Simvastatin 10mg Tablets
PATIENT INFORMATION LEAFLET
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 Tablets are and what they are used for
2. Before you take Simvastatin Tablets
3. How to take Simvastatin Tablets
4. Possible side effects
5. How to store Simvastatin Tablets
6. Further information
1. What Simvastatin Tablets are and what they are used for
This medicine contains simvastatin which belongs to a group of drugs known as HMG-CoA reductase inhibitors. These are used to reduce the amount of cholesterol and fatty substances called triglycerides in your blood. Cholesterol is vital to the normal functioning of the body, but if levels of cholesterol in the bloodstream get too high it can be deposited on the walls of the arteries, where it builds up eventually leading to the blocking of the blood vessel. Only a small amount of cholesterol comes from our diet. Nearly all of the cholesterol in our bodies is made by our own livers and is produced mostly at night.
If you have had a blood test which shows that you have too much fat (including cholesterol) in your blood, this medicine should lower these levels which will reduce the risk of developing heart disease. If you have coronary heart disease, simvastatin will lessen the risk of heart attack or of needing heart surgery.
2. Before you take Simvastatin Tablets
Do not take these tablets if:
• you are allergic to simvastatin or to any of the other ingredients (see section 6)
• you are pregnant or breast feeding (see “Pregnancy and breast feeding” section below)
• you have liver disease or have signs of liver damage
• you are taking any of the following medicines:
- antifungal drugs called itraconazole, ketoconazole, voriconazole or posaconazole which are used to treat fungal infections
- the antibiotics erythromycin, clarithromycin or telithromycin to treat infections
- the antidepressant nefazodone
- drugs for HIV infection such as indinavir, nelfinavir, ritonavir or saquinavir
- boceprevir or telaprevir used to treat hepatitis C virus infection
- gemfibrozil (a lipid-lowering medicine)
- ciclosporin, an immunosuppressant drug which can be used to prevent rejection following organ transplant or for treatment of psoriasis or arthritis
- danazol, used to treat endometriosis
• you are taking, or have taken within the last 7 days, a medicine called fusidic acid which is used to treat bacterial infections.
Check with your doctor before taking these tablets if:
• you have severe respiratory failure
• you suffer from persistent muscle aches, pains or weakness
• you have a muscle disorder or there is a family history of muscle disorders
• you have ever experienced a muscle problem when taking a cholesterol or a lipid lowering drug
• you have an underactive thyroid which is not under control
• you have kidney problems
• you are elderly
• you have an alcohol problem
• you have an inherited disease called porphyria.
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 How to take Simvastatin Tablets). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Taking other medicines:
Check with your doctor or pharmacist before taking these tablets if you are taking any other medicines including any you can buy without a prescription. This is especially important if you are taking any of the medicines listed above under “Do not take” or any of the following other medicines:
• other lipid-lowering medicines such as bezafibrate or fenofibrate, or large doses (higher than 1000 mg a day) of niacin or nicotinic acid
• heart drugs such as digoxin, amiodarone, verapamil, amlodipine or diltiazem
• warfarin or other “blood thinning” drugs
• fluconazole (used to treat infections)
• colchicine (used to treat gout)
• rifampicin (used to treat tuberculosis).
Other special warnings:
Simvastatin may cause muscle breakdown (see section 4 - Possible side effects). Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. The risk of muscle breakdown is greater at higher doses of simvastatin or if:
• you have kidney or thyroid problems
• you are more than 65 years old
• you are female
• you have ever had muscle problems during treatment with other statins or with fibrates
• you or a close family member has a hereditary muscle disorder
• you drink a lot of alcohol or have a history of alcohol abuse.
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
• Pregnancy and breast feeding
Do not take this medicine if you are pregnant or breast feeding. Do not become pregnant whilst taking this medicine.
If you discover you are pregnant, stop taking this medicine immediately and consult your doctor.
If you are a woman who could bear children, do not take this medicine unless you are using a reliable form of contraceptive; you may wish to discuss this with your doctor.
If you are planning to become pregnant you must stop taking this medicine at least one month before trying to become pregnant.
• Grapefruit juice - Avoid drinking grapefruit juice as it can affect the way Simvastatin works.
• Alcohol - Keep your alcohol intake to a minimum. If you are concerned about how much alcohol you can drink while you are taking simvastatin, discuss this with your doctor.
