EZETIMIBE/ATORVASTATIN Sandoz 10 mg/10 mg FILM-COATED TABLETS

2. What you need to know before you take Ezetimibe/Atorvastatin Sandoz Pharmaceutical

Do not take Ezetimibe/Atorvastatin Sandoz Pharmaceutical if:

• you are allergic to ezetimibe, atorvastatin, 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 an unexplained abnormal blood test result for liver function,
• you are a woman who can become pregnant and are not using reliable contraceptive methods,
• you are pregnant, trying to become pregnant, or are breast-feeding,
• you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before taking ezetimibe/atorvastatin if:

• you have had a previous stroke with bleeding in the brain, or have small accumulations of fluid in the brain from previous strokes,
• you have kidney problems,
• your thyroid gland does not produce enough hormones (hypothyroidism),
• you have had recurring or unexplained muscle pains or a family history of muscle problems,
• you have had previous muscle problems while taking other lipid-lowering medicines (e.g. other medicines containing "statins" or "fibrates"),
• you regularly drink large amounts of alcohol,
• you have a history of liver disease,
• you are over 70 years old,
• if your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine,
• if you have or have had myasthenia (a disease that causes general muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or trigger the onset of myasthenia (see section 4),
• you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and atorvastatin/ezetimibe can cause serious muscle problems (rhabdomyolysis).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or weakness while taking ezetimibe/atorvastatin.This is because muscle problems can be serious, including muscle breakdown that can cause kidney damage. Atorvastatin can cause muscle problems, and muscle problems have also been reported with ezetimibe.

Also, inform your doctor or pharmacist if you have persistent muscle weakness. You may need further tests and additional medicines to diagnose and treat this problem.

Consult your doctor or pharmacist before taking ezetimibe/atorvastatin:

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before taking ezetimibe/atorvastatin, as your doctor will need to perform a blood test before starting your treatment, and possibly during treatment, to predict the risk you present of experiencing muscle side effects. It is known that the risk of experiencing muscle side effects, e.g. rhabdomyolysis (breakdown of skeletal muscle), increases when certain medicines are taken simultaneously (see section 2 "Other medicines and Ezetimibe/Atorvastatin Sandoz Pharmaceutical").

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Tell your doctor about all your medical problems, including allergies.

The combined use of ezetimibe/atorvastatin and fibrates (medicines that lower cholesterol) should be avoided, as the combined use of ezetimibe/atorvastatin and fibrates has not been studied.

Children

Ezetimibe/atorvastatin is not recommended for children and adolescents.

Other medicines and Ezetimibe/Atorvastatin Sandoz Pharmaceutical

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

There are some medicines that can affect the way ezetimibe/atorvastatin works, or their effects can be altered by ezetimibe/atorvastatin (see section 3). This type of interaction could reduce the effectiveness of one or both medicines. On the other hand, it could also increase the risk or severity of side effects, including a serious disorder in which muscle tissue is destroyed, known as "rhabdomyolysis", which is described in section 4:

• cyclosporin (a medicine often used in transplant patients),
• erythromycin, clarithromycin, telithromycin, fusidic acid**, rifampicin (medicines used to treat bacterial infections),
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections),
• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, colestyramine (medicines used to regulate lipid levels),
• some calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
• medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• some medicines used to treat 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 bacteremia).

**If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when you can restart treatment with ezetimibe/atorvastatin. The use of this medicine with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Other medicines that are known to interact with ezetimibe/atorvastatin
• oral contraceptives (medicines to prevent pregnancy),
• stiripentol (an anticonvulsant medicine used to treat epilepsy),
• cimetidine (a medicine used for stomach acidity and peptic ulcers),
• phenazone (a pain reliever),
• antacids (medicines for the treatment of indigestion that contain aluminum or magnesium)
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clot formation),
• colchicine (used to treat gout),
• St. John's Wort (a medicine used to treat depression).

Taking Ezetimibe/Atorvastatin Sandoz Pharmaceutical with food and alcohol

See section 3 for instructions on how to take ezetimibe/atorvastatin. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can alter the effects of ezetimibe/atorvastatin.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For more details, see section 2 "Warnings and precautions".

