10 mg film-coated tablets
simvastatin
What Simvastatin Sandoz is and what it is used for
Simvastatin Sandoz contains the active substance simvastatin. Simvastatin Sandoz is a drug used to lower the levels of total cholesterol in the blood, the “bad” cholesterol ( LDL cholesterol ), and blood fats, so-called triglycerides.
Simvastatin Sandoz also increases the levels of “good” cholesterol ( HDL cholesterol ). Simvastatin Sandoz belongs to a group of medicines called statins.
Cholesterol is one of several fats found in your blood. Your total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called the “bad” cholesterol because it causes fat storage in your artery walls and forms plaque. This plaque buildup can eventually lead to the narrowing of your arteries. This narrowing can reduce or block blood flow to important organs such as the heart and brain. Blockage of blood flow can result in a heart attack or stroke.
HDL cholesterol is often called the “good” cholesterol because it helps prevent the “bad” cholesterol from being stored in the arteries and protects against heart disease.
Triglycerides are another type of fat in the blood that can increase the risk of heart disease.
You should continue with a cholesterol-lowering diet while you are taking this medicine.
Simvastatin Sandoz is used as a supplement to your cholesterol-lowering diet if you have:
- elevated blood cholesterol levels (primary hypercholesterolemia ) or elevated blood fats (combined hyperlipidemia )
- an inherited disease ( homozygous familial hypercholesterolemia ) that causes elevated cholesterol levels in the blood. You can also receive other treatments.
- coronary heart disease or if you are at high risk of developing coronary heart disease (because you have diabetes, had a previous stroke, or had another vascular disease). Treatment with Simvastatin Sandoz can lead to prolonged survival by reducing the risk of heart disease, regardless of the amount of cholesterol in your blood.
In most people, high cholesterol does not cause immediate symptoms. Your doctor can measure your cholesterol level with a simple blood test. Visit your doctor regularly, monitor your cholesterol levels, and discuss your goals with your doctor. Simvastatin found in
Simvastatin Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Simvastatin Sandoz
Do not take Simvastatin Sandoz
- if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6)
- if you have liver problems
- if you are pregnant or breastfeeding
- if you are taking medicines containing one or more of the following active substances:
- 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 in HIV infections )
- boceprevir or telaprevir (used to treat hepatitis C virus infection)
- nefazodone (used to treat depression)
- cobicistat
- gemfibrozil (used to lower cholesterol)
- ciclosporin (used in patients who have had an organ transplant)
- danazol (a synthetic 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 of Simvastatin Sandoz 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 cautions
Talk to your doctor or pharmacist before taking Simvastatin Sandoz:
- about all your medical ailments, including allergies.
- if you have high alcohol consumption.
- if you have or have had any liver disease. Simvastatin Sandoz may not be the right medicine for you.
- if you are taking or have taken a medicine called fusidic acid (a medicine for bacterial infections ) over the last 7 days, either by mouth or by injection. The combination of fusidic acid and Simvastatin Sandoz can lead to severe muscle problems ( rhabdomyolysis ).
- if you are going to have surgery. Discontinuation of treatment with Simvastatin Sandoz may need to be done for a short time.
- if you are of Asian descent, then another dose may apply to you.
Your doctor should prescribe a blood test before you start taking Simvastatin Sandoz and if you have any symptoms of liver problems during treatment with Simvastatin Sandoz. This blood test is performed to check your liver function.
Your doctor may also want to prescribe blood tests to check your liver function after you start taking Simvastatin Sandoz.
During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are more likely to be at risk for diabetes if you have high blood sugar and blood fat levels, are overweight, and have high blood pressure.
Tell your doctor if you have any serious lung disease.
Contact a doctor immediately if you experience unexplained muscle aches, soreness, or weakness. The reason for this is that in rare cases, the muscle problems can be serious and involve the breakdown of muscles with kidney damage as a result and in very rare cases, deaths have occurred.
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to diagnose and treat this.