• Your doctor may want to do simple blood tests to check your liver is working properly before and during your treatment with simvastatin.
• If you are due to undergo an operation, make sure the doctor in charge knows you are taking Simvastatin Tablets, as you will need to stop taking them a few days before the surgery.
• Diabetes - 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 sugar and fats in your blood, are overweight and have high blood pressure.
• Driving and using machines
This medicine may make you feel dizzy. If it has this effect on you, do not drive or operate machinery.
• Important information about one of the ingredients of Simvastatin Tablets
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this medicine.
3. How to take Simvastatin Tablets
Swallow the tablets whole with water.
Your doctor will decide the dose that Is best for you depending on your condition. 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 5mg, 10mg, 20mg, 40mg, or 80mg tablet by mouth once a day. Take it in the evening so that it will be working when the body is producing the most cholesterol.
The 80mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.
Your doctor may adjust your initial starting dose after at least four weeks up to a maximum of 80mg per day; or may prescribe lower doses if you are taking certain other medicines (as listed in section 2) or if you have certain kidney conditions.
For children (10-17 years old), the recommended usual starting dose is 10mg a day in the evening. The maximum recommended dose is 40mg a day.
Keep taking your tablets for as long as your doctor has asked you to.
If your doctor has prescribed simvastatin along with any bile acid sequestrant such as colestyramine (medicines used for lowering cholesterol), you should take simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you forget to take a dose:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSE.
If you have taken too many tablets:
If you think you have taken too many tablets, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
4. Possible side effects
Like all medicines simvastatin can cause side effects, although not everybody gets them.
The following rare effects have been reported (may happen to less than 1 in 1000 people).
If any of the following occur STOP TAKING the tablets and contact your doctor IMMEDIATELY:
• yellowing of the skin and/or whites of the eyes, dark urine, pale stools, loss of appetite, feeling tired or weak, abdominal pain caused by liver or blood problems or liver failure (very rare)
• allergic reactions. Signs of an allergic reaction include:
• swelling of the face, tongue and throat which may cause difficulty 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, often with skin rash
• reduction in blood platelets which increases risk of bleeding or 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).
If any of the following effects occur tell your doctor STRAIGHTAWAY:
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath, fatigue, weight loss or fever.
• muscle aches, pains, cramps, tenderness or weakness. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney problems and very rare deaths have occurred.
If any of the following rare effects occur tell your doctor or pharmacist:
• inflammation of the pancreas which causes severe pain in the abdomen and back
• feeling or being sick, stomach pain, constipation, diarrhoea, flatulence and indigestion
• anaemia (a reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
• skin rash, itching, hair loss
• weakness
• dizziness, headache, tingling or numbness in the skin (pins and needles)
• a disorder of the nerves which can cause weakness, tingling or numbness
• memory loss, poor memory, forgetfulness, confusion.
If any of the following very rare effects occur (affects less than 1 in 10,000 people) tell your doctor or pharmacist:
• difficulty sleeping
• memory impairment.
If any of the following effects occur tell your doctor or pharmacist. The frequency of these effects is not known:
• inability to develop or maintain an erection
• muscle weakness that is constant
• tendon problems, sometimes complicated by rupture of the tendon
• depression.
The following other effects have been reported with some statins.
If you notice any of these tell your doctor or pharmacist:
• sleep disturbances, including nightmares
• sexual difficulties
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Laboratory values:
Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Simvastatin Tablets
Keep this medicine in the pack provided. Do not store above 30°C Do not take the tablets if the expiry date on the pack has passed.
If you have any medicines that are out of date or leftover, return them to your pharmacist for safe disposal.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
6. Further information
Ingredients:
Each tablet contains 10mg of simvastatin as the active ingredient. The tablets also contain the following other ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, butylated hydroxyanisole (E320), ascorbic acid, citric acid, colloidal anhydrous silica, talc, magnesium stearate, hypromellose, iron oxides (E172), triethyl citrate, titanium dioxide (E171) and povidone.
What the medicine looks like:
The tablets are peach coloured, oval biconvex film coated tablets with score line.
This medicine is available in pack sizes of 28 or 30 tablets.
(Not all pack sizes may be marketed).
Who makes this medicine and holds the Product Licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK Date leaflet revised: April 2015
If you would like this leaflet in a different format please contact the licence holder at the above address.