Simvastatin 10mg Tablets
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Simvastatin 10 mg, 20 mg, 40 mg & 80 mg Tablets
What you should know about Simvastatin Tablets
Please read this leaflet carefully before you start to take your medicine. The leaflet provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
What is in your medicine?
Each tablet contains 10 mg, 20 mg, 40 mg or 80 mg of the active ingredient, simvastatin.
Other ingredients include: microcrystalline cellulose, lactose, pregelatinised starch, ascorbic acid, butylated hydroxyanisole, magnesium stearate, hydroxypropyl cellulose, hypromellose-15, titanium dioxide E171, talc, iron oxide red E172. In addition, Simvastatin 10 mg and 20 mg Tablets also contain iron oxide yellow E172 and iron oxide black E172.
Simvastatin 10 mg Tablets are light pink-coloured, oval film-coated tablets marked ‘SVN 10’ on one side and ‘NEO’ on the other.
Simvastatin 20 mg Tablets are tan-coloured, oval film-coated tablets marked ‘SVN 20’ on one side and ‘NEO’ on the other.
Simvastatin 40 mg Tablets are pink-coloured, oval film-coated tablets marked ‘SVN 40’ on one side and ‘NEO’ on the other.
Simvastatin 80 mg Tablets are pink-coloured, capsule-shaped film-coated tablets marked ‘SVN 80’ on one side and ‘NEO’ on the other.
The tablets are available in calendar packs containing 28 tablets.
What is Simvastatin?
The active ingredient in your tablets, simvastatin, belongs to a group of medicines known as ‘HMG-CoA reductase inhibitors’. These reduce the levels of cholesterol and fatty substances called triglycerides in your blood. Cholesterol is an important substance in the body, but if blood levels become too high it can be deposited on artery walls. There it can form plaques, which can build up and can eventually block the blood vessel completely.
Only a small amount of cholesterol comes from our diet; liver and egg yolks have high levels of cholesterol, but many other foods like fruit, vegetables, and fish are quite low in cholesterol. The liver makes nearly all of our bodies’ cholesterol and most of the cholesterol is produced at night.
The Marketing Authorisation Holder is Aptil Pharma Limited and manufacturer responsible for EU release is is Recipharm Limited, Vale of Bardsley, Ashton-Under-Lyne, Lancashire, OL7 9RR.
Why do you need to take these tablets?
Your doctor will explain to that you have been prescribed Simvastatin Tablets to lower the levels of cholesterol in your blood.
Your doctor has done some blood tests, which show that you have too much cholesterol, and perhaps triglycerides, in your blood, even if you are on a low-fat diet. It is generally accepted that a high blood cholesterol level adds to the risk of heart disease - the higher the level, the greater the risk. If there are also other factors e.g., existing heart disease, high blood pressure, high blood sugar (diabetes), excess weight, lack of exercise, and smoking, then these will greatly increase the risk of heart disease starting or getting worse.
Cholesterol can cause coronary heart disease (CHD) by clogging the blood vessels that carry oxygen and nutrients to the heart. This clogging or hardening of the arteries (“atherosclerosis”) can lead to chest pain (called angina) and heart attack. Simvastatin Tablets can help slow the progression of atherosclerosis and may also help stop the development of new atherosclerosis. If you have CHD, your doctor has prescribed Simvastatin Tablets to prolong your life, to lessen the risk of a heart attack, and to decrease the risk of needing surgery to restore the blood flow to your heart.
Your doctor will have explained the importance of staying on a low-fat diet as well as taking the
tablets.
Before taking your medicine
Do not take this medicine if:
• you are pregnant, think you may be pregnant
• you are planning to become pregnant; if so, you must stop taking Simvastatin Tablets at least one month before trying to get pregnant
• you discover you are pregnant while taking Simvastatin Tablets; in this case, you should stop taking the tablets immediately
• you are breast-feeding
• you are a woman who could have children, unless you are using a reliable form of contraceptive other than the pill. You may wish to discuss this with your doctor
• you have liver problems
• you have a rare inherited disease called porphyria
• you have been told by your doctor that you have an intolerance to some sugars. These tablets contain lactose
• you have had a bad reaction to this or similar medicines or to any of the ingredients in the past.
