Simvastatin 10 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SZ00000LT000
Simvastatin 5 mg Film-coated Tablets Simvastatin 10 mg Film-coated Tablets Simvastatin 20 mg Film-coated Tablets Simvastatin 40 mg Film-coated Tablets
simvastatin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Simvastatin Tablets are and what they are used for
2. What you need to know before you take Simvastatin Tablets
3. How to take Simvastatin Tablets
4. Possible side effects
5. How to store Simvastatin Tablets
6. Contents of the pack and other information
1. WHAT SIMVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR
Simvastatin Tablets are a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood.
In addition, Simvastatin tablets raise levels of “good” cholesterol (HDL cholesterol). Simvastatin tablets are member of the class of medicines called statins.
Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.
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.
Triglycerides are another form of fat in your blood that may increase your risk for heart disease.
You should stay on a cholesterol-lowering diet while taking this medicine.
Simvastatin Tablets are 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)
• 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 tablets 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIMVASTATIN TABLETS
Do not take Simvastatin Tablets
• if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6)
• if you currently have liver problems
• if you are pregnant or breast-feeding
• if you are taking medicine(s) with one or more than one of the following active ingredients:
- itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections)
- erythromycin, clarithromycin, or telithromycin (used to treat infections)
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used for HIV infections)
- boceprevir or telaprevir (used to treat hepatitis C virus infection)
- nefazodone (used to treat depression)
- gemfibrozil (used to lower cholesterol)
- ciclosporin (used in organ transplant patients)
in which the lining of the uterus grows called fusidic acid (used to treat
- danazol (a man-made hormone used to treat endometriosis, a condition outside the uterus)
• if you are taking or, in the last 7 days, have taken or been given a medicine bacterial infection)
Ask your doctor if you are not sure if your medicine is listed above.
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatin tablets
• about all your medical conditions including allergies.
• if you drink large amounts of alcohol.
• if you have ever had liver disease. Simvastatin tablets may not be right for you.
• 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 tablets and if you have any symptoms of liver problems while you take Simvastatin tablets. 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 tablets.
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.
Tell your doctor if you have severe lung disease.
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.
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.
The risk of muscle breakdown is greater at higher doses of Simvastatin tablets, particularly the 80-mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:
• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• 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.
Other medicines and Simvastatin tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important to tell your doctor if you are taking medicine(s) with any of the following active ingredients. Taking Simvastatin tablets with any of these medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin tablets”).
• 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)
• medicines with an active ingredient like itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections)
• fibrates with an active ingredient like gemfibrozil or bezafibrate (used to lower cholesterol)
• erythromycin, clarithromycin, telithromycin, or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine. Also see section 2 of this leaflet.
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat HIV infections)
• boceprevir or telaprevir (used to treat hepatitis C virus infection)
• nefazodone (used to treat depression).
• amiodarone (used to treat an irregular heartbeat)
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)
• colchicine (used to treat gout).
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 medicines(s) with any of the following active ingredients:
• medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants)
• fenofibrate (also used to lower cholesterol)
• niacin (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis).
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese.
You should also tell any doctor who is prescribing a new medicine for you that you are taking Simvastatin tablets. Simvastatin Tablets with food, drink and alcohol
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin tablets. Consuming grapefruit juice should be avoided.
Inform your doctor if you consume larger quantities of alcohol.
Use in children and adolescents (10-17 years of age)
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 Tablets). Simvastatin have not been studied in children under the age of 10 years. For more information, talk to your doctor.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Simvastatin tablets if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Simvastatin Tablets, stop taking them immediately and contact your doctor.
Do not take Simvastatin tablets if you are breast-feeding, because it is not known if the medicine is passed into breast milk.
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Driving and using machines
Simvastatin tablets are 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 tablets.
Simvastatin tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE SIMVASTATIN TABLETS
Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
You should stay on a cholesterol-lowering diet while taking Simvastatin Tablets.
The recommended dose is one tablet 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 have 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.
Children and adolescents (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 and duration of administration:
Take the medicine in the evening. You can take it with or without food. Keep taking the medicine unless your doctor tells you to stop.
