Pravastatin Sodium Tablets 10 mg/ 20 mg/ 40 mg
Consumer Medicine Information
What is in this leaflet
This medicine your doctor has prescribed for you is called Pharmacor Pravastat. The information in this leaflet will answer some of the questions you may have about Pharmacor Pravastat. This leaflet does not tell you everything about Pharmacor Pravastat. Your doctor and pharmacist have been provided with full information and can answer any questions you may have.
This leaflet is no substitute for talking with your doctor or pharmacist. You should follow all advice from your doctor when being treated with this medicine. This information is not intended to replace your doctor’s advice.
You should read this leaflet carefully before starting Pharmacor Pravastat and keep it in a safe place to refer to later.
What is Pharmacor Pravastat used for?
Pharmacor Pravastat 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 Pharmacor Pravastat can reduce the risk of further heart disease, reduce the possibility of needing a bypass operation, or reduce the risk of having a stroke.
Pharmacor Pravastat lowers high blood cholesterol levels (Doctors call this hypercholesterolemia). It is also used if your cholesterol levels are normal if you have had a heart attack or an episode of unstable angina.
Pharmacor Pravastat is used to treat heterozygous familial hypercholesterolemia in children and adolescent patients aged 8 years and older as an adjunct to diet and lifestyle changes.
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.
Pharmacor Pravastat may be used to lower lipids in heart or kidney transplant patients, who are also being given immunosuppressive medicine.
Pharmacor Pravastat is used to treat long-term (chronic) conditions so it is important that you take your Pharmacor Pravastat every day.
How does Pharmacor Pravastat work?
Pharmacor Pravastat contain Pravastatin sodium, a medicine that reduces the level of cholesterol in your blood and helps to protect you in other ways from heart attack or stroke. It is more effective if it is taken with a diet low in fat.
What should I know before I take Pharmacor Pravastat?
Before taking Pharmacor Pravastat, you should be aware of the following:
You should not take Pharmacor Pravastat if:
- You are or may become pregnant
- You are breastfeeding
- You have ever had an allergic reaction to Pravastatin sodium or any other ingredient listed at the end of this leaflet
- You have ever had liver disease
- You have had muscle pain from any other medicine used to treat high cholesterol
Do not give your Pharmacor Pravastat to anyone else even if they have the same condition as you have.
What should I tell my doctor before I take Pharmacor Pravastat?
Before you take Pharmacor Pravastat for the first time you should tell your doctor if:
- You are taking other medicines or treatment.
- You drink alcohol regularly
- You have ever had liver problems.
- You have a problem with your kidneys.
- You are or may become pregnant.
- You are breastfeeding.
- You suffer from hormonal disorders.
- You suffer from central nervous system vascular lesions.
- You suffer from allergies.
- You suffer from homozygous familial hypercholesterolemia, (a doctor will have told you this).
- You have increased triglycerides in your blood (a doctor will have told you this also).
- You suffer from muscle disease (including pain, tenderness or weakness).
Should I take Pharmacor Pravastat with other medicines?
Some medicines can affect the way Pharmacor Pravastat works. You should always tell your doctor about any other medicines you take, even those bought without a doctor’s prescription. It is especially important that you tell your doctor if you are taking any of the following:
- Any other medicine to lower cholesterol
- Cyclosporin
- Ketoconazole
- Spironolactone
- Cimetidine
- Gemfibrozil
- Cholestyramine and colestipol
- Antacids
Please discuss any of these with your doctor if you need to take any of them.
Should I drive or operate machinery while taking Pharmacor Pravastat?
Pharmacor Pravastat 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 Pharmacor Pravastat before you drive a car, or operate machinery.
How should I take Pharmacor Pravastat?
Pharmacor Pravastat should only be used as directed by your doctor. Your doctor will decide on the dose of Pharmacor Pravastat, this will depend on many factors including your cholesterol level. The dose for lowering cholesterol is 10 – 80mg, and is 40mg for reducing the possibility of a stroke or heart attack.
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 hypercholesterolemia.
Take Pharmacor Pravastat once a day in the evening before bedtime. To help you to remember to take your tablet, take it at the same time each day.
If you forget to take a dose of Pharmacor Pravastat, take the next dose normally at your usual time.
What side effects might Pharmacor Pravastat cause?
All medicines, including Pharmacor Pravastat, can sometimes cause unwanted effects. This is not an exhaustive list.
The most common side effects of Pharmacor Pravastat are: upset stomach, nausea, diarrhoea, wind, constipation, headache and dizziness.
If you have any of these side effects or any other problem while taking Pharmacor Pravastat tell your doctor as soon as possible. Your doctor may arrange blood tests.
You must tell your doctor immediately, or go to the hospital, if you suffer any of the following: unexplained muscle pain, tenderness or weakness.
It is also possible to suffer from an allergic reaction to Pharmacor Pravastat, so tell your doctor if you develop a skin rash or itchiness, fever, joint pain or shortness of breath.
What should I do if someone takes an overdose of Pharmacor Pravastat?
Call your doctor immediately if you or someone else has taken too much Pharmacor Pravastat.
If your doctor is not available call your nearest hospital or a Poisons Information Centre on 13 11 26.
Is there any other information that I should know about?
Pharmacor Pravastat is not addictive or habit forming. Pharmacor Pravastat is only available upon prescription from your doctor.
How should I store Pharmacor Pravastat?
Store Pharmacor Pravastat tablets below 25ºC in a cool dry place, and keep the tablets in the blister until it is time to take them. The expiry date for Pharmacor Pravastat is printed on the pack. Do not take Pharmacor Pravastat after the expiry date or if Pharmacor Pravastat tablets have changed in appearance colour or taste. Ask your pharmacist about disposal of unused tablets.
Keep all medicines out of reach of children.
Product description
What it looks like
Pharmacor Pravastat come in 10 mg, 20 mg & 40 mg:
- Pharmacor Pravastat 10 (AUST R 156357)
Yellow coloured, rounded rectangular shaped, biconvex, uncoated tablets debossed ‘PDT’ on one side and ‘10’ on the other side, in a pack of 30 tablets. - Pharmacor Pravastat 20 (AUST R 156364)
Yellow coloured, rounded rectangular shaped, biconvex, uncoated tablets debossed ‘PDT’ on one side and ‘20’ on the other side, in a pack of 30 tablets. - Pharmacor Pravastat 40 (AUST R 156358)
Yellow coloured, rounded rectangular shaped, biconvex, uncoated tablets debossed ‘PDT’ on one side and ‘40’ on the other side, in a pack of 30 tablets.
Ingredients
Active ingredients
- Pharmacor Pravastat 10 – 10 mg Pravastatin Sodium per tablet.
- Pharmacor Pravastat 20 – 20 mg Pravastatin Sodium per tablet.
- Pharmacor Pravastat 40 – 40 mg Pravastatin Sodium per tablet.
Inactive ingredients
Pharmacor Pravastat also contain Lactose, cellulose microcrystalline, magnesium oxide – light, croscarmellose sodium, iron oxide yellow (C177492), povidone and magnesium stearate
Name and Address of the Sponsor
Pharmacor Limited
Unit 5/36 Campbell Avenue
Cromer NSW 2099
Australia
Date of Approval
TGA approval: 5 May 2010
Date of Most Recent Amendment
20 July 2010
Published by MIMS December 2010