Leaflet: information for the user

Ezetimiba/Simvastatina Krka 10 mg/20 mg tablets EFG

Ezetimiba/Simvastatina Krka 10 mg/40 mg tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

Contents of theleaflet

1. What isEzetimiba/SimvastatinaKrkaand what it is used for
2. What you need to know before you start takingEzetimiba/SimvastatinaKrka
3. How to takeEzetimiba/SimvastatinaKrka
4. Possible side effects
5. Storage ofEzetimiba/SimvastatinaKrka
6. Contents of the pack and additional information

This medicationcontains the active ingredients ezetimibe and simvastatin.It is used to reduce total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain types of fat called triglycerides that circulate in the blood. Additionally, it increases the levels of "good" cholesterol (high-density lipoprotein, HDL).

Ezetimibe/simvastatinacts by reducing cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in the digestive tract. The active ingredient simvastatin, which belongs to the group of "statins," inhibits the production of cholesterol produced by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is composed mainly of LDL and HDL.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can slow down or interrupt blood flow to vital organs such as the heart and brain. This interruption of blood flow can cause a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

Triglycerides are another type of fat in your blood that can increase the risk of heart disease.

Ezetimibe/simvastatinis used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-reducing diet.

Ezetimibe/simvastatinis used, along with a cholesterol-reducing diet,if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial]) or elevated levels of fatty substances (mixed hyperlipidemia):
• that are not well controlled with a single statin
• for whom a statin and ezetimibe have been used in separate tablets
• a genetic disorder (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.
• cardiovascular disease,ezetimibe/simvastatin reduces the risk of heart attack, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

This medicationdoes not help you lose weight.

Do not take Ezetimiba/Simvastatina Krka

• if you are allergic to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in section 6),
• if you have liver problems currently,
• if you are pregnant or breastfeeding,
• if you are taking medicines with one or more of the following active ingredients:
• • 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 infection).
  • nefazodone (used to treat depression).
  • cobicistat.
  • gemfibrozil (used to reduce cholesterol).
  • ciclosporin (often used in patients who have had an organ transplant).
  • danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).
  • you are taking or have taken within the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and ezetimibe/simvastatin can cause severe muscle problems (rhabdomyolysis).

Do not take more than 10 mg/40 mg of Ezetimiba/Simvastatina Krka if you are taking lomitapida (used to treat rare and severe cholesterol disorders).

Consult your doctor if you are unsure if your medicine is mentioned above.

Warnings and precautions

Inform your doctor or pharmacist before taking Ezetimiba/Simvastatina Krka:

• of all your medical problems, including allergies.
• if you consume large amounts of alcohol or have had any liver disease. Ezetimiba/Simvastatina Krka may not be suitable for you.
• if you are scheduled for surgery. You may need to stop taking Ezetimiba/Simvastatina Krka for a short period of time.
• if you are of Asian origin, as you may need a different dose.
• if you have or have had myasthenia (a condition that causes generalized muscle weakness, which in some cases affects the muscles used for breathing), or myasthenic eye (a condition that causes weakness of the eye muscles), as it may worsen the condition or cause myasthenia (see section 4).

Your doctor should do a blood test before you start taking Ezetimiba/Simvastatina Krka and also if you have any symptoms of liver problems while taking Ezetimiba/Simvastatina Krka. The purpose is to check the liver function.

Your doctor may also want to do blood tests to check the liver function after starting treatment with Ezetimiba/Simvastatina Krka.

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

Talk to your doctor if you have a severe lung disease.

Avoid the combined use of Ezetimiba/Simvastatina Krka and fibrates (certain cholesterol-lowering medicines), as the combined use of Ezetimiba/Simvastatina Krka and fibrates has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems can be severe, such as muscle degradation that causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle degradation is higher with high doses of Ezetimiba/Simvastatina Krka, especially the 10 mg/80 mg dose. The risk of muscle degradation is also higher in certain patients.Inform your doctor in the following situations:

• you have kidney problems.
• you have thyroid problems.
• you are 65 years or older.
• you are a woman.
• 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 your close relatives have a hereditary muscle disorder.

Also inform your doctor or pharmacist if you have persistent muscle weakness. You may need further tests and additional medicines for your diagnosis and treatment.