The tablet can be divided into equal doses.
If your doctor has prescribed Simvastatin tablets along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin tablets at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Simvastatin Tablets than you should
Please consult your doctor without delay. In case of overdose, your doctor should take symptomatic and supportive measures.
If you forget to take Simvastatin Tablets
Do not take a double dose to make up for a forgotten dose, but continue treatment with the dose prescribed.
If you stop taking Simvastatin Tablets
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.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 (polymyalagia rheumatica)
• inflammation of the blood vessels (vasculitis)
• 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 rash, joint disorders, and effects on blood cells)
• inflammation of the liver with the following signs: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stool, feeling tired or weak, loss of appetite, and very rare liver failure
• inflammation of the pancreas often with severe abdominal pain.
The following side effects have also been reported:
Rare (may affect up to 1 in 1,000 people):
• 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.
• elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase)
• memory loss, confusion.
Very rare (may affect up to 1 in 10,000 people):
• trouble sleeping
• poor memory.
Not known (frequency cannot be estimated from the available data):
• erectile dysfunction
• depression
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever
• tendon problems, sometimes complicated by rupture
• muscle weakness that is constant.
Additional possible side effects reported with some statins:
• sleep disturbances, including 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.
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 (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 out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton after “Exp”. The expiry date refers to the last day of that month.
Do not store above 30°C. Keep the blister in the outer carton, in order to protect from light. Store in the original container, in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. The measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Simvastatin Tablet contains
• The active substance is simvastatin. One film-coated tablet contains 5 mg, 10 mg, 20 mg or 40 mg simvastatin
• The other ingredients are:
Tablet core for 5 mg and 10 mg: pregelatinized starch, lactose monohydrate, cellulose microcrystalline, butylhydroxyanisole (E 320), ascorbic acid (E 300), citric acid monohydrate (E330), magnesium stearate.
Tablet core for 20 mg and 40 mg: pregelatinized starch, lactose monohydrate, cellulose microcrystalline, butylhydroxyanisole (E 320), citric acid monohydrate (E330), magnesium stearate.
Film-coating for 5 mg: hypromellose, talc, titanium dioxide (E171), ferric oxide, yellow (E172).
Film-coating for 10 mg and 20 mg: hypromellose, talc, titanium dioxide (E171), ferric oxide, yellow (E172), ferric oxide, red (E172). Film-coating for 40 mg: hypromellose, talc, titanium dioxide (E171), ferric oxide, red (E172).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
What Simvastatin Tablets look like and contents of the pack
Simvastatin 5 mg film-coated Tablet is a yellow coated, oval, scored, convex tablet coded ‘SIM 5' on one side. Simvastatin 10 mg film-coated Tablet is a pale pink coated, oval, scored, convex tablet coded ‘SIM 10' on one side. Simvastatin 20 mg film-coated Tablet is an orange coated, oval, biconvex tablet with score line on both sides coded ‘20' on one side.
Simvastatin 40 mg film-coated Tablet is a red brown coated, oval, biconvex tablet with score line on both sides coded ‘40' on one side.
Tablets are available in the following packs:
Blister (Aluminium/PVC)
Pack size: 10, 20, 28, 30, 40, 49, 50, 50x1, (60, 84 and 90 not 5mg), 98 and 100 film-coated tablets.
Polyethylene tablet container with screw cap
Pack size 10, 20, 28, 30, 40, 50, (84 and 90 not 5mg), 100 and 250 film-coated tablets.
Simvastatin 10 mg, 20 mg 40 mg also available in pack size of 120 film-coated tablets.
Simvastatin 5 mg, 10 mg , 20 mg and 40 mg film-coated tablets can be divided into equal doses.
Not all pack sizes or pack types may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Manufacturer: Salutas Pharma GmbH, Otto-von-Guericke-Alle 1, D-39179 Barleben, Germany or S.C. Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu Mures, Jud. Mures, Romania or Salutas Pharma GmbH, Dieselstr. 5, D-70839 Gerlingen, Germany or LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland or Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia.
This leaflet was last revised in 05/2015.
SZ00000LT000