Pregnancy and breast-feeding

Do not take ezetimibe/atorvastatin if you are pregnant, think you may be pregnant, or are planning to become pregnant. Do not take ezetimibe/atorvastatin if you can become pregnant, unless you are using reliable contraceptive methods. If you become pregnant while taking ezetimibe/atorvastatin, stop taking it immediately and inform your doctor.

Do not take ezetimibe/atorvastatin if you are breast-feeding.

The safety of ezetimibe/atorvastatin during pregnancy and breast-feeding has not been established.

Consult your doctor or pharmacist before using this medicine

Driving and using machines

Ezetimibe/atorvastatin is not expected to interfere with your ability to drive or use machines. However, it should be noted that some people experience dizziness after taking ezetimibe/atorvastatin.

Ezetimibe/Atorvastatin10mg/10mg, 10mg/20mg, and 10 mg/40 mg

Ezetimibe/Atorvastatin Sandoz Pharmaceuticalcontains lactose

The tablets of Ezetimibe/Atorvastatin Sandoz Pharmaceutical contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Ezetimibe/Atorvastatin Sandoz Pharmaceutical contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Ezetimibe/Atorvastatin Sandoz Pharmaceutical

Follow the instructions for administration of this medicine exactly as indicated by your doctor. Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and personal risk situation. If in doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimibe/atorvastatin, you should be following a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking ezetimibe/atorvastatin.

How much to take

The recommended dose is one tablet of ezetimibe/atorvastatin orally once a day.

When to take it

Take ezetimibe/atorvastatin at any time of the day. You can take it with or without food.

If your doctor has prescribed ezetimibe/atorvastatin along with colestyramine or any other bile acid sequestrant (medicines that lower cholesterol levels), you should take ezetimibe/atorvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe/Atorvastatin Sandoz Pharmaceutical than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ezetimibe/Atorvastatin Sandoz Pharmaceutical

Do not take a double dose to make up for forgotten doses. Take the normal dose at the usual time the next day.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following serious adverse effects or symptoms, stop taking your tablets and inform your doctor immediately, or go to the emergency department of the nearest hospital.

• severe allergic reactions that cause swelling of the face, tongue, and throat and can cause great difficulty breathing,
• severe disease whose symptoms are intense exfoliation and skin inflammation, blister formation on the skin, mouth, eyes, genitals, and fever, skin rash with pink or red spots, especially on the palms of the hands or soles of the feet, which can lead to blisters,
• weakness, sensitivity, pain, or muscle rupture, change in urine color to reddish-brown, and especially if it occurs at the same time, a feeling of discomfort or high temperature that can be caused by abnormal muscle destruction, which can be potentially fatal and lead to kidney problems,
• lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells).

Consult your doctor as soon as possible if you experience problems associated with the unexpected or unusual appearance of bleeding or bruising, as this fact may be indicative of liver disease.

The following frequent adverse effects were reported (may affect up to 1 in 10 people):

• diarrhea,
• muscle pain.

The following infrequent adverse effects were reported (may affect up to 1 in 100 people):

• flu,
• depression, sleep problems, sleep disorder,
• dizziness, headache, tingling sensation,
• slow heart rate,
• hot flashes,
• breathing difficulties,
• abdominal pain, abdominal swelling, constipation, indigestion, flatulence, frequent bowel movements, stomach inflammation, nausea, stomach discomfort, stomach upset,
• acne, hives,
• joint pain, back pain, leg cramps, muscle fatigue, muscle spasms or weakness, pain in arms and legs,
• unusual weakness, feeling of tiredness or discomfort, swelling, especially in the ankles (edema),
• increase in some liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

Additionally, the following adverse effects have been reported in people taking ezetimibe/atorvastatin, or ezetimibe or atorvastatin tablets alone:

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (which requires immediate treatment),
• elevated 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 skin rash and hives,
• tendon injuries,
• gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting),
• pancreatitis, often with severe abdominal pain,
• reduction in blood cell count, which can cause bruising/bleeding (thrombocytopenia),
• nasal inflammation, nosebleeds,
• neck pain, pain, chest pain, throat pain,
• increases and decreases in blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels),
• having nightmares,
• numbness or tingling in the fingers and toes,
• reduced sensitivity to pain or touch,
• change in taste, dry mouth,
• memory loss,
• ringing in the ears and/or head, hearing loss,
• vomiting,
• belching,
• hair loss,
• increased temperature,
• positive urine tests for white blood cells,
• blurred vision, visual disturbances,
• gynecomastia (enlargement of the breasts in men).