Pediatric population

Ezetimiba/Simvastatina Krka is not recommended for children under 10 years.

Taking Ezetimiba/Simvastatina Krka with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicinewith any of the following active ingredients. Taking Ezetimiba/Simvastatina Krka with any of the following medicines may increase the risk of muscle problems (some of which have been mentioned in the previous section “Do not take Ezetimiba/Simvastatina Krka”).

• if you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop taking this medicine. Your doctor will tell you when you can restart the treatment with this medicine. The use of this medicine with fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• ciclosporin (often used in patients who have had an organ transplant),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus),
• medicines with an active ingredient such as itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with active ingredients such as gemfibrozil and bezafibrate (used to reduce cholesterol),
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections),
• antivirals for hepatitis C such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C infection)
• nefazodone (used to treat depression),
• medicines that contain cobicistat,
• amiodarone (used to treat heart arrhythmias),
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases),
• lomitapida (used to treat rare and severe cholesterol disorders),
• daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). The muscle problems caused by this medicine may be more severe when taken during simvastatin treatment (for example, this medicine). Your doctor may decide that you need to stop taking this medicine for a time,
• high doses (1 gram or more per day) of niacin or nicotinic acid (also used to reduce cholesterol),
• colchicine (used to treat gout).

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

• medicines with an active ingredient to prevent blood clot formation, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants),
• cholestyramine (also used to reduce cholesterol), because it affects how Ezetimiba/Simvastatina Krka works,
• fenofibrate (also used to reduce cholesterol),
• rifampicin (used to treat tuberculosis),
• ticagrelor (antiplatelet medicine).

You should also inform any doctor who prescribes a new medicine that you are taking Ezetimiba/Simvastatina Krka.

Taking Ezetimiba/Simvastatina Krka with food and drinks

Orange juice contains one or more components that alter the metabolism of some medicines, including Ezetimiba/Simvastatina Krka. You should avoid consuming orange juice, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

Do not take Ezetimiba/Simvastatina Krka if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetimiba/Simvastatina Krka, stop taking it immediately and inform your doctor.Do not take Ezetimiba/Simvastatina Krka if you are breastfeeding, as it is unknown whether this medicine passes into breast milk.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machines

Ezetimiba/Simvastatina Krka is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking Ezetimiba/Simvastatina Krka.

Ezetimiba/Simvastatina Krka contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult with your doctor or pharmacist.

Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and personal risk level.

• Before starting to takeEzetimiba/Simvastatina Krka, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while takingEzetimiba/Simvastatina Krka

Adults:The recommended dose is one tablet of Ezetimiba/Simvastatina Krka once a day by oral route.

Use in adolescents (10 to 17 years of age): the dose is 1 tablet of ezetimiba/simvastatina once a day by oral route (do not exceed a maximum dose of 10 mg/40 mg once a day).

The 10 mg/80 mg dose is only recommended for adults with very high cholesterol levels and a high risk of cardiac problems who have not achieved their cholesterol goal with lower doses.

Not all recommended doses are possible with these products; however, other products with a different dosage (10 mg/80 mg) are also available.

Take Ezetimiba/Simvastatina Krka at night. You can take it with or without food.

If your doctor has prescribed ezetimiba/simvastatina along with another cholesterol-lowering medication that contains the active ingredient colestiramine or any other bile acid sequestrant, you must take ezetimiba/simvastatina at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba/Simvastatina Krkathan you should

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, consult with your doctor or pharmacist.

If you forgot to take Ezetimiba/Simvastatina Krka

Do not take a double dose to make up for the missed dose, take your usual amount of Ezetimiba/Simvastatina Krka at the usual time.

If you interrupt treatment with Ezetimiba/Simvastatina Krka

Speak with your doctor or pharmacist because your cholesterol may increase again.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking the medicine and see your doctor immediately:

• muscle pain (frequent: may affect up to 1 in 10 people),
• signs indicating blood disorders, e.g. fatigue, unexplained bleeding or bruising, mouth ulcers (frequency not known: cannot be estimated from available data),
• pancreatitis, which can cause severe abdominal and back pain accompanied by a feeling of discomfort (frequency not known: cannot be estimated from available data),
• signs indicating liver problems, gallstones or inflammation of the gallbladder, e.g. yellowing of the skin, stomach pain, itching, dark urine or pale stools (frequency not known: cannot be estimated from available data),
• angioedema (stop taking Ezetimiba/Simvastatina Krka and contact your doctor immediately if you experience any of the following symptoms: swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties) (rare: may affect up to 1 in 1000 people).

