Cholib
fenofibrate, simvastatin
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What Cholib is and what it is used for
What you need to know before you take Cholib
How to take Cholib
Possible side effects
How to store Cholib
Contents of the pack and other information
Cholib contains two different active substances: fenofibrate (belongs to the group called ‘fibrates’) and simvastatin (belongs to the group called ‘statins’). They are both used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, they both raise levels of “good” cholesterol (HDL cholesterol).
Cholesterol is one of several fats found in your blood. Your total cholesterol is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called ‘bad’ cholesterol because it can build up in the walls of your arteries and form plaque. Over time, this plaque build-up can lead to a clogging of your arteries.
HDL cholesterol is often called ‘good’ cholesterol because it helps keep the ‘bad’ cholesterol from building up in the arteries and because it protects against heart disease.
Triglycerides are another fat in your blood. They may raise your risk of having heart problems.
In most people, there are no signs of cholesterol or triglycerides problems at first. Your doctor can measure your lipids with a simple blood test. Visit your doctor regularly to keep track of your lipids level.
Cholib is used in adults at high risk of problems like heart attack and stroke who have high blood levels of 2 types of fats (triglycerides and LDL cholesterol). It is given to lower triglycerides and increase the good cholesterol (HDL cholesterol) in patients whose bad cholesterol (LDL cholesterol) is already controlled with simvastatin alone in a dose of 20 mg.
You must continue a low fat diet or other measures (e.g. exercise, weight reduction) during treatment with 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 peanut, arachis oil, soya lecithin or related substances
If while taking other medicines, you have had an allergic reaction or skin damage from sunlight or UV light (these medicines include other fibrates and an anti-inflammatory medicine called “ketoprofen”)
If you have liver or gallbladder problems
If you have pancreatitis (inflamed pancreas which causes abdominal pain), which is not caused by high levels of fats in the blood
If you have moderate or severe kidney problems
If you have a history of muscle problems during treatment to lower the level of fats in the blood with either of the active substances in this medicine, or with other statins (such as atorvastatin, pravastatin or rosuvastatin) or fibrates (such as bezafibrate or gemfibrozil)
If you are already taking the following medicines:
danazol (a man-made hormone used to treat endometriosis)
ciclosporin (a medicine often used in organ transplant patients)
itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections)
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines
used for HIV infection and AIDS)
Cobicistat (medicine used for HIV infection)
glecaprevir or pibrentasvir (used to treat hepatitis C virus infection)
erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections)
nefazodone (a medicine for depression)
If you are already being treated and will continue your treatment with:
a fibrate (e.g. gemfibrozil)
a statin (medicines to lower the levels of fats in the blood, e.g. simvastatin, atorvastatin)
If you are under 18 years of age
If you are pregnant or breast-feeding
Do not take Cholib if any of the above applies to you. Check with your doctor or pharmacist if you are not sure.
Talk to your doctor or pharmacist before taking Cholib if:
you have an underactive thyroid gland (hypothyroidism)
you are due to have an operation. You may need to stop taking Cholib for a short time.
you drink large amounts of alcohol (more than 21 units (210 mL) a week of pure alcohol)
you have chest pain and are feeling breathless. These may be signs of a blood clot in the lung (pulmonary embolism)
you have severe lung disease
you have kidney disease
you or a close family member have a muscle problem which runs in the family
you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (a medicine for bacterial infection)
you are taking hepatitis C antiviral agents such as elbasvir or grazoprevir (used to treat hepatitis C virus infection)
If any of the above applies to you, talk to your doctor or pharmacist before taking Cholib. Check with your doctor or pharmacist if you are not sure.
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
Your doctor should do a blood test before you start taking Cholib. This is to check how well your liver is working.
Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Cholib.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
Your doctor may do a blood test to check your muscles before and after starting treatment.
Cholib must not be given to children and adolescents (age below 18 years).
It is particularly important to tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also concerns medicines obtained without a prescription including herbal medicines.
Tell your doctor or pharmacist if you are taking any of the following medicines:
danazol (a man-made hormone used to treat endometriosis)
ciclosporin (a medicine often used in organ transplant patients)
itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections)
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used
for HIV infection and AIDS)
Cobicistat (medicine used for HIV infection)
glecaprevir or pibrentasvir (used to treat hepatitis C virus infection)
erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections)
nefazodone (a medicine for depression)
a fibrate (e.g. fenofibrate, gemfibrozil)
a statin (e.g. simvastatin, atorvastatin)
Do not take Cholib if any of the above applies to you. Check with your doctor or pharmacist if you are not sure.
