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

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

Do not takeEzetimibe/Atorvastatin Teva

• if you are allergic to atorvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had a disease that affects the liver,
• if you have had any unexplained abnormal blood test results for liver function,
• if you are a woman who can become pregnant and are not using reliable contraception,
• if you are pregnant, trying to become pregnant or are breast-feeding,
• if 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 Teva if:

• you have severe respiratory problems,
• you have had a previous stroke with bleeding in the brain, or have small collections of fluid in the brain from previous strokes,
• you have kidney problems,
• your thyroid gland does not produce enough hormones (hypothyroidism),
• you have had repeated or unexplained muscle pains or a family history of muscle problems,
• you have had muscle problems while taking other lipid-lowering medicines (e.g. other medicines containing "statins" or "fibrates"),
• you have or have had a muscle disease called myasthenia gravis, which can cause muscle weakness, or myasthenic syndrome (a condition that causes muscle weakness), as statins can make these conditions worse (see section 4),
• you are taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and medicines containing atorvastatin/ezetimibe can cause muscle problems (rhabdomyolysis),
• you regularly drink large amounts of alcohol,
• you have a history of liver disease,
• you are over 70 years old.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness while taking Ezetimibe/Atorvastatin Teva.This is because, on rare occasions, muscle problems can be serious, including muscle breakdown, which can cause kidney damage.

Atorvastatin can cause muscle problems and muscle problems have also been reported with ezetimibe.

Tell your doctor or pharmacist if you experience persistent muscle weakness. You may need further tests and treatment to manage this condition.

If any of the above applies to you (or you are not sure), 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 of muscle side effects. The risk of muscle side effects, e.g. rhabdomyolysis (breakdown of skeletal muscle), increases when certain medicines are taken at the same time (see section 2 "Taking Ezetimibe/Atorvastatin Teva with other medicines").

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

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

Children and adolescents

Ezetimibe/Atorvastatin is not recommended for children and adolescents.

Taking Ezetimibe/Atorvastatin Teva with other medicines

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

Fibrates (medicines used to lower cholesterol) should be avoided while taking Ezetimibe/atorvastatin.

There are some medicines that can affect the way Ezetimibe/Atorvastatin works, or their effect can be influenced by Ezetimibe/Atorvastatin. 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 condition called "rhabdomyolysis", which is described in section 4:

• cyclosporin (a medicine 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, niacin, colestipol, colestyramine (medicines used to regulate lipid levels),
• certain calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem,
• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),
• letermovir (a medicine that helps prevent cytomegalovirus infection),
• medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir,
• if you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will tell you when you can restart the treatment with ezetimibe/atorvastatin. Taking 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 the combination ezetimibe/atorvastatin

• oral contraceptives (medicines that prevent pregnancy),
• stiripentol (an anticonvulsant medicine used to treat epilepsy),
• cimetidine (a medicine used to treat stomach acid and peptic ulcers),
• phenazone (a pain reliever),
• antacids (medicines used to treat indigestion that contain aluminium or magnesium),
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clotting),
• colchicine (used to treat gout),
• St John's Wort (a medicine used to treat depression).

Taking Ezetimibe/Atorvastatin Teva with food, drinks 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 affect the way ezetimibe/atorvastatin works.

Alcohol

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

Pregnancy, breast-feeding and fertility

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 use reliable contraception. If you become pregnant while taking ezetimibe/atorvastatin, stop taking it immediately and tell your doctor.

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Ezetimibe/Atorvastatin is unlikely to affect your ability to drive or use machines. However, it should be taken into account that some people experience dizziness after taking ezetimibe/atorvastatin. If you feel dizzy after taking this medicine, do not drive or use machinery.

Ezetimibe/Atorvastatin Teva contains lactose

The 10 mg/10 mg, 10 mg/20 mg and 10 mg/40 mg film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Ezetimibe/Atorvastatin Teva contains sodium

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

3. How to take Ezetimibe/Atorvastatin Teva

Follow exactly the instructions of your doctor to take this medicine.

Your doctor will determine the appropriate dose of Ezetimibe/Atorvastatin for you, depending on your current treatment and your 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 Ezetimibe/Atorvastatin tablet once a day. The tablet should be taken with a sufficient amount of liquid (e.g. a glass of water).

When to take it

You can take Ezetimibe/Atorvastatin at any time of the day. However, try to take your tablet at the same time every day. You can take it with or without food.

If your doctor has prescribed Ezetimibe/Atorvastatin 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 Teva 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ezetimibe/Atorvastatin Teva

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 stop taking Ezetimibe/Atorvastatin Teva

Talk to your doctor or pharmacist because your cholesterol levels may increase again.

If you have any further questions on the use of this medicine or wish to stop the treatment, 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 immediately inform your doctor, or go to the emergency department of the nearest hospital and take the tablets with you.

• 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 inflammation of the skin, 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, rupture, muscle pain, or change in urine color to reddish-brown, and especially if it occurs at the same time, a feeling of discomfort or high temperature that may 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 a liver condition.

Other Possible Adverse Effects

Frequent: (may affect up to 1 in 10 people)

• inflammation of the nasal passage, sore throat, nosebleeds,
• allergic reactions,
• increased blood glucose levels (diabetic patients should monitor their blood glucose levels),
• headache,
• nausea, constipation, flatulence, diarrhea, indigestion, abdominal pain,
• pharynx and/or larynx pain,
• joint and/or hand or foot pain, back pain, muscle pain (myalgia), muscle spasms, joint swelling,
• increases in some blood tests of muscle function (CK),
• abnormal liver function test results, increases in some blood tests of liver function (transaminases),
• fatigue.

