APX-ROSUVASTATIN

APX-ROSUVASTATIN

Active ingredient(s): rosuvastatin calcium

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Consumer Medicine Information (CMI)

This leaflet provides important information about taking APX-ROSUVASTATIN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking APX-ROSUVASTATIN.

Where to find information in this leaflet:

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

1. Why am I using APX-ROSUVASTATIN?

APX-ROSUVASTATIN contains the active ingredient rosuvastatin calcium. APX-ROSUVASTATIN 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.

APX-ROSUVASTATIN is used to lower high cholesterol levels.

Even though you may have normal cholesterol, APX-ROSUVASTATIN 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 APX-ROSUVASTATIN 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. APX-ROSUVASTATIN does not reduce the cholesterol that comes from fat in food. Because of this, when you are taking APX-ROSUVASTATIN, you need to follow a low-fat diet, control your weight and exercise regularly.

2. What should I know before I use APX-ROSUVASTATIN?

Warnings

Do not use APX-ROSUVASTATIN 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 use this medicine.
• you are pregnant, become pregnant while taking APX-ROSUVASTATIN, 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 APX-ROSUVASTATIN 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 APX-ROSUVASTATIN blood levels.

Pregnancy and breastfeeding

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

If you become pregnant, stop taking APX-ROSUVASTATIN as soon as you find out and see your doctor immediately.

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

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 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 lipidlowering agents.

It may not be safe for you to take APX-ROSUVASTATIN 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 APX-ROSUVASTATIN.

• 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 APX-ROSUVASTATIN.

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?

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 APX-ROSUVASTATIN and affect how it works. These include:

• ciclosporin, used for example, after organ transplant
• antacids, used to treat heartburn and indigestion. APX-ROSUVASTATIN 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, fenofibrate or ezetimibe, used to lower blood lipids
• fusidic acid, used to treat some infections
• 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, regorafenib and darolutamide used to treat cancer
• eltrombopag (REVOLADE), used to increase your platelet count in your blood.
• tafamidis, used to treat a protein disorder.

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

4. How do I take APX-ROSUVASTATIN?

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 APX-ROSUVASTATIN dose to 20 mg once daily. For most patients a maximum 20 mg APX-ROSUVASTATIN daily dose is sufficient to treat high cholesterol.
• A small number of patients may need to further increase their APX-ROSUVASTATIN 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 APX-ROSUVASTATIN must not exceed 40 mg daily.

DO NOT INCREASE OR ADJUST YOUR APX-ROSUVASTATIN DOSE YOURSELF.

• Swallow each tablet whole with a drink of water.
• You must continue to take it as directed.
• APX-ROSUVASTATIN helps lower your blood cholesterol and triglycerides. It does not cure your condition. If you stop taking APX-ROSUVASTATIN, your cholesterol and triglycerides levels may rise again.
• You may have to take cholesterol-lowering medicines for the rest of your life.

When to take APX-ROSUVASTATIN

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

If you forget to take APX-ROSUVASTATIN

APX-ROSUVASTATIN should be taken regularly at the same time each day. If you forget to take a dose of APX-ROSUVASTATIN, 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 hint.

If you take too much APX-ROSUVASTATIN

If you think that you have used too much APX-ROSUVASTATIN, 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 APX-ROSUVASTATIN?

Things you should do

Have your blood cholesterol and triglycerides checked when your doctor says so to make sure APX-ROSUVASTATIN is working.

Call your doctor straight away if you:

• become pregnant while you are taking APX-ROSUVASTATIN.

Remind any doctor, dentist or pharmacist you visit that you are taking APX-ROSUVASTATIN.

Things you should not do

• Do not stop taking APX-ROSUVASTATIN unless you have discussed it with your doctor.

Things that may help your condition

• While taking APX-ROSUVASTATIN, 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 APX-ROSUVASTATIN affects you.

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

Drinking alcohol

Tell your doctor if you regularly drink large amounts of alcohol.

Excessive alcohol consumption may not be safe in patients taking APX-ROSUVASTATIN.

Looking after your medicine

• Keep your tablets in the blister pack until it is time to take them.

Follow the instructions on the carton on how to take care of your medicine properly. Keep your tablets in the blister pack until it is time to take them. If you take APX-ROSUVASTATIN out of the blister pack, it will not keep well.

Store it in a cool dry place below 25°C and 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.

Less serious side effects

Less serious side effects	What to do
headache constipation dizziness nausea (feeling sick) stomach pain unusual tiredness or a general feeling of weakness (asthenia) muscle pain (myalgia) stiff or painful joints (arthralgia)	Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

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 develop 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 available with a doctor’s prescription.

What APX-ROSUVASTATIN contains

Active ingredient (main ingredient)	rosuvastatin calcium
Other ingredients (inactive ingredients)	APX-ROSUVASTATIN tablets contain: Microcrystalline cellulose Colloidal anhydrous silica Crospovidone Lactose monohydrate Magnesium stearate Opadry II Yellow 33K620000 (ARTG 109007, contains hypromellose, titanium dioxide, lactose monohydrate, triacetin, quinolone yellow aluminium lake, sunset yellow FCF, indigo carmine) – 5mg Opadry II Pink 33K640001 (ARTG 109004, contains hypromellose, titanium dioxide, lactose monohydrate, triacetin, sunset yellow FCF, indigo carmine, allura red AC aluminium lake) – 10mg & 20mg Opadry II Pink 33K640000 (ARTG 109005, contains hypromellose, titanium dioxide, lactose monohydrate, triacetin, sunset yellow FCF, indigo carmine, allura red AC aluminium lake) – 40mg
Potential allergens	This medicine contains sugars as lactose.

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

What APX-ROSUVASTATIN looks like

APX-ROSUVASTATIN 5 are Yellow, round, biconvex, coated tablet debossed with “ROS” over “5” on one side and plain on the other side. (ARTG 333449)

APX-ROSUVASTATIN 10 are Pink, round, biconvex, coated tablet debossed with “ROS” over “10” on one side and plain on the other side. (ARTG 333451)

APX-ROSUVASTATIN 20 are Pink, round, biconvex, coated tablet debossed with “ROS” over “20” on one side and plain on the other side. (ARTG 333453)

APX-ROSUVASTATIN 40 are Pink, oval, biconvex, coated tablet debossed with “ROS” on one side and “40” on the other side. (ARTG 333455)

Available in blister packs of 30 tablets.

Who distributes APX-ROSUVASTATIN

Arrow Pharma Pty Ltd
15-17 Chapel St
Cremorne VIC 3121
www.arrowpharma.com.au

This leaflet was prepared in October 2023.