In particular tell your doctor or pharmacist if you are taking any of the following medicines (taking Cholib with any of these medicines can increase the risk of muscle problems):
high doses of at least 1 gram per day of niacin (nicotinic acid) or a treatment containing niacin (medicine for lowering fat levels in the blood)
colchicine (a medicine used to treat gout)
Do not take fusidic acid (a medicine for bacterial infections) while using this medicine.
As well as the medicines listed previously, tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:
anticoagulants such as warfarin, fluindione, phenprocoumone or acenocoumarol (medicines to prevent blood clots)
pioglitazone (a particular class of medicines to treat diabetes)
rifampicin (a medicine used to treat tuberculosis)
elbasvir or grazoprevir (used to treat hepatitis C virus infection)
If any of the above applies to you, talk to your doctor or pharmacist before taking Cholib. Check with your doctor or pharmacist if you are not sure.
Grapefruit juice contains one or more components that alter how the body uses Cholib. Do not consume grapefruit juice with Cholib as it may increase your risk of muscle problems.
Do not take Cholib if you are pregnant, trying to get pregnant or think you may be pregnant.
If you get pregnant while taking Cholib, stop taking it immediately and contact your doctor.
Do not take Cholib if you are breast-feeding or plan to breast-feed your baby, because it is not known if the medicine passes into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Cholib is not expected to affect you being able to drive or use tools or machines. However, it should be taken into account that some people get dizzy after taking Cholib.
Cholib contains types of sugars called lactose and sucrose. If you have been told by your doctor 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 peanut, soya or arachis oil do not use Cholib. Cholib contains sunset yellow FCF (E110) that may cause allergic reactions.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine the appropriate strength for you, depending on your condition, your current treatment and your personal risk status.
The usual dose is one tablet per day.
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 a low-fat diet or other measures (e.g. exercise, weight reduction) whilst taking Cholib.
If you have taken more Cholib than you should or if someone else has taken your medicine, tell your doctor or pharmacist or contact your nearest hospital
Do not take a double dose to make up for a forgotten tablet. Take the next tablet at your regular time on the next day. If you are worried about this, talk to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Cholib can cause side effects, although not everybody gets them.
Unexplained muscle pain, tenderness, or weakness may be sign of muscle break down.
Therefore please contact your doctor immediately if you experience these symptoms. This is because on rare occasions, there have been cases of serious muscle problems including muscle breakdown resulting in kidney damage; and very rare deaths have occurred. Compared to a fibrate or a statin alone, the risk of muscle breakdown is increased when you take
these 2 medicines together, as in Cholib. It is higher in female patients or in patients 65 years or older.
Some patients have experienced the following serious side effects whilst taking fenofibrate or simvastatin (both active substances in Cholib):
hypersensitivity (allergic) reactions including swelling of the face, tongue and throat which may cause difficulty in breathing (angioedema) (rare)
a serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis) (very rare)
Hypersensitivity reaction to Cholib with symptoms like: pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells)
cramps or painful, tender or weak muscles, muscle rupture - these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death
stomach pain - this may be a sign that your pancreas is inflamed (pancreatitis)
chest pain and feeling breathless - these may be signs of a blood clot in the lung (pulmonary embolism)
pain, redness or swelling in the legs - these may be signs of a blood clot in the leg (deep vein thrombosis)
yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes - these may be signs of an inflamed liver (hepatitis and hepatic failure)
increased sensitivity of your skin to sunlight, sun lamps and sunbeds
rash that may occur on the skin or sores in the mouth (lichenoid drug eruptions)
If any of the previously listed serious side effects happen, stop taking Cholib and tell your doctor immediately or go to the emergency room at your nearest hospital - you may need urgent medical treatment.
Some patients have experienced the following side effects whilst taking Cholib, fenofibrate or simvastatin:
Very common side effects (may affect more than 1 in 10 people):
Increase in the blood level of “creatinine” (substance excreted by the kidneys)
Increase in blood levels of “homocysteine” (too much of this amino acid in the blood is related to a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal link has not been established)
Common side effects (may affect up to 1 in 10 people):
increase in blood platelets count
elevations in blood tests of liver function (transaminases)
digestive disturbances (stomach pain, nausea, vomiting, diarrhoea and flatulence)
infection of the upper respiratory tract
Uncommon side effects (may affect up to 1 in 100 people):
muscle problems
gallstones
rashes, itching, red patches on the skin
headache
sexual difficulties
Rare side effects (may affect up to 1 in 1,000 people):
low red blood cell count (anaemia)
numbness or weakness of the arms and legs
confusion
feeling dizzy
feeling exhausted (astenia)
increase in “urea” - produced by the kidneys - shown in tests
increase in “gamma-glutamyltransferase” - produced by the liver - shown in tests
increase in “alkaline phosphatase” - produced by the bile system - shown in tests
increase in “creatine phosphokinase” - produced by the muscle - shown in tests
drop in haemoglobin (that carries oxygen in blood) and white blood cells- shown in tests
trouble sleeping
poor memory or memory loss
hair loss
constipation
dyspepsia
blurred vision; impaired vision
Very rare side effect (may affect up to 1 in 10,000 people):
gynecomastia (breast enlargement in men)
The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):
severe allergic skin rash with blisters
complications of gall stones such as colic because of stones in bile duct, infection of the bile ducts or gall bladder
diabetes mellitus
erectile dysfunction
feeling depressed
sleep disturbances including nightmares
specific lung disease with difficulties breathing (called interstitial lung disease)
muscle weakness that is constant
increase in “glycosylated haemoglobin” and blood glucose levels - markers for blood glucose control in diabetes mellitus - shown in tests
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use Cholib after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substances are fenofibrate and simvastatin. Each tablet contains 145 mg of fenofibrate and 20 mg of simvastatin.
This medicine contains less than 1 mmol sodium (23 mg) per one tablet, that is to say essentially ‘sodium-free’.
The other ingredients are: Tablet core:
Butylhydroxyanisole (E320), lactose monohydrate, sodium laurilsulfate, starch, pregelatinised (maize), docusate sodium, sucrose, citric acid monohydrate (E330), hypromellose (E464), crospovidone (E1202), magnesium stearate (E572), silicified microcrystalline cellulose (comprised of cellulose, microcrystalline and silica, colloidal anhydrous), ascorbic acid (E300).
Film-coat:
Poly (vinyl alcohol), partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), lecithin (derived from soya bean (E322)), xanthan gum (E415), iron oxide red (E172), iron oxide yellow (E172), sunset yellow FCF (E110).
Oval, biconvex, tan coloured, film-coated tablet, with bevelled edges and 145/20 on one side. The diameter dimensions are 19.3 x 9.3 mm approximately and the tablet weight is about 734 mg.
The tablets are provided in carton boxes with blisters containing 10, 30 or 90 tablets. Not all pack sizes may be marketed.
Mylan IRE Healthcare Ltd, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 – Ireland.
Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Châtillon-sur-Chalaronne - France.
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Mylan EPD Tel/Tél: + 32 2 658 61 00 | Ireland Mylan IRE Healthcare Ltd Tel: +44 (0) 1707 853000 | Norge Mylan Healthcare Norge AS Tlf: + 47 66 75 33 00 |
България Майлан ЕООД Teл.: + 359 2 4455 400 | Ísland Icepharma hf. Sími: +354 540 8000 | Österreich Mylan Österreich GmbH Tel: + 43 1 891 24 -0 |
Česká republika Mylan Healthcare CZ s.r.o. Tel: +420 222 004 400 | Italia Mylan Italia S.r.l. Tel: + 39 (0) 2 61246921 | Polska Mylan Healthcare Sp. z o.o. Tel: +48 22 546 64 00 |
Danmark Mylan Denmark ApS Tlf. +45 28 11 69 32 | Κύπρος Βαρνάβας Χατζηπαναγής Λτδ (Varnavas Hadjipanayis Ltd) Τηλ: +357 22207700 | Portugal BGP Products, Unipessoal, Lda. Tel : +351 214 127 256 |
Deutschland Mylan Healthcare GmbH (Troisdorf) Tel: +49 511 4754 3400 | Latvija Mylan Healthcare SIA Tel: + 371 67 605 580 | România BGP Products S.R.L. Tel: +40 372 579 000 |
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363052 | Lietuva Mylan Healthcare UAB Tel: +370 52 051 288 | Slovenija Mylan Healthcare d.o.o. Tel: + 386 (0)123 63 180 |
Ελλάδα BGP ΠΡΟΪΟΝΤΑ Μ.Ε.Π.Ε. Τηλ.: +30 210 9891 777 | Luxembourg/Luxemburg Mylan EPD sprl-bvba Tel/Tél: + 32 2 658 6100 | Slovenská republika BGP Products s.r.o. Tel: +421 2 40 20 38 00 |
España Mylan pharmaceuticals S.L. +34 91 669 93 00 | Magyarország Mylan EPD Kft Tel: +36 1 465 2100 | Suomi/Finland Mylan Finland Oy Puh/Tel: +358 20 720 9555 |
France Mylan Medical SAS Tél: + 33 (0)1 56 64 10 70 | Malta V.J. Salomone Pharma Limited Tel: +356-22-98 31 43 | Sverige BGP Products AB Tel: +46 8 555 227 07 |
Mylan Hrvatska d.o.o. Tel: + 385 (0)1 2350 599
Mylan Healthcare B.V. Tel: +31 (0)20 426 33 00
Mylan IRE Healthcare Ltd Tel: +353 18711600