Infrequent: (may affect up to 1 in 100 people)

• swelling due to an allergic reaction,
• reduced blood glucose levels (diabetic patients should monitor their blood glucose levels),
• loss of appetite, weight gain,
• cough,
• fatigue or muscle weakness, neck pain, chest pain,
• hot flashes, high blood pressure,
• vomiting,
• belching,
• inflammation of the pancreas or liver,
• stomach acid,
• inflammation of the stomach lining,
• dry mouth,
• skin redness, hives, skin rash, itching,
• hair loss,
• nightmares, difficulty sleeping,
• dizziness,
• numbness, tingling in the fingers and toes,
• alteration of the sense of taste,
• amnesia,
• abnormal local sensations,
• blurred vision,
• ringing in the ears,
• feeling of general discomfort, restlessness, or pain,
• weakness,
• swelling, especially in the hands, ankles, and feet (edema),
• increased temperature,
• increase in the liver enzyme gamma-glutamyl transferase,
• positive urine test for white blood cells.

Rare: (may affect up to 1 in 1,000 people)

• reduction of blood platelets,
• inflammation of the lower layer of skin tissue on the face, tongue, throat, abdomen, arms, or legs (angioedema),
• generalized rash in the form of delimited red spots or rash with blisters or skin peeling, especially around the mouth, nose, eyes, and genitals due to an allergic reaction,
• visual disturbances,
• unexpected bleeding or bruising,
• yellowing of the skin and whites of the eyes.

Very Rare: (may affect up to 1 in 10,000 people)

• anaphylactic shock due to an allergic reaction,
• hearing loss,
• liver failure,
• increase in male breast size,
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Frequency Unknown (cannot be estimated from available data):

• allergic reaction, including rash and swelling of the lower layers of the skin,
• shortness of breath, gallbladder inflammation, gallstones,
• physical weakness and loss of strength, loss of muscle tissue due to autoimmune antibodies.
• depression.
• severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing), ocular myasthenia (a disease that causes weakness of 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 difficulty breathing.

In addition, the following adverse effects have been reported during the post-marketing of some statins (medicines used to reduce cholesterol):

• difficulty breathing, including persistent cough and/or shortness of breath or fever,
• diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• sexual dysfunction.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it 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 Teva

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

Do not use Ezetimibe/Atorvastatin Teva after the expiration date stated on the blister pack and carton after CAD or EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimibe/Atorvastatin Teva

• The active ingredients are ezetimibe and atorvastatin.

Ezetimibe/Atorvastatin Teva 10 mg/10 mg:

Each film-coated tablet contains 10 mg of ezetimibe and 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

Ezetimibe/Atorvastatin Teva 10 mg/20 mg:

Each film-coated tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

Ezetimibe/Atorvastatin Teva 10 mg/40 mg:

Each film-coated tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

Ezetimibe/Atorvastatin Teva 10 mg/80 mg:

Each film-coated tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other ingredients are:

Core of the tablet:microcrystalline cellulose 101; mannitol; calcium carbonate; sodium croscarmellose; hydroxypropylcellulose; polysorbate 80; yellow iron oxide (E172); magnesium stearate; povidone K29/32; sodium lauryl sulfate (see section 2 "Ezetimibe/Simvastatin Teva contains sodium").

Coating

Ezetimibe/Atorvastatin Teva 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg

Monohydrate lactose (see section 2 "Ezetimibe/Simvastatin Teva contains lactose"); hypromellose 2910 (E464); titanium dioxide (E171); macrogol 4000 (E1521).

Ezetimibe/Atorvastatin Teva 10 mg/80 mg:

Hypromellose 2910 (E464); titanium dioxide (E171); talc (E553b); macrogol 4000 (E1521); yellow iron oxide (E172).

Appearance of Ezetimibe/Atorvastatin Teva and Package Contents

Ezetimibe/Atorvastatin Teva 10 mg/10 mg tablets: white, round, biconvex film-coated tablets with a diameter of approximately 8.1 mm.

Ezetimibe/Atorvastatin Teva 10 mg/20 mg tablets: white, oval, biconvex film-coated tablets with a size of approximately 11.6 x 7.1 mm.

Ezetimibe/Atorvastatin Teva 10 mg/40 mg tablets: white, capsule-shaped, biconvex film-coated tablets with a size of approximately 16.1 x 6.1 mm.

Ezetimibe/Atorvastatin Teva 10 mg/80 mg tablets: yellow, oblong, biconvex film-coated tablets with a size of approximately 19.1 x 7.6 mm.

Packages of 30 tablets in OPA/Al/PVC//Al blisters and 30 tablets in OPA/Al/PVC//Al unit dose blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

ELPEN Pharmaceutical Co. Inc.

Marathonos Ave. 95, Pikermi Attiki, 19009

Greece

Or

ELPEN Pharmaceutical Co. Inc.

Zapani, Block 1048, Keratea, 190 01

Greece

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas 28108, Madrid (Spain)

This medicine is authorized in the Member States of the European Economic Area with the following names:

Spain: Ezetimibe/Atorvastatin Teva 10 mg/ 10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/ 80 mg film-coated tablets

Hungary: Cholezta 10 mg/ 10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/ 80 mg film-coated tablets

Netherlands: Ezeat 10 mg/ 10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/ 80 mg film-coated tablets

Date of the last revision of this prospectus:March 2023

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