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  Product Name: ATOMIBE

  
  


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  Available Strengths:

  
  


• ATOMIBE 10mg/10mg (Ezetimibe 10mg / Atorvastatin 10mg)


• ATOMIBE 10mg/20mg (Ezetimibe 10mg / Atorvastatin 20mg)


• ATOMIBE 10mg/40mg (Ezetimibe 10mg / Atorvastatin 40mg)

Therapeutic Indications

Prevention of Cardiovascular Events:
Reduces the risk of cardiovascular events in patients with coronary heart disease (CHD) and history of acute coronary syndrome (ACS), regardless of prior statin treatment.

Primary Hypercholesterolaemia / Mixed Hyperlipidaemia:
Adjunct to diet in adults:

Inadequately controlled with statin alone

Already treated with separate statin and ezetimibe tablets

Homozygous Familial Hypercholesterolaemia (HoFH):
Adjunct to diet in adults with HoFH; may also be combined with treatments such as LDL apheresis.

Mechanism of Action and Benefits

• Combines Ezetimibe, which inhibits intestinal cholesterol absorption, and Atorvastatin, which inhibits endogenous cholesterol synthesis.


• Reduces:


• Total cholesterol


• LDL-C ("bad" cholesterol)


• Triglycerides


• Increases:


• HDL-C ("good" cholesterol)


• Intended for patients whose cholesterol levels are not adequately managed by diet alone.

. Do not take ATOMIBE:

• If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).


• you have or have ever had a disease that affects the liver,


• you have had any unexplained abnormal blood tests for liver function,


• you are a woman able to have children and are not using reliable contraception,


• you are pregnant, trying to become pregnant or are breast-feeding,


• you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C.


• b. Take special care with the product


• Talk to your doctor or pharmacist before taking ATOMIBE if.


• you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes,


• you have kidney problems,


• you have an under-active thyroid gland (hypothyroidism),


• you have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems,


• you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other “statin” or “fibrate” medicines),


• you regularly drink a large amount of alcohol,


• you have a history of liver disease,


• you are older than 70 years,


• you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product,


• you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and ATOMIBE can lead to serious muscle problems (rhabdomyolysis).


• Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ATOMIBE. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage. Atorvastatin is known to cause muscle problems, and cases of muscle problems have also been reported with ezetimibe.


• 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.


• Check with your doctor or pharmacist before taking ATOMIBE


• if you have severe respiratory failure.


• If any of these apply to you (or you are not sure), talk to your doctor or pharmacist before taking ATOMIBE because your doctor will need to carry out a blood test before and possibly during your ATOMIBE treatment to predict your risk of muscle-related side effects. The risk of muscle-related side effects, e.g. rhabdomyolysis, is known to increase when certain medicines are taken at the same time (see section 2 “Other medicines and ATOMIBE”).


• 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.


• Tell your doctor about all your medical conditions including allergies.


• The combined use of ATOMIBE and fibrates (medicines for lowering cholesterol) should be avoided since the combined use of ATOMIBE and fibrates has not been studied.


• Children


• ATOMIBE is not recommended for children and adolescents.


• c. Taking or using other medicines, herbal or dietary supplements


• Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other


• There are some medicines that may change the effect of ATOMIBE or their effect may be changed by ATOMIBE (see section 3). This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side effects, including the important muscle wasting condition known as “rhabdomyolysis” described in section 4:


• ciclosporin (a medicine often used in organ transplant patients),


• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines for bacterial infections),


• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines for fungal infections),


• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, cholestyramine (medicines for regulating lipid levels),


• some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem,


• digoxin, verapamil, amiodarone (medicines to regulate your heart rhythm),


• medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (medicines for AIDS),


• some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir,


• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteraemia).


• **If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart ATOMIBE. Taking ATOMIBE with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.


• Other medicines known to interact with ATOMIBE


• oral contraceptives (medicines for preventing pregnancy),


• stiripentol (an anticonvulsant medicine for epilepsy),


• cimetidine (a medicine used for heartburn and peptic ulcers),


• phenazone (a painkiller),


• antacids (indigestion products containing aluminium or magnesium),


• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines to prevent blood clots),


• colchicine (used to treat gout),


• St John's wort (a medicine to treat depression).


• d. Taking ATOMIBE with food and drink


• See section 3 for instructions on how to take ATOMIBE. Please note the following:


• Grapefruit juice


• Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of ATOMIBE.


• Alcohol


• Avoid drinking too much alcohol while taking this medicine. See section 2 “Warnings and precautions” for details.


• e. Fertility, Pregnancy and Lactation


• Do not take ATOMIBE if you are pregnant, are trying to get pregnant or think you may be pregnant. Do not take ATOMIBE if you are able to become pregnant unless you use reliable contraceptive measures. If you get pregnant while taking ATOMIBE, stop taking it immediately and tell your doctor.


• Do not take ATOMIBE if you are breast-feeding.


• The safety of ATOMIBE during pregnancy and breast-feeding has not yet been proven.


• Ask your doctor or pharmacist for advice before taking this medicine.


• f. Driving and using machines


• ATOMIBE is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people may get dizzy after taking ATOMIBE.


• ATOMIBE contains lactose


• ATOMIBE tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


• ATOMIBE contains sodium


• This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.