EZETIMIBE/SIMVASTATIN TEVA-RATIO 10 mg/20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ezetimibe/Simvastatin Teva-ratio 10 mg/20 mg tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet

1. What is Ezetimibe/Simvastatin Teva-ratio and what is it used for
2. What you need to know before you take Ezetimibe/Simvastatin Teva-ratio
3. How to take Ezetimibe/Simvastatin Teva-ratio
4. Possible side effects
5. Storage of Ezetimibe/Simvastatin Teva-ratio
6. Package contents and further information

1. What is Ezetimibe/Simvastatin Teva-ratio and what is it used for

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

Ezetimibe/simvastatin works by reducing cholesterol in two ways. The active substance ezetimibe reduces the amount of cholesterol absorbed from the gut. The active substance simvastatin, which belongs to a group of medicines known as "statins", inhibits the production of cholesterol made by the body.

Cholesterol is one of the fatty substances that can be found in the blood. Your total cholesterol is made up mainly of LDL 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 can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This blocking of the blood flow can lead to 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 found in the blood that can increase the risk of heart disease.

Ezetimibe/simvastatin is used in patients who cannot control their cholesterol levels by diet alone. While you are taking this medicine, you should also follow a low-cholesterol diet.

Ezetimibe/simvastatin is used, along with a low-cholesterol diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous and non-familial]) or high levels of other fats (mixed hyperlipidaemia):
• that are not well controlled with a statin alone
• for which you have taken a statin and ezetimibe as separate tablets

• a rare inherited cholesterol disorder (homozygous familial hypercholesterolaemia) that can lead to high levels of cholesterol in the blood. You may also receive other treatments.

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

This medicine does not help to lose weight.

2. What you need to know before you take Ezetimibe/Simvastatin Teva-ratio

Do not take Ezetimibe/Simvastatin Teva-ratio if

• you are allergic to ezetimibe, simvastatin or any of the other ingredients of this medicine (listed in section 6)
• 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 organ transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)

• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and ezetimibe/simvastatin can cause muscle problems (rhabdomyolysis)

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

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

Warnings and precautions

Consult your doctor or pharmacist before you start taking Ezetimibe/Simvastatin Teva-ratio

• 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 due to have an operation. You may need to stop taking the ezetimibe/simvastatin tablets for a short time.
• if you are Asian, as you may need a different dose.

Your doctor will do a blood test before you start taking ezetimibe/simvastatin and 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. The risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight and have high blood pressure.

Tell 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 and fibrates has not been studied.

Tell your doctor immediately if you experience muscle pain, tenderness or weakness. 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 greater with higher doses of ezetimibe/simvastatin, especially the 10/80 mg dose. The risk of muscle breakdown is also greater 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 while taking medicines to lower cholesterol, known as "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
• you have or have had myasthenia (a disease that causes muscle weakness, which can affect the muscles used for breathing) or myasthenic syndrome (a disease that causes muscle weakness, affecting the eye muscles), as statins can sometimes make these conditions worse or trigger the onset of myasthenia (see section 4).

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

Children and adolescents

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

Taking Ezetimibe/Simvastatin Teva-ratio 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 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 Teva-ratio 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 you can restart the treatment with ezetimibe/simvastatin. The use of ezetimibe/simvastatin with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4

• cyclosporin (used in organ transplant patients)
• 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 such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections)
• 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)
• lomitapide (used to treat rare and severe genetic cholesterol disorders)
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteraemia). The side effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (such as ezetimibe/simvastatin). Your doctor may decide that you should stop taking 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, fludione, 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 Teva-ratio with food and drink

Grapefruit juice contains one or more components 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 taking any medicine.

Driving and using machines

Ezetimibe/simvastatin is not expected to interfere with 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 Teva-ratio 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 Teva-ratio 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/Simvastatin Teva-ratio

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 are not scored and should not be divided.

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. 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 cholestyramine 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 Teva-ratio 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 Teva-ratio

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

If you stop taking Ezetimibe/Simvastatin Teva-ratio

Talk to your doctor or pharmacist because your cholesterol levels may increase 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 taking Ezetimiba/Simvastatina Teva-ratio").

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

• Muscle pain
• Elevations in blood test results of 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; pain, hypersensitivity, 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

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), reduction in 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-like lesions (erythema multiforme)
• Blurred vision and vision impairment (may affect up to 1 in 1,000 people)
• Rash that may 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 may 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, hives, 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 severe allergic reaction (may affect up to 1 in 10,000 people) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis)
• Muscle pain, tenderness, 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
• Alterations in some blood tests of 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 the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication
• Persistent muscle pain, tenderness, or weakness that may not disappear after stopping treatment with ezetimiba/simvastatina (frequency not known).

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

• Severe myasthenia (a disease that causes generalized muscle weakness, which 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 the arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of Adverse Effects:

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. 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 Teva-ratio

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiration date stated on the carton, bottle, or blisters after [CAD]. The expiration 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. Deposit the containers and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimiba/Simvastatina Teva-ratio10 mg/ 20 mg

• The active ingredients are ezetimiba and simvastatina. Each tablet contains 10 mg of ezetimiba and 20 mg of simvastatina.
• The other ingredients are: Core of the tablet:lactose monohydrate, hypromellose, sodium croscarmellose, microcrystalline cellulose, ascorbic acid, citric acid, butylated hydroxyanisole, propyl gallate, and magnesium stearate. Pigment mixture:lactose monohydrate, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance of the Product and Package Contents

Ezetimiba/Simvastatina Teva-ratio 10 mg/ 20 mg EFG tablets are round, biconvex, light brown, speckled tablets, 8 mm in diameter, engraved with "512" on one side.

Package sizes:

Blister pack:

28, 30, 50, 90, 98, and 100 tablets

HDPE bottle:

28, 30, 90, and 100 tablets.

The HDPE bottles contain a desiccant capsule. This capsule should not be removed from the bottle.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 - Madrid

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str., Dupnitza 2600

Bulgaria

or

Actavis Ltd

BLB015-016, Bulebel Industrial Estate,

Zejtun, ZTN 3000,

Malta

Date of the Last Revision of this Leaflet: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/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82940/P_82940.html

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