Simvastatin 40 Mg Film-Coated Tablets
• severe muscle pain usually in the shoulders and hips
• rash with weakness of limbs and neck muscles
• pain or inflammation of the joints (polymyalgia 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 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 side effects have also been reported rarely:
• 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
• trouble sleeping (very rare)
• poor memory (very rare), memory loss, confusion
The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):
• 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 of the tendon.
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
• muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin Tablets (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 Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
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BROWN & BURK
Package leaflet: Information for the user
Simvastatin 10 mg film-coated tablet Simvastatin 20 mg film-coated tablet Simvastatin 40 mg film-coated tablet Simvastatin 80 mg film-coated tablet
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 the leaflet. See section 4.
What is in this leaflet:
1. What Simvastatin Tablets is and what it is 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
Keep this medicine out of the sight and reach of children.
Do not use Simvastatin Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
There are no special storage precautions for Simvastatin Tablets.
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.
What Simvastatin Tablets contains
The active substance is Simvastatin.
The other ingredients are lactose anhydrous, microcrystalline cellulose, pregelatinised maize starch, butylhydroxyanisole, magnesium stearate and talc. The film coat contains hydroxypropylcellulose, hypromellose, talc and titanium dioxide (E171).
What Simvastatin Tablets looks like and content of the pack
White, oblong, biconvex film-coated tablets scored on one side, debossed with “10”, “20”, “40” or “80” on the scored side and with “SVT” on the opposite side.
Pack size: Blister packs of 7, 10, 14, 15, 28, 30, 50, 56, 60, 98 and 100 tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Limited
5 Marryat Close, Hounslow West Middlesex, TW4 5DQ United Kingdom
This leaflet was last amended in August 2016
Simvastatin Tablets contains the active substance simvastatin. Simvastatin Tablets is 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 raises levels of “good” cholesterol (HDL cholesterol). Simvastatin Tablets is a 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 buildup 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 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)
• 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.
BBUK Code
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Do not take Simvastatin Tablets
• If you are allergic (hypersensitive) to simvastatin or to any of the other ingredients of this medicine (listed in Section 6: Contents of the pack and other information).
• 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:
o itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections)
o erythromycin, clarithromycin, or telithromycin (used to treat infections)
o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections) o boceprevir or telaprevir (used to treat hepatitis C virus infection) o nefazodone (used to treat depression) o cobicistat
o gemfibrozil (used to lower cholesterol) o ciclosporin (used in organ transplant patients) o danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).
Do not take more than 40-mg Simvastatin Tablets if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition)
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.
• if you are Asian, because a different dose may be applicable to you.
• 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).
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.
• 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 Tablets.
Simvastatin Tablets with food and drink
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.
Pregnancy and breast-feeding
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 it 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. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Simvastatin Tablets 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 Tablets.
Simvastatin Tablets contains lactose
Simvastatin Tablets contain sugar called 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.
Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.
PHARMACODE READING M DIRECTION
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.
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.
Children and adolescents
Safety and effectiveness of Simvastatin Tablets have been studied in 1017 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 Tablets has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Other medicines and Simvastatin Tablets
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 Tablets 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 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, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
• fibrates with an active ingredient like gemfibrozil and 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 4 of this leaflet.
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS)
• boceprevir or telaprevir (used to treat hepatitis C virus infection)
• nefazodone (used to treat depression)
• medicines with the active ingredient cobicistat
• 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)
• lomitapide (used to treat a serious and rare genetic cholesterol condition)
• colchicine (used to treat gout).
• 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.
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:
• medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants)
• fenofibrate (also used to lower cholesterol)
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
The recommended dose is Simvastatin Tablets 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 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.
You should stay on a cholesterol-lowering diet while taking Simvastatin Tablets.
Keep taking the tablets as long as your doctor has asked you to.
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 Tablets in the evening. You can take it with or without food. Keep taking Simvastatin Tablets unless your doctor tells you to stop.
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 contact your doctor or pharmacist.
If you forget to take Simvastatin Tablets
do not take a double dose to make up for a forgotten tablet. Just take your normal amount of simvastatin tablets at the usual time the next day.
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.
Like all medicines, Simvastatin Tablets can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported:
• Rare (may affect up to 1 of 1000 people)
• Very rare (may affect up to 1 of 10,000 people)
• Not known (frequency cannot be estimated from the available data)
The following rare serious side effects were reported.
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