Patient leaflet - Simvastatin 5 mg tablets
1. What Simvastatin is and what it is used for
The risk of muscle breakdown is greater at higher doses, particularly the 80 mg dose. This risk of muscle breakdown is also greater in certain patients. Talk with your doctor if you any of the following applies:
- you consume large amounts of alcohol
Simvastatin contains the active substance simvastatin. Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides the blood. In addition, Simvastatin raises levels of “good” cholesterol (HDL cholesterol). Simvastatin is a member of the class of medicines called statins.
- you have kidney problems
- you are female
- you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
- you or a close family member have a hereditary muscle disorder
- you are 65 years or older
Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.
- you have thyroid problems
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.
LDL cholesterol is often called bad cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.
Children and adolescents
Safety and effectiveness of Simvastatin have been studied in 10-17 year old boys and in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Simvastatin).
Triglycerides are another form of fat in your blood that may increase your risk for heart disease.
Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
You should stay on a cholesterol-lowering diet while taking this medicine.
Other medicines and Simvastatin
Tell your doctor if you are taking, have recently taken or might take any other medicine(s), with any of the following active ingredients. Taking Simvastatin with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin”).
Simvastatin is used in addition to your cholesterol-lowering diet if you have:
a raised cholesterol level in your blood (primary
hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia)
- If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Simvastatin. Taking Simvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
a hereditary illness (homozygous familial
hypercholesterolaemia), that increases the cholesterol levels 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.
- ciclosporin (often used in organ transplant patients)
- danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)
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.
- medicines with an active ingredient like itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections)
- fibrates with an active ingredient like bezafibrate and gemfibrozil (used to lower cholesterol)
2. What you need to know before you take Simvastatin
- erythromycin, clarithromycin or telithromycin (used to treat bacterial infections)
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir or saquinavir (used to treat AIDS)
Do not take Simvastatin:
if you are allergic (hypersensitive) to Simvastatin or any of the other ingredients in these tablets (listed in section 6: Contents of the pack and other information)
- Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection)
- nefazodone (used to treat depression)
if you currently have liver problems
- medicines with the active ingredient cobicistat
if you are pregnant or breast-feeding
- amiodarone (used to treat irregular heart beat)
if you are taking medicine(s) with one or more than one of the following active ingredients:
- diltiazem, verapamil or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions)
itraconazole, ketoconazole, posaconazole or voriconazole
(used to treat fungal infections)
- lomitapide (used to treat a serious and rare genetic cholesterol condition)
erythromycin, clarithromycin or telithromycin (used to treat
infections)
- daptomycin (a drug used to treat complicated skin and skin structure infections and bacteraemia). It is possible that side effects affecting the muscles may be higher when this medicine is taken during treatment with simvastatin (e.g. Simvastatin). Your doctor may decide that you stop taking Simvastatin for a while
HIV-protease inhibitors such as ritonavir, indinavir, saquinavir
or nelfinavir (HIV protease inhibitors used to treat HIV infections)
- boceprevir or telaprevir (used to treat hepatitis C virus infection)
- cobicistat
gemfibrozil (used to lower cholesterol)
- colchicine (used to treat gout)
ciclosporin (used in organ transplant patients)
- ribociclib (used to treat breast cancer)
danazol (a man-made hormone used to treat endometriosis, a
- palbociclib (used to treat breast cancer)
condition in which the lining of the uterus grows outside the uterus)
As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients:
- nefazodone
- if you are taking or have taken, in the last 7 days, a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin can lead to serious muscle problems (rhabdomyolysis).
- fenofibrate (also used to lower cholesterol),
- niacin (also used to lower cholesterol),
- rifampicin (used to treat tuberculosis).
You should also tell any doctor who is prescribing a new medicine for you that you are taking Simvastatin.
Simvastatin with food and drink
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 get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin, stop taking it immediately and contact your doctor. Do not take Simvastatin if you are breast-feeding, because it is not known if the medicine is passed into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking Simvastatin.
Simvastatin contains lactose
Simvastatin tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to lactose or other sugars, contact your doctor before taking this medicinal product.
3. How to take Simvastatin
Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.
Always take Simvastatin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with water. Simvastatin tablets may be taken with or without food. You should stay on a cholesterol-lowering diet while taking Simvastatin.
