10 mg Film-coated tablets
simvastatin
What Simvastatin Stada is and what it is used for
Simvastatin Stada contains the active substance simvastatin. Simvastatin Stada is a drug used to lower the levels of total cholesterol in the blood, the “bad” cholesterol ( LDL – cholesterol ), and blood fats called triglycerides. Simvastatin Stada also increases the levels of “good” cholesterol ( HDL – cholesterol ). Simvastatin Stada 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 Stada 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 treatment
- coronary heart disease or if you are at risk of developing coronary heart disease (because you have diabetes, previously had a stroke, or other vascular diseases). Treatment with Simvastatin Stada can lead to prolonged survival by reducing the risk of cardiovascular 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 contained in Simvastatin Stada 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 you use Simvastatin Stada
Do not use Simvastatin Stada
- 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)
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir ( HIV protease inhibitors 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)
- 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).
- 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 Stada can lead to severe muscle problems ( rhabdomyolysis ).
Do not take more than 40 mg of Simvastatin Stada 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 taking Simvastatin Stada.
Tell your doctor:
- about all your medical ailments, including allergies
- if you have high alcohol consumptionn
- , or if you have or have had any liver disease. Simvastatin Stada may not be the right medicine for you
- if you are going to have surgery. Discontinuation of treatment with Simvastatin Stada 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 take a blood sample before you start taking Simvastatin Stada, and if you have any symptoms of liver problems during treatment with Simvastatin Stada. 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 Stada.
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, 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 Stada, especially for a dose of 80 mg. The risk of muscle breakdown is also greater in some patients. Talk to your doctor if any of the following apply to you:
- if 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 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 Stada have been studied in boys 10 to 17 years of age and in girls who have been menstruating for at least one year (see section 3: How to take Simvastatin Stada). Simvastatin Stada has not been studied in children under 10 years of age. For further information, consult a doctor.
Other medicines and Simvastatin Stada
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
It is especially important to tell your doctor if you are taking medicines with any of the following active ingredients. Taking Simvastatin Stada 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 Stada”).
- 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 Stada again. Taking Simvastatin Stada 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)
- medicines containing an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
- fibrates with an active ingredient 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 AIDS )
- Hepatitis C medicines 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 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 Stada). Your doctor may decide to stop you from taking Simvastatin Stada for a while.
- colchicine (used in the treatment of gout ).
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 )
- ticagrelor (antiplatelet drug).
Tell your doctor who is prescribing a new medicine to you that you are taking Simvastatin Stada.
Simvastatin Stada with food and drink
Grapefruit juice contains one or more substances that can affect the body’s breakdown of certain drugs, including Simvastatin Stada. Intake of grapefruit juice should be avoided.
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.
You should not take Simvastatin Stada if you are pregnant, think you may be pregnant, or are planning to have a baby. If you become pregnant while taking Simvastatin Stada, stop treatment immediately and tell your doctor.
Do not take Simvastatin Stada if you are breastfeeding as it is unknown if the medicine passes into breast milk.
Driving and using machines
Simvastatin Stada 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 Stada.
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 Stada contains lactose
Simvastatin Stada contains a 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 medicine.
How to use Simvastatin Stada
Your doctor will decide which dose is right for you depending on your symptoms, your current treatment, and your risk profile.
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
You should continue with a cholesterol-lowering diet while taking Simvastatin Stada.
Dosage:
The recommended dose is one tablet of Simvastatin Stadaen daily.
Adults
The most common starting dose is 10, 20, 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 of cardiovascular disease, and who have not achieved their treatment goals at lower doses.
Children and adolescents:
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 Stada in the evening. Simvastatin Stada can be taken with or without food. Continue to take Simvastatin Stada unless your doctor tells you to stop.
If your doctor has prescribed Simvastatin Stada together with another cholesterol-lowering medicine that contains bile acid sequestrants, you should take Simvastatin Stada at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you use more Simvastatin Stada 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 Stada
Do not take a double dose to make up for a forgotten tablet, just take your regular dose of Simvastatin Stada at the usual time the next day.
If you stop using Simvastatin Stada
Talk to your doctor or pharmacist as 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)
- Has been reported (cannot be calculated from available data).
The following rare serious side effects have been reported:
If any of these serious side effects occur, stop taking your medicine and contact your doctor immediately or see an emergency department at the nearest hospital.
- 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 )
- bruising of unknown cause, skin rash, and swelling ( dermatomyositis ), hives, skin sensitivity to sun exposure, fever, redness
- shortness of breath ( dyspnoea ) and general malaise
- lupus-like disease picture (including rash, joint problems, and effects on blood cells )
- inflammation of the liver with the following symptoms: the yellowish color of the skin and eyes, itching, dark-colored urine or pale stools, feeling of tiredness or weakness, loss of appetite, liver failure (very rare)
- 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 ).
The following side effects have also been reported rarely:
- low red blood cell count ( anemia )
- numbness or weakness in the arms and legs
- headache, “ant crawls”, dizziness
- indigestion (abdominal pain, constipation, flatulence, dyspepsia, diarrhea, nausea, vomiting)
- rash, itching, hair loss
- weakness
- blurred vision and impaired vision.
The following side effects have also been reported in very rare cases:
- rash that may occur on the skin or sores in the mouth (drug-related lichenoid rash)
- gynecomastia (breast augmentation in men)
- muscle strain
- difficulty sleeping
- poor memory, memory loss, confusion.
The following side effects have also been reported, but the frequency cannot be determined with available information (has been reported):
- erectile dysfunction
- Depression
- inflammation of the lungs that causes breathing problems including persistent cough and/or shortness of breath or fever
- problems with tendons, sometimes aggravated by a tendon rupture
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 high blood fat levels, are overweight and have high blood pressure. Your doctor will check you while you are taking this medicine
- muscle pain, tenderness, or weakness that is persistent and may not go away after discontinuation of simvastatin (has been reported).
Laboratory values
In some blood tests, elevations in liver function values and a muscle enzyme (creatinine kinase) have been observed.
How to store Simvastatin Stada
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.
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:
- lactose
- microcrystalline cellulose
- pregelatinized corn starch
- butyl hydroxyanisole (E320)
- magnesium stearate
- talc
Film coating:
- hydroxypropylcellulose
- hypromellose
- talc
- titanium dioxide (E 171).
What the medicine looks like and the contents of the pack
White, oval, biconvex film-coated tablets marked with “SVT” and “10” on one side and with a score line on the other side.
PVC / PE / PVDC / Al-blister and PVC / PE / PVDC / Al-blister in aluminum can bag:
10, 14, 20, 28, 30, 40, 49, 50, 56, 60, 84, 90, 98, 100, 112, 120 and 250 film-coated tablets.
PVC / PE / PVDC / Al-blister in aluminum can bag:
10, 14, 20, 28, 30, 40, 48, 49, 50, 56, 60, 84, 90, 98, 100, 110, 112, 120 and 250 film-coated tablets.
HDPE jar with childproof closure:
100 film-coated tablets and 300, 500, and 1000 film-coated tablets for hospital use.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark