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CHOLIB 145 mg. / 20 mg. 30 tablets
What is Cholib and what it is used
Cholib contains two different active substances: fenofibrate (belonging to the group of so-called. "Fibrates"), and simvastatin (belonging to the group of so-called. "Statins"). Both are used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, both raise levels of "good" cholesterol (HDL cholesterol).
What should I know about cholesterol and triglycerides?
Cholesterol is one of several fatty substances in the blood. Total cholesterol is composed mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of arteries and form plaque. Over time, this accumulation of plaque can result in clogged arteries.
HDL cholesterol is often called "good" cholesterol because it helps prevent the accumulation of "bad" cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fatty substances in the blood. They may increase the risk of developing cardiovascular disease.
In most people, at first no signs of problems with cholesterol or triglycerides. Your doctor can measure lipids by simple blood test. Visit your doctor regularly to keep track of lipids.
Cholib is used in adults at high risk of problems such as heart attack and stroke, in which moreover are elevated levels of two types of blood fat (triglycerides and LDL cholesterol). It is given to reduce triglycerides and increase good cholesterol (HDL-cholesterol), after the bad cholesterol (LDL-cholesterol) is already controlled with simvastatin alone at a dose of 20 mg.
You should continue low-fat diet and other measures (eg exercise, weight loss) during treatment with Cholib.
2. What you need to know before taking Cholib
Do not use Cholib:
if you are allergic to fenofibrate or simvastatin or any of the other ingredients of Cholib (listed in section 6);
if you are allergic to peanuts, peanut oil, soy lecithin or related substances;
if while you are taking other medicines have an allergic reaction or skin damage from sunlight or UV light (these drugs include fibrates and other anti-inflammatory drug called "ketoprofen");
if you have problems with your liver or gall bladder;
if you have pancreatitis (inflammation of the pancreas, causing abdominal pain), which is not caused by high levels of blood fats;
if you have moderate or severe kidney problems;
if you have a history of muscle problems during treatment to reduce the levels of the fatty substances in the blood by any of the active substance, the drug or other statins (such as atorvastatin, pravastatin, or rosuvastatin) or fibrates (such as bezafibrate or gemfibrozil) ;
If you are taking the following medicines:
danazol (artificial hormone for treatment of endometriosis);
cyclosporine (a drug that is often used in patients with organ transplants);
itraconazole, ketoconazole, fluconazole, posaconazole or (drugs for fungal infections);
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for the treatment of HIV infection and AIDS);
erythromycin, clarithromycin or telithromycin (medicines against bacterial infections);
nefazodone (a medicine for depression);
if you are already being treated and will continue treatment with:
fibrate (eg. gemfibrozil);
statin (a drug to reduce fat levels in the blood, such as simvastatin, atorvastatin);
if you are under the age of 18 years;
if you are pregnant or breast-feeding.
Do not take Cholib, if any of the above applies to you. If you are not sure, ask your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Cholib, if:
have decreased activity of the thyroid (hypothyroidism);
yet your operation. You may need to stop for a short time taking Cholib;
drinking alcohol in large quantities (more than 21 units (210 ml) of pure alcohol per week);
you have chest pain and shortness of breath feel. These may be signs of a blood clot in your lung (pulmonary embolism);
you have severe lung disease;
have kidney disease;
You or your close family have muscle problems that are inherited in the family;
or take the last 7 days you are taking medicines called fusidic acid (a medicine for bacterial infection).
If any of these apply to you, talk to your doctor or pharmacist before taking Cholib. If you are not sure, ask your doctor or pharmacist.
Your doctor should do a blood test before you start taking Cholib. This is done to determine whether your liver is working well.
It is possible that your doctor may want you to have blood tests to check that your liver is working well after you have started taking Cholib.
While taking this medicine, your doctor will monitor your condition carefully if you have diabetes or are at risk to develop diabetes. There may be a risk of developing diabetes if you have high levels of sugar and fat in the blood, if you are overweight and have high blood pressure.
Your doctor may do blood tests to check your muscles before and after starting treatment.
Children and adolescents
Cholib should not be given to children and adolescents (under 18 years).
Other medicines and Cholib
It is extremely important to tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to medicines obtained without a prescription, including herbal medicines.
Tell your doctor or pharmacist if you are taking any of the following medications:
danazol (artificial hormone for treatment of endometriosis);
cyclosporine (a drug that is often used in patients with organ transplants);
itraconazole, ketoconazole, fluconazole, posaconazole or (drugs for fungal infections);
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for the treatment of HIV infection and AIDS);
erythromycin, clarithromycin or telithromycin (medicines against bacterial infections);
nefazodone (a medicine for depression);
fibrate (eg. fenofibrate, gemfibrozil);
statins (e.g. simvastatin, atorvastatin).
Do not take Cholib, if any of the above applies to you. If you are not sure, ask your doctor or pharmacist.
In particular, tell your doctor or pharmacist if you are taking any of these medicines (taking Cholib with any of these drugs may increase the risk of muscle problems):
high doses of at least 1 gram per day of niacin (nicotinic acid) or medicines that contain niacin (a medicine to reduce the level of fats in the blood);
colchicine (a medicine used to treat gout).
Do not take fusidic acid (a medicine for bacterial infection) while taking this medicine.
As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken or might take any of the following medications:
anticoagulants such as warfarin, fluindione, phenprocoumon or acenocoumarol (drugs that prevent blood clots);
pioglitazone (specific class of drugs for the treatment of diabetes);
rifampicin (a medicine used to treat tuberculosis).
