10 mg, 20 mg, 40 mg film-coated tablets
simvastatin
What Simidon is and what it is used for
Simidone contains the active substance simvastatin and belongs to a group of medicines called statins. These drugs work by reducing the amount of total cholesterol, the “bad” cholesterol ( LDL – cholesterol ), and certain fats called triglycerides in the blood. Simidon also increases the levels of the “good” cholesterol ( HDL – cholesterol ). You should continue with a cholesterol-lowering diet while you are taking this medicine.
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.
Simidone is used for:
- to lower cholesterol and triglyceride levels in the blood when a low-fat diet and other measures (eg exercise, weight loss) do not give the desired result (primary hypercholesterolemia or combined hyperlipidemia ).
- to lower hereditary levels of high cholesterol in the blood ( homozygous familial hypercholesterolemia ), in addition to diet and other treatments (eg LDL -apheresis), or when such treatments are not appropriate.
- to reduce the risk of coronary heart disease if you have atherosclerosis ( arteriosclerosis ) or diabetes, even if your cholesterol levels are normal, as a supplement to your diet and other treatments.
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 Simidon 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 take Simidon
Do not take Simidon:
- if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).
- if you have liver problems or continuous high levels of certain liver enzymes (serum transaminases).
- if you are pregnant or breastfeeding.
- if you are taking one or more of the following medicines at the same time:
- ketoconazole , itraconazole, posaconazole or voriconazole (medicines for fungal infections)
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for HIV infections )
- boceprevir or telaprevir (used to treat hepatitis C virus infection)
- erythromycin, clarithromycin, or telithromycin ( antibiotics for infection )
- nefazodone (an antidepressant)
- gemfibrozil (a cholesterol-lowering drug)
- ciclosporin (a medicine commonly used in organ transplant patients)
- danazol (a manufactured hormone used in the treatment of endometriosis ), a condition in which the uterine lining grows outside the uterus).
Do not take more than 40 mg Simidon 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 Simidon.
Tell your doctor:
- about all your medical ailments, including allergies.
- if you have high alcohol consumption.
- if you have or have had a history of liver disease. Simidon may not be the right medicine for you.
- if you are going to have surgery. Treatment interruption with Simidon may need to be done for a short time.
- If you are of Asian descent, then another dose may apply to you.
- if you are taking or in the last 7 days have taken a medicine called fusidic acid (used to treat bacterial infections ) either by mouth or by injection. The combination of fusidic acid and Simidone can lead to serious muscle problems ( rhabdomyolysis ).
Your doctor should take a blood sample before you start taking Simidon, and if you have any symptoms of liver problems during treatment with Simidon. 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 Simidon.
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.
Tell your doctor or pharmacist if you have persistent muscle weakness.
Additional tests and medications may be needed to investigate and treat this.
Contact a doctor immediately if you experience unexplained muscle pain, sensitivity to pressure, or muscle 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 may be greater for you with high doses of Simidon, especially with 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:
- you are over 65 years old
- you have kidney problems
- you have thyroid problems
- you or close family members have a hereditary muscle disease
- you are a woman
- you have ever had muscle problems during treatment with cholesterol-lowering drugs called “statins” or fibrates
- you have a high alcohol consumption
Talk to your doctor if any of the above apply to you or have been done before.
Children and young people
Safety and efficacy have been studied in boys aged 10 to 17 years and in girls who have had menstruation for at least one year (see section 3: How to take Simidon).
Simidon has not been studied in children under 10 years of age. For further information, consult a doctor.
Other medicines and Simidon
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines with any of the following active ingredients. Taking Simidon with any of these medicines may increase the risk of muscle problems (some of these have already been listed in the section above under the heading “Do not take Simidon”).
- 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 Simidon again. Taking Simidon with fusidic acid may in rare cases lead to weakness, soreness, or pain in the muscles ( 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 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 ),
- Hepatitis C medicines such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
- αmiodarone (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 (the presence of bacteria in the blood) the risk of side effects affecting muscles may be higher when this medicine is taken during treatment with simvastatin Your doctor may decide that you should stop taking Simidon for a while.
- colchicine (used in the treatment of gout ).
As with the medicines mentioned above, 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 )
Also, tell your doctor if you are taking niacin ( nicotinic acid ) or a product that contains niacin and is of Chinese origin.
Also, tell your doctor who is prescribing new medicines that you are taking Simidon.
Simidon with food and drink:
Grapefruit juice contains one or more ingredients that can increase the amount of Simidon in the blood. Therefore, do not drink grapefruit juice, as it may increase the risk of muscle damage.