The risk of muscle breakdown is greater with higher doses of Simvastatin Sandoz, especially for an 80 mg dose. The risk of muscle breakdown is also greater in some patients. Talk to your doctor if any of the following apply to you:
- you have a high alcohol consumption
- you have kidney problems
- you have thyroid problems
- you are 65 years or older
- you are a woman
- if you have ever had muscle problems during treatment with cholesterol-lowering drugs, so-called statins or fibrates
- you or a close relative has a hereditary muscle disease.
Children and young people
The safety and efficacy of simvastatin have been studied in boys aged 10–17 years and in girls who had menstruated for at least one year (see section 3: How to take Simvastatin Sandoz). Simvastatin has not been studied in children under 10 years of age. For further information, consult a doctor.
Other medicines and Simvastatin Sandoz
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines. Taking Simvastatin Sandoz with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in the section ‘Do not take Simvastatin Sandoz’ above).
- If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to start taking Simvastatin Sandoz again. Taking Simvastatin Sandoz with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). See more information on rhabdomyolysis in section 4.
- ciclosporin (often used by patients who have had an organ transplant)
- danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)
- drugs with an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
- fibrates with an active substance such as gemfibrozil and bezafibrate (used to lower cholesterol)
- erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections )
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections )
- medicines for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection)
- nefazodone (used to treat depression)
- medicines containing the active substance cobicistat
- amiodarone (used to treat irregular heartbeat)
- verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart problems)
- lomitapide (used to treat a serious and rare genetic cholesterol condition)
- daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia (presence of bacteria in the blood)). The risk of side effects affecting the muscles may be higher when this medicine is taken during treatment with simvastatin. Your doctor may decide that you should stop taking simvastatin for a while.
- colchicine (used to treat gout )
- ticagrelor (used by patients who have had a heart attack or who have chest pain that is not well controlled). Do not take more than 40 mg of Simvastatin Sandoz daily if you are taking ticagrelor.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking medicines with any of the following active substances:
- anticoagulants with an active substance 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 all doctors who prescribe you a new medicine that you are taking Simvastatin Sandoz.
Simvastatin Sandoz with food, drink, and alcohol
Grapefruit juice contains one or more substances that affect the body’s breakdown of certain drugs, including Simvastatin Sandoz. Intake of grapefruit juice should be avoided.
Tell your doctor if you drink large amounts of alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 Sandoz if you are pregnant, trying to conceive, or think you may be pregnant. If you become pregnant while taking Simvastatin Sandoz, stop using the tablets immediately and contact your doctor.
Do not take Simvastatin Sandoz if you are breastfeeding as it is unknown if the medicine passes into breast milk.
Driving and using machines
Simvastatin Sandoz is not expected to affect your ability to drive or use machines. However, you should keep in mind that some people have experienced dizziness after taking Simvastatin Sandoz.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Simvastatin Sandoz contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Simvastatin Sandoz
Your doctor will decide which dose is right for you depending on your ailments, your ongoing treatment, and your risk profile.
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
You should continue with a cholesterol-lowering diet while taking Simvastatin Sandoz.
The recommended dose is one tablet by mouth once a day.
Adults
The most common starting dose is 10, 20, or in some cases 40 mg daily. Your doctor may, after at least 4 weeks, adjust your dose to a maximum of 80 mg per day. Do not take more than 80 mg per day.
Your doctor may prescribe a lower dose for you, especially if you are taking certain medicines listed above or have certain kidney problems.
A dose of 80 mg is only recommended for adult patients with very high cholesterol levels and who are at high risk for heart disease and who have not achieved their treatment goals with lower doses.
Use for children and adolescents
The recommended starting dose for children (10–17 years) is usually 10 mg daily until the evening. The maximum recommended dose is 40 mg daily.
Method of administration and duration of treatment
Take the medicine in the evening. You can take it with or without food. Continue to take the medicine unless your doctor has told you to stop.
The tablet can be divided into two equal doses.
If your doctor has prescribed Simvastatin Sandoz with another cholesterol-lowering medicine that contains bile acid sequestrants, you should take Simvastatin Sandoz at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Simvastatin Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. If you overdose, your doctor should take symptomatic and supportive measures.
If you forget to take Simvastatin Sandoz
Do not take a double dose to make up for a forgotten dose. Continue treatment with the prescribed dose.
If you stop using Simvastatin Sandoz
Talk to your doctor or pharmacist as your cholesterol level may rise again.
If you have any further questions on the use of this product, 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 occur, stop taking your medicine and contact your doctor immediately or go to the nearest emergency department :
The following rare serious side effects have been reported:
- muscle aches, soreness, weakness, or cramps. In rare cases, muscle problems can be serious and involve the breakdown of muscles with kidney damage as a result, and in very rare cases, deaths have occurred.
- hypersensitivity (allergic reactions) including:
- swelling of the face, tongue, and throat, which may cause difficulty breathing ( angioedema )
- severe muscle pain, usually in the shoulders and hips
- rash with weakness in arms, legs, and neck muscles
- joint pain or inflammation (rheumatic polymyalgia)
- inflammation of blood vessels ( vasculitis )
- unusual bruising, skin changes and swelling ( dermatomyositis ), hives, skin sensitivity to sun exposure, fever, redness
- shortness of breath ( dyspnoea ) and general malaise
- lupus ‑ similar disease picture (including rash, joint problems, and effects on blood cells )
- inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-colored urine or pale stools, feeling of tiredness or weakness, loss of appetite, and very rarely a liver failure
- inflammation of the pancreas, often with severe abdominal pain.
The following very rare serious side effects have been reported:
- a severe allergic reaction that causes difficulty breathing or dizziness ( anaphylaxis )
- gynecomastia (breast augmentation in men)
- rash that may occur on the skin or sores in the mouth (drug-related lichenoid rash)
- muscle strain.
The following side effects have also been reported:
Rare (may affect up to 1 in 1,000 people):
- low red blood cell count ( anemia )
- numbness or weakness in the arms and legs
- headache, “ant crawls”, dizziness
- blurred vision and impaired vision
- indigestion (abdominal pain, constipation, flatulence, dyspepsia, diarrhea, nausea, vomiting)
- rash, itching, hair loss
- weakness
- elevations of liver function values and a muscle enzyme (creatine kinase) in blood samples
- memory loss, confusion.
Very rare (may affect up to 1 in 10,000 people):
- difficulty sleeping
- bad memory.
Has been reported (occurs in an unknown number of users):
- erectile dysfunction
- Depression
- inflammation of the lungs that causes difficulty breathing including persistent cough and/or shortness of breath or fever
- problems with tendons, sometimes aggravated by a tendon rupture
- persistent muscle weakness.
Additional possible side effects that have been reported with certain statins:
- sleep disorders including nightmares
- sexual problems
- Diabetes. This is more likely if you have high blood sugar and blood fat levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
How to store Simvastatin Sandoz
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 carton and blister/tablet after EXP. or EXP. The expiration date is the last day of the specified month. Do not store above 30 ° C.
Blister:
Store in the outer carton. Sensitive to light.
Tablet jar:
Store in the original package. Sensitive to light.
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.
Contents of the pack and other information
Content declaration
- The active substance is simvastatin. One film-coated tablet contains 10 mg of simvastatin.
- Other ingredients are:
Tablet core: pregelatinized starch, lactose monohydrate, microcrystalline cellulose, butyl hydroxy anisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), magnesium stearate.
Film coating: hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
What the medicine looks like and the contents of the pack
Simvastatin Sandoz 10 mg film-coated tablets are light red, oval, scored, convex tablets, marked with SIM 10 on one side. Simvastatin Sandoz 10 mg is available in the following packs:
Blister (Al / PVC)
Pack sizes: 10, 20, 28, 30, 40, 49, 50, 50 x 1, 60, 70, 80, 84, 90, 98 and 100 film-coated tablets.
Polyethylene tablet jar with a screw cap
Pack sizes: 10, 20, 28, 30, 40, 50, 84, 90, 100, 105 and 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia (tablet jar)
or
LEK SA, 16 Podlipie Street, 95-010 Stryków, Poland (blister packs)