Ezetimibe + Atorvastatin Sandoz

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, as 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 only. 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, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ezetimibe + Atorvastatin Sandoz and what is it used for
• 2. Important information before taking 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 packaging and other information

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

Ezetimibe + Atorvastatin Sandoz is a medicine that lowers high cholesterol. Ezetimibe + Atorvastatin Sandoz contains ezetimibe and atorvastatin.
Ezetimibe + Atorvastatin Sandoz is used in adults to lower total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat in the blood called triglycerides. It also raises the level of "good" cholesterol (HDL cholesterol).
Ezetimibe + Atorvastatin Sandoz works in two ways to lower cholesterol levels. It reduces the absorption of cholesterol from the gut and also reduces the production of cholesterol in the body.
Cholesterol is one of several fats found in the blood. Total cholesterol is mainly made up of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of the arteries and form plaques. Over time, this can lead to narrowing of the arteries, which can slow down or block blood flow to vital organs such as the heart and brain. Blocking blood flow can lead to a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the walls of the arteries and prevents heart disease.
Triglycerides are other fats found in the blood that can increase the risk of heart disease.
Ezetimibe + Atorvastatin Sandoz is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should follow a cholesterol-lowering diet.
Ezetimibe + Atorvastatin Sandoz is used as an addition to a cholesterol-lowering diet in the following cases:

• high levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial or non-familial]) or high levels of fats in the blood (mixed hyperlipidemia) if statin monotherapy has not provided adequate control or if statins and ezetimibe were previously administered as separate tablets.
• a hereditary disease (homozygous familial hypercholesterolemia) that causes high levels of cholesterol in the blood. Other treatments may also be used.
• heart disease. Ezetimibe + Atorvastatin Sandoz reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe + Atorvastatin Sandoz does not affect weight loss.

2. Important information before taking Ezetimibe + Atorvastatin Sandoz

When not to 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 had liver disease;
• if you have unexplained, abnormal liver function test results;
• if you are a woman of childbearing age and are not using effective contraception;
• if you are pregnant, trying to become pregnant, or breastfeeding;
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

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

• you have had a hemorrhagic stroke or have small cavities with fluid in the brain as a result of previous strokes;
• you have kidney disease;
• you have hypothyroidism;
• you have recurring or unexplained muscle pain, as well as muscle disease in the past or in your family;
• you have had muscle problems while taking other cholesterol-lowering medicines (e.g., other "statins" or "fibrates");
• you regularly consume large amounts of alcohol;
• you have had liver disease in the past;
• you are over 70 years old;
• you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine;
• you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles used for breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the condition or lead to myasthenia (see section 4).
• you are currently taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Ezetimibe + Atorvastatin Sandoz may lead to serious muscle problems (rhabdomyolysis),

You should contact your doctor immediately if you experience unexplained muscle pain,

tenderness or weakness while taking Ezetimibe + Atorvastatin Sandoz,as in rare cases, muscle disorders can be severe, including muscle breakdown, which can lead to kidney damage. It is known that atorvastatin causes muscle disorders. Cases of muscle disorders have also been reported with ezetimibe.
Your doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
Before taking Ezetimibe + Atorvastatin Sandoz, consult your doctor or pharmacist:

• if you have severe respiratory failure.

In the event of any of the above situations, consult your doctor or pharmacist, as your doctor will need to perform a blood test before starting treatment with Ezetimibe + Atorvastatin Sandoz and probably during treatment to determine the risk of side effects related to muscles. It is known that the risk of side effects related to muscles, such as rhabdomyolysis, is increased by certain medications taken at the same time (see section 2 "Ezetimibe + Atorvastatin Sandoz and other medicines").
While taking this medicine, your doctor will carefully monitor you for diabetes or the risk of developing it. You are at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.
Inform your doctor about all your illnesses, including allergies.
Avoid taking Ezetimibe + Atorvastatin Sandoz and fibrates (cholesterol-lowering medications) at the same time, as this treatment has not been studied.

Children

Ezetimibe + Atorvastatin Sandoz is not recommended for use in children and adolescents.

