SimvaHEXAL.20 mg. 30 tablets
SimvaHEXAL.20 mg. 30 tablets
SimvaHEXAL lowering elevated levels of cholesterol in the blood.
What is it used SimvaHEXAL?
Elevated levels of blood lipids
Treatment of elevated levels of lipids , which are not associated with other disease (primary hypercholesterolemia or mixed hyperlipidemia ) in addition to the diet , when not adequately effect only with diet and other non-pharmacological measures ( exercise and weight loss ) .
Treatment of hereditary elevated levels of blood lipids ( homozygous familial hypercholesterolemia ) as an adjunct to diet and other lipid-lowering agents (eg LDL apheresis ) or if such are not appropriate.
For the prevention of cardiovascular events
Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus with normal or elevated cholesterol levels in addition to the means of influencing other risk factors and other cardioprotective therapy.
When you must not take SimvaHEXAL?
SimvaHEXAL tablets should not be administered to :
- Hypersensitivity ( allergy) to simvastatin or any of the other ingredients of the product
- Liver disease or unexplained and persistently elevated liver enzymes ( serum transaminases)
- In pregnancy or lactation
- With the concomitant use of drugs that inhibit drug - metabolizing enzymes , such as ketoconazole , itraconazole ( antifungals ), HIV- protease inhibitors ( for the treatment of AIDS ) , macrolide antibiotics ( erythromycin , clarithromycin, telithromycin) and the antidepressant nefazodone
In which case you can use SimvaHEXAL only after consulting a doctor ?
• If you experience muscle pain, weakness or numbness during therapy SimvaHEXAL, please inform your doctor immediately. Sometimes simvastatin cause disease of the skeletal muscles ( myopathy ) . In rare cases, simvastatin can cause severe muscle problems leading to kidney failure ( rhabdomyolysis). The risk of muscle disease / breakdown of muscle cells is increased in patients receiving high doses of simvastatin or any concomitant treatment with certain other medicines.
• If you are aged over 70 years suffer from renal impairment, untreated thyroid disease ( hypothyroidism ) if you have a family history or pre-existing disease of the muscles or regularly consume alcohol, tell your doctor, as these factors may increase the risk of muscle disease .
• If you have liver disease. Moderate elevations of serum transaminases may occur and usually stopping treatment with simvastatin returned slowly to baseline.
• If you are planning surgery is recommended that you stop taking simvastatin few days before surgery.
Your doctor may decide to hold blood and liver tests to check whether the liver and muscle function before and during treatment with simvastatin . The product contains lactose. If you have an intolerance to some sugars, consult your doctor before taking this medicine.
Other products that interfere with the effect of SimvaHEXAL or may be affected by it ?
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following medicines may interact with simvastatin and increase the risk of side effects on the muscles . In such cases it may be necessary to adjust the dose or discontinuation of treatment with simvastatin :
• Itraconazole , ketoconazole , erythromycin , clarithromycin , telithromycin , HlV- protease inhibitors and nefazodone . These drugs should not be administered concomitantly with simvastatin .
• Fibrates ( other lipid-lowering medicines such as gemfibrozil, bezafibrate )
• Niacin or nicotinic acid (cholesterol - lowering drug) in high doses (> 1 g / day )
• Ciclosporin ( a drug for the prevention of graft rejection )
• Verapamil , Diltiazem ( for the treatment of high blood pressure or tightness of the chest ) and amiodarone (for the treatment of arrhythmias)
• Danazol ( synthetic hormone , a gonadotropin inhibitor )
Please tell your doctor if you are taking any of these medicines.
It is also important to tell your doctor if you are taking or have taken in the last 4 weeks:
• Medicinal products that inhibit blood coagulation (oral anticoagulants ) as anticoagulant effect is increased when co-administered with simvastatin.
What food and drink you should avoid ?
Grapefruit juice can increase the level of simvastatin in the blood. Avoid eating grapefruit juice during treatment with SimvaHEXAL.Informirayte your doctor if you consume large amounts of alcohol .
What should I take into account the elderly with use of SimvaHEXAL?
No adjustment of the dose of simvastatin in elderly patients .
Application of SimvaHEXAL in children and adolescents (under 18 years):
Not recommended simvastatin in children and adolescents.
What special precautions should be taken during pregnancy and lactation ?
Ask your doctor before taking any medicine
Do not use SimvaHEXAL, if you are pregnant , plan to become pregnant or suspect a pregnancy , as safety has not been established . If pregnancy occurs during treatment with SimvaHEXAL, you should stop taking and consult your doctor.
It is not known whether simvastatin , the active ingredient of SimvaHEXAL, passes into breast milk . Due to the risk of serious side effects in the newborn , treatment SimvaHEXAL tablets are not recommended during lactation. If treatment is necessary , breastfeeding should be discontinued .
What to be aware when driving or operating machinery ?
