AKTALIPID 20 mg. 28 tablets

WHAT AKTALIPID AND WHAT IT IS USED
AKTALIPID belongs to a group of medicines known as statins. They reduce the content of cholesterol and certain fatty acids, known as triglycerides in the blood.
AKTALIPID is used to:
• Reduction of cholesterol and triglycerides in the blood when a diet low in fat and other measures (exercise, reduction of body weight) are ineffective.
• Reduction of congenital high levels of blood cholesterol (homozygous familial hiperholesgerolemiya), together with dieting and other treatments (LDL - apheresis) or if such treatments is inappropriate
• Reduce the risk of coronary heart disease, if there is a hardening of the arteries (atherosclerosis), diabetes, or even at normal levels of cholesterol, simultaneously with dieting and other treatments.
2. BEFORE YOU TAKE AKTALIPID
Simvastatin does not apply:
• if you are allergic (hypersensitive) to simvastatin or any other substance contained in the tablet;
• if you have liver problems or sustained high levels of certain liver enzymes (serum transaminases);
• If you are pregnant or breast-feeding;
• if you are taking the following medicines (see "Use with other medicines" below):
> Certain antifungal medicines (ketoconazole, itraconazole, fluconazole, posaconazole)
> Certain drugs for treatment of AIDS (HIV-protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir)
> Certain antibiotics (erythromycin, clarithromycin or telithromycin)
> Antidepressant nefazodone
Take special care with AKTALIPID
• If during treatment with simvastatin experience unexplained muscle pain, sensitivity to pressure or muscle weakness. Simvastatin may cause muscle problems and sometimes muscle disorders, accompanied by cramps, fever and red-brown discolouration of urine. The risk of muscle disorders is greater at higher doses. Contact your doctor immediately if you experience muscle pain, muscle tenderness or weakness.
• If any of the following apply to you because you may be exposed to greater risk of muscle disorders:
> Your age is more than 70 years
> You have kidney problems
> Do you have thyroid problems (and are not taking medicines)
> You or your family members have a hereditary muscle diseases
> If you had muscle problems during treatment with simvastatin or other statins or fibrates (other cholesterol-lowering drugs)
• if you have severe respiratory failure if you are taking certain other medicines: see "Taking other medicines" below.
• If you consume large amounts of alcohol or have had liver problems or disease in the past. Simvastatin can affect the activity of your liver without you noticing it directly. Your doctor may order blood tests to check the condition of your liver before and after starting treatment.
Talk to your doctor if any of the above conditions apply to you or has applied to you in the past.
Taking other medicines
Please note that the following may apply to drugs that are taken in the past or may make in the future.
The risk of muscle problems increases if Simvastatin is used together with the following medicines: (some of them have already been listed in the above paragraph "Simvastatin not applicable")
• Fibrates (other cholesterol-lowering medicines, such as gemfibrozil, bezafibrate) (the dose of simvastatin should not exceed 10 mg daily)
• Ciclosporin (drug used to suppress the immune system) (the dose of simvastatin should not exceed 10 mg daily)
• Niacin (another medicine for lowering cholesterol) (daily dose of simvastatin should not exceed 10 mg)
• Some antifungal agents (such as itraconazole, ketoconazole, posaconazole or fluconazole)
• antibiotics erythromycin, clarithromycin
• Some medicines for the treatment of AIDS (HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir)
• Danazol (medicine used to treat endometriosis and breast cysts in women) (the dose of simvastatin should not exceed 10 mg daily)
• antidepressant nefazodone Amiodarone, a medicine used for irregular heart beat (the dose of simvastatin should not exceed 20 mg daily)
• Verapamil and diltiazem (medicine used to treat high blood pressure, chest pain associated with heart disease or other heart conditions). If you are taking verapamil, the dose of simvastatin should not exceed 20 mg daily if you take diltiazem the dose of simvastatin should not exceed 40 mg unless your doctor believes that clinical benefit outweighs the increased risk of muscle problems.
• Fusidic acid as a tablet or infusion (drug used to treat bacterial infections)
• Colchicine (medicine to treat gout)
You should tell your doctor if you take:
• medicines to prevent blood clots (anticoagulants such as warfarin and acenocoumarol). Simvastatin may increase the effect of these drugs.
• Rifampicin (antibiotic used to treat tuberculosis)
• Amlodipine (medicine for the treatment of high blood pressure, chest pain (angina pectoris)
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Application of simvastatin in intake of foods and drinks:
Grapefruit juice contains one or more components which may increase the amount of simvastatin in the blood. Therefore, it should not drink grapefruit juice as it could increase the risk of muscle damage.
Pregnancy and lactation
Do not use simvastatin if you are pregnant, trying to become pregnant or suspect you may be pregnant, as the safety in pregnant women has not been established. If you become pregnant while using simvastatin, you should stop taking it immediately and tell your doctor.
No information on release of simvastatin in breast milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions associated with it should not breast-feed while taking simvastatin.
Seek advice from your doctor or pharmacist before you start taking any medicine.
children
Safety and effectiveness have been studied in 10-17 year old boys and girls who are menstruating at least one year (see How to take simvastatin).
Simvastatin has not been studied in children under the age of 10. For more information, talk to your doctor.
Driving and using machines
Simvastatin has no effect or has a less pronounced effect on ability to drive and use machines.
However, there are rare reports of dizziness in patients taking simvastatin tablets (see section 4). Do not drive vehicles or operate machines that require attention if you experience this side effect.
Important information about some of the ingredients of Simvastatin:
Among other ingredients, Simvastatin contains lactose monohydrate. If your doctor has informed you have a problem in accepting certain sugars, contact your doctor before you start taking this medicine.