Pregnancy and breastfeeding
Do not take Simidon if you are pregnant, trying to conceive, or suspect you may be pregnant. If you become pregnant while taking Simidon, you must stop taking the tablets immediately and consult a doctor.
Do not take Simidon if you are breastfeeding as it is unknown if the medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Simidone is not expected to affect the ability to drive and use machines. However, keep in mind that some people get dizzy when they take Simidon.
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.
Simidone 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 Simidon
Your doctor will decide which dose is right for you, depending on your condition, 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 your cholesterol-lowering diet while you are taking Simidon.
Dosage:
The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg once daily.
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 is 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.
Use for children and adolescents
For children (10-17 years) with a hereditary disease called familial hypercholesterolemia, the usual recommended starting dose is 10 mg daily in the evening. The maximum recommended dose is 40 mg per day.
Method of administration:
Take Simidon in the evening. Simidone can be taken with or without food. Continue to take Simidon unless your doctor tells you to stop.
If your doctor has prescribed Simidon with another cholesterol-lowering medicine that contains bile acid sequestrants, you should take Simidon at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Simidon than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If you forget to take Simidon
Do not take a double dose to make up for a forgotten tablet. Just take your usual dose of Simidon at the time you usually take the next day.
If you stop taking Simidon
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),
- No known frequency (cannot be calculated from the 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 go to the nearest emergency department:
- muscle pain, tenderness, weakness, cramping, or muscle strain (very rare). In rare cases, these muscle problems can be serious and involve muscle breakdown ( rhabdomyolysis ) 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
- severe muscle pain, usually in the shoulders and hips
- 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),
- 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 yellowish skin and eyes, itching, dark urine or pale stools, and liver failure (very rare).
– inflammation of the pancreas (severe abdominal pain radiating to the back, nausea, and vomiting).
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)
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
- blurred vision, impaired vision
- indigestion (abdominal pain, constipation, flatulence, dyspepsia, 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 frequency cannot be determined with available information (no known frequency):
- erectile dysfunction,
- Depression,
- inflammation of the lungs that causes breathing problems including persistent cough and/or shortness of breath or fever,
- problems with the tendons, sometimes aggravated by 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 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 of liver function and a muscle enzyme (creatinine kinase) have been observed.
How to store Simidon
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 after EXP. The expiration date is the last day of the specified month.
Store below 30 ° C. Store in the original package. Sensitive to light. Moisture sensitive.
After first opening, the tablet can: Do not store it above 25 ° C and use it within 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 packaging and other information
Content declaration
The active substance is simvastatin. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of simvastatin.
Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized maize starch, butyl hydroxy anisole (E320), ascorbic acid (E300), anhydrous citric acid (E330), colloidal anhydrous silica (E551), talc (E70bearate).
Coating: hypromellose (E464), red iron oxide (E172), yellow iron oxide (E172), triethyl citrate (E1505), titanium dioxide (E171), talc (E553b), povidone K-30.
What the medicine looks like and the contents of the pack
Simidon 10 mg is a peach-colored, oval, biconvex, film-coated tablet with a score line on one side.
The tablet can be divided into two equal parts along the breaking groove.
Simidone 20 mg is a medium brown, oval, biconvex, film-coated tablet with a score line on one side.
The tablet can be divided into two equal parts along the breaking groove.
Simidon 40 mg is a brick red, oval, biconvex, film-coated tablet with a score line on one side.
The tablet can be divided into two equal parts along the breaking groove.
The tablets are packaged in blister packs in a carton or HPDE can.
Blister packs:
Simidone 10 mg film-coated tablets: 10, 20, 28, 30, 50, 60, 98 or 100 tablets.
Simidone 20 mg film-coated tablets: 10, 20, 28, 30, 50, 60, 98 or 100 tablets.
Simidone 40 mg film-coated tablets: 10, 20, 28, 30, 50, 60, 98 or 100 tablets.
Tablet jars:
Simidone 10 mg film-coated tablets: 100, 250 or 500 tablets.
Simidone 20 mg film-coated tablets: 100, 250 or 500 tablets.
Simidone 40 mg, film-coated tablets: 100, 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Rivopharm Ltd.
17 Corrig Road
Sandyford, Dublin 18
Ireland
Manufacturer
Balkanpharma-Dupnitsa AD
3, Samokovsko shosse Str.
2600 Dupnitsa
Bulgaria
Agent:
SanoSwiss UAB
Love 25-701
LT-09320 Vilnius
Lithuania
info@sanoswiss.com