Ezetimibe/simvastatin Kern Pharma 10 mg/20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ezetimibe/Simvastatin Kern Pharma 10 mg/20 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ezetimibe/Simvastatin Kern Pharma is and what it is used for
2. What you need to know before taking Ezetimibe/Simvastatin Kern Pharma
3. How to take Ezetimibe/Simvastatin Kern Pharma
4. Possible side effects
5. How to store Ezetimibe/Simvastatin Kern Pharma
6. Contents of the pack and other information

1. What Ezetimibe/Simvastatin Kern Pharma is and what it is used for

This medicine contains the active substances ezetimibe and simvastatin. It is used to reduce blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. It also increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/simvastatin works to reduce cholesterol in two ways. The active substance ezetimibe reduces the cholesterol absorbed from the digestive tract. The active substance simvastatin, which belongs to the group of drugs known as "statins", inhibits the production of cholesterol made by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL cholesterol and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage can cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

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

Ezetimibe/simvastatin is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

Ezetimibe/simvastatin is used, together with a cholesterol-lowering diet, if you have:

• high blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia):

• that are not well controlled with a statin alone

• for whom a statin and ezetimibe have previously been used as separate tablets

• a hereditary condition (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You may also receive other treatments.

• heart disease: ezetimibe/simvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

This medicine does not help you to lose weight.

2. What you need to know before starting Ezetimiba/Simvastatina Kern Pharma

Do not take Ezetimiba/Simvastatina Kern Pharma if:

• you are allergic to ezetimibe, simvastatin, or any of the other components of this medicine (listed in section 6)

• you currently have liver problems

• you are pregnant or breastfeeding

• you are taking medicines containing 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 reduce cholesterol)
  • cyclosporine (used in organ transplant patients)
  • danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus)

• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by oral or injectable route. The combination of fusidic acid and ezetimibe/simvastatin may cause serious muscle problems (rhabdomyolysis).

Do not take more than 10/40 mg of ezetimibe/simvastatin if you are taking lomitapide (used to treat rare, severe genetic cholesterol disorders).

Consult your doctor if you are unsure whether your medicine is listed above.

Warnings and precautions

Inform your doctor:

• about all your medical conditions, including allergies.
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• if you consume large amounts of alcohol or have ever had liver disease. Ezetimibe/simvastatin may not be suitable for you.
• if you are scheduled for surgery. You may need to temporarily stop taking ezetimibe/simvastatin tablets.
• if you are of Asian origin, as you may require a different dose.

Your doctor will perform a blood test before you start taking ezetimibe/simvastatin and also if you develop any symptoms of liver problems while taking it. This is to monitor your liver function.

Your doctor may also want to perform blood tests to monitor your liver function after you start treatment with ezetimibe/simvastatin.

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

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

The combined use of ezetimibe/simvastatin and 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, although rarely, muscle problems can be serious, including muscle breakdown leading to 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. Inform your doctor in the following situations:

• if you have kidney problems
• if you have thyroid problems
• if you are over 65 years old
• if you are female
• if 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)
• if you or your close relatives have an inherited muscle disorder

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

• Ezetimibe/simvastatin is not recommended for children under 10 years of age.

Other medicines and Ezetimiba/Simvastatina Kern Pharma

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine containing any of the following active substances. Taking ezetimibe/simvastatin with any of the following medicines may increase the risk of muscle problems (some of these are already included in the previous section “Do not take Ezetimiba/Simvastatina Kern Pharma if”).

• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when you can restart treatment with ezetimibe/simvastatin. The use of ezetimibe/simvastatin with fusidic acid rarely may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4
• cyclosporine (often used in transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus)
• medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
• fibrates containing active substances 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 AIDS)
• hepatitis C antivirals such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection)
• nefazodone (used to treat depression)
• medicines containing the active substance cobicistat
• amiodarone (used to treat irregular heart rhythm)
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)
• lomitapide (used to treat rare, severe genetic cholesterol disorders)
• high doses (1 gram or more per day) of niacin or nicotinic acid (also used to reduce cholesterol)
• colchicine (used to treat gout)
• ribociclib (used to treat breast cancer)
• palbociclib (used to treat breast cancer)

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

• medicines containing active substances to prevent blood clotting, such as warfarin, phenindione, phenprocoumon, or acenocoumarol (anticoagulants)
• colestyramine (also used to reduce cholesterol), as it affects how ezetimibe/simvastatin works
• fenofibrate (also used to reduce cholesterol)
• rifampicin (used to treat tuberculosis)

You should also inform any doctor prescribing you a new medicine that you are taking ezetimibe/simvastatin.