Contact your doctor immediately if you experience unexplained muscle pain, weakness or stiffness. The reason is that, in rare cases, muscle problems can be serious, for example, muscle degeneration that causes kidney damage; and very rarely, deaths have occurred.

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

• laboratory blood test abnormalities in liver function (transaminases) and/or muscle function (CK).

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

• liver function test abnormalities; elevated blood uric acid levels; prolonged blood clotting time; proteinuria; weight loss.
• dizziness; headache; tingling sensation.
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; heartburn.
• skin rash; itching; urticaria.
• joint pain; muscle pain, weakness, stiffness or spasms; neck pain; arm and leg pain; back pain.
• unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet.
• sleep disturbances; difficulty sleeping.

In addition, the following side effects have been reported in people takingEzetimiba/Simvastatina Krkaor medicines containing the active ingredients ezetimiba or simvastatina:

• 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.
• hair loss;highly elevated, sometimes with lesions in the form of a target (erythema multiforme).
• blurred vision and vision problems (which may affect up to 1 in 1000 people).
• skin rash that may appear on the skin or mouth sores (drug eruptions) (which may affect up to 1 in 10,000 people).
• hypersensitivity reactions, which include some of the following:a severe allergic reaction accompanied by swelling of the face, lips, tongue and/or throat that may cause difficulty breathing or swallowingand requires immediate treatment (angioedema), joint pain or inflammation, inflammation of blood vessels, unusual bruising, skin rash and swelling, urticaria, sun sensitivity, fever, hot flushes, difficulty breathing and feeling unwell, a condition similar to lupus (including skin rash, joint problems and effects on white blood cells). A seriousside effect that is very rare (may affect up to 1 in 10,000 people) may occur and causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis).
• muscle pain, weakness, stiffness or cramps; muscle failure;muscle rupture (which may affect up to 1 in 10,000 people),problems with tendons, sometimes complicated by tendon rupture.
• gynecomastia (breast enlargement in men) (which may affect up to 1 in 10,000 people).
• decreased appetite.
• hot flushes; high blood pressure.
• pain.
• erectile dysfunction.
• depression.
• abnormalities in some laboratory blood tests for liver function.
• myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• myasthenia ocular (a disease that causes weakness of the eye muscles).

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

Other possible side effects reported with some statins:

• sleep disturbances; including nightmares.
• sexual problems.
• diabetes. This is more likely if you have high blood sugar and fat levels, are overweight and have high blood pressure.Your doctor will monitor you while you are taking this medicine.
• constant muscle pain, weakness or stiffness that may not go away after stopping Ezetimiba/Simvastatina Krka (frequency unknown).

Reporting of side effects

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

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

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

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from light and moisture.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Ezetimiba/Simvastatina Krka

• The active ingredients are ezetimiba and simvastatina.

Each tablet contains 10 mg of ezetimiba and 20 mg of simvastatina.

Each tablet contains 10 mg of ezetimiba and 40 mg of simvastatina.

• The other components are lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 2910, and iron oxide red (E172) – only for the 10 mg/20 mg tablets. See section 2 "Ezetimiba/Simvastatina Krka contains lactose and sodium".

Appearance of the product and contents of the package

10 mg/20 mg white-pinkish oval biconvex tablets. Length of the tablet 11 mm, width 5.5 mm.

10 mg/40 mg white to almost white biconvex tablets. Dimensions of the tablet 14 x 6 mm.

Ezetimiba/Simvastatina Krka is available in packages containing:

-14,28, 30, 50, 56, 60, 90, 98 or 100 tablets in blisters,

• 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1 or 100 x 1 tablets in perforated unit dose blisters.

Only some package sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last revision date of this leaflet: November 2023

Further detailed and updated information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es