Ezetimibe + Atorvastatin Sandoz and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
There are medicines that can change the effect of Ezetimibe + Atorvastatin Sandoz or whose effect may be changed by Ezetimibe + Atorvastatin Sandoz (see section 3). This type of interaction can lead to reduced efficacy of one or both medicines. It can also increase the risk or exacerbate side effects, including the risk of serious muscle damage called "rhabdomyolysis", described in section 4:

• cyclosporine (a medicine often used in patients who have had organ transplants),
• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (antibiotics),
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (antifungal medications),
• gemfibrozil, other fibrates, nicotinic acid, derivatives, cholestyramine, colestipol (medicines used to regulate lipid levels),
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir, etc. (medicines used in AIDS);
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir and grazoprevir,
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia).

**If you need to take fusidic acid orally or by injection to treat a bacterial infection, you should temporarily stop taking this medicine. Your doctor will tell you when you can safely resume taking Ezetimibe + Atorvastatin Sandoz. Taking Ezetimibe + Atorvastatin Sandoz at the same time as fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

• Other medicines, in which an interaction with Ezetimibe + Atorvastatin Sandoz has been reported: oral contraceptives (used to prevent pregnancy), stiripentol (an antiepileptic medicine used to treat epilepsy), cimetidine (a medicine used for heartburn and stomach ulcers), phenazon (a pain reliever), antacids (medicines for indigestion containing aluminum or magnesium compounds), warfarin, phenprocoumon, acenocoumarol, or fluindion (medicines given to prevent blood clots), colchicine (used to treat gout), St. John's Wort (a medicine used to treat depression).

Ezetimibe + Atorvastatin Sandoz with food and drink

Instructions for taking Ezetimibe + Atorvastatin Sandoz can be found in section 3. Note the following:

• 1. You should pay attention to the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may change the effect of Ezetimibe + Atorvastatin Sandoz.
Alcohol
Avoid excessive alcohol consumption while taking this medicine. More information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Pregnant women, women trying to become pregnant, and women who suspect they are pregnant should not take Ezetimibe + Atorvastatin Sandoz. Do not take Ezetimibe + Atorvastatin Sandoz if you are at risk of becoming pregnant and are not using effective contraception. If you become pregnant while taking Ezetimibe + Atorvastatin Sandoz, stop taking the medicine immediately and inform your doctor.
Do not take Ezetimibe + Atorvastatin Sandoz while breastfeeding.
The safety of Ezetimibe + Atorvastatin Sandoz during pregnancy and breastfeeding has not been confirmed.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Ezetimibe + Atorvastatin Sandoz is not expected to affect your ability to drive or use machines. However, keep in mind that some people may experience dizziness after taking Ezetimibe + Atorvastatin Sandoz.

Ezetimibe + Atorvastatin Sandoz contains lactose

Ezetimibe + Atorvastatin Sandoz tablets contain a sugar called lactose. If you have been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

Ezetimibe + Atorvastatin Sandoz contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Ezetimibe + Atorvastatin Sandoz

Always take this medicine exactly as your doctor has told you. Your doctor will prescribe the appropriate strength of tablets based on your current treatment and individual risk. If you are unsure, consult your doctor or pharmacist.

• Before starting treatment with Ezetimibe + Atorvastatin Sandoz, you should follow a cholesterol-lowering diet.
• You should continue this diet while taking Ezetimibe + Atorvastatin Sandoz.

Recommended dose
The recommended dose is one Ezetimibe + Atorvastatin Sandoz tablet, taken orally, once a day.
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 cholestyramine or another bile acid sequestrant (medicines used to lower cholesterol), take Ezetimibe + Atorvastatin Sandoz at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking more than the recommended dose of Ezetimibe + Atorvastatin Sandoz

Consult your doctor or pharmacist.

Missing a dose of Ezetimibe + Atorvastatin Sandoz

Do not take an extra dose. Take your usual dose of Ezetimibe + Atorvastatin Sandoz at the normal time the next day.
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.

If you experience any of the following serious side effects or symptoms, stop taking the medicine and contact your doctor immediately or go to the nearest emergency room.

• severe allergic reactions causing swelling of the face, tongue, and throat, which can greatly difficulty breathing,
• severe skin disease with severe peeling and swelling of the skin, with blistering of the skin, mouth, eyes, and genitals, and fever; skin rash with pink-red blisters, especially on the palms and soles, which can lead to blistering,

of the skin.

• weakness, tenderness, pain, or rupture of muscles or reddish-brown urine, especially if accompanied by malaise or fever, may be caused by muscle breakdown, which can be life-threatening and lead to kidney disease,
• lupus-like syndrome (including rash, joint disease, and effects on blood cells).

In the event of unexpected or unusual bleeding or bruising, contact your doctor as soon as possible, as these may be symptoms of liver damage.
The following common side effects have been reported (may affect up to 1 in 10 people):

• diarrhea,
• muscle pain.

The following uncommon side effects have been reported (may affect up to 1 in 100 people):

• The following have been reported:
• flu,
• depression, difficulty sleeping, sleep disturbances,
• dizziness, headache, tingling sensation,
• slow heart rate,
• hot flashes,
• shortness of breath,
• abdominal pain, bloating, constipation, indigestion, flatulence, frequent bowel movements, stomach inflammation, nausea, stomach discomfort, stomach problems;
• acne, hives,
• joint pain, back pain, muscle cramps, fatigue, muscle spasms or weakness, pain in the hands and feet,
• unusual weakness, feeling tired or unwell, swelling, especially swelling of the ankles,
• increased values of certain blood tests for liver function or muscle (CK),
• weight gain.

The following side effects have also been reported in people taking Ezetimibe + Atorvastatin Sandoz, ezetimibe, or atorvastatin tablets:

• allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing (requiring immediate treatment),
• red rash, sometimes with target-like lesions,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions, including rash and hives,
• tendon damage,
• gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting),
• pancreatitis, often with severe abdominal pain,
• decreased blood cell count, which can cause bruising/bleeding (thrombocytopenia),
• nasal inflammation; nosebleeds,
• neck pain; pain; chest pain; throat pain,
• increased or decreased blood sugar levels (in diabetes, continue to monitor blood sugar levels carefully),
• nightmares,
• numbness or tingling of fingers and toes,
• reduced sensation of pain or touch,
• change in taste; dry mouth,
• memory loss,
• ringing in the ears and/or head; hearing loss,
• vomiting,
• belching,
• hair loss,
• fever,
• positive urine test for white blood cells,
• blurred vision; vision disturbances,
• gynecomastia (breast enlargement in men).

Possible side effects reported with some statins

• sexual disorders,
• depression,
• breathing problems, including persistent cough and/or shortness of breath or fever,
• diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor your condition while taking this medicine,
• muscle pain, tenderness, or persistent weakness, especially if accompanied by malaise, high fever, which may not resolve after stopping Ezetimibe + Atorvastatin Sandoz (frequency not known).
• Mitochondrial myopathy (a disease that causes muscle weakness, including in some cases muscles used for breathing).
• Ocular myasthenia (a disease that causes muscle weakness in the eyes).

Consult your doctor if you experience weakness in your arms or legs, which worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49-21-301, Fax: +48 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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 stated on the packaging. The expiry date refers to the last day of the month stated.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ezetimibe + Atorvastatin Sandoz contains

Ezetimibe + Atorvastatin Sandoz 10 mg + 10 mg; each film-coated tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as calcium trihydrate).
Ezetimibe + Atorvastatin Sandoz 10 mg + 20 mg: each film-coated tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as calcium trihydrate).
Ezetimibe + Atorvastatin Sandoz 10 mg + 40 mg: each film-coated tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as calcium trihydrate).
Ezetimibe + Atorvastatin Sandoz 10 mg + 80 mg: each film-coated tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as calcium trihydrate).
Other ingredients are:
Tablet core:
microcrystalline cellulose 101, mannitol, calcium carbonate, sodium croscarmellose, hypromellose (E 463), polysorbate 80, yellow iron oxide, 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
consisting of:
lactose monohydrate
hypromellose 2910
titanium dioxide
macrogol 4000
Ezetimibe + Atorvastatin Sandoz 10 mg + 80 mg - DrCoat FCU consisting of:
hypromellose 2910
titanium dioxide
talc
macrogol 400
yellow iron oxide

