Simvastatin 80mg Tablets
Read all of this leaflet carefully before you start taking this medicine
Keep this leaflet. You may need to read it again
If you have any further questions, ask your doctor or pharmacist
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Simvastatin 80mg is and what it is used for
- 2. Before you take Simvastatin 80mg
- 3. How to take Simvastatin 80mg
- 4. Possible side effects
- 5. How to store Simvastatin 80mg
- 6. Further information
What Simvastatin 80Mg Is And What It Is Used For
Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin raises levels of “good” cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. Simvastatin is a member of the class of drugs called statins.
Simvastatin is used along with diet if you have:
- a raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia)
- a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
- coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.
In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.
Before You Take Simvastatin 80Mg
Do not take Simvastatin 80mg:
- if you are allergic (hypersensitive) to simvastatin or to any of the other ingredients of the tablet
- if you have liver problems or a continuous high level of certain liver enzymes (serum transaminases)
- if you are pregnant or breast-feeding
- if you are taking the following medicines (see also the section “Taking other medicines” below):
- certain antifungals (ketoconazole or itraconazole)
- certain medicines for the treatment of AIDS (HIV-protease inhibitors, such as indinavir, nelfinavir, ritonavir and saquinavir)
- certain antibiotics (erythromycin, clarithromycin or telithromycin)
- the antidepressant nefazodone
Take special care with Simvastatin 80mg:
- Tell your doctor about all your medical conditions including allergies.
- Tell your doctor if you drink large amounts of alcohol
- Tell your doctor if you have ever had liver disease. Simvastatin may not be right for you.
- Tell your doctor if you are due to have an operation. You may need to stop taking Simvastatin tablets for a short time.
- Your doctor should do a blood test before you start taking Simvastatin. This is to check how well your liver is working.
- Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Simvastatin.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
The risk of muscle breakdown is greater at higher doses of Simvastatin and is greater in certain patients. Tell your doctor if any of the following applies to you:
- you consume large amounts of alcohol
- kidney problems
- thyroid problems
- you are more than 70 years old
- you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
- you or close family members have a hereditary muscle disorder.
Taking other medicines
It is particularly important to tell your doctor if you are taking any of the following drugs. Taking Simvastatin with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin 80mg:”)
Please note that the following statements may also apply to products you took some time ago or may take at some time in the future.
The risk of muscle problems can be greater if simvastatin is taken with the following medicines: (some of these have already been listed in the above section “Do not take the tablets”)
- Fibrates (other cholesterol-lowering medicines, such as gemfibrozil, bezafibrate); the simvastatin dose should not exceed 10mg daily
- Ciclosporin (drug used to suppress the immune system); the simvastatin dose should not exceed 10mg daily
- Certain antifungals (such as itraconazole or ketoconazole)
- The antibiotics erythromycin, clarithromycin and telithromycin
- Certain medicines for the treatment of AIDS (HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir and saquinavir)
- Danazol (medicine used to treat endometriosis and breast cysts in women) the simvastatin dose should not exceed 10mg daily
- The antidepressant nefazodone
- Amiodarone, a medicine used for irregular heart beat; the simvastatin dose should not exceed 20mg daily
- Verapamil and diltiazem (medicine used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions); if you take verapamil, the dose of simvastatin should not exceed 20mg daily. If you take dilitazem, the dose of simvastatin should not exceed 40mg daily, unless your doctor considers that the clinical effects is likely to outweigh the increased risk of muscle problems
- Fusidic acid as a tablet or infusion (a medicine used to treat bacterial infections)
As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following:
- medicines to prevent blood clots, such as warfarin phenprocoumon or acenocoumarol (anticoagulants).
- fenofibrate (another medicine for lowering cholesterol).
- niacin (another medicine for lowering cholesterol).
Taking Simvastatin 80mg with food and drink
Grapefruit juice contains one or more components which may increase the amount of simvastatin in the blood. Therefore, you should not drink grapefruit juice as it could increase the risk of muscle damage.
Pregnancy and breast-feeding
Do not take simvastatin if you are pregnant, trying to become pregnant or suspect you may be pregnant, as the safety in pregnant women has not been established. If you become pregnant while using simvastatin, you must stop taking the tablets immediately and contact your doctor.
No data on the excretion of simvastatin in breast milk are available. Because many medicinal products are excreted in human milk and because of the potential for serious side effects, you must not breast-feed your infant while taking simvastatin.
Children
Simvastatin is not recommended for use in children.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Simvastatin has no effect or only a negligible effect on the ability to drive or use machines. However, there have been rare cases of dizziness reported in patients taking simvastatin tablets (see section 4 “Possible side effects”). Do not drive vehicles or operate machines that require attention if you experience this side effect.
Important information about some of the ingredients of Simvastatin 80mg
Amongst other ingredients, Simvastatin 80mg tablets contain lactose monohydrate. If your doctor has told you that you cannot tolerate certain sugars, contact your doctor before taking this medicine.
How To Take Simvastatin 80Mg?
