|The name of the preparation
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Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:simvastatin
The drug is available on prescription
What is Apo-Simva?
A medicine that reduces blood lipids.
What does Apo-Simva contain and how does it work?
The active substance is Simvastatin
. It is a substance belonging to a group of medicines called statins. Statins are used to reduce the levels of lipids (mainly cholesterol) in the blood. The risk of cardiovascular disease is associated with an increased level of blood lipids, especially with an increased concentration of a certain fraction of cholesterol occurring in the form associated with low density lipoproteins (LDL cholesterol). LDL cholesterol higher than or equal to 3 mmol / L (115 mg / dL) is considered to be abnormal. Increased LDL cholesterol in the blood is referred to as hypercholesterolemia. Statins work by inhibiting the activity of a key enzyme involved in the cholesterol synthesis process (this enzyme is reductase of 3-hydroxy-3-methyl-glutaryl-coenzyme A, in short HMG-CoA reductase). Inhibition of this enzyme in liver cells limits the synthesis of cholesterol and stimulates liver cells to increase the uptake of LDL cholesterol molecules from the blood. This action leads to an effective reduction in LDL cholesterol in the blood. Statins are used in the treatment of hypercholesterolemia and prophylactically in people with risk factors for cardiovascular diseases. They reduce the risk of cardiovascular events (myocardial infarction, stroke, death related to ischemic heart disease).
When should I use Apo-Simva?
The preparation is indicated for the treatment of:
· Primary hypercholesterolemia or mixed dyslipidemia, while maintaining diet when diet and other non-pharmacological treatments (physical exercise, weight loss) have been insufficient;
· Familial homozygous hypercholesterolaemia in combination with diet and other treatments, or when other treatments are inappropriate or unavailable;
and in the prevention of cardiovascular events in people with atherosclerosis or diabetes, with normal or elevated cholesterol (reduction in morbidity and mortality) as adjunctive therapy.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients.You also can not use the product if you have active liver disease or persistent elevation of transaminases (liver enzymes) in the blood, with an undetermined cause. You can not use drugs that strongly inhibit CYP3A4
enzymes such as Itraconazole
, ketoconazole, HIV protease inhibitors, Erythromycin
, telithromycin and nefazodone.
The preparation is contraindicated during pregnancy and breastfeeding.
Take special care with Apo-Simva?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Simvastatin, like other statin drugs, may cause myopathy, i.e. muscle diseases manifesting in pain, weakness or excessive sensitivity to touch. These symptoms are accompanied by increased creatine kinase (CK) activity, detectable in laboratory tests. This kinase is an enzyme important for muscle work, and its activity is a biochemical indicator of muscle damage. Myopathy may lead to rhabdomyolysis, a set of symptoms associated with damage and muscle breakdown. Rhabdomyolysis may be life-threatening. Rhabdomyolysis may be accompanied by acute renal failure
, in very rare cases leading to death.
The risk of myopathy and / or rhabdomyolysis is dependent on the dose of medicine used.
If during the treatment period you notice increased muscle sensitivity to touch (tenderness), pain, spasms or muscle weakness, you should consult a doctor as soon as possible. These symptoms may be associated with the onset and development of myopathy and may require discontinuation of the preparation.
Before starting treatment and if you are suspected of having myopathy, your doctor will prescribe blood creatine kinase (CK) in your blood. This examination should not be performed after considerable physical effort. If the CK activity significantly (more than 5 times) exceeds the upper limit of normal values, the measurement should be repeated after 5-7 days to confirm the results. In the case of significantly increased CK activity, simvastatin treatment should not be initiated. In patients undergoing treatment, the doctor will recommend discontinuation of the preparation. If symptoms suggestive of myopathy disappear and CK activity returns to normal, your doctor may recommend continuing treatment with this or any other statin preparation using the lowest possible dose and with extreme caution.
Some patients have an increased risk of rhabdomyolysis. Particular care should be taken in patients:
· In the elderly (over 65 years of age)
· Female sex
· With impaired renal function
· With hereditary muscle diseases
· Who have had muscle side effects in the past with statins or fibrates
· Alcohol abusers.
If you know or suspect you belong to any of the above groups, inform your prescriber before using this medicine. Your doctor will assess the risk-benefit ratio of the treatment and will make the appropriate decision. It may recommend you to conduct more frequent laboratory tests and remain under strict control.
The risk of myopathy and rhabdomyolysis increases significantly in the case of parallel use of cyclosporin, danazol and gemfibrozil, as well as drugs that strongly inhibit CYP3A4 enzymes such as itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone. Therefore, the parallel use of these drugs is contraindicated.
The risk of myopathy and rhabdomyolysis also increases significantly in the case of parallel use of: other fibrates, niacin (nicotinic acid), Amiodarone
, diltiazem. In the above cases, caution should be exercised and under close medical supervision. The use of gemfibrozil in parallel should be avoided, in the opinion of the physician, the benefit of such combination is not greater than the risks. In the above cases, the physician will consider the risk / benefit ratio of the treatment and, if necessary, apply the corr
ect dosage (usually no more than 10 mg daily). Avoid consuming grapefruit juice during treatment.
Caution should also be exercised if fenofibrate is taken in parallel, as both simvastatin and fenofibrate can independently cause myopathy.
Patients taking fusidic acid (antibiotic) concurrently, if such combination therapy is necessary, should remain under close medical supervision due to the increased risk of myopathy and rhabdomyolysis.
Due to the increased risk of myopathy, caution should be used when simvastatin is administered at a dose of 80 mg daily in combination with Amlodipine
Caution should be exercised if simvastatin is used in people of Asian origin (especially at a dose of 40 mg daily or more). Because the risk of developing myopathy depends on the dose, people of Asian origin do not recommend the use of 80 mg simvastatin in addition to niacin (nicotinic acid) or niacin containing products.
If you are planning a surgery, you should inform your doctor about the use of a statin. The use of simvastatin, after consultation with a doctor, should be temporarily interrupted for a few days before the planned major surgery or in case of serious conditions requiring medical or surgical treatment.
The use of the preparation may increase the activity of liver enzymes (aminotransferases) determined in blood laboratory tests. In order to check your liver's function, your doctor will advise you to perform appropriate tests before starting treatment, as well as periodic (your doctor will determine how often) during the treatment and in addition if you increase your dose. In case of elevated aminotransferase activity, if the marked value exceeds the upper limit of the norm 3 times, the physician may recommend discontinuation of the preparation. Exercise caution in the case of people consuming significant amounts of alcohol.
Occasionally, the use of statin preparations may be associated with the occurrence of interstitial lung disease, especially during long-term use. If you experience symptoms that may indicate the development of interstitial pneumonia (shortness of breath, cough without expectoration, deterioration of general health, dizziness, weight loss and fever), please consult your doctor. The doctor will make a diagnosis and consider the need to stop using the preparation.
Medicines in this group increase blood Glucose
levels, and in some people with a high risk of developing diabetes in the future, they may cause hyperglycaemia, even if properly managed. However, the benefits of statin reduction in vascular risk outweigh this threat. People with a high risk of diabetes (fasting glucose 5.6 to 6.9 mmol / l, BMI> 30 kg / m2, increased triglycerides, hypertension) should be subject to special control.
Limited data are available on the use of the preparation in children and adolescents 10.-17. of a family history of heterozygous hypercholesterolemia indicates no effect of the preparation on the growth or sexual maturity of adolescent girls and boys and on the length of the menstrual cycle in girls. These data refer to doses of no more than 40 mg and used for no longer than 48 weeks. The influence of simvastatin on physical, intellectual and sexual maturation is not known over time. There are no data on the use of simvastatin in children under 10 years of age or in children before adolescence.
Additional information about the other ingredients of the preparation:
the preparation contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not use this preparation.
Does this preparation affect the ability to drive vehicles?
Simvastatin does not affect (or is unimportant) the ability to drive or use machines. However, caution should be exercised because in rare cases side effects (such as dizziness) may occur that may impair the ability to drive vehicles and operate machinery / equipment.
Dosage of Apo-Simva
The preparation is in the form of coated tablets. It is intended for oral use. The tablets should be taken usually once a day, in the evening, regardless of the meal. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life.If you have any doubts regarding the use of the preparation, consult a physician. During the treatment period, a standard low-cholesterol diet should be maintained and appropriate physical activity should be maintained.
The starting dose is usually 10-20 mg (in some cases 20-40 mg) taken once a day, in the evening. If necessary, the doctor may then gradually increase the dose. The maximum dose is 80 mg once daily.
A dose of 80 mg per day is only recommended for acute hypercholesterolaemia and a high risk of cardiovascular complications.
Familial homozygous hypercholesterolemia:
40 mg once daily, or 80 mg daily, in 3 divided doses (ie 20 mg in the morning, 20 mg at noon, 40 mg in the evening).
Prevention of cardiovascular events:
In patients with a high risk of coronary events (coronary artery disease with or without hyperlipidemia): 20-40 mg once daily. If necessary, the doctor will individually adjust the dosage.
If the preparation is used in parallel with bile acid sequestrants, it should be taken no more than 2 hours before or no earlier than 4 hours after taking bile acid-binding preparations.
If the patient takes in parallel: cyclosporine, danazol, gemfibrozil, other fibrates (except fenofibrate) or niacin, the dose should not exceed 10 mg daily. If amiodarone or verapamil is administered in parallel, the dose should not exceed 20 mg daily.
In patients with mild to moderate renal impairment, there is no need to modify the dosage. In patients with severe renal impairment, the dose will be adjusted by your doctor (no more than 10 mg daily), and you must be carefully monitored during treatment.
Elderly patients do not need to adjust their dosage.
Children and adolescents 10.-17. age:
Family heterozygote hypercholesterolaemia: starting dose of 10 mg once daily, in the evening. The doctor will select a further dosage individually, in accordance with the guidelines for pediatric treatment. Dosage adjustment should take place no more than every 4 weeks. The maximum dose is 40 mg per day. The appropriate diet should be continued during the treatment period.
There are no data on the use of the preparation in children before the onset of puberty.