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

Ezetimibe + Atorvastatin Sandoz 10 mg + 10 mg film-coated tablets: white, round, biconvex film-coated tablets with a diameter of about 8.1 mm.
Ezetimibe + Atorvastatin Sandoz 10 mg + 20 mg film-coated tablets: white, oval, biconvex film-coated tablets with dimensions of about 11.6 x 7.1 mm.
Ezetimibe + Atorvastatin Sandoz 10 mg + 40 mg film-coated tablets: white, capsule-shaped, biconvex film-coated tablets with dimensions of about 16.1 x 6.1 mm.
Ezetimibe + Atorvastatin Sandoz 10 mg + 80 mg film-coated tablets: yellow, elongated, biconvex film-coated tablets with dimensions of 19.1 x 7.6 mm.
Ezetimibe + Atorvastatin Sandoz 10 mg + 10 mg, 10 mg + 20 mg, 10 mg + 40 mg film-coated tablets
Blisters of OPA/Aluminum/PVC//Aluminum foil containing 30, 90, and 100 film-coated tablets in a cardboard box.
Single-dose blisters of OPA/Aluminum/PVC//Aluminum foil containing 30x1, 90x1, and 100x1 film-coated tablets in a cardboard box.
Ezetimibe + Atorvastatin Sandoz 10 mg + 80 mg film-coated tablets
Blisters of OPA/Aluminum/PVC//Aluminum foil containing 30, collective packaging containing 90 (2 packages of 45) and collective packaging containing 100 (2 packages of 50) film-coated tablets in a cardboard box.
Single-dose blisters of OPA/Aluminum/PVC//Aluminum foil containing 30 x 1 dose, collective packaging containing 90 x 1 (2 packages of 45 x 1) and collective packaging containing 100 x 1 (2 packages of 50 x 1) film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
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 authorized in the Member States of the European Economic Area under the following names:

Netherlands
Ezetimibe/ Atorvastatine Sandoz 10 mg/10 mg, film-coated tablets
Ezetimibe/Atorvastatine Sandoz 10 mg/20 mg, film-coated tablets
Ezetimibe/Atorvastatine Sandoz 10 mg/40 mg, film-coated tablets
Ezetimibe/Atorvastatine Sandoz 10 mg/80 mg, film-coated tablets
Belgium
Tymyzato 10 mg/20 mg film-coated tablets
Tymyzato 10 mg/40 mg film-coated tablets
Tymyzato 10 mg/80 mg film-coated tablets
Spain
Ezetimiba/Atorvastatina Sandoz Farmacéutica 10 mg/10 mg
film-coated tablets
Ezetimiba/Atorvastatina Sandoz Farmacéutica 10 mg/20 mg
film-coated tablets
Ezetimiba/Atorvastatina Sandoz Farmacéutica 10 mg/40 mg
film-coated tablets
Ezetimiba/Atorvastatina Sandoz Farmacéutica 10 mg/80 mg
film-coated tablets
France
EZETIMIBE/ATORVASTATINE SANDOZ 10
mg/10 mg, film-coated tablet
EZETIMIBE/ATORVASTATINE SANDOZ 10
mg/20 mg, film-coated tablet
EZETIMIBE/ATORVASTATINE SANDOZ 10
mg/40 mg, film-coated tablet
EZETIMIBE/ATORVASTATINE SANDOZ 10
mg/80 mg, film-coated tablet
Italy
Ezetimibe e Atorvastatina Sandoz
Portugal
Atorvastatina + Ezetimiba Sandoz Farmacêutica
Germany
Ezetimib/Atorvastatin - 1 A Pharma 10 mg/ 10 mg film-coated tablets
Ezetimib/Atorvastatin - 1 A Pharma 10 mg/ 20 mg film-coated tablets
Ezetimib/Atorvastatin - 1 A Pharma 10 mg/ 40 mg film-coated tablets
Ezetimib/Atorvastatin - 1 A Pharma 10 mg/ 80 mg film-coated tablets
Greece
Ancilleg
Lithuania
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
Croatia
Ezetimib/atorvastatin Sandoz 10 mg/10 mg film-coated tablets
Ezetimib/atorvastatin Sandoz 10 mg/20 mg film-coated tablets
Ezetimib/atorvastatin Sandoz 10 mg/40 mg film-coated tablets
Ezetimib/atorvastatin Sandoz 10 mg/80 mg film-coated tablets
Poland
Ezetimibe + Atorvastatin Sandoz
Hungary
Ezetimibe/Atorvastatin 1 A Pharma 10 mg/10 mg film-coated tablet
Ezetimibe/Atorvastatin 1 A Pharma 10 mg/20 mg film-coated tablet
Ezetimibe/Atorvastatin 1 A Pharma 10 mg/40 mg film-coated tablet
Ezetimibe/Atorvastatin 1 A Pharma 10 mg/80 mg film-coated tablet
Romania
Ezetimib/Atorvastatină Sandoz 10 mg/10 mg film-coated tablets
Ezetimib/Atorvastatină Sandoz 10 mg/20 mg film-coated tablets
Ezetimib/Atorvastatină Sandoz 10 mg/40 mg film-coated tablets
Ezetimib/Atorvastatină Sandoz 10 mg/80 mg film-coated tablets
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:

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