VABADIN. 20 mg. 28 tablets
VABADIN. 20 mg. 28 tablets
What is in your medicine?
Active substance : One tablet contains 20 mg simvastatin.
Excipients: Tablet core: Lactose monohydrate mikrokrisgalna PH 101 , pregelatinized starch, 12500 , butylated hydroxyanisole, ascorbic acid , citric acid , colloidal anhydrous silica, talc , magnesium stearate.
Film coat : Hydroxypropyl methylcellulose (Pharmacoat ® 606 ) , hydroxypropyl methylcellulose (Methocel ® E15 LV Premium), red iron oxide, yellow iron oxide , triethyl citrate , titanium dioxide, talc , povidone K-30 .
Vabadin 20 were yellow- brown , oval , biconvex tablets.
The tablets are packed in blisters in cartons of 14, 28 or 56 tablets. Not all pack sizes may be available .
How does Vabadin 20 ?
Simvastatin, the active substance of Vabadin 20 , belongs to a group of medicines known as statins. Statins reduce cholesterol and certain fatty substances in the blood called triglycerides .
What is it used Vabadin 20 ?
• For lowering cholesterol and triglyceride levels in low-fat diet failure or other measures ( exercise and weight reduction ) ;
• lowering of inherited high cholesterol levels in the blood ( homozygous familial hypercholesterolemia ) , along with dieting and other treatments (e.g., LDL- apheresis ) or if such treatments are not appropriate ;
• to reduce the risk of coronary heart disease in the presence of a narrowing of the arteries ( atherosclerosis ) or diabetes , even in the normal levels of cholesterol , along with dieting and other treatments .
When not to apply Vabadin 20
• if you are allergic ( hypersensitive) to simvastatin or to any of the excipients of the tablet ;
• if you have liver problems or continued high levels of certain liver enzymes ( serum transaminzai ) ;
• if you are pregnant or breast-feeding ;
• if you are taking the following medicines:
- Certain antifungals (ketoconazole , itraconazole ) ;
- Certain medications for treating AIDS (HIV- PI ) ;
- Certain antibiotics ( erythromycin , clarithromycin, telithromycin) ;
- The antidepressant nefazodone .
(see also " What interactions occur between 20 and Vabadin other medicines you are taking ?")
When to take special care with Vabadin 20 ?
• If during treatment with simvastatin experience unexplained muscle pain, tenderness to pressure or muscle weakness. Simvastatin can cause muscle problems and sometimes muscle damage with muscle cramps , fever and red - brownish colored urine . The risk of muscle damage is greater at higher doses. Immediately consult your doctor if you experience muscle cramps , tenderness or weakness.
• If any of these apply to you , there may be a greater risk of muscle damage :
- If you are over the age of 70 years ;
- If you have kidney problems ;
- If you have thyroid problems ( and not taking medication for this) ;
- If you or a close relative suffering from an inherited muscle damage ;
- If treatment with simvastatin or other statins or fibrates (another cholesterol - lowering drugs ) have had muscle problems ;
- If you are taking certain medications (see also " What interactions occur between 20 and Vabadin other medicines you are taking ?") ;
- If you consume large amounts of alcohol and are currently or have previously had liver problems or liver disease. Simvastatin can damage the liver alone without noticing . Your doctor may conduct some blood tests to assess liver function before and after treatment .
Consult your doctor if you have had any of the above factors before.
What interactions occur between 20 and Vabadin other medicines you are taking ?
These warnings may apply to drugs that have recently taken or might take soon.
The following medicines may have been known under a different name , most often - trade name. This text does mention of trade names, and only the name of the drug or group of drugs. So always check the carton or package leaflet to find out what is his drug .
The risk of muscle problems can be greater if simvastatin taken with the following drugs : (some are referred to in " When not to be used Vabadin " )
- Fibrates ( other holesgerol -lowering medicines such as gemfibrozil and bezafibrate ) ;
- Niacin or nicotinic acid (another cholesterol - lowering drug) in high doses (> 1 g daily) ;
- Ciclosporin ( a medicine used to suppress the immune system) ;
- Certain antifungal medicines (such as itraconazole or ketoconazole) ;
- Antibiotics erythromycin, clarithromycin, and telithromycin ;
- Certain medications for treatment of AIDS (HIV protease inhibitor ) ;
- Danazol ( medicine used to treat endometriosis and breast cysts in women ) ;
- The antidepressant nefazodone ;
- Amiodarone, a medicine used in irregular heartbeat ;
- Verapamil and diltiazem ( medicines to treat high blood pressure , chest pain with heart disease or other heart diseases) .
You should also tell your doctor if you are taking drugs that preventing the clotting (anticoagulants , eg . Acenocoumarol and warfarin) . Simvastatin may increase the effect of these drugs.
