Lorstat Tablets

Lorstat Tablets is a brand of medicine containing the active ingredient atorvastatin.

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.

Lorstat

contains the active ingredient atorvastatin calcium


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Lorstat.

It does not contain all 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 Lorstat against the benefits expected 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 Lorstat is used for

Lorstat lowers high cholesterol levels.

Lorstat is also used to help 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 example, if they have diabetes, a history of stroke, or small blood vessel disease).

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 wall lining, 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 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 (low-density lipoprotein) is the 'bad' cholesterol that can block your blood vessels and HDL (high density lipoprotein) is the good cholesterol that is thought to remove 'bad' cholesterol from the blood vessels.

When you have high levels of 'bad' cholesterol it may begin to '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 blood vessel wall and float in the bloodstream where it can reach a smaller vessel and cause a complete block This blocking of your blood vessels can lead to blood vessel disease, heart disease (such as heart attack and angina) and stroke.

There is another type of blood fat called triglyceride. Triglycerides are an energy source for the body. However, high levels of triglyceride can 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.

How Lorstat works.

Lorstat belongs to a group of medicines known as HMG-CoA reductase inhibitors (also known as "statins"). The medicine works by reducing the amount of cholesterol made by the liver. More specifically, Lorstat reduces the amount of LDL (bad cholesterol) and can raises the amount of HDL (good cholesterol). Lorstat also helps to protect you from a heart attack or stroke.

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

Ask your doctor if you have any questions about why Lorstat has been prescribed for you. Your doctor may have prescribed Lorstat for another reason.

Lorstat has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Lorstat is available only with a doctor's prescription.

There is no evidence that Lorstat is addictive.

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Before you take Lorstat

When you must not take it

Do not take Lorstat if:

  • you are allergic to medicines containing atorvastatin 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.
  • You have active liver disease.

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

Women of child-bearing age who are taking the medicine should use a proven method of birth control to avoid pregnancy. The medicine may affect your unborn developing baby if you take it during pregnancy.

Do not take the medicine if you are breastfeeding or intend to breastfeed. The medicine may pass into breast milk and affect your baby.

Do not take Lorstat if the expiry date (EXP.) printed on the bottle or pack has passed. If you take this medicine after the expiry date has passed, it may not work or it may make you unwell.

Do not take Lorstat if the packaging shows signs of tampering or the tablets do not look quite right.

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

Before you start to take it

Your doctor will ask you to have a liver function test before you start to taking Lorstat.

Tell your doctor if you:

  • Have any medical conditions including:
    - Liver problems
    - Muscle pain, tenderness or weakness from other medicines used to treat cholesterol or triglycerides.
    - Kidney problems
  • Have a history of haemorrhagic stroke or a lacunar stroke
    If you have had one of these strokes before, this medicine may increase the risk of you having a haemorrhagic stroke.
  • Drink alcohol regularly
  • Have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

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

Taking other medicines

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

Some medicines may be affected by Lorstat, or may affect how well it works. These include:

  • digoxin, a medicine used to treat some heart problems
  • the antibiotics erythromycin, clarithromycin and rifampicin
  • phenytoin, a medicine used to treat epilepsy
  • oral contraceptives
  • other medicines used to treat high cholesterol or triglycerides
  • antacids, medicines used to treat reflux or ulcers
  • cyclosporin, used to suppress the immune system
  • some medicines used to treat some fungal infections
  • protease inhibitors which are used to treat HIV infections and/or hepatitis C, such as efavirenz, fosamprenavir, ritonavir and boceprevir.
  • ketoconazole (Nizoral) and itraconazole (Sporanox), used to treat certain fungal infections
  • diltiazem, a medicine used to treat angina.
  • spironolactone, a medicine used to treat high blood pressure or certain types of swelling
  • vitamin B3
  • colchicine, a medicine used to treat a disease with painful, swollen joints caused by uric acid crystals.

These medicines may be affected by Lorstat, or may affect how well it works. Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Lorstat.

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 Lorstat.

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How to take 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 bottle or pack, ask your doctor or pharmacist.

How much to take

Take Lorstat only when prescribed by your doctor.

Your doctor will tell you how many tablets you need to take each day. This may depend on your condition and whether or not you are taking any other medicines.

The usual dose of Lorstat is between 10-80 mg taken once a day.

Follow all directions given to you by your doctor and pharmacist carefully. If you do not understand the instructions ask your doctor or pharmacist for help.

How to take it

Swallow the tablets with a glass of water, with or without food.

Do not chew or crush the tablets.

When to take it

Lorstat can be taken at any time of the day. However, your dose of Lorstat should be taken at about the same time each day. Taking your tablet at the same time each night will have the best effect. It will also help you remember when to take the tablet(s).

How long to take it for

Keep taking Lorstat for as long as your doctor recommends. Lorstat helps lower your cholesterol. It does not cure your condition. Therefore, you must continue to take Lorstat as directed by your doctor if you expect to lower your cholesterol and keep it down.

You may have to take cholesterol-lowering medicine for the rest of your life. If you stop taking Lorstat, your cholesterol levels may rise again.