If you think any of these apply to you, do not take the tablets before you have talked to your doctor and followed their advice.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Simvastatin Tablets might sometimes interfere with other medicines, so it is important that you tell your doctor about all the medicines you are taking, including those bought without a prescription. Before you start taking Simvastatin Tablets, you should check with your doctor if:
• you have persistent muscle aches or pains
• you are taking medicines for a heart condition, e.g. digoxin
• you are taking medicines for thinning the blood, e.g. warfarin
• you are taking medicines called immunosuppressants, e.g. ciclosporin
• you are taking other cholesterol-lowering medicines, e.g.fibric acid derivatives such as bezafibrate, fenofibrate, gemfibrozil
• you are taking an antifungal drug called itraconazole or ketoconazole
• you are taking large doses (more than 1 g a day) of niacin or nicotinic acid
• you are taking the antibiotics erythromycin or clarithromycin.
• you are taking the antidepressant nefazodone
• you are taking a medicine for the treatment of HIV infections (HIV protease inhibitor) such as indinavir, nelfinavir, ritonavir, or saquinavir.
• you have severe respiratory failure
Children
Safety and effectiveness have been studied in 10-17 year old boys and in girls who had started their menstrual period at least one year before (see TAKING YOUR MEDICINE).
Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Grapefruit juice contains one or more components that alter the metabolism of some medicines, including simvastatin. Consuming very large quantities of grapefruit juice (more than 1 litre daily) should be avoided. However, a typical consumption (one 250 ml glass daily) is unlikely to cause any problems.
Your doctor may want to do simple blood tests to check your liver is working properly before and during your treatment with Simvastatin Tablets.
Your doctor will have told you that you should keep your alcohol intake to a minimum. If you are worried about how much alcohol you can drink while you are taking Simvastatin Tablets,
talk to your doctor.
Taking your medicine
Always take simvastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You should stay on a cholesterol-lowering diet while taking simvastatin.
The dose is 1 simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by mouth once a day.
For children (10 -17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.
The 80 mg dose is only recommended in for adult patients with very high cholesterol levels and at high risk of heart disease problems.
The usual starting dose is 10 mg per day for high cholesterol levels and 20 mg per day for coronary heart disease. It is best that simvastatin is taken in the evening, or at night, so that it will be working when the body is producing the most cholesterol. Your doctor may adjust your dose to a maximum of 80 mg per day, given as a single dose in the evening.
Your doctor may prescribe lower doses, particularly if you are taking ciclosporin or have certain kidney conditions. Your doctor may need to change this dose in order to have the best effect. Do not take more or less than your doctor has prescribed. Keep taking your tablets for as long as your doctor has asked you to.
If you forget to take your medicine:
If you miss a dose, do not worry. DO NOT take an extra dose. Just carry on with the next one as normal.
If you take too many tablets:
Tell your doctor or go to the nearest hospital casualty department AS SOON AS POSSIBLE. If you go to the hospital/doctor remember to take this leaflet and any remaining tablets with you so the doctor knows what you have taken.
Possible side-effects
- Like all medicines, Simvastatin Tablets can cause unwanted side effects in some people. The most common side effects are stomach upsets (sickness, stomach pain, constipation, diarrhoea, and flatulence), rash, itchiness, weakness, headache, or indigestion. The following have also occurred: dizziness, hair loss, abdominal pain, abnormal sensations in the arms and legs, sleep disturbances, including insomnia and nightmares, memory loss, sexual difficulties, depression, breathing problems including persistent cough and/or shortness of breath or fever.
- Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Rarely, a few patients have experienced the following: liver disease, muscle disease presenting as pains and aches, or an allergic reaction to simvastatin. The allergic reaction may include some of the following: swelling of the face or neck, muscle and joint pains, joint and blood vessel inflammation, urticaria, a high temperature, flushing, difficulty in breathing, or tiredness.
Since muscle problems are on rare occasions serious, you should contact your doctor promptly if you get muscle pain, tenderness or weakness.
If you suffer from any of these unwanted side effects, or any other effects not mentioned in this leaflet, stop taking the tablets and contact your doctor immediately.
Storing your medicine
Do not keep this medicine after the expiry date shown on the carton. Store them in the original package. Keep all medicines out of the reach and sight of children. Your medicine can harm them.
These tablets have been prescribed for you. Only a doctor can prescribe these tablets for you. Do not give them to other people even if their symptoms are the same as yours. It may harm them.
This leaflet was last revised in August 2012.