SIMVAHEXAL 10 mg. 30 tablets

What is SimvaHEXAL?
SimvaHEXAL lowering elevated levels of cholesterol in the blood.
 
 
What is SimvaHEXAL?
Elevated levels of blood lipids
Treatment of elevated levels of lipids in the blood that are not associated with another disease (primary hypercholesterolemia or mixed hyperlipidemia) in addition to diet, when not adequately effect on diet and other nonpharmacological measures (exercise and weight loss).
Treatment of hereditary increased fat levels in the blood (homozygous familial hypercholesterolemia) as an adjunct to diet and other lipid-lowering agents (eg. LDL apheresis) or if such are not suitable.


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 should not take SimvaHEXAL?
 
SimvaHEXAL tablets should not be used in:
- Hypersensitivity (allergy) to simvastatin or any of the other ingredients of the product
- Liver disease or unexplained and persistently elevated liver enzymes (serum transaminases)
- During pregnancy or lactation
- With concomitant administration of drugs that suppress the drug metabolizing enzyme systems such as ketoconazole, itraconazole (antifungal products), 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 causes a disease of the skeletal muscle (myopathy). In rare cases, simvastatin can cause severe muscle problems that can lead to renal failure (rhabdomyolysis). The risk of muscle disease / breakdown of muscle cells is increased in patients receiving high doses of simvastatin or any of concomitant treatment with certain other medicines.
• If you are aged over 70, if you 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 can increase the risk by muscle disease.
• If you have liver disease. Moderate elevations of serum transaminases can occur and usually with discontinuation of simvastatin returned slowly to baseline values.
• If you are planning surgery is recommended stop taking simvastatin several 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, talk to your doctor before taking this medicine.


What other products influence 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 adverse effects on the muscles. In such cases it may be necessary to adjust the dose or discontinuation of therapy with simvastatin:
• Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HlV-protease inhibitors, and nefazodone. These drugs should not be administered concomitantly with simvastatin.
• Fibrates (other cholesterol-lowering medicines such as gemfibrozil, bezafibrate)
• Niacin or nicotinic acid (cholesterol-lowering drug) at high doses (> 1 g / day)
• ciclosporin (a medicine to prevent transplant rejection)
• Verapamil, Diltiazem (products to treat high blood pressure or tightness of the chest) and amiodarone (to treat arrhythmias)
• Danazol (a synthetic hormone, a gonadotropin inhibitor)
Please tell your doctor if you are taking any of the drugs.
 
It is also important to tell your doctor if you are taking or have taken within the last 4 weeks:
• Medicinal products inhibiting blood coagulation (oral anticoagulants) as the anticoagulant effect is increased when co-administered with simvastatin.
 
 
What foods and drinks you should avoid?
Grapefruit juice can increase the levels of simvastatin in the blood. Avoid eating grapefruit juice during treatment with SimvaHEXAL®.
Tell your doctor if you drink large amounts of alcohol.
 
What must comply elderly patients when administering 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


pregnancy
Do not use SimvaHEXAL, if you are pregnant, plan to become pregnant or suspect pregnancy, since safety has not been established. If pregnancy occurs during treatment with SimvaHEXAL®, you should stop taking and consult your doctor.
 
breastfeeding
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, breast-feeding 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. It should be borne in mind that dizziness has been reported postmarketing.
 
 
Dosage, method and duration of administration:
Always take SimvaHEXAL exactly as advised by your doctor. If you have any doubts, please ask your doctor or pharmacist.
Take the tablets with sufficient liquid (water glass) as a single dose in the evening, with or without food. Tablets can be divided into equal halves.
 
 
How much and how often you can take SimvaHEXAL?


When elevated levels of blood lipids 10-20 mg SimvaHEXAL® daily 20-40 mg SimvaHEXAL daily
In hereditary increased fat levels in the blood (homozygous familial hypercholesterolemia) 40 mg SimvaHEXAL® or 20 mg in the morning, 20 mg at noon and 40 mg in the evening (80 mg of simvastatin 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 of cardiovascular yclozhneniya.
 
 
Concomitant use with other medicinal products
SimvaHEXAL is effective alone or in combination with anion exchange resins (cholestyramine, colestipol). If additionally receive products lowering cholesterol as colestipol and cholestyramine, simvastatin should be administered 1 hour before or 4 hours after administration of 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 simvastatin per day should not be exceeded. In patients taking amiodarone or verapamil concomitantly with SimvaHEXAL, the daily dose of simvastatin 20 mg should not be exceeded.
 
Elderly
In the elderly (over '70) is not necessary to adjust the dose.
 
Children and adolescents (under 18 years)
Application of SimvaHEXAL not recommended for children, as they are not studied safety and efficacy.
 
Use in renal function
In patients with moderate renal impairment 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 require a daily dose above 10 mg simvastatin, treatment should be performed carefully.
 
 
How long can you take SimvaHEXAL?
SimvaHEXAL therapy is prolonged. Your doctor will decide how long to continue treatment.
If you feel 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 amounts (intentional or inadvertent overdose)?
 
In case of overdose, please contact your doctor immediately. It will take the 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 for the missed and continue taking SimvaHEXAL, as prescribed.
 
What you should know if you are discontinued or have it terminated prematurely?
Lipid levels in the blood can rise again.
If you have questions about the application of the product, ask your doctor or pharmacist.
 

What side effects can cause the application of SimvaHEXAL?
Like all medicines, SimvaHEXAL can cause side effects, although not everybody gets them.
Rarely notice any of these side effects. The frequency is between 1 and 10 in 10 000 patients treated.
Blood and lymphatic system disorders: Anemia
Nervous system disorders:
Headaches, numbness, dizziness, peripheral neuropathy
Gastrointestinal disorders:
Constipation, abdominal pain, flatulence and heartburn, diarrhea, vomiting, nausea, inflammation of the pancreas
Disorders of liver and bile: Hepatitis / jaundice
Skin and subcutaneous tissue disorders: rash, itching, hair loss
Disorders of the musculoskeletal system and connective tissue disorders: Myopathy, rhabdomyolysis, myalgia, muscle cramps
General disorders and administration site conditions: Weakness
 
research:
Elevations in serum transaminases (ALAT, ASAT and gamma glutamiltranspeptidaza), elevated alkaline phosphatase, elevated serum kreatininkinaza.
Rarely, patients may have allergic reactions, including some of the following signs: swelling of vessels (angioedema), lupus-like syndrome, rheumatic disease of the muscles, autoimmune disease with skin changes mainly in the face and neck (dermatomyositis), vasculitis, change the blood (thrombocytopenia, eosinophilia, elevated ESR), inflammation and joint pain, urticaria, photosensitivity, fever, flushing, shortness of breath and fatigue.
If 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 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.
Store in the original container at a temperature below 30 ° C.
Keep out of reach of children!