Ezetimibe + Atorvastatin Sandoz

Package Leaflet: Information for the Patient

Ezetimibe + Atorvastatin Sandoz, 10 mg + 10 mg, film-coated tablets

Ezetimibe + Atorvastatin Sandoz, 10 mg + 20 mg, film-coated tablets

Ezetimibe + Atorvastatin Sandoz, 10 mg + 40 mg, film-coated tablets

Ezetimibe + Atorvastatin Sandoz, 10 mg + 80 mg, film-coated tablets

Ezetimibe + Atorvastatin

Read this carefully before taking your medicine

• You should 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Ezetimibe + Atorvastatin Sandoz is and what it is used for
• 2. Before you take Ezetimibe + Atorvastatin Sandoz
• 3. How to take Ezetimibe + Atorvastatin Sandoz
• 4. Possible side effects
• 5. How to store Ezetimibe + Atorvastatin Sandoz
• 6. Contents of the pack and other information

1. What Ezetimibe + Atorvastatin Sandoz is and what it is used for

Ezetimibe + Atorvastatin Sandoz is a medicine to lower excessive cholesterol levels. Ezetimibe + Atorvastatin Sandoz contains ezetimibe and atorvastatin.

Ezetimibe + Atorvastatin Sandoz is used in adults to lower the levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. It also raises the levels of “good” cholesterol (HDL cholesterol).

Ezetimibe + Atorvastatin Sandoz works by reducing the absorption of cholesterol in the gut and the production of cholesterol in the body.

Cholesterol is one of several fatty substances found in the blood. 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 the arteries forming plaques. Over time, this can lead to narrowing of the arteries (atherosclerosis) which can reduce or completely block the blood flow to important organs such as the heart and brain. This can cause a heart attack or stroke.

HDL cholesterol is often called “good” cholesterol because it helps prevent the build-up of cholesterol in the walls of the arteries and reduces the risk of heart disease.

Triglycerides are another type of fatty substance in the blood. High levels of triglycerides can increase the risk of heart disease.

Ezetimibe + Atorvastatin Sandoz is used in patients who cannot control their cholesterol levels by diet alone.

Ezetimibe + Atorvastatin Sandoz is used as an addition to diet to reduce cholesterol levels in:

• patients with high blood cholesterol levels (primary hypercholesterolaemia, heterozygous familial or non-familial) or high levels of fatty substances in the blood (mixed hyperlipidaemia) when these conditions have not been adequately controlled by statins alone or when statins are not tolerated;
• patients with a hereditary disease (homozygous familial hypercholesterolaemia) that causes very high cholesterol levels in the blood. Other treatments may also be used;
• patients with heart disease to reduce the risk of heart attack, stroke, the need for surgery to improve blood flow to the heart or hospitalisation due to chest pain (angina).

Ezetimibe + Atorvastatin Sandoz does not affect weight loss.

2. Before you take Ezetimibe + Atorvastatin Sandoz

Do not take Ezetimibe + Atorvastatin Sandoz

• if you are allergic to ezetimibe, atorvastatin or any of the other ingredients of this medicine (listed in section 6);
• if you have or have ever had liver disease;
• if you have had any unexplained abnormal blood test results for liver function;
• if you are a woman able to become pregnant and are not using reliable contraception;
• if you are pregnant or breast-feeding;
• if you are taking glecaprevir/pibrentasvir (used to treat hepatitis C virus infection).

Warnings and precautions

Before taking Ezetimibe + Atorvastatin Sandoz, tell your doctor or pharmacist if:

• you have ever had a stroke caused by bleeding;
• you have kidney problems;
• you have hypothyroidism (an underactive thyroid gland);
• you have had muscle problems or have a family history of muscle problems;
• you have had muscle problems while taking other cholesterol-lowering medicines (e.g. other statins or fibrates);
• you regularly drink large amounts of alcohol;
• you have ever had liver disease;
• you are over 70 years old;
• you have ever had an intolerance to certain sugars (lactose intolerance);
• you have or have had muscle weakness that is persistent and unexplained (myasthenia gravis or other conditions);
• you are taking or have taken in the last 7 days fusidic acid (a medicine for bacterial infection) by mouth or injection as the combination of fusidic acid and Ezetimibe + Atorvastatin Sandoz may lead to serious muscle problems (rhabdomyolysis);

Consult your doctor if you experience

unexplained muscle pain, tenderness or weakness while taking Ezetimibe + Atorvastatin Sandoz,as this can be a sign of a rare but serious side effect called rhabdomyolysis that can lead to kidney damage. Atorvastatin may cause muscle pain, but cases of muscle damage have also been reported with ezetimibe. Your doctor may need to perform additional tests, such as blood tests, to diagnose and treat this condition.

Before taking Ezetimibe + Atorvastatin Sandoz, tell your doctor or pharmacist if:

• you have severe respiratory problems.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Ezetimibe + Atorvastatin Sandoz.

Your doctor will need to check your liver function with a blood test before starting treatment with Ezetimibe + Atorvastatin Sandoz and may need to do so thereafter.

While taking Ezetimibe + Atorvastatin Sandoz, your doctor will monitor you for signs of diabetes or increased risk of diabetes, particularly if you have high levels of sugars and fats in your blood, are overweight or have high blood pressure.

Tell your doctor about all your medical conditions and allergies before taking Ezetimibe + Atorvastatin Sandoz.

Do not take Ezetimibe + Atorvastatin Sandoz if you are taking fusidic acid by mouth or by injection as this may cause serious muscle problems (rhabdomyolysis).

**If you need to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Ezetimibe + Atorvastatin Sandoz. Taking Ezetimibe + Atorvastatin Sandoz with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

• Other medicines and Ezetimibe + Atorvastatin Sandoz

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including those obtained without a prescription.

Some medicines can affect how Ezetimibe + Atorvastatin Sandoz works, or Ezetimibe + Atorvastatin Sandoz can affect how other medicines work. These include:

• cyclosporin (used in organ transplant patients);
• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (used to treat bacterial infections);
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (used to treat fungal infections);
• gemfibrozil, other fibrates, nicotinic acid, or nicotinamide, colestyramine, colestipol (used to lower cholesterol);
• certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem;
• digoxin, verapamil, amiodarone (used to treat irregular heart rhythms);
• HIV protease inhibitors, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc. (used to treat AIDS);
• certain hepatitis C virus protease inhibitors, e.g. telaprevir, boceprevir, and a combination of elbasvir and grazoprevir;
• daptomycin (used to treat complicated skin and soft tissue infections and bacteremia).

**If you need to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Ezetimibe + Atorvastatin Sandoz. Taking Ezetimibe + Atorvastatin Sandoz with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

• Other medicines that can interact with Ezetimibe + Atorvastatin Sandoz include:

oral contraceptives (used to prevent pregnancy), stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and peptic ulcers), phenofibrate (a fibrate), resins such as colestyramine, colestipol, and cholestyipol (used to lower cholesterol), warfarin, acenocoumarol, or fluindione (used to thin the blood), colchicine (used to treat gout), St. John's Wort (a herbal remedy used to treat mild depression).

Ezetimibe + Atorvastatin Sandoz with food and drink

See section 3 for instructions on how to take Ezetimibe + Atorvastatin Sandoz.

• Pay attention to the following:

Grapefruit juice

Do not drink more than 1 litre of grapefruit juice per day as this may increase the risk of side effects.

Alcohol

Avoid excessive alcohol consumption while taking Ezetimibe + Atorvastatin Sandoz. See section 2 for more information.

Pregnancy and breast-feeding

Do not take Ezetimibe + Atorvastatin Sandoz if you are pregnant or breast-feeding. If you become pregnant while taking Ezetimibe + Atorvastatin Sandoz, stop taking the medicine immediately and tell your doctor.

Women of child-bearing potential must use reliable contraception when taking Ezetimibe + Atorvastatin Sandoz.

Driving and using machines

Ezetimibe + Atorvastatin Sandoz is unlikely to affect your ability to drive or use machines. However, dizziness has been reported rarely with Ezetimibe + Atorvastatin Sandoz.

Ezetimibe + Atorvastatin Sandoz contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ezetimibe + Atorvastatin Sandoz contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially sodium-free.

3. How to take Ezetimibe + Atorvastatin Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Before starting treatment with Ezetimibe + Atorvastatin Sandoz, you should be on a cholesterol-lowering diet.
• Continue to follow this diet while taking Ezetimibe + Atorvastatin Sandoz.

Recommended dose

The recommended dose is one Ezetimibe + Atorvastatin Sandoz tablet per day, taken orally.

When to take the medicine

Ezetimibe + Atorvastatin Sandoz can be taken at any time of day, with or without food.

If your doctor has prescribed Ezetimibe + Atorvastatin Sandoz with colestyramine or another bile acid sequestrant (to lower cholesterol), take Ezetimibe + Atorvastatin Sandoz at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe + Atorvastatin Sandoz than you should

Contact your doctor or pharmacist.

If you forget to take Ezetimibe + Atorvastatin Sandoz

Do not take a double dose to make up for a forgotten dose. Take your normal dose of Ezetimibe + Atorvastatin Sandoz the next day at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and seek medical help immediately if you experience any of the following symptoms

• severe allergic reactions, including swelling of the face, tongue and throat, which may cause difficulty in breathing;
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis, with symptoms such as blistering of the skin, mouth, eyes and genitals, and flu-like symptoms;
• muscle weakness, tenderness or pain, which may be a sign of a rare but serious side effect called rhabdomyolysis that can lead to kidney damage;
• lupus-like disease syndrome (including skin rash, joint and muscle pain, and/or inflammation of various body organs).

Common side effects (may affect up to 1 in 10 people)

• diarrhoea;
• muscle pain.

Uncommon side effects (may affect up to 1 in 100 people)

• The following have also been reported:
• flu;
• depression, difficulty sleeping, sleep disturbances;
• dizziness, headache, numbness or tingling sensation;
• slow heart rate;
• hot flushes;
• shortness of breath;
• abdominal pain, abdominal distension, constipation, indigestion, flatulence, vomiting, nausea, stomach discomfort;
• acne, itching, rash;
• joint pain, back pain, muscle spasms, muscle weakness, pain in arms and legs, feeling tired or weak;
• unusual tiredness or weakness, swelling, especially of the ankles;
• increased results of some liver or muscle blood tests;
• weight gain.

Other side effects have been reported with ezetimibe or atorvastatin tablets:

• allergic reactions, including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing;
• red rash, sometimes with target-shaped lesions;
• liver problems;
• cough;
• heartburn;
• loss of appetite;
• high blood pressure;
• skin rash, itching, hives;
• tendon injury;
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting);
• inflammation of the pancreas, often with severe abdominal pain;
• reduced number of blood cells, which may cause pale skin, fatigue, or weakness, bruising, or frequent infections (anaemia, thrombocytopenia, leucopenia);
• inflammation of the nasal passages, throat, or sinuses; nosebleeds;
• neck pain; pain; chest pain; throat pain;
• increased or decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels);
• nightmares;
• numbness or tingling sensation in the fingers and toes;
• reduced sensation or sensitivity;
• altered sense of taste; dry mouth;
• memory loss;
• ringing in the ears, or hearing difficulties;
• vomiting;
• belching;
• hair loss;
• raised body temperature;
• positive test results for blood in the urine (which may not be accompanied by any symptoms);
• blurred vision; visual disturbances;
• breast enlargement in men (gynaecomastia).

Other possible side effects with statins:

• sexual problems;
• depression;
• breathing problems, including persistent cough and/or shortness of breath or fever;
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• muscle pain, tenderness or weakness that is persistent and unexplained (frequency not known).

Rare cases of myasthenia gravis (a disease characterized by muscle weakness that may lead to muscle fatigue and paralysis) have been reported.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 the Medication Guide.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ezetimibe + Atorvastatin Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton.

This medicine does not require any special storage conditions.

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.

6. Contents of the pack and other information

What Ezetimibe + Atorvastatin Sandoz contains

Ezetimibe + Atorvastatin Sandoz 10 mg + 10 mg film-coated tablets: each tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

Ezetimibe + Atorvastatin Sandoz 10 mg + 20 mg film-coated tablets: each tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

Ezetimibe + Atorvastatin Sandoz 10 mg + 40 mg film-coated tablets: each tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

Ezetimibe + Atorvastatin Sandoz 10 mg + 80 mg film-coated tablets: each tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other ingredients are:

Tablet core: microcrystalline cellulose, mannitol, calcium carbonate, croscarmellose sodium, hypromellose, polysorbate 80, iron oxide yellow, magnesium stearate, povidone K29/32, sodium lauryl sulfate.

Tablet coating:

Ezetimibe + Atorvastatin Sandoz 10 mg + 10 mg, 10 mg + 20 mg, 10 mg + 40 mg: Opadry White OY-L-28900, containing lactose monohydrate, hypromellose 2910, titanium dioxide, macrogol 4000.

Ezetimibe + Atorvastatin Sandoz 10 mg + 80 mg: DrCoat FCU, containing hypromellose 2910, titanium dioxide, talc, macrogol 400, iron oxide yellow.

What Ezetimibe + Atorvastatin Sandoz looks like and contents of the pack

Ezetimibe + Atorvastatin Sandoz 10 mg + 10 mg film-coated tablets: white, round, biconvex tablets, approximately 8.1 mm in diameter.

Ezetimibe + Atorvastatin Sandoz 10 mg + 20 mg film-coated tablets: white, oval, biconvex tablets, approximately 11.6 x 7.1 mm in size.

Ezetimibe + Atorvastatin Sandoz 10 mg + 40 mg film-coated tablets: white, capsule-shaped, biconvex tablets, approximately 16.1 x 6.1 mm in size.

Ezetimibe + Atorvastatin Sandoz 10 mg + 80 mg film-coated tablets: yellow, elongated, biconvex tablets, approximately 19.1 x 7.6 mm in size.

Ezetimibe + Atorvastatin Sandoz 10 mg + 10 mg, 10 mg + 20 mg, 10 mg + 40 mg film-coated tablets

Blister packs (OPA/Aluminium/PVC//Aluminium) containing 30, 90 and 100 film-coated tablets in a cardboard box.

Unit dose blister packs (OPA/Aluminium/PVC//Aluminium) containing 30x1, 90x1 and 100x1 film-coated tablets in a cardboard box.

Ezetimibe + Atorvastatin Sandoz 10 mg + 80 mg film-coated tablets

Blister packs (OPA/Aluminium/PVC//Aluminium) containing 30, and multipacks containing 90 (2 packs of 45) and 100 (2 packs of 50) film-coated tablets in a cardboard box.

Unit dose blister packs (OPA/Aluminium/PVC//Aluminium) containing 30x1, and multipacks containing 90x1 (2 packs of 45x1) and 100x1 (2 packs of 50x1) film-coated tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50C

02-672 Warszawa

tel. 22 209 70 00

Manufacturer

Elpen Pharmaceuticals Co. Inc.

Marathonos Avenue 95

19009 Pikermi

Greece

Lek Pharmaceuticals d.d.

Verovskova Ulica 57

1526 Ljubljana

Slovenia

This medicine is authorised in the Member States of the European Economic Area under the following names:

Netherlands

Ezetimibe/Atorvastatine Sandoz 10 mg/10 mg, filmomhulde tabletten

Ezetimibe/Atorvastatine Sandoz 10 mg/20 mg, filmomhulde tabletten

Ezetimibe/Atorvastatine Sandoz 10 mg/40 mg, filmomhulde tabletten

Ezetimibe/Atorvastatine Sandoz 10 mg/80 mg, filmomhulde tabletten

Belgium

Tymyzato 10 mg/20 mg filmomhulde tabletten

Tymyzato 10 mg/40 mg filmomhulde tabletten

Tymyzato 10 mg/80 mg filmomhulde tabletten

Spain

Ezetimiba/Atorvastatina Sandoz Farmacéutica 10 mg/10 mg comprimidos recubiertos con película EFG

Ezetimiba/Atorvastatina Sandoz Farmacéutica 10 mg/20 mg comprimidos recubiertos con película EFG

Ezetimiba/Atorvastatina Sandoz Farmacéutica 10 mg/40 mg comprimidos recubiertos con película EFG

Ezetimiba/Atorvastatina Sandoz Farmacéutica 10 mg/80 mg comprimidos recubiertos con película EFG

France

EZETIMIBE/ATORVASTATINE SANDOZ 10 mg/10 mg, comprimé pelliculé

EZETIMIBE/ATORVASTATINE SANDOZ 10 mg/20 mg, comprimé pelliculé

EZETIMIBE/ATORVASTATINE SANDOZ 10 mg/40 mg, comprimé pelliculé

EZETIMIBE/ATORVASTATINE SANDOZ 10 mg/80 mg, comprimé pelliculé

Italy

Ezetimibe e Atorvastatina Sandoz

Portugal

Atorvastatina + Ezetimiba Sandoz Farmacêutica

Germany

Ezetimib/Atorvastatin - 1 A Pharma 10 mg/ 10 mg Filmtabletten

Ezetimib/Atorvastatin - 1 A Pharma 10 mg/ 20 mg Filmtabletten

Ezetimib/Atorvastatin - 1 A Pharma 10 mg/ 40 mg Filmtabletten

Ezetimib/Atorvastatin - 1 A Pharma 10 mg/ 80 mg Filmtabletten

Greece

Ancilleg

Lithuania

Ezetimibe/Atorvastatin Sandoz 10 mg/10 mg plėvele dengtos tabletės

Ezetimibe/Atorvastatin Sandoz 10 mg/20 mg plėvele dengtos tabletės

Ezetimibe/Atorvastatin Sandoz 10 mg/40 mg plėvele dengtos tabletės

Croatia

Ezetimib/atorvastatin Sandoz 10 mg/10 mg filmom obložene tablete

Ezetimib/atorvastatin Sandoz 10 mg/20 mg filmom obložene tablete

Ezetimib/atorvastatin Sandoz 10 mg/40 mg filmom obložene tablete

Ezetimib/atorvastatin Sandoz 10 mg/80 mg filmom obložene tablete

Poland

Ezetimibe + Atorvastatin Sandoz

Hungary

Ezetimibe/Atorvastatin 1 A Pharma 10 mg/10 mg filmtabletta

Ezetimibe/Atorvastatin 1 A Pharma 10 mg/20 mg filmtabletta

Ezetimibe/Atorvastatin 1 A Pharma 10 mg/40 mg filmtabletta

Ezetimibe/Atorvastatin 1 A Pharma 10 mg/80 mg filmtabletta

Romania

Ezetimib/Atorvastatină Sandoz 10 mg/10 mg comprimate filmate

Ezetimib/Atorvastatină Sandoz 10 mg/20 mg comprimate filmate

Ezetimib/Atorvastatină Sandoz 10 mg/40 mg comprimate filmate

Ezetimib/Atorvastatină Sandoz 10 mg/80 mg comprimate filmate

Slovakia

Ezetimib/Atorvastatín Sandoz 10 mg/10 mg

Ezetimib/Atorvastatín Sandoz 10 mg/20 mg

Ezetimib/Atorvastatín Sandoz 10 mg/40 mg

Ezetimib/Atorvastatín Sandoz 10 mg/80 mg

Date of last revision of the leaflet

Logo Sandoz