Consumer medicine information

Simvastatin AN tablets

Simvastatin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Simvastatin AN. It does not contain all of the available information.

If you have any concerns about using Simvastatin AN, ask your doctor or pharmacist. Your doctor or pharmacist may have more information.

Keep this leaflet with your Simvastatin AN tablets. You may need to read it again.

What Simvastatin AN is used for

Simvastatin AN helps to lower cholesterol and triglyceride levels.

SIMVASTATIN AN is used in people who have coronary heart disease (CHD) or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease).

SIMVASTATIN AN may be used in these people, regardless of their cholesterol level to:

  • Help prolong life by reducing the risk of a heart attack
  • Reduce the risk of stroke
  • Reduce the need for surgery to increase blood flow to the heart
  • Reduce the need for hospitalisation due to angina.

Cholesterol

Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things, including building cell walls, making bile acids (which help to digest food) and certain hormones. However, too much cholesterol can be a problem.

Your body makes cholesterol, but it also comes from food.

Normally the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol comes from food, less is made by the body.

However, if you eat a diet high in fat, your body may not keep this balance and your cholesterol levels rise.

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

When you have high levels of cholesterol, 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 plaque, on the walls of blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to coronary heart disease (such as heart attack and angina), and stroke.

In people with CHD, SIMVASTATIN may slow down the hardening of blood vessels and reduce the risk of developing new plaques.

There are different types of cholesterol, called LDL and HDL cholesterol. LDL cholesterol is the ‘bad’ cholesterol that can block your blood vessels. HDL cholesterol, on the other hand, is the ‘good’ cholesterol that is thought to remove the bad cholesterol from the blood vessels.

Triglycerides

Triglycerides are an energy source for the body. However, as with cholesterol, too much triglycerides can be a problem.

How SIMVASTATIN AN works

SIMVASTATIN AN belongs to a group of medicines known as HMGCoA reductase inhibitors. It works by reducing the amount of cholesterol made by the liver. In terms of good and bad cholesterol, SIMVASTATIN AN reduces the bad cholesterol and raises the good cholesterol.

SIMVASTATIN AN does not reduce the cholesterol and triglycerides that come from fat in food.

Therefore, when you are taking SIMVASTATIN AN, you also need to follow a low fat diet and other measures, such as exercise and weight control.

In most people, there are no symptoms of high cholesterol or triglycerides. Your doctor can measure your cholesterol and triglycerides with a simple blood test.

SIMVASTATIN AN is not recommended for use in children, as there have been no studies of its effects in children.

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

SIMVASTATIN AN is not addictive.

Before you take Simvastatin AN

When you must not take Simvastatin AN

Do not take Simvastatin AN if:

  • you have an allergy to SIMVASTATIN AN, or to any of the ingredients listed at the end of this leaflet
    Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the tongue or face, or painful joints.
  • you are pregnant or breastfeeding
    Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby.
  • you have liver disease
  • you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides
  • the packaging is torn or shows signs of tampering
  • the expiry date on the pack has passed.
    If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking SIMVASTATIN AN, talk to your doctor.

Before you start to take SIMVASTATIN AN

Tell your doctor if:

  1. You intend to become pregnant or plan to breast feed
    SIMVASTATIN AN should not be used during pregnancy or while breast feeding.
  2. You have ever had liver disease
    Your doctor will do a blood test to make sure you have no problems with your liver.
  3. You have kidney disease or any other medical problems
  4. You drink alcohol regularly
  5. You 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 take any SIMVASTATIN AN.

Tell your doctor if:

  1. You intend to become pregnant or plan to breast feed
    SIMVASTATIN AN should not be used during pregnancy or while breast feeding.
  2. You have ever had liver disease
    Your doctor will do a blood test to make sure you have no problems with your liver.
  3. You have kidney disease or any other medical problems
  4. You drink alcohol regularly
  5. You 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 take any SIMVASTATIN AN.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines should not be taken with SIMVASTATIN AN as they may increase the risk of muscle side effects with SIMVASTATIN AN.

It is particularly important to tell your doctor if you are taking:

  • Nefazodone, used to treat depression
  • Protease inhibitors, used to treat HIV infection, including indinavir, nelfinavir, ritonavir, saquinavir
  • Erythromycin and clarithromycin, antibiotics used to treat infections
  • Ketoconazole and itraconazole, used to treat certain fungal infections

If you are taking any of the above, your doctor may suggest stopping SIMVASTATIN AN temporarily or permanently.

Some medicines and SIMVASTATIN AN may interfere with each other. Because taking SIMVASTATIN AN with any of the following drugs can increase the risk of muscle problems (see Side Effects), it is particularly important to tell your doctor if you are taking:

  • Other medicines to lower cholesterol levels, for example, fibric acid derivatives (such as gemfibrozil and bezafibrate)
  • Cyclosporin, used to suppress the immune system
  • Danazol
  • Verapamil, diltiazem or amlodipine used to treat high blood pressure, angina or other heart conditions
  • Amiodarone, used to treat irregular heart beat

It is also important to tell your doctor if you are taking anticoagulants (drugs that prevent blood clots, such as warfarin, nicotinic acid (also known as niacin) or fenofibrate, another fibric acid derivative.

Also tell your doctor if you are taking niacin or a niacin-containing product and you are Chinese.

These medicines may be affected by SIMVASTATIN AN, may affect how well it works, or may increase the risk of side effects with SIMVASTATIN AN. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking SIMVASTATIN AN.

How to take SIMVASTATIN AN

How much to take

Take SIMVASTATIN AN only when prescribed by your doctor. Your doctor will tell you how many tablets you need to take each day.

This depends on your cholesterol and triglyceride levels and other factors, such as kidney disease.

For Adult, the recommended starting dose is 10 mg or 20 mg per day, taken in the evening, which may need to be increased up to 80 mg daily to have the best effect.

The 80 mg dose is only for patients who have not reached their cholesterol goal on the 40 mg dose.

People with CHD or risk factors for CHD are usually started on 40 mg per day, taken in the evening.

Swallow SIMVASTATIN AN with a glass of water.

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, ask your doctor or pharmacist for help.

When to take SIMVASTATIN AN

Take SIMVASTATIN AN once a day in the evening. The liver produces its greatest amount of cholesterol when the body is at rest and when there is no dietary intake. For most people this is at night when asleep. Therefore, SIMVASTATIN AN is more effective when taken in the evening. A good time would be after your evening meal. However, it does not matter whether you take it before or after food.

Take SIMVASTATIN AN at about the same time each evening. Taking your tablet(s) at the same time each evening will have the best effect. It will also help you remember when to take the tablets.

How long to take SIMVASTATIN AN

SIMVASTATIN AN helps lower your cholesterol. It does not cure your condition. Therefore, you must continue to take it 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 SIMVASTATIN AN, your cholesterol levels may rise again.

If you forget to take SIMVASTATIN AN.

If it is almost time for 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 tablet(s) as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

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

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

If you take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much SIMVASTATIN AN.

Do this even if there are no signs of discomfort or poisoning.

While you are using SIMVASTATIN AN

Things you must do

If you become pregnant while you are taking SIMVASTATIN AN, stop taking it and contact your doctor immediately.

Have your blood fats checked when your doctor says, to make sure SIMVASTATIN AN is working.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking SIMVASTATIN AN.

If you are about to have elective surgery, tell your doctor that you are taking SIMVASTATIN AN. Your doctor may suggest stopping the tablets a few days before surgery.

Things you must not do

Do not give SIMVASTATIN AN 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 may increase your chance of SIMVASTATIN AN causing liver problems.

Avoid drinking large quantities of grapefruit juice. Grapefruit juice contains one or more components that alter the metabolism of some medicines, including SIMVASTATIN AN.

Therefore, drinking very large quantities (over 1 litre) of grapefruit juice each day increases your chance of SIMVASTATIN AN causing side effects. These include aching muscles, muscle tenderness or weakness, not caused by exercise. However, one glass (250 mL) of grapefruit juice each day has not been shown to have any significant effect.

Be careful driving or operating machinery until you know how SIMVASTATIN AN affects you. SIMVASTATIN AN generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, SIMVASTATIN AN may cause dizziness in some people. Make sure you know how you react to SIMVASTATIN AN before you drive a car or operate machinery.

Changes to lifestyle that may help reduce the chance of coronary heart disease. Lowering high cholesterol can help reduce your chances of having coronary heart disease (CHD). However, your chances of having CHD may be increased by several other factors including high blood pressure, cigarette smoking, diabetes, excess weight, family history of CHD, being a male and being a woman who has reached menopause. Some self help measures suggested below may help your condition and help reduce your chances of having CHD. Talk to your doctor, pharmacist, or dietician about these measures and for more information.

  • Diet – continue the low fat diet recommended by your doctor, dietician or pharmacist.
  • Weight – your doctor may advise you to lose weight if you are overweight.
  • Exercise – make exercise a part of your routine – walking is good. Ask your doctor for advice before starting exercise.
  • Smoking – your doctor may advise you to stop smoking or at least cut down.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SIMVASTATIN AN. SIMVASTATIN AN helps most people with high cholesterol, but it may have unwanted side effects in a few people. 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, wind
  • Stomach upset or pain, feeling sick (nausea)
  • Headache
  • Dizziness

These are the more common side effects of SIMVASTATIN AN. For the most part these have been mild and short-lived.

Tell your doctor immediately if you notice any of the following:

  • Aching muscles, muscle tenderness or weakness, not caused by exercise
  • Brown/black coloured urine

On rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage.

The risk of muscle problems is greater for:

  • patients taking higher doses of simvastatin
  • older patients (65 years of age and older)
  • female patients
  • patients with abnormal kidney function
  • patients with thyroid problems

Tell your doctor immediately if you notice any of the following:

  • Tingling in the hands or feet
  • Yellowing of the skin and/or eyes, also called jaundice
  • Signs of anaemia, such as tiredness, being short of breath, and looking pale
  • Fever, generally feeling unwell
  • Skin rash, itchiness
  • Pinkish, itchy swellings on the skin, also called hives or nettlerash
  • Painful, swollen joints
  • Bruising more easily than normal
  • Larger breasts than normal in men

These may be serious side effects of SIMVASTATIN AN. Some of these may be symptoms of an allergic reaction to SIMVASTATIN AN. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

  • Swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing
  • Shortness of breath

These are serious side effects. If you have them, you may have had a serious allergic reaction to SIMVASTATIN AN.

You may need urgent medical attention or hospitalisation. Serious side effects are rare.

Also, tell your doctor if you notice:

  • Hair loss
  • Muscle cramps
  • Trouble sleeping
  • Poor memory
  • Feelings of depression
  • Erectile dysfunction
  • Breathing problems including persistent cough and/or shortness of breath or fever

These are other side effects that have been reported with SIMVASTATIN AN.

Liver problems can also occur and may be serious. Your doctor will do blood tests to check your liver.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

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

After using SIMVASTATIN AN

Storage

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 may not keep well.

Keep SIMVASTATIN AN in a cool dry place where the temperature stays below 25°C. Do not store it or any other medicine in the bathroom or near a sink.

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

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.

Disposal

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

Product Description

What it looks like

You can identify SIMVASTATIN AN Tablets by their colour and shape. This is important because there are 5 types of SIMVASTATIN AN, each containing a different amount of simvastatin:

  • SIMVASTATIN AN 5 (AUST R 170524) are yellow coloured, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘15’ on the other side.
  • SIMVASTATIN AN 10 (AUST R 170525) are light pink coloured, round shaped, biconvex, film coated tablets debossed with ‘A’ on one side and ‘01’ on the other side
  • SIMVASTATIN AN 20 mg (AUST R 170526) are light pink coloured, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘02’ on the other side.
  • SIMVASTATIN AN 40 mg (AUST R 170527) are pink coloured, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘03’ on the other side.
  • SIMVASTATIN AN 80 mg (AUST R 170528) are pink coloured, capsule shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘04’ on the other side.

A box of SIMVASTATIN AN contains 30 tablets.

Ingredients

Active ingredient:
Simvastatin

The tablets contain either 5, 10, 20, 40 or 80 mg (milligrams) of simvastatin.

Inactive ingredients:

  • Ascorbic acid
  • Lactose monohydrate
  • Microcrystalline cellulose
  • Pregelatinised maize starch
  • Citric acid monohydrate
  • Butylated hydroxyanisole
  • Magnesium stearate

5 mg tablets also contain:
Opadry yellow

10 & 20 mg tablets also contain:
Opadry pink

40 & 80 mg tablets also contain:
Opadry pink

Name and Address of the Sponsor

Amneal Pharma Australia Pty Ltd
12 River Street
South Yarra,
VIC – 3141
Australia

Date of Preparation
November 2014

Published by MIMS June 2015