ROSUVASTATIN RBX Tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about ROSUVASTATIN RBX. It does not contain all the information that is known about ROSUVASTATIN RBX.
It does not take the place of talking to your doctor and pharmacist.
This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor will have weighed the risks of you taking ROSUVASTATIN RBX against the benefits they expect it will 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 ROSUVASTATIN RBX is used for
ROSUVASTATIN RBX is used to lower high cholesterol levels. Even though you may have normal cholesterol, ROSUVASTATIN RBX can also be used to reduce the risk of you having a stroke or heart attack if you are a man 50 or more years old or a woman 60 or more years old and have at least 2 risk factors for having a heart attack or stroke, such as high blood pressure, low levels of “good” cholesterol (HDL), smoking or a family history of premature coronary heart disease. Your doctor may also do a blood test to measure a substance called C Reactive Protein to help decide if you should be given ROSUVASTATIN RBX for this use.
Cholesterol and triglycerides
Everyone has cholesterol and triglycerides in their blood. They are fatty substances needed by the body for many things.
Triglycerides are an energy source for the body. Cholesterol is used for such things as building cells, making bile acids (which help to digest foods) and making some hormones.
There are different types of cholesterol. Too much of the “bad” cholesterol (LDL) can block the blood vessels that supply your heart and brain with blood, and can cause heart attack, angina and stroke. The “good” cholesterol (HDL) helps to remove the bad cholesterol from the blood vessels. High levels of triglycerides can be associated with a low level of “good” cholesterol and may increase the risk of heart disease.
ROSUVASTATIN RBX belongs to a group of medicines known as HMG-CoA reductase inhibitors (also known as ‘statins’). It lowers the “bad” cholesterol, and raises the “good” cholesterol when exercise and changes to diet are not enough on their own.
Cholesterol is present in many foods and is also made by your body. ROSUVASTATIN RBX does not reduce the cholesterol that comes from fat in food. Because of this, when you are taking ROSUVASTATIN RBX, you need to follow a low-fat diet, control your weight and exercise regularly.
High cholesterol is also more likely to occur with certain diseases or if you have a family history of high cholesterol.
Your doctor will have explained why you are being treated with ROSUVASTATIN RBX and told you what dose to take. Your doctor may need to check your cholesterol levels before prescribing ROSUVASTATIN RBX or changing your dose.
Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
ROSUVASTATIN RBX is not addictive.
ROSUVASTATIN RBX is not recommended for use in children as its effects in children have not been established.
Before you use ROSUVASTATIN RBX
When you must not use it
Do not use ROSUVASTATIN RBX if you are pregnant or intend to become pregnant. Ask your doctor about effective methods of contraception.
If you become pregnant, stop taking ROSUVASTATIN RBX as soon as you find out and see your doctor immediately.
Do not use ROSUVASTATIN RBX if you are breast feeding. We do not know if your baby can take in ROSUVASTATIN RBX from breast milk if you are breast feeding.
Do not use ROSUVASTATIN RBX if you have active liver disease or if tests show you have elevated levels of liver enzymes which may show that you have a problem with your liver.
Do not use ROSUVASTATIN RBX 40 mg if you have:
- low thyroid hormone levels (hypothyroidism)
- a personal or family history of hereditary muscular disorders
- a previous history of muscular problems from using other lipid lowering agents
- a history of very heavy alcohol use
- Asian heritage
- been prescribed another class of lipid lowering agent called a fibrate
- been prescribed any medicine containing fusidic acid
- severe kidney impairment
- situations that may increase ROSUVASTATIN RBX blood levels
Do not use after the use by (expiry) date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.
Do not use ROSUVASTATIN RBX if the packaging is torn or shows signs of tampering.
Do not use it to treat any other complaints unless your doctor tells you to. Do not give this medicine to anyone else.
Before you start to use it
You must tell your doctor if:
- you have any allergies to
- any other statins such as simvastatin (e.g. ZOCOR, LIPEX); pravastatin (e.g. PRAVACHOL); atorvastatin (e.g. LIPITOR); fluvastatin (e.g. VASTIN)
- any ingredients listed at the end of this leaflet
If you have an allergic reaction, you may get a skin rash, hay fever, difficulty in breathing or feel faint.
