Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cholib

Document Subject

Generated Narrative: MedicinalProductDefinition mp63e581259f99b3ad3581a50239777ba2

identifier: http://ema.europa.eu/identifier/EU/1/13/866/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Cholib 145 mg/20 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-63e581259f99b3ad3581a50239777ba2

identifier: http://ema.europa.eu/identifier/EU/1/13/866/001-002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - cholib

Attesters

What is in this leaflet

1. What Cholib is and what it is used for
2. What you need to know before you take Cholib
3. How to take Cholib
4. Possible side effects
5. How to store Cholib
6. 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). What should I know about cholesterol and triglycerides? 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.

Do not take 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. Warnings and precautions: 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)

you have or have had myasthenia (a disease with general muscle weakness including in some cases muscles used when breathing), or ocular myasthenia (a disease causing eye muscle weakness) as statins may sometimes aggravate the condition or lead to the occurrence of myasthenia (see section 4). 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. Children and adolescents Cholib must not be given to children and adolescents (age below 18 years). Other medicines and Cholib: 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. Cholib with food and drink 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. Pregnancy and breast-feeding

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. Driving and using machines 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. Important information about some of the ingredients of 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 take more Cholib than you should 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 If you forget to take Cholib 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

myasthenia gravis (a disease causing general muscle weakness including in some cases muscles used when breathing). Ocular myasthenia (a disease causing eye muscle weakness). Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping of your eyelids, difficulty swallowing, or shortness of breath. Reporting of side effects 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.

What Cholib contains 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). What Cholib looks like and contents of the pack 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. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland Manufacturer: Mylan Laboratories SAS, Route de Belleville - Lieu-dit Maillard, 01400 Ch tillon-sur-Chalaronne - France. Mylan Hungary Kft., Mylan utca 1, Kom rom 2900, Hungary For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Viatris Tel/T l: + 32 2 658 61 Ireland Mylan Ireland Limited Tel: +353 1 8711Norge Viatris AS Tlf: + 47 66 75 33

Te .: + 359 2 4455 sland Icepharma hf. S mi: +354 540 8 sterreich Arcana Arzneimittel GmbH Tel: + 43 1 416 2 esk republika Viatris CZ s.r.o. Tel: +420 222 004 Italia Viatris Italia S.r.l. Tel: + 39 (0) 2 61246Polska Mylan Healthcare Sp. z o.o. Tel: +48 22 546 64 Danmark Viatris ApS Tlf. +45 28 11 69
Varnavas Hadjipanayis Ltd : +357 22207Portugal Viatris Healthcare, Lda. Tel : +351 214 127 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 Latvija Mylan Healthcare SIA Tel: + 371 67 605 Rom nia BGP Products S.R.L. Tel: +40 372 579 Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363Lietuva Mylan Healthcare UAB Tel: +370 52 051 Slovenija Viatris d.o.o. Tel: + 386 (0)123 63
Viatris Hellas Ltd .: +30 2100 100 Luxembourg/Luxemburg Viatris Tel/T l: + 32 2 658 6Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Espa a Viatris Pharmaceuticals, S.L.U. +34 900 102 Magyarorsz g Viatris Healthcare Kft Tel: +36 1 465 2Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9France Viatris Sant
T l: + 33 (0)1 40 80 15 Malta V.J. Salomone Pharma Ltd. Tel: +356 21 22 01 Sverige Viatris AB Tel: +46 8 630 19 Hrvatska Viatris Hrvatska d.o.o. Tel: + 385 1 23 50 Nederland Mylan B.V. Tel: +31 (0)20 426 33 United Kingdom (Northern Ireland) Mylan IRE Healthcare Ltd Tel: +353 18711This leaflet was last revised in <{MM/YYYY}>: Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: