10 mg, 20 mg, 40 mg, 80 mg film-coated tablets simvastatin
What Simvastatin Teva is and what it is used for
Simvastatin Teva contains the active substance simvastatin. Simvastatin Teva 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 Teva also increases the levels of “good” cholesterol ( HDL cholesterol ). You should continue your cholesterol-lowering diet while you are taking this medicine. Simvastatin Teva 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 vessel walls and forms plaque. This plaque storage can eventually lead to a narrowing of your vessels. 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 vessels 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 Teva is used as a supplement to your cholesterol-lowering diet if you have:
- an elevated blood cholesterol level (primary hypercholesterolemia ) or elevated blood fat levels (mixed hyperlipidemia ).
- an inherited disease ( homozygous familial hypercholesterolemia ) that increases blood cholesterol levels. You can also get other treatments.
- coronary artery disease or are at high risk of getting coronary artery disease (because you have diabetes, have previously had a stroke, or another disease of the blood vessels). Simvastatin Teva can prolong your life by reducing the risk of heart disease problems regardless of your blood cholesterol level.
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 levels and discuss your goals with your doctor.
Simvastatin contained in Simvastatin Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 you use Simvastatin Teva
Do not use Simvastatin Teva
- 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 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, or saquinavir (used to treat HIV infection ),
- boceprevir or telaprevir (used to treat hepatitis C virus infection),
- nefazodone (used to treat depression),
- cobicistat,
- gemfibrozil (used to lower cholesterol),
- cyclosporine (often used in organ transplant patients),
- 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 Teva if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).
Consult a doctor if you are unsure if your medicine is listed above.
Warnings and cautions
Talk to your doctor or pharmacist before using Simvastatin Teva.
Tell your doctor:
- about all your medical ailments, including allergies,
- if you have a high alcohol consumption,
- and if you have or have had any liver disease. Simvastatin Teva may not be the right medicine for you.
- if you are going to have surgery. Discontinuation of treatment with Simvastatin Teva tablets may need to be done for a short time.
- if you have severe breathing problems,
- if you are of Asian descent, then another dose may apply to you.
- if you are taking or within the last 7 days have taken a medicine called fusidic acid (a medicine for bacterial infections ) by mouth or by injection. The combination of fusidic acid and Simvastatin Teva can lead to severe muscle problems ( rhabdomyolysis ).
Your doctor should take a blood sample before you start taking Simvastatin Teva, and if you have any symptoms of liver problems during treatment with Simvastatin Teva. This blood test is taken to check your liver function.
Your doctor may also need to take a blood test to check your liver function after you start taking Simvastatin Teva.
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.
Contact a doctor immediately if you experience unexplained muscle aches, soreness, or weakness. The reason for this is that 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.
The risk of muscle breakdown is greater with higher doses of Simvastatin Teva, 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.
Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.
Children and young people
The safety and efficacy of Simvastatin Teva 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 use Simvastatin Teva”). Simvastatin Teva has not been studied in children under 10 years of age. For further information, consult a doctor.
Other medicines and Simvastatin Teva
Tell your doctor if you have recently taken, or might take any other medicines with any of the following active ingredients. Taking Simvastatin Teva with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in the section above “Do not take Simvastatin Teva”).
- If you have to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to take simvastatin again. The use of simvastatin 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 ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
- fibrates with an active ingredient such as gemfibrozil or bezafibrate (used to lower cholesterol),
- erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections).
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, or saquinavir (used to treat HIV
- hepatitis C medicines such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
- nefazodone (used to treat depression),
- medicinal products 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 cardiovascular 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 (eg Simvastatin Teva). Your doctor may decide to stop you from taking Simvastatin Teva for a while.
- colchicine (used in the treatment of gout ).
- ticagrelor (antiplatelet drug).
Also 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 ingredients:
- anticoagulants with an active ingredient such as warfarin, phenprocoumon or acenocoumarol ( anticoagulants ),
- fenofibrate (also used to lower cholesterol),
- niacin (also used to lower cholesterol),
- rifampicin (used to treat tuberculosis ).
You should also tell a doctor who is prescribing a new medicine to you that you are taking Simvastatin Teva.
Simvastatin Teva with food and drink
Grapefruit juice contains one or more substances that can affect the body’s breakdown of certain drugs, including Simvastatin Teva. Intake of grapefruit juice should be avoided.
Pregnancy and breastfeeding
Do not use Simvastatin Teva if you are pregnant, trying to conceive, or think you may be pregnant. If you become pregnant while taking Simvastatin Teva, stop treatment immediately and contact your doctor.
Do not take Simvastatin Teva if you are breastfeeding as it is not known if the medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Simvastatin Teva is not expected to affect your ability to drive or use machines. However, keep in mind that some people get dizzy when they take Simvastatin Teva.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 Teva 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 use Simvastatin Teva
Your doctor will decide which dose is right for you depending on your symptoms, your current treatment, and your risk profile.
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
You should continue your cholesterol-lowering diet while you are taking Simvastatin Teva.
Dosage:
The recommended dose is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of simvastatin once daily. The tablet should be swallowed.
Adults
The most common starting dose is 10 mg, 20 mg, or in some cases 40 mg daily. Your doctor may, after at least 4 weeks, need to 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 cardiovascular disease and who have not achieved their treatment goals at lower doses.
Children and young people
The recommended starting dose for children (10–17 years) is usually 10 mg in the evening. The maximum recommended dose is 40 mg daily.