If any of these apply to you, talk to your doctor or pharmacist before taking Cholib. If you are not sure, ask your doctor or pharmacist.
Cholib with food and drink
Grapefruit juice contains one or more components that alter the way the body uses Cholib. Do not consume grapefruit juice with Cholib, as this may increase the risk of problems with your muscles.
Pregnancy and lactation
Cholib not take if you are pregnant, trying to become pregnant or think you may be pregnant. If you become pregnant while taking Cholib, immediately stop taking it and contact your doctor.
Do not take Cholib if breast-feeding or plan to breast-feed your baby, as it is not known whether this medication passes into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Cholib not expected to affect your ability to drive or operate any tools or machines. It must be borne in mind that some people get dizzy after taking Cholib.
Important information about some of the ingredients of Cholib
Cholib contains sugars which are known as lactose and sucrose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Cholib contains soya lecithin. If you are allergic to peanuts or soya or peanut oil, do not use Cholib.
Cholib contains sunset yellow FCF (E110), which may cause allergic reactions.
3. How to use Cholib
Always use this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the appropriate type of tablets for you depending on your condition, your current treatment and your personal risk status.
The usual dose is one tablet daily.
You can take Cholib with or without food.
Swallow the tablet with a glass of water.
Do not crush or chew the tablet.
You should continue low-fat diet and other measures (eg exercise, weight loss) during treatment with Cholib.
If you take more dose Cholib
If you take more than the amount Cholib or if someone else has taken your medicine, tell your doctor or pharmacist and contact the nearest hospital.
If you forget to take Cholib
Do not take a double dose to make up for a forgotten tablet. Take the next tablet on the following day at the usual time for you. If you are worried, talk to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Cholib can cause side effects, although not everybody gets them:
Unexplained muscle pain, tenderness or weakness may be signs of muscle breakdown. Therefore, please contact your doctor immediately if you experience any of these symptoms. This is because there have been rare cases of serious muscle problems, including muscle breakdown leading to kidney damage and in very rare cases have died. In comparison with a fibrate or a statin alone, the risk of muscle breakdown is higher when these two drugs are taken together, at Cholib. It is higher in women and in patients aged 65 years or more.
Some patients have experienced these serious side effects while taking fenofibrate or simvastatin (both active ingredients Cholib):
allergic reactions - signs and symptoms include swelling of the face, lips, tongue or throat which may cause difficulty in breathing;
Hypersensitivity reactions to Cholib with symptoms such as pain or inflammation of the joints, inflammation of blood vessels, unusual bruising (bruises), skin rash or swelling of the skin, hives, increased sensitivity to the sun, fever, flushing , shortness of breath and feeling unwell, lupus-like disease (including rash, joint disorders, and effects on white blood cells);
cramps or painful, tense or weakened muscles - these may be signs of inflammation or muscle breakdown, which can cause kidney damage and even death;
stomach pain - this may be a sign that your pancreas is inflamed (pancreatitis);
chest pain and a feeling of shortness of breath - these may be signs of a blood clot in your lung (pulmonary embolism);
pain, redness or swelling of the feet - they may be signs of a blood clot in the leg (deep vein thrombosis);
yellowing of the skin and whites of the eyes (jaundice) or increased levels of liver enzymes - these may be signs of an inflamed liver (hepatitis and liver failure)
increased sensitivity of the skin to sunlight, sunlamps, or tanning beds.
If any of the listed here serious side effects, stop taking Cholib and tell your doctor immediately or go to the casualty department at your nearest hospital - you may be required emergency medical care.
Some patients have experienced these serious side effects while taking Cholib, fenofibrate or simvastatin:
Very common side effects (may affect more than 1 in 10 people):
increasing blood levels of "creatinine" (a substance which is excreted through the kidneys);
increased blood levels of "homocysteine" (too much of this amino acid in the blood are associated with an increased risk of ischemic heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established so far) .
Common side effects (affects up to 1 in 10 people):
an increased number of blood platelets;
elevated liver function tests (transaminases);
digestive disorders (stomach pain, nausea, vomiting, diarrhea and flatulence);
infections of the upper respiratory tract.
Uncommon side effects (affects up to 1 in 100 people):
muscle problems;
gallstones;
rashes, itching, red spots on the skin;
headache;
sexual problems.
Rare side effects (affects up to 1 in 1000 people):
reduced number of red blood cells (anemia);
numbness or weakness in the arms and legs;
confusion;
dizziness;
feeling of fatigue (asthenia);
increase "urea" - produced by the kidneys - sets with research;
increasing the "gamma-glutamyl transferase" - produced by the liver - sets with research;
increasing the "ALP" - produced by biliary system - established with research;
increase of "creatine phosphokinase" - produced by muscles - sets with research;
decrease in hemoglobin (which carries oxygen in the blood) and white blood cells - sets with research;
difficulty sleeping;
poor memory or memory loss;
hair loss;
constipation;
dyspepsia (indigestion).
The following adverse reactions have been reported, but their frequency can not be estimated from available data (not known):
severe allergic skin rash with blisters;
complications of gallstones, such as colic due to stones in the bile ducts, bile duct infections, or gall bladder;
diabetes mellitus;
erectile dysfunction;
feeling depressed;
sleep disturbances, including nightmares;
especially lung disease have difficulty breathing (called interstitial lung disease);
increase "glycated hemoglobin" and blood sugar levels - (tags to control blood sugar in diabetes) - is revealed through research.
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.
5. How to store Cholib
Keep out of the reach and sight of children.
Cholib not use after the expiry date stated on the carton and blister after "EXP / EXP". The expiry date refers to the last day of that month.
Do not store above 30 ° C. |
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