PRAVASTATIN-RL(TM)
TABLETS
pravastatin
Consumer Medicine Information
What is in this leaflet?
Please read this leaflet carefully
before you take Pravastatin-RL
tablets.
This leaflet answers some common
questions about Pravastatin-RL
tablets. 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 risks and
benefits. Your doctor has weighed
the expected benefits of you taking
Pravastatin-RL tablets against the
risks this medicine could have for
you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What are PravastatinRL tablets used for?
The name of your medicine is
Pravastatin-RL. It contains the active
ingredient pravastatin sodium.
Pravastatin-RL is used to lower
cholesterol levels. It is also used in
people who have had a heart attack or
an episode of unstable angina, even
when their cholesterol levels are
normal.
Cholesterol
Everyone has cholesterol in their
blood. It's a type of blood fat needed
by the body for many things, such as
building cell walls, making bile acids
(which help to digest food) and some
hormones.
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 levels become
too high.
If you have had a heart attack, an
episode of unstable angina or 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 plaque) 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 Coronary Heart Disease (such
as heart attack and angina), and
stroke.
Your doctor may have prescribed
Pravastatin-RL for another reason.
Ask your doctor if you have any
questions about why Pravastatin-RL
was prescribed for you.
How Pravastatin-RL works
Pravastatin-RL belongs to a group of
medicines called HMG-CoA
reductase inhibitors.
It works by reducing the amount of
cholesterol made by the liver.
PRAVASTATIN-RL(TM) TABLETS
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. Pravastatin-RL
reduces the 'bad' cholesterol and
raises the 'good' cholesterol in the
blood.
Pravastatin-RL does not reduce the
cholesterol that comes from fats in
food. Therefore, Pravastatin-RL
treatment should be accompanied by
a diet that is low in fat and the used
fats should be preferably unsaturated
and of vegetable origin.
Pravastatin-RL tablets are not
addictive.
Before you take
Pravastatin-RL tablets
When you must not take
Pravastatin-RL
Do not take Pravastatin-RL if:
* You are allergic to the active
ingredient or any of the inactive
ingredients mentioned at the end
of this leaflet under Product
Description.
Signs of allergic reaction may
include itchy skin rash, shortness
of breath and swelling of the face
or tongue.
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* It is past its expiry date or the
packaging appears to have been
tampered with.
* You are pregnant or
breastfeeding, unless permitted
your doctor.
* You have or ever had liver
disease.
* You had muscle pain from other
medicines used to treat high
cholesterol.
Ask your doctor or pharmacist if you
are not sure if you have been taking
one of these medicines.
If you are uncertain whether you
should be taking Pravastatin-RL, talk
to your doctor.
Before you start to take
Pravastatin-RL
Tell your doctor if you have allergies
to:
* Any other medicines, especially
if they are in the same drug class
as Pravastatin-RL.
* Any other substances, including
foods, preservatives or dyes.
Tell your doctor if you plan on
becoming pregnant or will be
breastfeeding while you are using
Pravastatin-RL.
Tell your doctor if you have or have
had any medical conditions,
especially the following:
* Kidney problems.
* Liver problems. Your doctor will
do a blood test to make sure you
have no problems with your
liver.
Tell you doctor if you drink alcohol
regularly.
Taking other medicines
Tell your doctor if you are taking
any other medicine, including any
that you buy without a
prescription from your pharmacy,
supermarket or health food shop.
In particular, tell your doctor if you
take any of the following:
* Any other medicine to lower
cholesterol.
PRAVASTATIN-RL(TM) TABLETS
* Cyclosporin, used to suppress the
immune system.
These medicines may be affected by
Pravastatin-RL or may affect how
well it works. You may need to use
different amounts of your medicine,
or you may need to take different
medicines. Your doctor will advise
you.
* Other medicines used to treat
depression.
* Erythromycin and
clarithromycin, used to treat
infections.
* Antiarrhythmics, medicines used
to treat irregular heart beats.
* Antipsychotics, medicines used
to treat mental disorders.
How do I take
Pravastatin-RL tablets
Follow your doctor's instructions
about how and when to take
Pravastatin-RL. They may be
different to the information listed
below, depending on your
cholesterol levels as well as other
factors such as your other medical
conditions.
The usual dose for lowering
cholesterol is 10-40mg and is 40mg
for reducing the risk of a stroke or
heart attack.
Read the directions on the pharmacy
label carefully. If you have any
concerns about how to take
Pravastatin-RL, talk to your doctor
or pharmacist.
If you need to break Pravastatin-RL
hold tablet with both hands and snap
along break line.
Swallow the tablets with a glass of
water or another liquid. The tablets
can be broken in half, but should not
be chewed.
Pravastatin-RL can be taken with or
without food
Keep taking Pravastatin-RL for as
long as your doctor tells you to.
If you forget to take your dose
Take your dose as soon as you
remember, and continue to take it as
you would normally.
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 are not sure what to do, ask
your doctor or pharmacist.