If you forget to take it

If 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 the missed dose as soon as you remember, and then go back to taking your tablets as you would normally. If you are unsure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting unwanted side effects.

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

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

If you have any questions about this, check with your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Lorstat. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

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While you are taking Lorstat

Things you must do

Have your cholesterol and triglyceride levels checked regularly to make sure that Lorstat is working.

Have your liver function tested from time to time while you are taking Lorstat to make sure the medicine is working and to prevent unwanted side effects.

If you become pregnant while taking Lorstat, stop taking the medicine and contact your doctor immediately.

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

Visit your doctor regularly so they can check on your progress.

Things you must not do

Do not stop taking Lorstat, or lower the dose even if you are feeling better, without checking with your doctor.

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

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

Things to be careful of

Avoid drinking large quantities of alcohol. Drinking large quantities of alcohol while taking Lorstat may increase your chance of getting liver problems.

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 litres) each day increases the chance of Lorstat causing side effects.

Be careful driving or operating machinery 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 feel dizzy, do not drive, operate machinery or do anything else that could be dangerous.

Lifestyle measures that help reduce heart disease risk

By following these simple measures, you can further reduce the risk from heart disease.

  • Quit smoking and avoid second-hand smoke.
  • Limit alcohol intake.
  • Enjoy healthy eating by:
    - eating plenty of vegetables and fruit;
    - reducing your saturated fat intake (eat less fatty meats, full fat dairy products, butter, coconut and palm oils, most take-away foods, commercially-baked products).
  • Be active. Progress, over time, to at least 30 minutes of moderate-intensity physical activity on 5 or more days each week. Can be accumulated in shorter bouts of 10 minutes duration. If you have been prescribed anti-angina medicine, carry it with you when being physically active.
  • Maintain a healthy weight.
  • Discuss your lifestyle and lifestyle plans with your doctor.
  • For more information and tools to improve your heart health, call Heartline, the Heart Foundation's national telephone information service, on 1300 36 27 87 (local call cost).

Know warning signs of heart attack and what to do:

  • Tightness, fullness, pressure, squeezing, heaviness or pain in your chest, neck, jaw, throat, shoulders, arms or back.
  • You may also have difficulty breathing, or have a cold sweat or feel dizzy or light headed or feel like vomiting (or actually vomit).

If you have heart attack warning signs that are severe, get worse or last for 10 minutes even if they are mild, call triple zero (000). Every minute counts.

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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 Lorstat. 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:

  • constipation, diarrhoea
  • unusual tiredness or weakness
  • stomach or belly pain, nausea
  • headache
  • trouble sleeping
  • heartburn, indigestion or wind
  • urine infection
  • stuffy or runny nose
  • nose bleeds

These are the more common side effects, and are usually mild and short-lived.

Tell your doctor immediately or go to the casualty department of your nearest hospital if you notice any of the following:

  • symptoms of allergy such as swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing and 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 accomplished by nausea, vomiting, loss of sensation, tingling on the hands or feet
  • rash, itching
  • problems with breathing, including shortness of breath, persistent cough and fever.
  • severe blisters and bleeding of the lips, eye, mouth, nose or genitals.

These may be serious side effects requiring urgent medical attention. Serious side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell. Do not be alarmed by the list of possible side effects. You may not experience any of them.

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After taking Lorstat

Storage

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

Keep your tablets in a cool dry place where the temperature stays below 25°C and protect from light.

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

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

Disposal

If your doctor tells you to stop taking Lorstat, 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

Lorstat tablets are available in 4 different strengths:

  • LORSTAT 10 mg - White, oval shaped, bi-convex, film coated tablet, debossed "ATO 10" on one side and "G" on the other side.
  • LORSTAT 20 mg - White, oval shaped, bi-convex, film coated tablet, debossed "ATO 20" on one side and "G" on the other side.
  • LORSTAT 40 mg - White, oval shaped, bi-convex, film coated tablet, debossed "ATO 40" on one side and "G" on the other side.
  • LORSTAT 80 mg - White, oval shaped, bi-convex, film coated tablet, debossed "ATO 80" on one side and "G" on the other side.

Each blister pack contains 30 tablets.

Ingredients

The active ingredient of Lorstat is atorvastatin.

The inactive ingredients are:

  • lactose anhydrous
  • sodium lauryl sulphate
  • crospovidone
  • magnesium oxide - light
  • poloxamer
  • croscarmellose sodium
  • magnesium stearate and
  • Opadry II White Y-30-18037

Supplier

Lorstat is supplied in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au

Medical Information
Phone: 1800 028 365

Australian registration numbers:

  • Lorstat 10 Blister pack -
    AUST R 151296
  • Lorstat 20 Blister pack
    AUST R 151297
  • Lorstat 40 Blister pack -
    AUST R 151298
  • Lorstat 80 Blister pack -
    AUST R 151299
  • This leaflet was prepared on
    18 November 2013.

Lorstat_cmi/NOV13\00

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CMI provided by MIMS Australia, March 2014  

Latest information - Lorstat Tablets

Audience:
       

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