- You have any of these medical conditions
- liver problems
- kidney problems
- low thyroid hormone levels (hypothyroidism)
- a personal or family history of muscle disorders
- a history of muscle problems from using other lipid lowering agents
It may not be safe for you to take ROSUVASTATIN RBX if you have any of these conditions. Your doctor may do a blood test to check if you have any problems, and may adjust the dose of ROSUVASTATIN RBX.
- you have any unexplained aches or pains in your muscles
- you regularly drink large amounts of alcohol
Excessive alcohol consumption may not be safe in patients taking ROSUVASTATIN RBX.
ROSUVASTATIN RBX contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including
- cyclosporin (e.g. SANDIMMUN and NEORAL, used, for example after organ transplant)
- antacids (medicines used to treat heartburn and indigestion). ROSUVASTATIN RBX can be taken 2 hours before or 2 hours after taking an antacid
- warfarin (e.g. COUMADIN and MAREVAN, used to stop blood clots)
- gemfibrozil (e.g. LOPID, GEMFITRIL and AUSGEM, used to lower blood lipids)
- fusidic acid (e.g. FUCIDIN) used to treat some infections
- various protease inhibitors used in combination with ritonavir to treat HIV infection (e.g. KALETRA)
- medicines that you buy at the chemist, supermarket or health food shop, including herbal medicines.
Your doctor will consider if ROSUVASTATIN RBX should be used together with any of these medicines, or may wish to adjust the dose of ROSUVASTATIN RBX or the other medicines. These medicines may affect the way ROSUVASTATIN RBX works.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
If you have not told your doctor about any of these things, tell them before you take ROSUVASTATIN RBX.
Effects on driving and using machinery
Be careful driving a car or operating machinery until you know if ROSUVASTATIN RBX affects you. ROSUVASTATIN RBX generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, ROSUVASTATIN RBX may cause dizziness in some people.
Using ROSUVASTATIN RBX
How to take it
If you have high cholesterol, the usual starting dose is one 5 mg or 10 mg tablet taken once daily. Depending on your condition and ethnic background, your doctor will decide the most appropriate starting dose for you.
Your doctor will monitor your cholesterol and triglyceride levels during your treatment, and, if needed, may increase your ROSUVASTATIN RBX dose to 20 mg once daily. For most patients a maximum 20 mg ROSUVASTATIN RBX daily dose is sufficient to treat high cholesterol.
A small number of patients may need to further increase their ROSUVASTATIN RBX dose to 40 mg once daily, for example patients whose high cholesterol is hereditary.
If your cholesterol is not high but you have risks for having a heart attack or stroke, your doctor may start you on 20 mg.
Your doctor will advise you on the dose that’s right for your condition. The daily dose of ROSUVASTATIN RBX must not exceed 40 mg daily.
DO NOT INCREASE OR ADJUST YOUR ROSUVASTATIN RBX DOSE YOURSELF.
Take ROSUVASTATIN RBX once a day, at about the same time each day. Keeping a regular time for taking ROSUVASTATIN RBX will help to remind you to take it.
Swallow each tablet whole with a drink of water.
ROSUVASTATIN RBX can be taken at any time of the day. It does not matter whether you take ROSUVASTATIN RBX with food or on an empty stomach.
While taking ROSUVASTATIN RBX you also need to follow a low-fat diet, control your weight and exercise regularly.
How long to take it
You must continue to take it as directed. ROSUVASTATIN RBX helps lower your blood cholesterol and triglycerides. It does not cure your condition. If you stop taking ROSUVASTATIN RBX, your cholesterol and triglycerides levels may rise again.
You may have to take cholesterol-lowering medicines for the rest of your life.
If you forget to take it
If you forget to take a dose of ROSUVASTATIN RBX, take it as soon as you remember, as long as it is more than 6 hours before your next dose is due. Otherwise, wait until your next dose is due and take it as normal.
Do not double the dose to make up for the one you missed. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Telephone your doctor or the Poisons Information Centre (13 11 26), or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much ROSUVASTATIN RBX even if there are no signs of discomfort or poisoning.
