consumer Medicine Information (CMI)
This leaflet provides important information about taking CHOLSTAT. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking CHOLSTAT.
Where to find information in this leaflet:
CHOLSTAT contains the active ingredient pravastatin sodium. CHOLSTAT is a drug that reduces the level of cholesterol in your blood and helps
to protect you in other ways from having a heart attack or stroke. It is more effective
if it is taken with a diet low in fat.
CHOLSTAT is used to:
lower high blood cholesterol levels (known as hypercholesterolaemia).
treat people who have had a heart attack or an episode of unstable angina pectoris
(chest pain), even when their cholesterol levels are normal.
lower cholesterol in heart or kidney transplant patients, who are also being given
immunosuppressive medicine.
reduce the risk of further heart disease.
reduce the risk of having a stroke.
treat heterozygous familial hypercholesterolaemia in children and adolescent patients
aged 8 years and older as an added measure to diet and lifestyle changes.
There are different types of cholesterol, called LDL and HDL. LDL cholesterol is the
'bad' cholesterol that can block your blood vessels. HDL cholesterol is the 'good'
cholesterol that is thought to remove the 'bad' cholesterol from the blood vessels.
Cholesterol is present in many foods and is also made in your body by the liver. If
your body does not balance the amount of cholesterol it needs with the amount of cholesterol
eaten, then your cholesterol becomes too high.
High cholesterol is more likely to occur with certain diseases or if you have a family
history of high cholesterol.
When you have high levels of cholesterol it may 'stick' to the inside of your blood
vessels instead of being carried to the parts of the body where it is needed. Over
time, this can form hard areas (called plaques) on the walls of your blood vessels,
making it more difficult for the blood to flow. This blocking of your blood vessels
can lead to heart disease (such as heart attack and angina), and stroke.
If you have had a heart attack, an episode of unstable angina or you have too much
cholesterol in your blood, then you have an increased risk of a blood clot forming
in your blood vessels and causing a blockage. Blood vessels that become blocked in
this way can lead to further heart disease, angina or stroke.
Ask your doctor if you have any questions about why CHOLSTAT has been prescribed for
you.
Your doctor may have prescribed CHOLSTAT for another reason.
It is not addictive or habit forming.
Do not take CHOLSTAT if:
you are allergic to pravastatin sodium, any other medicine used to reduce the level
of cholesterol in your blood or any of the ingredients listed at the end of this leaflet.
you have ever had liver problems.
you have had muscle pains cause by any other medicines used to treat high cholesterol
or triglycerides (fats).
you are or may become pregnant.
you are breastfeeding.
Check with your doctor if you:
are allergic to any other medicines, foods, dyes or preservatives.
are drinking alcohol regularly.
have or have had any medical conditions, especially the following:
liver problems
kidney problems
increased triglycerides in the blood or diabetes
under-active thyroid
suffer from central nervous system vascular lesions
hormonal disorders
homozygous familial hypercholesterolaemia
suffer from muscle disease (including pain, tenderness or weakness)
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or plan to become pregnant.
Talk to your doctor if you are breastfeeding or plan to breastfeed.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with CHOLSTAT and affect how well it works. These include:
any other medicines to lower cholesterol
bile acid sequestrants
fibrates such as gemfibrozil and fenofibrate
colestyramine and colestipol
ciclosporin
colchicine
ketoconazole
spironolactone
cimetidine
nicotinic acid
macrolides such as erythromycin, clarithromycin and roxithromycin
antacids
lenalidomide
fusidic acid
propranolol
rifampicin
digoxin
warfarin or other coumarin anticoagulants.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect CHOLSTAT.
How much to take
The usual starting dose for lowering cholesterol is 10 mg to 20 mg at night, and varied
ultimately between 10 mg to 80 mg once a day.
The dose for reducing the possibility of a stroke or heart attack is 40 mg per day.
The recommended dose is 20 mg once daily for children 8-13 years of age and 40 mg
once daily in adolescents 14-18 years of age, with heterozygous familial hypercholesterolaemia.
However, the dose varies from patient to patient. Also, people over 65 may require
a lower than usual dose. Therefore, your doctor will decide on the right dose for
you after taking into consideration a number of factors including your cholesterol
level and any other medicines that you are taking.
Follow the instructions provided and use CHOLSTAT until your doctor tells you to stop.
When to take CHOLSTAT
Take CHOLSTAT once a day in the evening before bed-time. For the best result, take
CHOLSTAT on an empty stomach (e.g., 3 hours after your dinner).
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
Swallow the tablets with a glass of water.
CHOLSTAT tablets should not be divided.
If you forget to take CHOLSTAT
CHOLSTAT should be taken regularly at the same time each day. If you forget to take
a dose of CHOLSTAT, take the next dose normally at your usual time.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much CHOLSTAT
If you think that you have taken too much CHOLSTAT, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Call your doctor straight away if you:
suffer from an allergic reaction to PRAVACHOL, tell your doctor if you develop a skin
rash or itchiness, fever, joint pain or shortness of breath.
have or have had myasthenia (a disease with general muscle weakness including in some
cases muscles used when breathing), or ocular myasthenia (a disease causing eye muscle
weakness).
become pregnant.
plan to have surgery, including dental surgery.
notice that you are getting muscle pain, tenderness or weakness for no reason.
have to have any blood tests.
Tell all the doctors, dentists or pharmacists you visit that that you are taking CHOLSTAT.
Things you should not do
Do not stop taking this medicine suddenly without checking with your doctor.
Do not take CHOLSTAT to treat any other conditions unless your doctor tells you to.
Do not give CHOLSTAT to anyone else, even if they have the same condition as you have.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how CHOLSTAT
affects you.
CHOLSTAT may cause dizziness and visual disturbances in some people. It generally
does not interfere with your ability to drive or operate machinery.
Looking after your medicine
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
When to discard your medicine
The expiry date is printed on the carton. Do not take it after the expiry date or
if the tablets have changed in appearance colour or taste.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Nervous System
headache
dizziness
tiredness
nervousness
sleep disturbance including insomnia
Special Senses
blurred or double vision
ringing in the ears.
Gastrointestinal
nausea
vomiting
indigestion
upset stomach
wind
constipation
diarrhoea.
Skin and Hair
itching
rashes
scalp and hair problems (including hair loss)
pimples
Urinary
bladder problems (painful urination or passing urine more often).
Genital
sexual dysfunction.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
Your doctor may wish to arrange blood tests for you.
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Serious side effects
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Serious side effects
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What to do
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symptoms of an allergic reaction including skin rash, itching or hives, swelling of
the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing
or shortness of breath.
unexplained muscle pain
muscle rupture
muscle cramps
tenderness and/or weakness (including eye and facial muscle)
joint pain
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What CHOLSTAT contains
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Active ingredient
(main ingredient)
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pravastatin sodium
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Other ingredients
(inactive ingredients)
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aluminium magnesium silicate
croscarmellose sodium
povidone
microcrystalline cellulose
purified talc
lactose monohydrate
magnesium stearate.
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Potential allergens
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contains soya bean products and sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What CHOLSTAT looks like
CHOLSTAT 10 is a white to off-white, capsule shaped, biconvex tablet with "G | G"
on one side and "PR | 10" on the other side (AUST R 98486).
CHOLSTAT 20 is a white to off-white, capsule shaped, biconvex tablet with "G | G"
on one side and "PR | 20" on the other side (AUST R 98488).
CHOLSTAT 40 is a white to off-white, capsule shaped, biconvex tablet with "G" on one
side and "PR 40" on the other side (AUST R 98489).
