APO-Simvastatin

Simvastatin

Consumer Medicine Information

This leaflet answers some common questions about simvastatin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

Simvastatin is used:

to help lower high cholesterol and triglyceride levels (together with dietary changes)

in people who have coronary heart disease (CHD)

in people with a high risk of CHD (e.g. diabetes, stroke or other blood vessel disease)

Simvastatin can reduce the risk of a heart attack or stroke, and can reduce the need for hospitalisation due to angina.

Cholesterol:

Everyone has cholesterol and triglycerides in their blood. The body uses them for many things, such as building cell walls and hormones.

Your body makes cholesterol, but it also comes from food. 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 high-fat diet, your body may not keep this balance and your cholesterol levels rise.

Too much cholesterol or triglycerides can be a problem. 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 heart attacks, angina and stroke. High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol.

There is usually no symptoms of high cholesterol or triglycerides. Your doctor can measure your cholesterol and triglycerides with a blood test.

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

Simvastatin belongs to a group of medicines known as HMG-CoA reductase inhibitors.

Simvastatin works by reducing bad (LDL) cholesterol made by the liver and raises the good (HDL) cholesterol. It may slow the hardening of blood vessels and reduce the risk of developing new plaque.

Simvastatin does not reduce the cholesterol and triglycerides that come from fatty food. Therefore, you also need to follow a low-fat diet while you are taking simvastatin.

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

Your doctor may have prescribed this medicine for another reason.

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

This medicine is not addictive.

Safety and effectiveness have not been studied in boys under 10 years of age or in girls who have not yet started their periods.

Do not take this medicine if you have an allergy to:

simvastatin

lactose

any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue, throat or other parts of the body

rash, itching or hives on the skin

Do not take this medicine if you have or have had any of the following medical conditions:

liver disease or unexplained high levels of liver enzymes

muscle pain, tenderness or weakness (myopathy) from other medicines used to treat high cholesterol or triglycerides

Do not take this medicine if you are taking the following medicines:

gemfibrozil

cyclosporin

danazol

CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole)

HIV protease inhibitors (e.g. indinavir, nelfinavir, ritonavir, saquinavir)

hepatitis C virus protease inhibitors (e.g. boceprevir, telaprevir)

some antibiotics (e.g. fusidic acid, erythromycin, clarithromycin, telithromycin)

nefazodone

Do not take this medicine if you are pregnant or there is a chance that you could become pregnant (e.g. not using adequate contraception).

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

Do not take this medicine if you are breastfeeding.

Your baby may absorb this medicine from breast milk, and therefore there is a possibility of harm to the baby.

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.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

liver disease

kidney disease

thyroid problems

unexplained muscle pain, tenderness or weakness not caused by exercise

Tell your doctor if you drink alcohol regularly.

Tell your doctor if you are taking niacin (also known as nicotinic acid) or a niacin-containing product, particularly if you are Chinese.

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

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

Some medicines must not be taken with simvastatin. These include:

nefazodone, used to treat depression

gemfibrozil, used to treat high cholesterol levels

cyclosporin, used to suppress the immune system

danazol

medicines known as ‘CYP3A4 inhibitors’ (e.g. itraconazole, ketoconazole, posaconazole, voriconazole)

medicines containing cobicistat, used for HIV infection

HIV protease inhibitors (e.g. indinavir, nelfinavir, ritonavir, saquinavir)

hepatitis C virus protease inhibitors (e.g. boceprevir, telaprevir)

antibiotics used to treat infections (e.g. erythromycin, fusidic acid, clarithromycin, telithromycin)

Some other medicines may interact with simvastatin. These include:

other medicines used to lower cholesterol levels, such as other fibrates, niacin (also known as nicotinic acid)

warfarin and other medicines used to prevent blood clots

colchicine, used for gout

medicines used for heart problems (e.g. digoxin, verapamil, diltiazem, amlodipine, amiodarone)

lomitapide, used for a serious and rare genetic cholesterol condition

These medicines may be affected by this medicine 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.

Grapefruit juice, especially in large amounts, may also interfere with the way simvastatin works in your body. However, one glass of grapefruit juice per day is unlikely to have any effect.

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

They may differ to the information contained in this leaflet.

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

Your doctor will tell you how much of this medicine you should take, depending on your condition and whether you are taking other medicines.

The maximum dose of simvastatin is 80 mg per day. This dose should only be used in patients at a high risk of heart problems who have responded to lower doses.

High cholesterol and triglyceride levels:

The usual starting dose is 10 mg or 20 mg taken in the evening.

For CHD or risk of CHD:

The usual starting dose is 40 mg taken in the evening.

