Crosuva Tablets

Crosuva Tablets is a brand of medicine containing the active ingredient rosuvastatin.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Crosuva

contains the active ingredient rosuvastatin (as calcium)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about CROSUVA.

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 benefits and risks. Your doctor has weighed the risks of you taking CROSUVA against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

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What CROSUVA is used for

CROSUVA is used to lower cholesterol levels.

Even though you may have normal cholesterol, CROSUVA 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 women 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 CROSUVA 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. 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 low level of “good” cholesterol and may increase the risk of heart disease.

How CROSUVA works

CROSUVA belongs to a group of medicines called HMG-CoA reductase inhibitors (also known as statin’s). These medicines work by lowering the “bad” cholesterol and raising the “good cholesterol” when exercises and changes in diet are not enough on their own.

Cholesterol is present in many foods and is also made by your body. CROSUVA does not reduce the cholesterol that comes from fat in food. Because of this, when you are taking CROSUVA, 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 CROSUVA and told you what dose to take. Your doctor may need to check your cholesterol levels before prescribing CROSUVA 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 have prescribed CROSUVA for another reason. Ask your doctor if you have any questions about why CROSUVA has been prescribed for you.

CROSUVA is not recommended for use in children, as its effects in children have not been established.

CROSUVA is available only with a doctor's prescription.

CROSUVA is not addictive.

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Before you take CROSUVA

When you must not take it

Do not take CROSUVA if you are allergic to medicines containing rosuvastatin or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not take CROSUVA if you have active liver disease or if tests show you have elevated levels of liver enzymes which may indicate that you have a problem with your liver.

Do not take CROSUVA 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
  • severe kidney impairment
  • situations that may increase CROSUVA blood levels.

Do not take CROSUVA if you are pregnant. CROSUVA may affect your developing baby if you take it during pregnancy.

Do not take CROSUVA if you are breastfeeding. It is not known whether CROSUVA passes into breast milk.

Do not take CROSUVA if the expiry date (Exp.) printed on the pack has passed.

Do not take CROSUVA if the packaging is torn or shows signs of tampering.

Do not give CROSUVA to children.

Before you start to take it

Tell your doctor if you have allergies to:

  • any other statin medicines including simvastatin (e.g. ZOCOR, LIPEX); prasvstatin (e.g. PRAVACHOL); atorvastatin (e.g. LIPTOR); fluvastatin (e.g. VASTIN)
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you plan to become pregnant or breastfeed

Tell your doctor if you have any medical conditions, especially the following:

  • 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

Your doctor may want to take special care if you have any of these conditions.

Tell your doctor if you have any unexplained aches or pains in your muscles.

Tell your doctor if you regularly drink large amounts of alcohol. Excessive alcohol consumption may not be safe in patients taking CROSUVA.

Tell your doctor if you plan to have surgery.

If you have not told your doctor about any of the above, tell them before you start taking CROSUVA.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may be affected by CROSUVA, or may affect how well it works. These include:

  • cyclosporine (e.g. SANDIMMUN and NEORAL, used, for example, after organ transplant)
  • antacids (medicines used to treat heartburn and indigestion). CROSUVA 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, JEZIL and AUSGEM, used to lower blood lipids).
  • various protease inhibitor combinations with ritonavir used to treat HIV infection
  • medicines that you buy at the chemist, supermarket or health food shop, including herbal medicines

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking CROSUVA.

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How to take CROSUVA

How much to take

The dose varies from patient to patient. Depending on your condition and ethnic background, your doctor will decide the most appropriate starting dose for you.

If you have high cholesterol, your doctor will probably start you on 5 mg or 10 mg tablet taken once daily. Your doctor will then monitor your cholesterol and triglyceride levels during your treatment, and, if needed, may increase your CROSUVA dose to 20 mg once daily. For most patients a maximum 20 mg CROSUVA daily dose is sufficient to treat high cholesterol.

