pravastatin sodium
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine. Ask your doctor or pharmacist if you do not understand anything or are worried about taking your medicine.
This leaflet answers some common questions about pravastatin. It does not contain all 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 risks of you using this medicine against the benefits they expect it will have for you.
Keep this leaflet with your medicine. You may want to read it again.
What Pravastatin-GA is used for
The name of your medicine is Pravastatin-GA. It contains the active ingredient, pravastatin (as pravastatin sodium).
It is used to treat people who have had a heart attack or an episode of unstable angina, or who have high blood cholesterol levels. In these people pravastatin can reduce the risk of further heart disease, reduce the possibility of needing a bypass operation, or reduce the risk of having a stroke.
Pravastatin lowers high blood cholesterol levels (doctors call this hypercholesterolaemia). It is also used if your cholesterol levels are normal if you have had a heart attack or an episode of unstable angina.
It is more effective if it is taken with a diet low in fat.
Pravastatin is used to treat heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older as an adjunct to diet and lifestyle changes.
How it works
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.
Pravastatin may be used to lower lipids in heart or kidney transplant patients, who are also being given immunosuppressive medicine.
Pravastatin is used to treat long term (chronic) conditions so it is important that you take your medicine every day.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed pravastatin for another reason.
This medicine is available only with a doctor’s prescription.
There is no evidence that this medicine is addictive.
Use in children
Pravastatin can be used in children and adolescents aged 8 years and over, if they need treatment for heterozygous familial hypercholesterolaemia.
There is not enough information to recommend the use of this medicine in children less than 8 years of age.
Before you take pravastatin
When you must not take it
Do not take this medicine if you have had an allergic reaction to pravastatin or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue, throat or other parts of the body
- muscle pain or tenderness
- joint pain or rash, itching or hives on the skin.
Do not take this medicine if you are pregnant. Pravastatin may affect your developing baby if you take it during pregnancy.
Do not take this medicine if you are breast-feeding. Pravastatin can pass into human breast milk and may affect a baby being breast-fed.
Do not take this medicine after the expiry date (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well.
Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor if you:
- have allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes.
- have or have had any medical conditions, especially the following:
- liver problems
- kidney problems
- hormonal disorder
- central nervous system vascular lesions
- allergies
- homozygous familial
- hypercholesterolaemia (a doctor will have told you this)
- increased triglycerides in your blood (a doctor will have told you this)
- muscle disease (including pain, tenderness or weakness)
- plan to become pregnant or breast-feed.
- drink alcohol every day; or if you have, or have had, any problems with drug or alcohol dependence.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and pravastatin may interfere with each other. These include:
- any other medicine to lower cholesterol
- cyclosporin
- ketoconazole
- spironolactone
- cimetidine
- gemfibrozil
- cholestyramine and colestipol
- antacids
These medicines may be affected by pravastatin 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 can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking pravastatin.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully. They may be different to the information in this leaflet.
If you do not understand any written instructions, ask your doctor or pharmacist for help.
How much to take
Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether or not you are taking any other medicines.
The dose for lowering cholesterol is 10 – 80 mg. To reduce the possibility of a stroke or heart attack, the dose is 40 mg.
In children with heterozygous familial hypercholesterolaemia, 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.
How to take it
Swallow the tablets whole with a glass of water.
When to take it
Take your medicine once a day, in the evening before bed-time.
For best results, take your medicine on an empty stomach, usually two or more hours after your last meal.
Take it at about the same time each day. Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
The number of doses you take each day, the time allowed between doses and the length of time you take your medicine depend on the medical problem for which you are taking pravastatin.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
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 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 the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (13 11 26) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much pravastatin. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are taking pravastatin
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking pravastatin.
Tell your doctor immediately if you become pregnant.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Go to your doctor regularly for a check-up. Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not take your medicine to treat any other complaints unless your doctor or pharmacist tells you to.
Do not stop taking your medicine, or change the dosage, without checking with your doctor.
Things to be careful of
Be careful while driving or operating machinery until you know how pravastatin affects you.
Pravastatin generally does not interfere with your ability to drive or operate machinery. However, some people may experience dizziness, so you should be sure how you react to pravastatin before you drive a car, or operate machinery.
Be careful when drinking alcohol while you are taking this medicine. It is best not to drink alcohol when you are taking pravastatin as side effects may be worse.
Side effects
All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time, they are not.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking pravastatin.
Ask your doctor or pharmacist to answer any questions you may have.
The following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.
Tell your doctor or pharmacist if you notice any of the following:
- upset stomach
- nausea, diarrhoea
- wind
- constipation
- headache
- dizziness
The above list includes the more common side effects. Mostly, these are mild. Your doctor may arrange blood tests.
If any of the following happen, stop taking your medicine and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- unexplained muscle pain
- muscle tenderness
- muscle weakness
These are very serious side effects.
You may need urgent medical attention or hospitalisation. These side effects are very rare.
Other side effects not listed above may occur in some patients. Some of these side effects can only be found when your doctor does tests from time to time to check your progress.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After taking this medicine
Storage
Keep your medicine in its original packaging until it is time to take them. If you take the tablets out of their original packaging they may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
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 it 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.
Disposal
If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
- 10 mg tablets:
White to off-white, capsule-shaped tablet, with “>” on one side and “PV” scoreline “10” on the other. - 20 mg tablets:
White to off-white, capsule-shaped tablet, with “>” on one side and “PV” scoreline “20” on the other. - 40 mg tablets:
White to off-white, capsule-shaped tablet, with “>” on one side and “PV 40” on the other. - 80 mg tablets:
Yellow, oval shaped, biconvex, film-coated tablets debossed with ‘80’ on one side and ‘PRV’ on the other.
Each tablet strength is available in blister packs containing 30 tablets.
Ingredients
Each tablet contains 10 mg, 20 mg, 40 mg or 80 mg of Pravastatin sodium as the active ingredient.
The 10 mg, 20 mg and 40 mg tablets also contains the following inactive ingredients:
- lactose
- microcrystalline cellulose
- aluminium magnesium silicate
- purified talc
- povidone
- croscarmellose sodium
- magnesium stearate
The 80 mg tablets also contain the following inactive ingredients:
- lactose
- crospovidone
- sodium bicarbonate
- colloidal anhydrous silica
- magnesium stearate
- Opadry 03F52262 yellow
This medicine does not contain gluten, sucrose, tartrazine or any other azo dyes.
Australian Registration Numbers
- Pravastatin-GA 10 mg: AUST R 207992
- Pravastatin-GA 20 mg: AUST R 207991
- Pravastatin-GA 40 mg: AUST R 207993
- Pravastatin-GA 80 mg: AUST R 139606
Supplier
Actavis Pty Ltd
Level 5, 117 Harrington Street
The Rocks, NSW, 2015
For further information telephone 1800 554 414.
This leaflet was prepared in April 2015.
Published by MIMS August 2015