EZETIMIBE/SIMVASTATIN SUN 10 mg/40 mg TABLETS

2. What you need to know before you take Ezetimibe/Simvastatin SUN

Do not take Ezetimibe/Simvastatin SUN if

• you are allergic (hypersensitive) to ezetimibe, simvastatin or any of the other ingredients of this medicine (listed in section 6. Contents of the pack and other information)
• you currently have liver problems
• you are pregnant or breast-feeding
• you are taking medicines with one or more of the following active substances:

• itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections)
• erythromycin, clarithromycin or telithromycin (used to treat infections)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used to treat HIV infections)
• boceprevir or telaprevir (used to treat hepatitis C virus infection)
• nefazodone (used to treat depression)
• cobicistat
• gemfibrozil (used to lower cholesterol)
• cyclosporin (used in patients who have had an organ transplant)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)

Do not take more than 10/40 mg of Ezetimibe/Simvastatin if you are taking lomitapida (used to treat a rare and serious genetic cholesterol disorder).

Consult your doctor if you are not sure if your medicine is mentioned above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions, including allergies.
• if you drink large amounts of alcohol or if you have ever had liver disease. Ezetimibe/Simvastatin may not be suitable for you.
• if you are going to have an operation. You may need to stop taking the tablets of Ezetimibe/Simvastatin for a short time.
• if you are Asian, as you may need a different dose.
• If you have or have had myasthenia (a disease that causes muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes make these conditions worse or trigger the onset of myasthenia (see section 4).

Your doctor will do a blood test before you start taking Ezetimibe/Simvastatin and may also do a blood test if you have any symptoms of liver problems while taking Ezetimibe/Simvastatin. This is to check how well your liver is working.

Your doctor may also want to do blood tests to check how well your liver is working after you start treatment with Ezetimibe/Simvastatin.

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 is higher if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Talk to your doctor if you have severe lung disease.

The combined use of Ezetimibe/Simvastatin and fibrates (certain medicines used to lower cholesterol) should be avoided, as the use of Ezetimibe/Simvastatin with fibrates has not been studied.

Tell your doctor immediately if you experience muscle pain, tenderness or weakness that is unexplained. This is because, on rare occasions, muscle problems can be serious, including muscle breakdown, which can cause kidney damage; and, very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of Ezetimibe/Simvastatin, especially the 10/80 mg dose. The risk of muscle breakdown is also higher in certain patients. Tell your doctor if:

• you have kidney problems
• you have thyroid problems
• you are over 65 years old
• you are female
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called "statins" (such as simvastatin, atorvastatin and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate).
• you or a close family member have a muscle problem that runs in the family

Also, tell your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this condition.

Children and adolescents

Ezetimibe/Simvastatin is not recommended in children under 10 years of age.

Taking Ezetimibe/Simvastatin SUN with other medicines

Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. Taking the tablets of Ezetimibe/Simvastatin with some of the following medicines may increase the risk of muscle problems (some of these are already included in the section above "Do not take Ezetimibe/Simvastatin SUN if").

• 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 it is safe to restart the treatment with Ezetimibe/Simvastatin. Taking Ezetimibe/Simvastatin with fusidic acid can very rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

• cyclosporin (often used in patients who have had an organ transplant),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active substance used to treat fungal infections, such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole,
• fibrates with an active substance such as gemfibrozil and bezafibrate (used to lower cholesterol),
• erythromycin, clarithromycin or telithromycin (used to treat bacterial infections)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS),
• antivirals for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active substance cobicistat,
• amiodarone (used to treat irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions),
• lomitapida (used to treat rare and serious genetic cholesterol disorders),
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteraemia). The risk of side effects that affect the muscles may be increased when this medicine is taken with simvastatin (e.g. Ezetimibe/Simvastatin tablets). Your doctor may decide that you should stop taking the tablets of Ezetimibe/Simvastatin for a while.
• high doses (1 gram or more per day) of niacin or nicotinic acid (also used to lower cholesterol),
• colchicine (used to treat gout).

As well as the medicines mentioned above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following:

• medicines with an active substance used to prevent blood clots, such as warfarin, flindione, phenprocoumon or acenocoumarol (anticoagulants)
• cholestyramine (also used to lower cholesterol), as it affects how Ezetimibe/Simvastatin works
• fenofibrate (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis)
• ticagrelor (an antiplatelet medicine).

You should also tell any doctor who prescribes you a new medicine that you are taking Ezetimibe/Simvastatin.

Taking Ezetimibe/Simvastatin SUN with food and drink

Grapefruit juice contains one or more ingredients that alter the metabolism of some medicines, including Ezetimibe/Simvastatin. You should avoid drinking grapefruit juice, as it can increase the risk of muscle problems.

Pregnancy and breast-feeding

Do not take Ezetimibe/Simvastatin if you are pregnant, if you are trying to become pregnant or if you think you may be pregnant. If you become pregnant while taking Ezetimibe/Simvastatin, stop taking it immediately and tell your doctor. Do not take Ezetimibe/Simvastatin if you are breast-feeding, as it is not known whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Ezetimibe/Simvastatin 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/Simvastatin.

Ezetimibe/Simvastatin SUN contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Ezetimibe/Simvastatin SUN contains sodium

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

3. How to take Ezetimibe/Simvastatin SUN

Your doctor will decide on the appropriate dose of Ezetimibe/Simvastatin for you, depending on your current treatment and your personal risk situation.

The tablets should not be broken and should be swallowed whole.

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

• Before you start taking Ezetimibe/Simvastatin, you should be on a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking Ezetimibe/Simvastatin.