Can I use Apo-Simva during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
The use of the preparation is contraindicated in pregnant women and women planning to become pregnant in the near future and during breastfeeding.
If you suspect you are pregnant, consult your doctor prescribing this medicine.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter. In particular, inform your doctor if you use:
· Strong CYP3A4 inhibitors such as, for example, itraconazole, ketoconazole, HIV protease inhibitors (such as, for example, ritonavir, nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone
· Niacin (nicotinic acid)
· Anticoagulants such as Warfarin
, phenprocoumon, acenocoumarol.
In the case of parallel use of: fibrates (except fenofibrate) or niacin, the risk of myopathy and rhabdomyolysis increases. The concomitant use of gemfibrozil leads to increased blood levels of simvastatin.
Simvastatin is metabolised through the cytochrome P450 3A4 isoenzyme. Parallel use of drugs that strongly inhibit the activity of cytochrome P450 3A4 isoenzyme such as eg itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone significantly increases the exposure to simvastatin acid and the risk of myopathy and rhabdomyolysis. Therefore, the parallel use of these drugs with simvastatin is contraindicated.
Caution should be exercised when it is necessary to use inferior inhibitors of cytochrome P450 3A4 isoenzyme, such as cyclosporin, verapamil, diltiazem.
If you need to use ciclosporin in parallel, the risk of myopathy and rhabdomyolysis increases.
Parallel use of danazol or gemfibryzol increases the risk of myopathy and rhabdomyolysis. If you are taking concomitant medications: cyclosporin, danazol, gemfibrozil, other fibrates (except fenofibrate) or niacin, you must not use a daily dose of more than 10 mg. In patients treated with simvastatin at a dose of not more than 40 mg, parallel administration of diltiazem did not increase the risk of myopathy; therefore, in patients receiving diltiazem, the daily dose of simvastatin should not exceed 40 mg.
The concurrent use of amiodarone or verapamil increases the risk of myopathy and rhabdomyolysis. If amiodarone or verapamil are administered in parallel, a dose of more than 20 mg per day should not be used.
During the treatment period, grapefruit juice should be avoided (grapefruit juice inhibits the activity of the cytochrome P450 3A4 isoenzyme).
Simvastatin at a dose of 20-40 mg per day may increase the effect of anticoagulant coumarin derivatives; in patients using such combination therapy, the blood coagulation parameters (prothrombin time) should be determined at the frequency recommended by the physician (usually often especially at the beginning of treatment and in the case of increasing the doses of simvastatin or after discontinuation of simvastatin therapy).
What side effects can occur?
Like all medicines, also Apo-Simva 10, -20, -40 can cause side effects, although they will not occur in all patients using this product. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Rarely may occur: anemia, headache, paresthesia, dizziness, peripheral neuropathy, constipation, abdominal pain, flatulence, indigestion, diarrhea, nausea, vomiting, pancreatitis, hepatitis / jaundice, rash, pruritus, alopecia, myopathy (including myositis), rhabdomyolysis (rhabdomyolysis) with or without acute renal failure, myalgia, muscle spasms, tendon damage, sometimes complicated by its interruption, asthenia, hypersensitivity symptoms such as angioneurotic edema
, lupus-like syndrome, pains rheumatoid muscle, muscle and skin inflammation, vasculitis, thrombocytopenia, eosinophilia, increased OB, arthritis and Arthra
lgia, hypersensitivity to light, urticaria, fever, hot flushes, shortness of breath, malaise, elevation of transaminases, increased alkaline phosphatase, increase in activity Creatinine kinase in the blood.
Very rarely: insomnia, impaired memory, hepatic failure or fatal outcome.
In addition, depression, interstitial lung disease, erectile dysfunction may occur with unknown frequency.
Other preparations on the Polish market containing simvastatin
Apo-Simva 10 (tablets)
Apo-Simva 20 (tablets)
Simcovas (coated tablets)
Simorion (coated tablets)
Simratio 10 (coated tablets)
Simratio 20 (coated tablets)
Simratio 40 (coated tablets)
Simvacard 10 (coated tablets)
Simvacard 20 (coated tablets)
Simvacard 40 (coated tablets)
Simvachol (coated tablets)
Simvacor 10 (coated tablets)
Simvacor 20 (coated tablets)
Simvagamma 10 (coated tablets)
Simvagamma 20 (coated tablets)
Simvagamma 40 (coated tablets)
Simvagen 20 (coated tablets)
Simvagen 40 (coated tablets)
SimvaHEXAL 10 (coated tablets)
SimvaHEXAL 20 (coated tablets)
SimvaHEXAL 40 (coated tablets)
Simvastatin Bluefish (coated tablets)
Simvastatin Genoptim (coated tablets)
Simvastatin Krka (coated tablets)
Simvastatinum 123ratio (coated tablets)
Simvastatinum Accord (coated tablets)
Simvasterol (coated tablets)
Sistat (coated tablets)
Vasilip (coated tablets)
Vastan (coated tablets)
Ximve (coated tablets)
Zocor 10 (coated tablets)
Zocor 20 (coated tablets)
Zocor 40 (coated tablets)