Lorstat (New Formulation)

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

LORSTAT contains the active ingredient atorvastatin (as calcium trihydrate). LORSTAT is used to treat lowers high cholesterol levels and to reduce the risk of having a heart attack or stroke in people who have high blood pressure and coronary heart disease (CHD) or who are at risk of CHD. For more information, see Section 1. Why am I taking LORSTAT? in the full CMI.

Do not use if you have ever had an allergic reaction to LORSTAT or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take LORSTAT? in the full CMI.

Some medicines may interfere with LORSTAT and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

More instructions can be found in Section 4. How do I take LORSTAT? in the full CMI.

For more information, see Section 5. What should I know while taking LORSTAT? in the full CMI.

Speak to your doctor or pharmacist if you have any of these: muscle and joint pain, muscle weakness, especially in the forearms, thighs, hips, shoulders, neck, and back; difficulty climbing stairs or standing up from a chair; difficulty lifting arms over the head; falling and difficulty getting up from a fall; constipation, diarrhoea; stomach or belly pain, nausea (feeling sick); heartburn, indigestion or wind; urine infection; headache; stuffy or runny nose; nose bleeds; rash. Tell your doctor as soon as possible if you have any of these: yellowing of the skin and eyes and dark coloured urine; feeling weak and tired, excessively thirsty and passing more urine; problems with breathing, including shortness of breath, persistent cough and fever. Tell your doctor immediately or go straight to the Emergency Department at your nearest hospital if you have any of these: symptoms of allergy such as skin rash, itching, swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing or breathing; chest pain; unexpected muscle pain, tenderness or weakness not caused by exercise, particularly if you also feel unwell or have a fever; sudden severe headache, which may be accompanied by nausea, vomiting, loss of sensation, tingling in any part of the body or ringing in the ears; severe blisters and bleeding of the lips, eyes, mouth, nose or genitals.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Active ingredient(s): atorvastatin (as calcium trihydrate)

This leaflet provides important information about taking LORSTAT. 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 LORSTAT.

Where to find information in this leaflet:

LORSTAT contains the active ingredient atorvastatin (as calcium trihydrate). LORSTAT belongs to a group of medicines known as HMG-CoA reductase inhibitors. It works by reducing the amount of cholesterol made by the liver. LORSTAT 'bad' cholesterol and can raise the 'good' cholesterol. LORSTAT also helps to protect you from a heart attack or stroke.

LORSTAT is used to:

What is cholesterol

Everyone has cholesterol in their blood. It is a type of blood fat needed by the body for many things, such as building cell walls, making bile acids (which help to digest food) and some hormones. However, too much cholesterol can be a problem.

Cholesterol is present in many foods and is also made in your body by the liver. If your body makes too much cholesterol or you have too much cholesterol in your diet, then your cholesterol level becomes too high.

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

There are different types of cholesterol. LDL, or low-density lipoprotein, is the 'bad' cholesterol that can block your blood vessels. HDL, or high density lipoprotein cholesterol is the 'good' cholesterol that is thought to remove the 'bad' cholesterol from the blood vessels.

When you have high levels of 'bad' cholesterol in your blood, it may 'stick' to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can form hard areas (called plaques) on the walls of your blood vessels, making it more difficult for the blood to flow. Sometimes, the plaque can detach from the vessel wall and float in the bloodstream; it can then reach a smaller vessel and completely block it. This blocking of your blood vessels can lead to several types of blood vessel disease, heart attack, angina and stroke.

There is another type of fat called triglyceride, which is a source of energy. However, high levels of be associated with low level of 'good' cholesterol and may increase your risk of heart disease.

In some patients, LORSTAT is used to treat high cholesterol and high triglycerides together.

In most people, there are no symptoms of abnormal cholesterol or triglyceride levels. Your doctor can measure your levels with a simple blood test.

When you are taking LORSTAT, you also need to follow a low fat diet and other measures, such as exercise and weight control.

LORSTAT may be used alone, or in combination with other medicines, to treat your condition.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is not addictive.

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

This medicine is not expected to affect your ability to drive a car or operate machinery.

There is not enough information to recommend the use of this medicine for children.

Do not give this medicine to a child.

Information of safety and effectiveness in children is limited.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Your doctor will ask you to have your liver function tested before you start to take LORSTAT.

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?

Do not take this medicine if you are pregnant or intend to become pregnant.

Check with your doctor if you are pregnant or intend to become pregnant.

If you are a woman of child-bearing age and are taking this medicine, use a proven method of birth control to avoid pregnancy.

It may affect your developing baby if you take it during pregnancy.

Do not breast-feed if you are taking this medicine.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

The active ingredient in LORSTAT passes into breast milk and there is a possibility that your baby may be affected.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking LORSTAT.

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 LORSTAT and affect how it works. These include:

These medicines may be affected by LORSTAT or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

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

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

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

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.

LORSTAT should be used regularly at the same time each day.

If you miss your dose at the usual time and it is less than 12 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you think that you or anyone else have used too much LORSTAT, urgent medical attention may be needed.

You should immediately:

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

Remind any doctor, dentist or pharmacist you visit that you are taking LORSTAT.

Avoid drinking large quantities of grapefruit juice. Grapefruit juice contains one or more constituents that alter the metabolism of some medicines, including LORSTAT. Therefore, drinking very large quantities of grapefruit juice (over 1.2 litre) each day increases the chance of LORSTAT causing side effects.

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

LORSTAT generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, LORSTAT may cause dizziness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Avoid drinking large quantities of alcohol.

Tell your doctor if you drink alcohol regularly.

Drinking large quantities of alcohol may increase your chance of LORSTAT causing liver problems.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Some self-help measures suggested below may help your condition. Your doctor or pharmacist can give you more information about these measures.

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

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

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.

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

Do not use this medicine after the expiry date.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LORSTAT.

This medicine helps most people with lowering high cholesterol levels and reducing the risk of having a heart attack or stroke in people who have high blood pressure and coronary heart disease (CHD) or who are at risk of CHD, but it may have unwanted side effects in some people.

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.

Do not be alarmed by the following list of side effects. You may not experience any of them.

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

Some of these side effects (for example, changes in thyroid function, cholesterol level or blood pressure) can only be found when your doctor does tests from time to time to check your progress.

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.

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

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

LORSTAT 10 mg tablets: white, oval, biconvex, film coated tablet plain on one side and debossed '10' on the other side. (AUST R 334865 & AUST R 334861)

LORSTAT 20 mg tablets: white, oval, biconvex, film coated tablet with break line on one side and debossed '20' on the other side. (AUST R 334862 & AUST R 334868)

LORSTAT 40 mg tablets: white, oval, biconvex, film coated tablet with break line on one side and debossed '40' on the other side. (AUST R 334863 & AUST R 334867)

LORSTAT 80 mg tablets: white, oval, biconvex, film coated tablet with break line on one side and debossed '80' on the other side. (AUST R 334864 & AUST R 334866)

Available in blister packs of 30 tablets and bottle packs of 90 tablets.

Alphapharm Pty Ltd trading as Viatris

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.viatris.com.au 

Phone: 1800 274 276

This leaflet was prepared in January 2024.

LORSTAT^® is a Viatris company trade mark

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