Taking Ezetimiba/Simvastatina Kern Pharma with food and drink

Grapefruit juice contains one or more components that alter the metabolism of certain medicines, including ezetimibe/simvastatin. Consumption of grapefruit juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Ezetimibe/simvastatin is not expected to affect your ability to drive or use machines. However, bear in mind that some people may experience dizziness after taking ezetimibe/simvastatin.

This medicine contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ezetimiba/Simvastatina Kern Pharma

Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your individual risk situation.

The tablets do not have a score line and must not be divided.

Always follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Before starting ezetimiba/simvastatina, you should already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimiba/simvastatina.

Adults: the dose is 1 tablet of ezetimiba/simvastatina once daily, taken orally.

Use in adolescents (10 to 17 years of age): the dose is 1 tablet of ezetimiba/simvastatina once daily, taken orally (the maximum dose should not exceed 10 mg/40 mg once daily).

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

Take ezetimiba/simvastatina at night. It may be taken with or without food.

If your doctor has prescribed ezetimiba/simvastatina together with another cholesterol-lowering medicine containing the active ingredient colestyramine 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 Kern Pharma than you should

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

If you forget to take Ezetimiba/Simvastatina Kern Pharma

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

If you stop taking Ezetimiba/Simvastatina Kern Pharma

• Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any further questions about 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 everyone will experience them (see section 2. What you need to know before you start taking Ezetimibe/Simvastatin Kern Pharma).

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

• muscle pain
• increases in blood laboratory tests of liver function (transaminases) and/or muscle function (CK)

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

• increased liver function in blood tests; elevations in blood uric acid levels; prolonged blood clotting time; protein in urine; weight loss
• dizziness; headache; tingling sensation
• abdominal pain; indigestion; flatulence; nausea; vomiting; bloating; diarrhoea; dry mouth; heartburn
• rash; itching; urticaria
• joint pain; muscle pain, tenderness, weakness, or spasms; neck pain; pain in arms and legs; back pain
• unusual tiredness or weakness; feeling tired; chest pain; swelling, especially of the hands and feet
• sleep disorders; difficulty sleeping

Adverse reactions with unknown frequency (cannot be estimated from available data):

• myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing) (frequency not known)
• ocular myasthenia (a disease causing weakness of the eye muscles)

Consult your doctor if you experience worsening weakness in the arms or legs 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 ezetimibe/simvastatin or medicines containing the active substances ezetimibe or simvastatin:

• low red blood cell count (anaemia), reduced blood cell count, which may cause bruising/bleeding (thrombocytopenia)
• numbness or weakness in arms and legs; memory impairment, memory loss, confusion
• respiratory problems including persistent cough and/or difficulty breathing or fever
• constipation
• inflammation of the pancreas, often with severe abdominal pain
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stools, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• hair loss; red, raised rash, sometimes with target-like lesions (erythema multiforme)
• blurred vision and deterioration of vision (may affect up to 1 in 1,000 people)
• rash that may appear on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people)
• hypersensitivity reaction which may include: hypersensitivity (allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing and requires immediate treatment (angioedema), joint pain or inflammation, inflammation of blood vessels, atypical bruising, skin rashes and swelling, urticaria, photosensitivity, fever, hot flushes, breathing difficulties and general malaise, pseudolupus syndrome (including skin rash, joint disorders and effects on white blood cells))
• muscle pain, tenderness, weakness or cramps; muscle failure; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture
• gynaecomastia (enlargement of breast tissue in men) (may affect up to 1 in 10,000 people)
• decreased appetite
• hot flushes; high blood pressure
• pain
• erectile dysfunction
• depression
• changes in certain blood tests of liver function

The following very rare serious adverse effects have been reported: a severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction).

With some statins, the following additional adverse events have been reported:

• sleep disorders, including nightmares
• sexual dysfunction
• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine
• persistent muscle pain, tenderness or weakness, which may not resolve after stopping treatment with ezetimibe/simvastatin (frequency not known)

If any of these serious adverse effects occur, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines:

https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe/Simvastatin Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba/Simvastatina Kern Pharma

The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 20 mg of simvastatin.

The other components are: monohydrate lactose, hypromellose, sodium croscarmellose, microcrystalline cellulose, ascorbic acid, anhydrous citric acid, butylated hydroxyanisole, propyl gallate, magnesium stearate, yellow iron oxide, red iron oxide, black iron oxide.

Appearance of the medicine and pack contents

Ezetimiba/Simvastatina Kern Pharma 10/20 mg tablets are round, biconvex, white to bone-coloured tablets, mottled and marked with "512" on one side.

Pack sizes:

28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Balkanpharma-Dupnitsa AD,

3 Samokovsko Shosse Street,

Dupnitsa, 2600,

Bulgaria

or

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of the most recent revision of this leaflet: March 2026

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es