The name of your medicine is APO-Pravastatin. It contains the active ingredient pravastatin (as pravastatin sodium).
It is used to treat:
In these people, pravastatin can reduce the risk of having a stroke, further heart disease, or needing a bypass operation.
It is also used to treat children and adolescent patients aged 8 years and older who have heterozygous familial hypercholesterolaemia (an inherited disorder which produces high blood cholesterol levels). This is in combination with diet and lifestyle changes.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
Pravastatin lowers high blood cholesterol levels (hypercholesterolaemia). It is more effective if it is taken with a cholesterol lowering diet.
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.
There is no evidence that this medicine is addictive.
Pravastatin can be used in children and adolescents aged 8 years and over, if they need treatment for heterozygous familial hypercholesterolaemia (a genetic disorder causing high cholesterol levels).
There is not enough information to recommend the use of this medicine in children less than 8 years of age.
Do not take this medicine if:
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
2. You have or have had any medical conditions, especially the following:
3. You drink alcohol every day or you have, or have had, any problems with drug or alcohol dependence.
4. You have had an organ (e.g. kidney or heart) transplant.
5. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant. You should also check with your doctor about your contraceptive use, to ensure that you don't become pregnant accidentally.
6. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding.
7. You are planning to have surgery or an anaesthetic.
8. You are currently receiving or are planning to receive dental treatment.
9. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with pravastatin. These include:
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with pravastatin.
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
The recommended dose for lowering cholesterol in adults is 10-80 mg daily.
The recommended dose for reducing the possibility of a stroke or heart attack is 40 mg daily.
If you are over 65 and/or have liver or kidney disease, or you are taking cyclosporin, you may be prescribed a lower dose.
The recommended dose for heterozygous familial hypercholesterolaemia is 20 mg once daily for children 8-13 years of age and 40 mg once daily for adolescents 14-18 years of age.
Swallow the tablets whole with a glass of water.
Take your medicine once a day, in the evening before bed-time.
For best results, take your medicine on an empty stomach (i.e. two or more hours after your last meal).
Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Tell your doctor immediately if you experience any unexplained muscle pain, tenderness or weakness.
Stop taking your medicine and tell your doctor or go to a hospital immediately if you have dark or brown urine, together with the symptoms above.
Tell your doctor immediately if you have a dry cough, problems breathing, have a temperature, lose weight and/or generally feel tired.
These may be signs of a potentially fatal condition called interstitial lung disease.
Tell your doctor that you are taking this medicine if:
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking this medicine.
Be careful while driving or operating machinery until you know how this medicine affects you.
Pravastatin generally does not interfere with your ability to drive or operate machinery. However, as with many other medicines, this medicine may cause dizziness in some people. Make sure you know how you react to this medicine before you drive a car or operate machinery.
Avoid drinking large quantities of alcohol. Drinking large amounts of alcohol may increase the chance of this medicine causing liver problems.
Tell your doctor as soon as possible if you do not feel well while you are taking pravastatin or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to Accident and Emergency at your nearest hospital.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to pravastatin, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C. Protect it from light and moisture.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine 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.
If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
10 mg tablets:
Light pink, round, unscored tablets, imprinted "APO" on one side and "PRA" over "10" on the other side.
20 mg tablets:
Off-white to light yellow, round, unscored tablets, imprinted "APO" on one side and "PRA" over "20" on the other side.
40 mg tablets:
Light green, round, unscored tablets, imprinted "APO" on one side and "PRA" over "40" on the other side.
80 mg tablets:
Off-white to light yellow, round, unscored tablets, imprinted "APO" on one side and "PRA" over "80" on the other side.
Each tablet strength is contained in a blister pack containing 30 tablets.
The tablets may also be available in bottles containing 30, 100 or 500 tablets.
Each tablet contains 10 mg, 20 mg, 40 mg or 80 mg of pravastatin sodium as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Pravastatin 10 mg tablets:
AUST R 118735 (blister)
AUST R 166255 (bottle).
APO-Pravastatin 20 mg tablets:
AUST R 118736 (blister)
AUST R 166256 (bottle).
APO-Pravastatin 40 mg tablets:
AUST R 118737 (blister)
AUST R 166257 (bottle).
APO-Pravastatin 80 mg tablets:
AUST R 145169 (blister)
AUST R 145178 (bottle).