Adults:the dose is 1 tabletof Ezetimibe/Simvastatin once a day by mouth.

Use in adolescents(10 to 17 years of age): the dose is 1 tabletof Ezetimibe/Simvastatin once a day by mouth (do not exceed a maximum dose of 10 mg/40 mg once a day).

The dose of Ezetimibe/Simvastatin 10 mg/80 mg is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease who have not reached their treatment goal with lower doses.

Take Ezetimibe/Simvastatin in the evening. You can take it with or without food.

If your doctor has prescribed Ezetimibe/Simvastatin with another cholesterol-lowering medicine that contains the active substance colestyramine or any other bile acid sequestrant, you should take Ezetimibe/Simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe/Simvastatin SUN than you should

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, consult your doctor or pharmacist.

If you forget to take Ezetimibe/Simvastatin SUN

Do not take a double dose to make up for forgotten doses, take your normal dose of Ezetimibe/Simvastatin at the usual time.

If you stop taking Ezetimibe/Simvastatin SUN

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

If you have any further questions on the use of this product, 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 (see section 2. What you need to know before starting to take Ezetimiba/Simvastatina SUN).

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

• Muscle pain
• Elevations in blood test results for liver function (transaminases) and/or muscle (CK)

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

• Elevation of liver function in blood tests; elevations of uric acid in the blood; elevations in the time it takes for blood to clot; protein in urine; weight loss
• Dizziness; headache; tingling sensation
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; heartburn
• Rash; itching; hives
• Joint pain, muscle pain, sensitivity, weakness, or muscle spasms; neck pain; pain in the arms and legs; back pain
• Unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet
• Sleep disorder; difficulty sleeping

Adverse reactions with unknown frequency:

• 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.

Additionally, the following adverse effects have been reported in people taking Ezetimiba/Simvastatina or medications containing the active ingredients ezetimiba or simvastatina:

• Low red blood cell count (anemia), reduced blood cell count, which can cause bruising/hemorrhage (thrombocytopenia)
• Numbness or weakness of the arms and legs; poor memory, memory loss, confusion
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Constipation
• Pancreatitis, often with severe abdominal pain
• Liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark-colored urine or pale-colored stools, feeling tired or weak, loss of appetite; liver failure; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting)
• Hair loss; reddened and swollen rash, sometimes with target-shaped lesions (erythema multiforme)
• Blurred vision and vision impairment (may affect up to 1 in 1,000 people)
• Rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people).
• Hypersensitivity reactions that can include the following: allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing and requires immediate treatment (angioedema), pain or inflammation of the joints, inflammation of blood vessels, atypical bruising, skin rash, and swelling, urticaria, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, pseudolupus syndrome (including skin rash, joint disorders, and effects on white blood cells) A very rare allergic reaction (which may affect up to 1 in 10,000 people) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis).
• Muscle pain, sensitivity, weakness, or muscle cramps; muscle failure; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture
• Gynecomastia (enlargement of breast tissue in men) (may affect up to 1 in 10,000 people)
• Decreased appetite
• Hot flashes; high blood pressure
• Pain
• Erectile dysfunction
• Depression
• Abnormalities in some blood tests for liver function

The following additional adverse events have been reported with some statins:

• Sleep disorders, including nightmares
• Sexual dysfunction
• 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 you while you are taking this medication
• Constant muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with Ezetimiba/Simvastatina (frequency not known).

Consult your doctor immediately if you experience pain, sensitivity to pressure, or unexplained muscle weakness. This is because, in rare cases, muscle problems can be serious, including muscle failure, which can lead to kidney failure; and very rarely, deaths have occurred.

Reporting 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 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 Ezetimiba/Simvastatina SUN

• 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 or blister pack after [EXP].
• Do not store Ezetimiba/Simvastatina tablets at a temperature above 25°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Ezetimiba/Simvastatina SUN

The active ingredients are ezetimiba and simvastatina. Each tablet contains 10 mg of ezetimiba and 20 mg or 40 mg of simvastatina.

The other ingredients are: butylhydroxyanisole (E320), citric acid monohydrate (E330), sodium croscarmellose (E468), hypromellose (E464), lactose monohydrate, magnesium stearate (E470b), microcrystalline cellulose (E460i), and propyl gallate (E310).

Appearance of the product and package contents

Ezetimiba / Simvastatina SUN 10 mg/20 mg tablets are uncoated, white to off-white, capsule-shaped tablets engraved with the code "I" on one side and smooth on the other. Each tablet contains 10 mg of ezetimiba and 20 mg of simvastatina. The tablets are approximately 10.70 mm in length and 5.4 mm in width.

Ezetimiba / Simvastatina SUN 10 mg/40 mg tablets are uncoated, white to off-white, capsule-shaped tablets engraved with the code "F" on one side and smooth on the other. Each tablet contains 10 mg of ezetimiba and 40 mg of simvastatina. The tablets are approximately 13.80 mm in length and 6.00 mm in width. Ezetimiba / Simvastatina is presented in unit dose blisters (OPA/Al/PVC/Al). Package size: 14, 21, 28, 30, 50, 56, 84, 90, 98, 100, or 112 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

Manufacturer

Alkaloida Chemical Company Zrt.

Kabay János u. 29, Tiszavasvári, H-4440,

Hungary

Or

Terapia SA

Str. Fabricii nr. 124, Cluj-Napoca, 400 632,

Romania

Or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132JH, Hoofddorp,

Netherlands

Or

FACTORY BENNETT PHARMACEUTICALS S.A.

Aigaiou 26, Thesi Karela,

Koropi Attiki, 19441,

Greece

Date of the last revision of this prospectus: September 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