Always take your tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Take the tablets either on an empty stomach or after a meal.
Before starting your treatment with Simvastatin 80mg you should be on a diet to lower your cholesterol and should keep on this diet while you are taking Simvastatin 80mg.
The usual dose is 5mg to 80mg simvastatin per day as a single dose in the evening. If needed, your doctor can increase the dose at intervals of at least 4 weeks to a maximum of 80mg per day as a single dose in the evening. The dose of 80mg is only recommended in patients with very high cholesterol levels and high-risk cardiovascular complications.
Your doctor will decide the appropriate dose for you and when you should take your tablets. This will depend on why you need to lower your cholesterol (see also section 1 “What Simvastatin 80mg is and what it is used for”):
Adults
To lower cholesterol and triglycerides in the blood (Hypercholesterolaemia), a usual starting dose is 10-20mg as a single dose in the evening. If a stronger effect is needed, the starting dose can be 20-40mg as a single dose in the evening. Your doctor can decide to increase the dose as mentioned above.
To lower inherited high levels of cholesterol in your blood (homozygous familial hypercholesterolemia), the recommended dose is 40mg as a single dose in the evening, or 80mg per day in 3 divided doses: 20mg in the morning, 20mg in the afternoon and 40mg in the evening.
To reduce the risk of coronary heart disease, the usual dose is 20-40mg as a single dose in the evening. Your doctor can decide to increase the dose as mentioned above.
If you have moderate kidney problems your dose will not have to be adjusted. If you have severe kidney problems your doctor may prescribe a lower dose, which will not be more than 10mg per day.
If your doctor has prescribed a bile acid sequestrant (another medicine for lowering cholesterol such as colestyramine) along with Simvastatin 80mg, you should take Simvastatin 80mg at least two hours before or four hours after taking the bile acid sequestrant.
Children and adolescents
Efficacy and safety of use in children have not been established.
Elderly
No dosage adjustment is necessary.
Duration of treatment:
You will have to take simvastatin over a long period of time. Your doctor will tell you how long you need to take simvastatin.
If you have the impression that the effect of simvastatin is too strong or too weak, talk to your doctor or pharmacist.
If you take more Simvastatin 80mg than you should
Although no specific information about simvastatin overdose is available, any medication taken in excess can have serious consequences. If you take too many tablets by mistake, contact a doctor or pharmacist immediately.
If you forget to take Simvastatin 80mg
If you realise you have forgotten to take a dose soon after its due time, take it as soon as possible. However, if it is almost time to take the next dose, omit the forgotten dose and take the next one when it is due. Ask your doctor or pharmacist in case of doubt.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Simvastatin 80mg
If you suddenly stop taking this medicine, your cholesterol may rise again. It is therefore important that you consult a doctor before stopping treatment. He/she can tell you if you can stop and the best way to do so.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Simvastatin 80mg can cause side effects, although not everybody will have them.
The following term is used to describe how often side effects have been reported:
Rare (occurring in 1 or more of 10,000 and less than 1 of 1000 patients treated)
The following rare serious side effects were reported.
If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.
- muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
- hypersensitivity (allergic) reactions including:
- swelling of the face, tongue and throat which may cause difficulty in breathing
- severe muscle pain usually in the shoulders and hips
- rash with weakness of limbs and neck muscles
- pain or inflammation of the joints
- inflammation of the blood vessels
- unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing
- shortness of breath and feeling unwell
- lupus-like disease picture (including rash, joint disorders, and effects on blood cells)
- inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, liver failure (very rare)
- inflammation of the pancreas often with severe abdominal pain.
The following side effects have also been reported rarely:
- low red blood cell count (anaemia)
- numbness or weakness of the arms and legs
- headache, tingling sensation, dizziness
- digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
- rash, itching, hair loss
- weakness.
Laboratory values
Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Simvastatin 80Mg
Keep out of the reach and sight of children.
Store the tablets in the original package in order to protect from light and moisture.
Do not store above 30°C.
Do not use the tablets after the ¨do not use after¨ or ¨expiry¨. date stated on the packaging. The first 2 digits denote the month, the last digits the year.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Simvastatin 80mg contains:
- The active substance is: Simvastatin, 80mg per tablet
- The other ingredients are:
Tablet core: Lactose monohydrate, cellulose microcrystalline (E460), pregelatinised maize starch, butylhydroxyanisole (E320), ascorbic acid (E300), citric acid (E330), colloidal anhydrous silica (E551), talc (E553b), magnesium stearate (E470b).
Film-coating: Hypromellose (E464), red iron oxide (E172), triethylcitrate (E1505), titanium dioxide (E171), talc (E553b), povidone K-30.
Product appearance and pack size
Simvastatin 80mg is a dark pink-coloured , oblong, film-coated tablet, scored on one side. The tablets can be divided into equal halves.
The tablets are packed in blisters in a carton box, containing 10, 20, 28, 30, 40, 50, 56, 60, 98 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturers
Actavis Nordic A/S
Distributor
This leaflet was last revised in: October 2009
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