Swallow the tablets whole with a glass of water.

Take this medicine at the same time each day, preferably 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, this medicine is more effective when taken in the evening, such as after your evening meal, however it can be taken without food.

Taking it at the same time each day will have the best effect and will also help you remember when to take it.

Continue taking this medicine for as long as your doctor tells you.

Simvastatin helps to lower your cholesterol, but it does not cure your condition. It is important to keep taking your medicine even if you feel well.

Make sure you have enough to last over weekends and holidays.

If it is almost time to take your next dose, skip the dose you missed and take your next dose at the usual time.

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 missed doses.

This may increase the chance of you experiencing side effects.

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

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

You may need urgent medical attention.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

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

Do not take your medicine to treat any other complaint unless your doctor tells you to.

Do not stop taking your medicine or change the dosage without first checking with your doctor.

Be careful driving or operating machinery until you know how this medicine affects you.

Simvastatin generally does not affect your ability to drive a car or operate machinery. However, this medicine may cause dizziness in some people. Make sure you know how you react to this medicine before you drive a car or operate machinery.

Avoid drinking large quantities of alcohol.

Drinking large amounts of alcohol may increase the risk of liver problems.

Avoid drinking large quantities of grapefruit juice.

Grapefruit juice can alter the metabolism of simvastatin.

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

This medicine helps most people, but may cause unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following:

stomach upset, such as nausea, vomiting, constipation, diarrhoea, flatulence, pain, reflux

headache

dizziness

hair loss

muscle cramps

trouble sleeping

poor memory, memory loss, confusion

erectile dysfunction

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

depression

tingling or numbness in the hands or feet

tiredness, shortness of breath, looking pale (signs of anaemia)

fever, flushing and/or generally feeling unwell

sunburn type rash after only a short time in the sun

skin rash, itchiness

pinkish, itchy swellings on the skin, also called hives or nettle rash

painful, swollen joints

bruising more easily than normal

larger breasts than normal in men

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, or other parts of the body; rash, itching or hives on the skin (signs of an allergic reaction)

dry cough, trouble breathing, high temperature, weight loss, feeling tired (signs of interstitial lung disease)

feeling unusually tired or weak; loss of appetite; yellowing of the skin and/or eyes, also called jaundice; dark urine (signs of a liver problem)

sharp pain in the upper stomach (pancreatitis)

brown or dark coloured urine, severe muscle aching all through the body, muscle weakness (muscle breakdown)

Rarely, muscle breakdown can be serious and result in kidney damage or lead to death. The risk of muscle problems is greater for:

patients taking higher doses of simvastatin, such as 80 mg

older patients (65 years of age and older)

female patients

patients with abnormal kidney function

patients with thyroid problems.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some patients.

Keep your medicine in its pack until it is time to take it.

If you take your medicine out of its pack it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C. Protect from light and moisture.

Do not store your medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep this medicine 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.

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine leftover.

10 mg Tablets

Light pink coloured, oval, biconvex film-coated tablets, marked ‘SVN 10’ on one side and ‘NEO’ on the other side.

Blister packs of 30 tablets: AUST R 223448.

Bottles of 30 tablets: AUST R 223452.

20 mg Tablets

Tan coloured, oval, biconvex film-coated tablets, marked with ‘SVN 20’ on one side and ‘NEO’ on the other side.

Blister packs of 30 tablets: AUST R 223449

Bottles of 30 tablets:): AUST R 223453.

40 mg Tablets

Pink coloured, oval, biconvex film-coated tablets, marked ‘SVN 40’ on one side and ‘NEO’ on the other side. Blister packs of 30 tablets: AUST R 223450.

Bottles of 30 tablets: AUST R 223454.

80 mg Tablets

Pink coloured, capsule-shaped, biconvex film-coated tablets marked with ‘SVN 80’ on one side and ‘NEO’ on the other side.

Blister packs of 30 tablets: AUST R 223451.

Bottles of 30 tablets: AUST R 223455.

*Not all strengths, pack types and/or pack sizes may be available.

Each tablet contains either 10, 20, 40 or 80 mg of simvastatin as the active ingredient.

It also contains the following:

butylated hydroxyanisole

ascorbic acid

citric acid monohydrate

microcrystalline cellulose

magnesium stearate

lactose monohydrate

pregelatinised maize starch

Opadry 20A54692 Pink (10 mg only)

Opadry 20A56767 Brown (20 mg only)

Opadry 20A54535 Pink (40 mg and 80 mg only)

This medicine does not contain gluten, sucrose, tartrazine or any other azo dyes.

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

 

APO and APOTEX are registered trademarks of Apotex Inc.

 

This leaflet was prepared in December 2018.