3. HOW TO USE AKTALIPID
Always take the tablets in the way your doctor recommends. Ask your doctor or pharmacist if you are unsure.
You must follow cholesterol-lowering diet while taking simvastatin.
The dosage is 1 tablet of simvastatin 10 mg, 20 mg, 40 mg or 80 mg orally once daily in the evening.
The dose of 80 mg is recommended for adults with very high cholesterol levels and at high risk of cardiovascular disease.
If necessary, your physician may increase the dose at intervals of at least 4 weeks, to a maximum of 80 mg per day as a single dose in the evening.
If you have been prescribed simvastatin because of the need for lowering the hereditary high cholesterol (homozygous familial hypercholesterolemia). Your doctor will recommend taking simvastatin 40 mg daily in the evening or 80 mg daily of 3 doses: 2 taking 20 mg daytime +1 evening dose of 40 mg.
If your doctor has prescribed a bile acid sequestrant (another medicine for lowering cholesterol such as cholestyramine) along with simvastatin you should take simvastatin at least two hours before or four hours after administration of a bile acid sequestrant.
Children and adolescents (10-17 years old)
For children (10-17 years old) with a hereditary condition called familial hypercholesterolemia, the recommended starting dose is 10 mg daily in the evening. The maximum recommended dose is 40 mg daily.
Elderly
No need dose adjustment in elderly patients.
Instructions for use:
Simvastatin tablets should be taken with water before a meal (on an empty stomach) or after a meal.
Duration of treatment:
Simvastatin should be used for a long time. Your doctor will tell you how long you should be taking simvastatin. If you have the impression that the effect of simvastatin is too strong or too weak, talk to your doctor or pharmacist.
If you take a large amount of the drug than they should:
Although no specific information about simvastatin overdose, any medication administered in large quantities, can cause serious consequences. If you accidentally take a large number of tablets, ask your doctor or pharmacist immediately.
If you forget to take Simvastatin:
If you find that you forget to take a dose soon after had, take it as soon as possible. If it is almost time to take the next dose, skip the missed dose and take the next dose at the scheduled time. If in doubt, ask your doctor or pharmacist.
Do not take a double dose to make up for a missed dose tablet.
If you stop use of simvastatin:
If you suddenly stop taking this medicine, your cholesterol may rise again. Therefore, it is important to consult your doctor before stopping treatment, even if you suffer from physical complaints. He / she can tell you whether you should stop taking and the best way to do this.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Simvastatin can cause side effects, although not everybody gets them. They are mostly mild and transient.
You should stop taking the drug immediately and tell your doctor or go to the emergency room of the nearest hospital if any of the following side effects:
• Muscle pain, tenderness, weakness or cramps. This is necessary because in rare cases muscle damage can be serious (see section 2 "0barnete special care with Simvastatin").
• Rapid swelling of the face, tongue and throat (angioedema), which may cause significant disturbances of breathing. It is possible to simultaneously develop a rash and swelling is accompanied by itching.

The following uncommon side effects have been reported (1 to 10 patients in 1000):
• sleep disorders, including insomnia and nightmares
• memory loss
• depression
• impaired sexual function
The following adverse reactions have been reported rarely (1 to 10 patients in 10,000):
• anemia;
• stomach disorders (such as nausea, constipation, abdominal pain, bloating, nausea, indigestion, diarrhea, vomiting);
• inflammation of the pancreas (severe abdominal pain, reaching to the back, nausea and vomiting);
• headache, dizziness, weakness, blunting or loss of sensation in hands and feet;
• hair loss, rash, itching;
• muscle pain, touch, weakness or cramps, dark colored urine, pale colored stools (see above and section 2);
• liver disease (which unfolds as yellowing of the eyes and / or skin)
• an increase in liver enzymes in the blood;
• allergic reaction that may include some of the following symptoms: sudden swelling of the face, tongue or throat (angioedema, see below), certain skin disease (lupus-like syndrome) with rash, fever and joint pain, inflammation joints and blood vessels, abnormal results of laboratory blood tests (eosinophilia, increased ESR), joint pain, the occurrence of unusual bruising, skin rashes, swelling, hives, skin sensitivity to the sun, fever, flushing, breathing difficulty or fatigue (see above and paragraph 2).
The following adverse reactions have been reported very rarely (less than 1 patient in 10,000):
• breathing problems including persistent cough and / or shortness of breath or fever;
• liver failure
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE AKTALIPID
• Keep out of reach of children!
• Keep your tablets in the original package in order to protect them from light and moisture.
• Do not store the medicinal product above 30 ° C
• Do not use the tablets after the expiry date stated on the packaging. The first two digits indicate the month, the last digits the year.
• Medicines should not be disposed of with water or household waste. Consult your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What AKTALIPID
• Active substance: simvastatin 10 mg; 20 mg or 40 mg
• Excipients:
Tablet core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinised maize starch, butyl hydroxyanisole (E320), butyl hydroxytoluene (E321), ascorbic acid (E 300), citric acid (EZZO), colloidal silica (E551), talc (E553Y), magnesium stearate (E470b). Film coating: hypromellose (E464), red iron oxide (E172), yellow iron oxide (E172), triethyl citrate (E1505), titanium dioxide (E171), talc (E553Y), povidone K-30.
Simvastatin looks like and contents of the pack
• simvastatin 10 mg is an oval, biconvex, film-coated tablet peach-colored, scored on one side;
• simvastatin 20 mg is light brown, oval, biconvex, film-coated tablet, scored on one side;
• simvastatin 40 mg is reddish, oval, biconvex, film-coated tablet, scored on one side;
The tablets can be divided into equal halves along the dividing line.
The tablets are packaged in blisters in a carton containing 10, 20, 28, 30, 50, 98 and 100 tablets. Not all pack sizes may be marketed.