Dosage:
The recommended dose is Simvastatin 10 mg, 20 mg, 40 mg or 80 mg by mouth once a day.
Adults:
The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day. Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or certain kidney conditions. The 80 mg 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.
Use in children and adolescents:
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.
Method of administration:
Take Simvastatin in the evening. You can take it with or without food. Keep taking Simvastatin unless your doctor tells you to stop. If your doctor has prescribed Simvastatin along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Simvastatin than you should
- Please contact your doctor or pharmacist.
If you forget to take Simvastatin
- Do not take a double dose (two doses at the same time) to make up for a forgotten tablet. Just take your normal amount of Simvastatin at the usual time the next day.
If you stop taking Simvastatin
- Talk to your doctor or pharmacist because your cholesterol may rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Simvastatin can cause side effects, although not everybody gets them.
The following rare serious side effects were reported. If any of the following 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 or throat which may cause
difficulty in breathing (angioedema)
severe muscle pain and stiffness usually in the shoulders and
hips
- rash with weakness of the limbs and neck muscles
- pain or inflammation of the joints (polymyalgia rheumatica)
- inflammation of the blood vessels
- stiffness, pain or inflammation of the joints
unusual bruising, skin eruptions and swelling (dermatomyositis),
hives, skin sensitivity to the sun, fever, flushing
- shortness of breath (dyspnoea) and feeling unwell
Lupus-like disease picture (including rashes, joint disorders,
and effects blood cells)
inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or
pale-coloured stool, feeling tired or weak, loss of appetite, liver failure (very rare)
- inflammation of the pancreas often with severe abdominal pain. The following very rare serious side effect was reported:
- a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis)
- rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
- muscle rupture
- gynecomastia (breast enlargement in men)
Rare side effects (may affect up to 1 in 1000 people):
- low red blood cells counts (anaemia)
- weakness or numbness of the arms and legs
- headache, tingling or ‘pins and needles’, dizziness
- digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
- weakness
- trouble sleeping (very rare)
- rash, itching, hair loss
- poor memory (very rare), memory loss, confusion.
- blurred vision and impaired vision
Very rare side effects (may affect up to 1 in 10,000 people):
- erectile dysfunction
- tendon problems, sometimes complicated by rupture of the tendon.
- depression
- inflammation of the lungs causing breathing problems including a persistent cough and/or shortness of breath or fever Not known (frequency can not be estimated from available data)
- myasthenia gravis (a disease causing general muscle weakness including in some cases muscles used when breathing)
- ocular myasthenia (a disease causing eye muscle weakness)
- talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping of your eyelids, difficulty swallowing, or shortness of breath Additional possible side-effects reported with some statins:
- sleep disturbances, including sleeplessness and nightmares
- sexual difficulties
- 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 muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin (frequency not known) 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Simvastatin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date [“EXP”]. stated on the container. The expiry date refers to the last day of that month. Do not store above 25°C. Store the tablets in the original package. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Simvastatin tablets contain
The active substance is Simvastatin. Each tablet contains 5 mg or 10 mg or 20 mg or 40 mg of the active substance.
The other ingredients are: lactose anhydrous, microcrystalline cellulose (E460), pregelatinised maize starch, butylhydroxyanisole (E320), talc (E553b), magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464) and titanium dioxide (E171). The 5 mg tablets also contain yellow iron oxide (E172). What Simvastatin tablets look like and contents of the pack
Simvastatin 5 mg Tablets are yellow, oblong, scored film-coated tablets, with ‘SVT’ on one side and ‘5’ on the other.
Simvastatin 10 mg Tablets are white, oblong, biconvex film-coated tablets, scored on one side, embossed with ‘10’ on the scored side and with “SVT” and logo on the other side.
Simvastatin 20 mg Tablets are white, oblong, biconvex film-coated tablets, scored on one side, embossed with “20” on the scored side and with “SVT” and logo on the other side.
Simvastatin 40 mg Tablets are white, oblong, biconvex film-coated tablets, scored on one side, embossed with “40” on the scored side and with “SVT” and logo on the other side.
Simvastatin tablets are available in blister packs of 28 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
84 Pembroke Road, London, W8 6NX, UK
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was revised in 02/2026
CL0101-0102-0103-0104/O/PIL/CL1