While you are using it
Things you must do
Have your blood cholesterol and triglycerides checked when your doctor says so to make sure ROSUVASTATIN RBX is working.
Stop taking ROSUVASTATIN RBX and contact your doctor immediately if you become pregnant while you are taking ROSUVASTATIN RBX
Things you must not do
Do not stop taking ROSUVASTATIN RBX unless you have discussed it with your doctor.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ROSUVASTATIN RBX.
ROSUVASTATIN RBX helps most people with too much cholesterol, but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- nausea (feeling sick)
- stomach pain
- unusual tiredness
- itchy skin
- memory loss
- stiff or painful joints (arthralgia)
These side effects are usually mild.
Tell your doctor if you notice a significant increase in your need to urinate or if you are significantly more hungry or thirsty than usual.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
- aching muscles, muscle tenderness or weakness not caused by exercise, particularly if you also have a fever or generally feel unwell
- difficulty breathing, swelling of the face, eyelids or lips
- difficulty breathing, coughing, particularly if you also feel generally unwell (e.g. fatigue, weight loss, fever).
These are all serious side effects. You may need urgent medical attention.
Serious side effects are rare.
Tell your doctor if you notice anything else that is making you feel unwell. Some people may get other side effects while taking ROSUVASTATIN RBX.
Do not be alarmed by this list of side effects. You may not experience any of them.
After using ROSUVASTATIN RBX
Keep your tablets in the blister pack until it is time to take them. If you take your tablets out of the box or blister pack they will not keep well.
Keep ROSUVASTATIN RBX in a cool, dry place where the temperature stays below 25 degrees C.
Do not store ROSUVASTATIN RBX or any other medication in the bathroom or near a sink. Heat and dampness can destroy some medicines.
Keep ROSUVASTATIN RBX where young children cannot reach it. A locked cupboard at least one and a half metres (1.5 m) above the ground is a good place to store medicines.
Do not leave ROSUVASTATIN RBX in the car on hot days.
Ask your pharmacist what to do with any ROSUVASTATIN RBX tablets you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.
What ROSUVASTATIN RBX looks like
ROSUVASTATIN RBX 5 mg tablets are light yellow to yellow, round, film-coated tablets with ‘RT 1’ debossed on one side and plain on other side.
ROSUVASTATIN RBX 10 mg tablets are light pink to pink, round, film-coated tablets with ‘RT 2’ debossed on one side and plain on other side.
ROSUVASTATIN RBX 20 mg tablets are light pink to pink, round, film-coated tablets with ‘RT 3’ debossed on one side and plain on other side.
ROSUVASTATIN RBX 40 mg tablets are light pink to pink, oval, film-coated tablets with ‘RT 4’ debossed on one side and plain on other side.
ROSUVASTATIN RBX tablets are available in blister packs of 30 tablets.
ROSUVASTATIN RBX 5 mg tablets - 5 mg of rosuvastatin (as calcium)
ROSUVASTATIN RBX 10 mg tablets - 10 mg of rosuvastatin (as calcium)
ROSUVASTATIN RBX 20 mg tablets - 20 mg of rosuvastatin (as calcium)
ROSUVASTATIN RBX 40 mg tablets - 40 mg of rosuvastatin (as calcium)
Lactose, microcrystalline cellulose, sodium citrate dihydrate, magnesium stearate and crospovidone.
In addition, the 5 mg tablet contains Opadry complete film coating system 02B82338 Yellow (PI 107551) and the 10, 20 and 40 mg tablets contain Opadry complete film coating system 03B24082 Pink (PI 107549).
ROSUVASTATIN RBX contains lactose and sugars and does not contain gluten.
ROSUVASTATIN RBX is supplied in Australia by:
Sun Pharma ANZ Pty Ltd
Macquarie Park NSW 2113
Tel: 1800 726 229
Australian Registration Numbers
ROSUVASTATIN RBX 5 mg tablets: AUST R 184709
ROSUVASTATIN RBX 10 mg tablets: AUST R 184707
ROSUVASTATIN RBX 20 mg tablets: AUST R 184717
ROSUVASTATIN RBX 40 mg tablets: AUST R 184721
This leaflet was prepared in September 2018.
Published by MIMS February 2019