Please tell your doctor or pharmacist if you are currently or have recently taken any other medicines, including medicines obtained without a prescription.
What interactions occur between Vabadin 20 w food and drink ?
Grapefruit juice contains one or more substances, which may increase the amount of simvastatin in the blood. Therefore, you should not take grapefruit juice as it may increase the risk of muscle damage .
Can be used Vabadin 20 during pregnancy and lactation ?
Do not take simvastatin if you are pregnant, trying to become pregnant or if you suspect that you are pregnant, because safety has not been established in pregnant women. If you become pregnant while taking simvastatin, should immediately stop taking the tablets and consult your doctor.
There are no data on the excretion of simvastatin in human milk. Because many drugs are excreted in human milk and the risk of severe side effects, you should not breastfeed your child while taking simvastatin.
Consult your doctor or pharmacist before taking any medicine .
Affect you Vabadin 20 ability to drive and use machines ?
Simvastatin has no effect or a negligible effect on the ability to drive and use machines. However, there are rare cases of dizziness in patients taking tablets simvastatin ( see section 4 " What interactions occur between 20 and Vabadin other medicines you are taking ?") - If the side effects occur and you do not drive or operate machines that require attention .
What you need to know about the ingredients of Vabadin 20 ?
Among other substances Vabadin 20 contains lactose. If you are informed that you have an intolerance to certain sugars , consult your doctor before use of this medicine.
How and how much time should be used Vabadin 20 ?
Always take the tablets exactly as the doctor . You should consult with your doctor or pharmacist if you are unsure . The usual dose is from 5 mg to 80 mg simvastatin daily as a single dose taken in the evening . There are also divisible tablet with a lesser amount of drug in need of lower doses . If necessary , the physician will increase dose at intervals of at least 4 weeks to a maximum of 80 mg simvastatin daily as a single dose taken in the evening. Dose of 80 mg is recommended only in patients with very high cholesterol levels and increased risk of cardiovascular complications.
Vabadin 20 should be taken with water. Take the tablets or fasting or after meals.
Duration of treatment
You should take Vabadin 20 a long time. Your doctor will tell you how long you should take Vabadin 20.
If you feel that the effect of simvastatin is too strong or too weak, talk to your doctor or pharmacist.
What should I do overdose with Vabadin 20 ?
If you accidentally take many tablets Vabadin 20 , consult your doctor or pharmacist.
What should be done by passing the intake Vabadin 20 ?
If you miss some intake and remember soon after taking the medicine as soon as possible . However, if it is almost time for your next dose , do not compensate by taking the missed dose and wait until the appointed time for taking the next dose . If in doubt, consult your doctor or pharmacist.
Do not take a double dose to make up the missed dose.
What should be done if you stop taking Vabadin 20 ?
If you suddenly stop taking this medicine , your cholesterol levels may rise again . Therefore, it is important to consult a doctor before stopping treatment , even in event of any complaints . The doctor will explain if you can stop the medicine, and the best way to do it .
If you have any questions about using this medicine , consult your doctor or pharmacist.
What side effects may cause Vabadin 20 ?
As with all medications , Vabadin 20 can lead to side effects that occur at each . Most adverse reactions were mild and transient. The following adverse reactions have been reported rarely ( more than 1 in 10,000 , but less than 1 in 1,000 patients): anemia , abdominal complaints ( pain, constipation , abdominal pain, gas , nausea , indigestion, diarrhea , vomiting ) inflammation of the pancreas ( severe abdominal pain , nausea and vomiting ), weakness , headache, dizziness, numbness and loss of sensation in hands and feet, hair loss, rash , itching, liver disease ( can occur with yellowish discoloration of the skin and / or eclairs eyes ) , dark colored urine , pale colored stools , muscle damage (see below) , abnormal blood tests or allergic reaction to simvastatin. An allergic reaction may occur with any of the following symptoms: sudden swelling of the face, tongue and throat (angioedema , cf. Below) , certain skin diseases ( lupus-like syndrome) with rash , fever and joint pain , joint inflammation and vessels , joint pain , unusual bruising, skin rash , swelling , hives , skin sensitivity to sunlight , fever , flushing, breathing difficulties or fatigue.
Immediately consult a doctor for pain , tenderness, weakness or cramps in muscles. In rare cases, muscle damage can be severe . Moreover, immediately consult your physician for rapid swelling of the face , tongue and throat (angioedema) , which can lead to severe breathing difficulties . Both can occur hives and swelling can start Serbs.
If you notice the event, of any side effects not mentioned in this leaflet, or if you feel that any of these side effects are serious , please tell your doctor or pharmacist.
How to store Vabadin 20 ?
Keep out of reach of children! Do not store above 25 ° C.
The expiry date is printed on the carton and blister. Do not use after the expiry date printed on the package !