A small number of patients may need to further increase their CROSUVA 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 CROSUVA must not exceed 40 mg daily.

DO NOT INCREASE OR ADJUST YOUR CROSUVA DOSE YOURSELF.

Follow all directions given to you by your doctor and pharmacist carefully.

How to take CROSUVA

Swallow the tablets whole with a glass of water.

Take CROSUVA once a day, at about the same time each day. Keeping a regular time for taking CROSUVA will help to remind you to take it.

CROSUVA can be taken at any time of the day. It does not matter whether you take CROSUVA with food or on an empty stomach.

While taking CROSUVA you also need to follow a low-fat diet, control your weight and exercise regularly.

If you forget to take CROSUVA

If you forget to take a dose of CROSUVA, 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 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 any questions about this, check with your doctor or pharmacist.

How long to take CROSUVA for

Do not stop taking CROSUVA unless advised by your doctor. CROSUVA helps lower your blood cholesterol and triglycerides. It does not cure your condition. If you stop taking CROSUVA, your cholesterol and triglycerides levels may rise again.

You may have to take cholesterol-lowering medicines for the rest of your life.

If you take too much CROSUVA (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) if you think you or anyone else may have taken too much CROSUVA. Do this even if there are no signs of discomfort or poisoning.

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While you are taking CROSUVA

Things you must do

While taking CROSUVA you also need to follow a low-fat diet, control your weight and exercise regularly.

Before starting any new medicine, tell your doctor or pharmacist that you are taking CROSUVA.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking CROSUVA.

Stop taking CROSUVA and contact your doctor immediately if you become pregnant while taking CROSUVA.

If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking CROSUVA.

Visit your doctor regularly so they can check on your progress. Have your blood cholesterol and triglycerides checked when your doctor says so to make sure CROSUVA is working.

Things you must not do

Do not use CROSUVA to treat any other conditions unless your doctor tells you to.

Do not give CROSUVA to anyone else, even if they have the same condition as you.

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Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CROSUVA. Like all other medicines, CROSUVA may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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:

  • headache
  • constipation
  • dizziness
  • 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 the 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
  • swelling of the face, eyelids and lips.

These are rare, but serious side effects which can need urgent medical attention.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

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After using CROSUVA

Storage

Keep CROSUVA 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.

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store CROSUVA or any other medicine in the bathroom or near a sink.

Do not leave CROSUVA in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking CROSUVA, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

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Product description

What it looks like

CROSUVA comes in 4 strengths of tablets:

  • CROSUVA 5 - round, white, biconvex tablet, embossed with ‘ST 1’ on one side
  • CROSUVA 10 - round, pink, biconvex tablet, embossed with ‘ST 2’ on one side
  • CROSUVA 20 - round, pink, biconvex tablet, embossed with ‘ST 3’ on one side
  • CROSUVA 40 - oval, pink, biconvex tablet, embossed with ‘ST 4’ on one side.

Each pack contains 30 tablets.

Ingredients

The active ingredient in CROSUVA is rosuvastatin (as calcium).

  • each CROSUVA 5 tablet contains 5 mg of rosuvastatin
  • each CROSUVA 10 tablet contains 10 mg of rosuvastatin
  • each CROSUVA 20 tablet contains 20 mg of rosuvastatin
  • each CROSUVA 40 tablet contains 40 mg of rosuvastatin.

The tablets also contain:

  • microcrystalline cellulose
  • calcium hydrogen phosphate
  • crospovidone
  • lactose
  • magnesium stearate
  • Opadry II White 33G28435 (5 mg tablet only)
  • Opadry II Pink 33G240007 (10 mg, 20 mg and 40 mg tablets).

The tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.

Supplier

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065

Australian registration numbers:
CROSUVA 5 - AUST R 183636
CROSUVA 10 - AUST R 183642
CROSUVA 20 - AUST R 183646
CROSUVA 40 - AUST R 183649

Date of preparation: 27 February 2014

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CMI provided by MIMS Australia, August 2014  

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