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-lowering diet.

Ezetimibe/simvastatinis used, along with a cholesterol-lowering 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 hereditary disease (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 ezetimiba, simvastatina 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).
  • protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir and saquinavir (protease inhibitors for HIV 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 ezetimiba/simvastatina may 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 ever had liver disease. Ezetimiba/Simvastatina Krka may not be suitable for you.
• if you are due to have an operation. You may need to stop taking the Ezetimiba/Simvastatina Krka tablets for a short 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 generalised muscle weakness, which in some cases affects the muscles used for breathing), or myasthenic eye symptoms (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 how well your liver is working.

Your doctor may also wish to do blood tests to check how well your liver is working after starting treatment with Ezetimiba/Simvastatina Krka.

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 sugar and fats in your blood, being overweight and having high blood pressure.

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

Combining Ezetimiba/Simvastatina Krka with fibrates (certain cholesterol-lowering medicines) should be avoided, as the combination 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, for example, muscle breakdown that causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with high doses of Ezetimiba/Simvastatina Krka, especially the 10 mg/80 mg dose. The risk of muscle breakdown 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 simvastatina, atorvastatina and rosuvastatina) or fibrates (such as gemfibrozilo or bezafibrato).
• you or your close relatives have a hereditary muscle disorder.

Also inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and additional medicines may be needed 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 section above “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. Taking 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 bezafibrato (used to reduce cholesterol),
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir and saquinavir (protease inhibitors for HIV are 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 with simvastatina (for example, this medicine). Your doctor may decide that you should 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 clotting, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants),
• colestiramine (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 lactation

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 not known 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 him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this 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 administration.

Use in adolescents (10 to 17 years of age): the dose is 1 tablet of ezetimiba/simvastatina once a day by oral administration (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 that may 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, tenderness or weakness. 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; prolonged blood clotting time; proteinuria; weight loss.
• dizziness; headache; tingling sensation.
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal distension; diarrhea; dry mouth; heartburn.
• skin rash; itching; urticaria.
• joint pain; muscle pain, tenderness, weakness or spasms; neck pain; arm and leg pain; back pain.
• unusual fatigue or weakness; feeling of fatigue; chest pain; swelling, especially of the hands and feet.
• sleep disturbances; difficulty sleeping.

In addition, the following side effects have been reported in people taking Ezetimiba/Simvastatina Krka or 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 that 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 seriousvery rare side effect (which may affect up to 1 in 10,000 people) may occur and causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis).
• muscle pain, tenderness, weakness 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 that, 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 cholesterol levels, are overweight and have high blood pressure.Your doctor will monitor you while you are taking this medicine.
• constant muscle pain, tenderness or weakness that may not disappear 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 storage temperature.

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

Medicines should not be thrown down the drains or in the 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. Tablet length 11 mm, width 5.5 mm.

10 mg/40 mg white to almost white biconvex capsules. Tablet dimensions 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

Manufacturer:

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

or

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

For further information about this medicinal product, please contact 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

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Products (AEMPS)http://www.aemps.gob.es