If you have trouble remembering
when to take your medicine, ask your
pharmacist for some hints.
If you forget to take it
If you miss a dose and remember in
less than 12 hours, take it straight
away, then continue as normal the
next day. Otherwise, skip that day's
dose but be sure to take the next day's
dose when it is due. Do not take a
double dose to make up for the dose
you missed.
What do I do if I take
too much? (Overdose)
Immediately telephone your doctor
or Poisons Information Centre
(telephone 131126) for advice, if
you think you or anyone else may
have taken too much
Pravastatin-RL tablets, even if
there are no signs of discomfort or
poisoning. If you are not sure what
to do, contact your doctor or
pharmacist.
While you are taking
Pravastatin-RL tablets
Things you must do
* Always follow your doctor's
instructions carefully.
* Have your cholesterol levels
checked regularly by your doctor,
to make sure Pravastatin-RL is
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working.
* Tell your doctor immediately if
you become pregnant while
taking Pravastatin-RL.
* If you are about to start taking a
new medicine, tell your doctor
and pharmacist that you are
taking Pravastatin-RL.
Things you must not do
* Do not stop taking
Pravastatin-RL without your
doctor's permission.
* Do not use Pravastatin-RL to
treat any other complaint unless
your doctor says so.
* Do not give this medication to
anyone else, even if their
symptoms seem similar to yours.
Things to be careful of
Be careful driving or operating
machinery until you know how
Pravastatin-RL affects you.
Pravastatin-RL generally does not
cause any problems with your ability
to drive a car or operate machinery.
However, as with many other
medicines, Pravastatin-RL may cause
dizziness in some people. Make sure
you know how you react to
Pravastatin-RL before you drive a car
or operate machinery.
Side effects
All medicines can have unwanted
effects. Sometimes they are serious,
most of the time they are not. Do not
be alarmed by this list of possible
side effects. You may not experience
any of them.
Tell your doctor if you notice any of
the following and they worry you:
* Upset stomach, nausea, diarrhoea,
wind.
* Constipation.
* Headache.
* Dizziness.
PRAVASTATIN-RL(TM) TABLETS
These are the more common side
effects of Pravastatin-RL. Mostly,
these are mild and short-lived.
Tell your doctor immediately if you
notice any of the following:
* Unexplained muscle pain, muscle
tenderness or weakness.
* Yellowing of the skin or eye, also
called jaundice.
* Skin rash, itchiness.
* Fever, generally feeling unwell.
* Pinkest, itchy swelling on the
skin, also called hives or
nettlerash.
Tell your doctor immediately if
you notice any of the following:
* Wheezing, swelling of the
lips/mouth, difficulty in
breathing, hayfever, lumpy
rash (hives) or fainting. These
could be a symptom of an
allergic reaction.
This is not a complete list of all
possible side effects. Others may
occur in some people and there may
be some side effects not yet known.
Do not be alarmed by this list of
possible side effects. You may not
experience any of them.
Product description
What Pravastatin-RL tablets
look like
Pravastatin-RL 10mg: A yellow,
oval, convex, sidewall scored tablet
encoded "P 10"
Pravastatin-RL 20mg: A yellow,
oval, convex, sidewall scored tablet
encoded "P 20"
Pravastatin-RL 40mg: A yellow,
oval, convex, sidewall scored tablet
encoded "P 40"
Ingredients
As well as the active ingredient,
pravastatin sodium, Pravastatin-RL
also contains some inactive
ingredients. These are: Calcium
hydrogen phosphate anhydrous,
sodium starch glycollate,
microcrystalline cellulose,
trometamol, disodium phosphate
dihydrate, povidone, magnesium
stearate, ferric oxide.
Supplier
Your Pravastatin-RL tablets are
supplied by:
How do I store
Pravastatin-RL tablets?
Real-RL
A Division of
Keep this medicine where children
cannot reach it, such as in a locked
cupboard.
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia Victoria 3155
AUSTRALIA
Keep Pravastatin-RL tablets in a
cool, dry place where it stays below
25 degrees C.
Do not leave in a car, on a window
sill or in the bathroom.
Keep Pravastatin-RL tablets in the
container supplied until you need
to take it.
Return any unused or expired
medicine to your pharmacist.
Where to go for further
information
Pharmaceutical companies are not in
a position to give people an
individual diagnosis or medical
advice. Your doctor or pharmacist is
the best person to give you advice on
the treatment of your condition.
This leaflet was prepared on
2 May 2006.
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The information provided applies
only to: Pravastatin-RL (TM)
(TM) Pravastatin-RL is a trademark
of the GlaxoSmithKline Group of
Companies.
Pravastatin-RL 10mg tablets AUST
R 119207
Pravastatin-RL 20mg tablets AUST
R 119209
Pravastatin-RL 40mg tablets AUST
R 119213
This leaflet is subject to copyright
(C) 2005 GlaxoSmithKline
Issue No 1
PRAVASTATIN-RL(TM) TABLETS
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