Possible adverse effects observed with some statins:

• sexual difficulties,
• depression,
• respiratory problems such as persistent cough and/or difficulty breathing 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, sensitivity, or weakness that is constant and particularly if you feel unwell or have a high fever that may not disappear after stopping [ezetimibe/atorvastatin] (frequency not known).
• myasthenia gravis (a disease that causes general muscle weakness, including in some cases the muscles used for breathing).
• ocular myasthenia (a disease that causes weakness in the eye muscles).

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

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ezetimibe/Atorvastatin Sandoz Pharmaceutical

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

Do not use this medicine after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofEzetimibe/Atorvastatin Sandoz Pharmaceutical

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

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

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

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

The other components are:

Tablet core:

Microcrystalline cellulose 101 (E460), mannitol (E421), calcium carbonate (E170), sodium croscarmellose (E468), hydroxypropylcellulose (E463), polysorbate 80 (E433), yellow iron oxide (E172), magnesium stearate (E470b), povidone K29/32 (E1201), sodium lauryl sulfate (E487).

Tablet coating

Ezetimibe/Atorvastatin Sandoz Pharmaceutical 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg:

Opadry white OY-L28900 consisting of:

Lactose monohydrate,

Hypromellose 2910 (E464),

Titanium dioxide (E171),

Macrogol 4000 (E1521).

Ezetimibe/Atorvastatin Sandoz Pharmaceutical 10 mg/80 mg: DrCoat FCU consisting of:

Hypromellose 2910,

Titanium dioxide (E171),

Talc (E553b),

Macrogol 400,

Yellow iron oxide (E172).

Appearance of the Product and Package Contents

Ezetimibe/Atorvastatin Sandoz Pharmaceutical 10 mg/10 mg:

white, round, biconvex film-coated tablets with a diameter of approximately 8.1 mm.

Ezetimibe/Atorvastatin Sandoz Pharmaceutical 10 mg/20 mg:

white, oval, biconvex film-coated tablets with dimensions of approximately 11.6 x 7.1 mm.

Ezetimibe/Atorvastatin Sandoz Pharmaceutical 10 mg/40 mg:

white, capsule-shaped, biconvex film-coated tablets with dimensions of approximately 16.1 x 6.1 mm.

Ezetimibe/Atorvastatin Sandoz Pharmaceutical 10 mg/80 mg:

yellow, oblong, biconvex film-coated tablets with dimensions of approximately 19.1 x 7.6 mm.

Ezetimibe/Atorvastatin Sandoz Pharmaceutical 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg:

Packages of 30, 90, and 100 film-coated tablets in OPA/Al/PVC//Al blisters.

Packages of 30x1, 90x1, and 100x1 film-coated tablets in precut unit-dose OPA/Al/PVC//Al blisters.

Ezetimibe/Atorvastatin Sandoz Pharmaceutical 10 mg/80 mg:

Packages of 30, multiple packages of 90 (2 packages of 45), and 100 (2 packages of 50) film-coated tablets in OPA/Al/PVC//Al blisters.

Packages of 30x1, multiple packages of 90x1 (2 packages of 45x1), and 100x1 (2 packages of 50x1) film-coated tablets in OPA/Al/PVC//Al blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

ELPEN Pharmaceutical Co. Inc.

Marathonos Avenue 95

Pikermi Attiki, 19009

Greece

or

Lek Pharmaceuticals d.d

Verovskova ulica 57

1526 Ljubljana

Slovenia

Or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048,

Keratea, 190 01

Greece

Date of the Last Revision of this Prospectus:March 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.