Method of administration:
Take Simvastatin Teva in the evening. Simvastatin Teva can be taken with or without food. Continue to take Simvastatin Teva unless your doctor tells you to stop. 10 mg, 20 mg, 40 mg, and 80 mg tablets can be divided into equal doses.
If your doctor has prescribed Simvastatin Teva together with bile acid sequestrants (medicines that lower your cholesterol), you should take Simvastatin Teva at least 2 hours before or 4 hours after taking your dose of bile acid sequestrants.
If you take more Simvastatin Teva 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 forget to use Simvastatin Teva
Do not take a double dose to make up for a forgotten tablet. Just take your usual dose of Simvastatin Teva at the usual time the next day.
If you stop using Simvastatin Teva
If you stop taking Simvastatin Teva, your cholesterol levels 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.
The following classification is used to describe how often side effects have been reported:
- rare (may affect up to 1 in 1,000 people),
- very rare (may affect up to 1 in 10,000 people),
- no known frequency (cannot be calculated from available data).
The following rare serious side effects have been reported:
If any of the following serious side effects occur, stop taking the medicine and contact a doctor immediately or see an emergency doctor at the nearest hospital.
- aches, soreness, weakness, muscle cramps, or muscle strains (very rare). In rare cases, these muscle problems can become serious, i.a. degradation of muscle tissue ( rhabdomyolysis ) leading to kidney damage and in very rare cases death.
- hypersensitivity reactions ( allergy ), eg:
- swelling of the face, tongue, and throat, which may cause difficulty breathing ( angioedema ),
- severe muscle pain, usually in the shoulders and hips (rheumatic polymyalgia),
- rash with weakness in arms, legs, and neck muscles,
- rash that may occur on the skin or sores in the mouth (drug-related lichenoid rash) (very rare),
- pain or inflammation in the joints,
- inflammation of the blood vessels ( vasculitis ),
- unusual bruising, skin rash and swelling ( dermatomyositis ), hives, sun-sensitive skin, fever, redness,
- shortness of breath ( dyspnoea ) and malaise,
- lupus-like disease picture (eg rash, joint problems, and effects on blood cells ),
- inflammation of the liver with the following symptoms: yellowish skin and yellowish eyes, itching, dark-colored urine or light-colored stools, feeling of tiredness or weakness, loss of appetite, fatal and non-fatal liver failure (very rare),
- inflammation of the pancreas, often with severe abdominal pain.
The following very rare serious side effects have also been reported:
- a severe allergic reaction that causes difficulty breathing or dizziness ( anaphylaxis ),
- gynecomastia (breast augmentation in men)
The following side effects have also been reported rarely:
- low red blood cell count ( anemia ),
- numbness or weakness in the arms and legs,
- headache, tingling, dizziness,
- blurred vision, impaired vision,
- digestive problems (abdominal pain, constipation, flatulence, indigestion, diarrhea, nausea, vomiting),
- rash, itching, hair loss,
- weakness,
- difficulty sleeping (very rare),
- poor memory (very rare), memory loss, confusion.
The following side effects have also been reported, but the incidence can not be calculated from the available information (occurs in an unknown number of users):
- erectile dysfunction,
- Depression,
- problems with tendons, sometimes aggravated by tendon rupture,
- persistent muscle weakness.
The following side effects have been reported with some statins:
- sleep problems including nightmares,
- sexual difficulties,
- difficulty breathing including persistent cough and/or shortness of breath or fever,
- diabetes. This is more likely if you have high blood sugar and high blood fat levels, are overweight and have high blood pressure. Your doctor will check you while you are taking this medicine.
Laboratory values
Elevated values for certain blood tests regarding liver function and a muscle enzyme (creatine kinase) have been observed.
How to store Simvastatin Teva
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 after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Plastic jar (10 mg, 20 mg and 40 mg):
Shelf life after the first opening is 6 months.
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. Each tablet contains 10, 20, 40 or 80 mg simvastatin .
The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, butyl hydroxy anisole (E320), magnesium stearate, ascorbic acid, citric acid monohydrate, hypromellose (E464), titanium dioxide, macrogol 3350, triacetin, E17 iron).
10 mg, 20 mg, and 80 mg also contain yellow iron oxide (E172).
80 mg also contains black iron oxide (E172).
What the medicine looks like and the contents of the pack
Film-coated tablets:
Simvastatin Teva 10 mg are light pink, oval film-coated tablets with a score line on one side.
Simvastatin Teva 20 mg are golden brown, oval film-coated tablets with a score line on one side.
Simvastatin Teva 40 mg are pink, oval film-coated tablets with a score line on one side.
Simvastatin Teva 80 mg are brick red, oval film-coated tablets with a score line on one side.
Simvastatin Teva film-coated tablets can be divided into two equal doses.
Simvastatin Teva is available in pack sizes of 10, 20, 28, 30, 50, 98, 100, 105 and 120 film-coated tablets. Simvastatin Teva 20 mg and 40 mg film-coated tablets are also available in pack sizes of 60, 84, or 90 tablets.
Simvastatin Teva 10 mg, 20 mg, and 40 mg are also available in pack sizes of 250 plastic cans.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Pharmachemie BV, Haarlem, The Netherlands
TEVA Pharmaceutical Works Private Limited Company, Debrecen, Hungary
Teva Operations Poland Sp. z oo, Krakow, Poland