SimvaHEXAL tablets no impact or negligible influence on the ability to drive and use machines. Should be borne in mind that dizziness has been reported postmarketing.
Dose , route and duration of administration :
Always take SimvaHEXAL exactly as your doctor has appointed . If you have any doubts , please ask your doctor or farmatsevt.Priemayte tablets with enough liquid ( water glass ) as a single dose in the evening , with or without food . The tablets can be divided into equal halves.
How much and how often you can take SimvaHEXAL?
With increased levels of blood lipids 10-20 mg SimvaHEXAL daily 20-40 mg SimvaHEXAL once dnevnoPri inherited elevated levels of blood lipids ( homozygous familial hypercholesterolemia ) 40 mg SimvaHEXAL or 20 mg in the morning , 20 mg at noon and 40 mg in the evening ( simvastatin 80 mg daily) in the prevention of cardiovascular events 20-40 mg SimvaHEXAL daily
Maximum dose : 80 mg SimvaHEXAL.
If necessary , your doctor will increase the dose at intervals of weeks. 80 mg is only recommended in patients with severe hypercholesterolaemia and high risk for cardiovascular yclozhneniya .
Concomitant use with other medicinal products
SimvaHEXAL is effective alone or in combination with anion - exchange resins (cholestyramine , colestipol ) . If further accept products , lowering cholesterol as colestipol and cholestyramine , simvastatin should be taken 1 hour before or 4 hours after taking these products.
In patients receiving cyclosporin, fibrates (except fenofibrate ) or lipid-lowering doses of niacin (> 1 g / day) together with SimvaHEXAL, the dose of 10 mg of simvastatin per day should not be exceeded. Patients taking amiodarone or verapamil simultaneously with SimvaHEXAL, the daily dose of simvastatin 20 mg should not be exceeded.
In elderly patients (over 70 years) is not necessary to adjust the dose .
Children and adolescents (under 18 years)
Application of SimvaHEXAL not recommended for children because they are not studied safety and efficacy.
Use in impaired renal function
In patients with moderate impairment of renal function is generally not necessary to adjust the dose. In patients with severe renal impairment (creatinine clearance below 30 ml / min) should be carefully considering raising the daily dose of 10 mg. If you need a daily dose of 10 mg simvastatin treatment should be carried out carefully.
How long can you take SimvaHEXAL?
SimvaHEXAL therapy is prolonged . Your doctor will decide how long to continue lechenieto.Ako have the impression that the effect of SimvaHEXAL is too strong or too weak , please talk to your doctor.
What should I do if SimvaHEXAL was adopted in very large quantities ( intentional or unintentional overdose ) ?
In case of overdose , please contact your doctor immediately . He will take appropriate symptomatic and supportive measures.
What should you do if you forget to take SimvaHEXAL?
You should not take a double dose to make up and continue taking SimvaHEXAL, as prescribed.
What you should know if you have discontinued or have it terminated prematurely ?
Lipid levels in the blood may increase otnovo.Ako have questions about the use of this product, ask your doctor or pharmacist. What side effects can cause the application of SimvaHEXAL?
Like all medicines , SimvaHEXAL can cause side effects, although they do not occur in vseki.Ryadko may notice some of these side effects . The frequency is between 1 and 10 to 10, 000 -treated patients.
Blood and lymphatic system disorders: Anemia
Nervous System: Headache , numbness, dizziness , peripheral neuropathy
Gastrointestinal disorders: Constipation , abdominal pain, flatulence and heartburn , diarrhea, nausea , vomiting, inflammation of the pancreas
Disorders of the liver and bile Hepatitis / Jaundice
Skin and subcutaneous tissue disorders: rash, itching, hair loss
Musculo - skeletal and connective tissue disorders: Myopathy, rhabdomyolysis , myalgia , muscle cramps
General disorders and administration site conditions: Weakness
Elevations in serum transaminases (ALAT, ASAT and gamma glutamiltranspeptidaza ) , increased alkaline phosphatase, elevated serum kreatininkinaza.Ryadko patients may have allergic reactions, including some of the following symptoms : swelling of vessels ( angioedema) , lupus - like syndrome rheumatic disease muscle , autoimmune disease with skin changes, mainly in the face and neck ( dermatomyositis ) , vasculitis , changes in blood count (thrombocytopenia , eosinophilia, elevated ESR ), inflammation and joint pain, urticaria , photosensitivity , fever , flushing, difficulty breathing and otpadnalost.Ako during treatment with SimvaHEXAL unexplained muscle pain, tenderness or weakness, please inform your doctor immediately.
If you notice any side effects not listed in this leaflet , please tell your doctor or pharmacist.
What measures should be taken in relation to the side effects ?
Tell your doctor who will decide what measures to take.
Storage Instructions :
Do not use the product after the expiry date stated on the packaging.
Keep in the original container at a temperature below 30 ° C.
Keep out of reach of children!