Rosuvastatin Sandoz®

Rosuvastatin Sandoz®

Active ingredient(s): rosuvastatin calcium

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Rosuvastatin Sandoz. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Rosuvastatin Sandoz.

Where to find information in this leaflet:

1. Why am I using Rosuvastatin Sandoz?
2. What should I know before I use Rosuvastatin Sandoz?
3. What if I am taking other medicines?
4. How do I use Rosuvastatin Sandoz?
5. What should I know while using Rosuvastatin Sandoz?
6. Are there any side effects?
7. Product details

1. Why am I using Rosuvastatin Sandoz?

Rosuvastatin Sandoz contains the active ingredient rosuvastatin calcium. Rosuvastatin Sandoz belongs to a group of medicines known as HMG-CoA reductase inhibitors (also known as ‘statins’). It lowers the “bad” cholesterol (LDL), and raises the “good” cholesterol (HDL) when exercise and changes to diet are not enough on their own.

Rosuvastatin Sandoz is used to lower high cholesterol levels.

Even though you may have normal cholesterol, Rosuvastatin Sandoz 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, 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 Sandoz 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 essential for 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 can block the blood vessels that supply your heart and brain with blood, and can cause heart attack, angina and stroke. The “good” cholesterol 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.

High cholesterol is also more likely to occur with certain diseases or if you have a family history of high cholesterol.

Cholesterol is present in many foods and is also made by your body. Rosuvastatin Sandoz does not reduce the cholesterol that comes from fat in food. Because of this, when you are taking Rosuvastatin Sandoz, you need to follow a low-fat diet, control your weight and exercise regularly.

2. What should I know before I use Rosuvastatin Sandoz?

Warnings

Do not use Rosuvastatin Sandoz if:

• you are allergic to rosuvastatin calcium, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can take this medicine.
• you are pregnant, become pregnant while taking Rosuvastatin Sandoz, are breastfeeding, or trying to become pregnant unless you are taking adequate contraceptive precautions
• 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 take Rosuvastatin Sandoz 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 Sandoz blood levels.

Check with your doctor if you:

• have allergies to any other statins such as simvastatin, pravastatin, atorvastatin, or fluvastatin. If you have an allergic reaction, you may get a skin rash, hay fever, difficulty in breathing or feel faint
• have any other 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 Sandoz 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 Sandoz.
• have any unexplained aches or pains in your muscles
• regularly drink large amounts of alcohol. Excessive
• alcohol consumption may not be safe in patients taking Rosuvastatin Sandoz.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not take Rosuvastatin Sandoz if you are pregnant or intend to become pregnant. Ask your doctor about effective methods of contraception.

If you become pregnant, stop taking Rosuvastatin Sandoz as soon as you find out and see your doctor immediately.

Do not take Rosuvastatin Sandoz if you are breastfeeding. Your baby may absorb this medicine from breast milk and there is a possibility of harm to the baby.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Rosuvastatin Sandoz and affect how it works. These include:

• ciclosporin, used for example, after organ transplant
• antacids (medicines used to treat heartburn and indigestion). Rosuvastatin Sandoz can be taken 2 hours before or 2 hours after taking an antacid
• warfarin, used to stop blood clots
• clopidogrel or ticagrelor, used to prevent blood clots
• gemfibrozil, used to lower blood lipids
• fusidic acid, used to treat some infections
• fostamatinib, used to treat low platelet counts
• febuxostat, used to treat and prevent high blood levels of uric acid
• teriflunomide, used to treat relapsing remitting multiple sclerosis
• antiviral medications (alone or in combination), such as atazanavir, darunavir, glecaprevir, lopinavir, pibrentasvir, ritonavir, sofosbuvir, velpatasvir, and voxilaprevir, used to fight infections, including the HIV infection
• anti-cancer medications, such as regorafenib and darolutamide, used to treat cancer
• eltrombopag, used to increase your platelet count in your blood
• tafamidis, used to treat a protein disorder.

Your doctor will consider if Rosuvastatin Sandoz should be used together with any of these medicines, or may wish to adjust the dose of Rosuvastatin Sandoz or the other medicines. These medicines may affect the way Rosuvastatin Sandoz works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Rosuvastatin Sandoz.

