Taking Simvastatins
What simvastatin is and what it is used for?
Cautions, contraindications and interactions with other drugs
How to take simvastatin
Possible side effects
How to store to store simvastatin
What simvastatin is and what it is used for?
Simvastatin belongs to a group of medicines called statins which work by reducing your body's production of "bad cholesterol" (LDL cholesterol) and raising the levels of "good" (HDL cholesterol) cholesterol.
Cholesterol is a lipid that can cause coronary heart disease by narrowing the vessels that supply the heart with blood. This condition, called hardening of the arteries or atherosclerosis, may lead to angina, a heart attack (myocardial infarction) or stroke.
When you use simvastatin, your doctor will recommend other actions as part of your treatment, such as a low-fat diet and exercise.
Simvastatin may prolong your life by reducing the risk of heart disease problems and stroke, regardless of the amount of cholesterol in your blood.
If an individual is found to have a fasting LDL-C (low density cholesterol) level of 5.5mmol/l or greater before or during treatment, they should be advised to consult their doctor, since it is unlikely that simvastatin 10mg will give a satisfactory reduction in cholesterol.
In most people, there are no immediate symptoms of high cholesterol.
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Cautions, contraindications and interactions with other drugs
Do not take simvastatin when there is:
Hypersensitivity to simvastatin or any ingredient; previous history of muscular toxicity with a statin or fibrate; individuals already taking prescription cholesterol lowering drugs; concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone); active liver disease or unexplained persistent elevations of serum transaminases; pregnancy and breast feeding women of childbearing potential.
Look out for muscle problems:
Stop simvastatin and contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because on very 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 very low and is possible with all statins. The risk is much greater at higher doses. Tell your doctor if any of the following applies to you: you consume large amounts of alcohol, have kidney problems or 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, or you or close family members have a hereditary muscle disorder.
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.
Using other medicines
The following drugs with simvastatin can increase the risk of muscle problems (some of these have already been listed in the above section), ciclosporin ( a medicine often used in organ transplant patients), danazol (a man-made hormone used to treat endometriosis), medicines like itraconazole or ketoconazole (medicines for fungal infections), fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol), erythromycin, clarithromycin, telithromycin or fusidic acid (medicines for bacterial infections), HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines for AIDS), nefadozone (a medicine for depression), amiodarone,(a medicine used for an irregular heart beat), verapamil or diltiazem (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions)
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).
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including simvastatin. Consuming grapefruit juice should be avoided.
Pregnancy and breast feeding
Do not take simvastatin if you are pregnant, trying to become pregnant or think you may be pregnant. If you get pregnant while taking simvastatin, stop taking it immediately and contact your doctor.
Driving
Simvastatin is not expected to interfere with your ability to drive or use machinery. However, it should be taken into account that some people get dizzy after taking simvastatin.
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How to take simvastatin
Take simvastatin in the evening. You can take it with or without food. Keep taking simvastatin 10mg unless your doctor tells you to stop.
If you take more simvastatin than you should contact your doctor or pharmacist.
If you forget to take simvastatin do not take an extra dose, just take the normal amount of simvastatin at the usual time the next day.
If you stop taking simvastatin your cholesterol may rise again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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Possible side effects
Like all medicines, simvastatin can have side effects, but most people have felt well while taking these tablets.
Less than 2% of patients on simvastatin were discontinued from clinical trials due to side effects attributable to simvastatin
Contact your doctor as soon as possible and stop taking sivastatin if you develop any unexplained or persistent muscle pain, tenderness, weakness or cramps, especially, if at the same time you feel unwell or have a high temperature. In very rare cases this has progressed to become a serious and potentially life-threatening condition (called rhabdomyolysis).
Other side effects that can occur but are uncommon include: Skin reactions such as itching and rashes, or scalp and hair problems including hair loss, muscle and joint pain, dizziness, tiredness, headache and sleep disturbances, bladder problems (painful or frequent urination, having to pass water at night) and sexual difficulties, stomach and bowel problems such as indigestion, sickness, diarrhoea or constipation and wind.
Problems with sight such as blurred or double vision. Problems with touch including burning/tingling sensations or numbness which may indicate damage to nerve endings. This occurs very rarely.
Very rarely some people may develop severe allergic reactions including localised swelling of the face, lips and/or tongue.
Very rarely inflammation of the liver or pancreas. 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.
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How to store to store simvastatin
Keep out of the reach and sight of children. Do not put them into another container as they might get mixed up. If you have any tablets left over when your doctor tells you to stop taking them, return them to your doctor or pharmacist. Do not take them past the expiry date which is clearly marked on the pack. 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.
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