4. How do I use Rosuvastatin Sandoz?

How much to take

• 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 a 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 Rosuvastatin Sandoz dose to 20 mg once daily. For most patients a maximum 20 mg Rosuvastatin Sandoz daily dose is sufficient to treat high cholesterol.
• A small number of patients may need to further increase their Rosuvastatin Sandoz 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 Sandoz must not exceed 40 mg daily.
  DO NOT INCREASE OR ADJUST YOUR ROSUVASTATIN SANDOZ DOSE YOURSELF.

When to take Rosuvastatin Sandoz

• Take Rosuvastatin Sandoz once a day, at about the same time each day. Keeping a regular time for taking Rosuvastatin Sandoz will help to remind you to take it.
• Rosuvastatin Sandoz can be taken at any time of the day. It does not matter whether you take Rosuvastatin Sandoz with food or on an empty stomach.

How to take Rosuvastatin Sandoz

• Swallow each tablet whole with a drink of water.

How to long to take Rosuvastatin Sandoz

• You must continue to take it as directed.
• Rosuvastatin Sandoz helps lower your blood cholesterol and triglycerides. It does not cure your condition. If you stop taking Rosuvastatin Sandoz, 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 use Rosuvastatin Sandoz

Rosuvastatin Sandoz should be taken regularly at the same time each day. If you forget to take a dose of Rosuvastatin Sandoz, 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 have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you use too much Rosuvastatin Sandoz

If you think that you have used too much Rosuvastatin Sandoz, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Rosuvastatin Sandoz?

Things you should do

Have your blood cholesterol and triglycerides checked when your doctor says so to make sure Rosuvastatin Sandoz is working.

Call your doctor straight away if you:

• Become pregnant while you are taking Rosuvastatin Sandoz.

Remind any doctor, dentist or pharmacist you visit that you are using Rosuvastatin Sandoz.

Things you should not do

• Do not stop taking Rosuvastatin Sandoz unless you have discussed it with your doctor.

Things that may help your condition

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

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Rosuvastatin Sandoz affects you.

Rosuvastatin Sandoz generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Rosuvastatin Sandoz may cause dizziness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Excessive alcohol consumption may not be safe in patients taking Rosuvastatin Sandoz.

Looking after your medicine

• Keep your tablets in the blister pack until it is time to take them. If you take Rosuvastatin Sandoz out of the blister pack, it will not keep well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place below 25°C away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to take this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not take this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
General disorders headache dizziness unusual tiredness or a general feeling of weakness (asthenia) Gastrointestinal or Gut related nausea (feeling sick) stomach pain constipation Muscle-joint related muscle pain (myalgia) stiff or painful joints (arthralgia)	Speak to your doctor if you have any of these less serious side effects and they worry you. They are generally mild and do not cause patients to stop taking Rosuvastatin Sandoz.

Serious side effects

Serious side effects

What to do

Metabolism-related significant increase in your need to urinate or if you are significantly more hungry or thirsty than usual Muscle-related aching muscles, muscle tenderness or weakness not caused by exercise (including eye muscles, or muscles used when breathing), particularly if you also have a fever or generally feel unwell Allergic and severe skin reaction-related difficulty breathing, swelling of the face, eyelids or lips widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome rash on the skin or sores in the mouth Lung-related difficulty breathing, coughing, particularly if you also feel generally unwell (e.g. fatigue, weight loss, fever)

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Rosuvastatin Sandoz contains

Active ingredient (main ingredient)	rosuvastatin calcium
Other ingredients (inactive ingredients)	lactose colloidal anhydrous silica maize starch purified talc sodium stearylfumarate hypromellose mannitol macrogol 6000 titanium dioxide iron oxide yellow iron oxide red microcrystalline cellulose silicon dioxide
Potential allergens	lactose

Do not take this medicine if you are allergic to any of these ingredients.

What Rosuvastatin Sandoz looks like

Rosuvastatin Sandoz 5mg – Brown, round, film coated tablets (AUST R 311400).

Rosuvastatin Sandoz 10mg – Brown, round, film coated tablets with “RSV 10” debossed on one side (AUST R 311401).

Rosuvastatin Sandoz 20mg – Brown, round, film coated tablets with “RSV 20” debossed on one side (AUST R 311402).

Rosuvastatin Sandoz 40mg – Brown, round, film coated tablets with “RSV 40” debossed on one side (AUST R 311403).

Available in blister packs of 30 tablets.

Who distributes Rosuvastatin Sandoz

Sandoz Pty Ltd
100 Pacific Highway
North Sydney, NSW 2060
Australia
Tel 1800 726 369

This leaflet was revised in December 2023.

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