Ezetimibe/simvastatin Teva-Ratio 10 mg/20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ezetimiba/Simvastatina Teva-ratio 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 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. This interruption in blood flow 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:

• elevated blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or elevated 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 cholesterol levels in the blood. 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 will not help you lose weight.

2. What you need to know before taking Ezetimiba/Simvastatina Teva-ratio

Do not take Ezetimiba/Simvastatina Teva-ratio 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 lower 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 infection) orally or by injection. 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

Talk to your doctor or pharmacist before starting to take Ezetimiba/Simvastatina Teva-ratio

• about all your medical conditions, including allergies.
• if you consume large amounts of alcohol or have ever had liver disease. Ezetimiba/Simvastatina may not be suitable for you.
• if you are scheduled for surgery. You may need to stop taking ezetimibe/simvastatin tablets for a short period.
• if you are of Asian descent, 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 check how well your liver is functioning.

Your doctor may also want to perform blood tests to monitor 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 is higher 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 medicines to lower cholesterol) 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, 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 while being treated with cholesterol-lowering medicines called “statins” (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate)
• if you or your close family members have an inherited muscle disorder
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which 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).

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.

Taking Ezetimiba/Simvastatina Teva-ratio with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines containing 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 section above “Do not take Ezetimiba/Simvastatina Teva-ratio if”).

• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can restart ezetimibe/simvastatin treatment. Using ezetimibe/simvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on 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 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)

• 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)

• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteremia). Adverse effects affecting muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., ezetimibe/simvastatin). Your doctor may decide that you should temporarily stop taking ezetimibe/simvastatin

• high doses (1 gram or more per day) of niacin or nicotinic acid (also used to lower cholesterol)

• colchicine (used to treat gout).

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even 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 clots, such as warfarin, phenindione, phenprocoumon, or acenocoumarol (anticoagulants)
• colestyramine (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 inform any doctor who prescribes you a new medicine that you are taking ezetimibe/simvastatin.

Taking Ezetimiba/Simvastatina Teva-ratio with food and drinks

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 ezetimibe/simvastatin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking ezetimibe/simvastatin, stop taking it immediately and inform your doctor. Do not take ezetimibe/simvastatin while breastfeeding, 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 not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking ezetimibe/simvastatin.

Ezetimiba/Simvastatina Teva-ratio contains lactose

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

Ezetimiba/Simvastatina Teva-ratio contains sodium

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

3. How to take Ezetimibe/Simvastatin Teva-ratio

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 instructions for use of this medicine provided by your doctor or pharmacist. In case of doubt, please consult your doctor or pharmacist again.

• Before starting ezetimibe/simvastatin, you should already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimibe/simvastatin.

Adults: The dose is 1 tablet of ezetimibe/simvastatin once daily, taken orally.

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

The ezetimibe/simvastatin 10 mg/80 mg dose is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease-related complications who have not achieved treatment goals with lower doses.

Take ezetimibe/simvastatin in the evening. It may be taken with or without food.

If your doctor has prescribed ezetimibe/simvastatin together with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you must 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, or consult your doctor or pharmacist.

If you forget to take Ezetimibe/Simvastatin Teva-ratio

Do not take a double dose to make up for a missed dose. Take your usual amount of Ezetimibe/Simvastatin Teva-ratio at the usual time.

If you stop taking Ezetimibe/Simvastatin Teva-ratio

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 everybody gets them (see section 2 “What you need to know before you start taking Ezetimibe/Simvastatin Teva-ratio”).

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

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

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

• increased liver function in blood tests; increased blood uric acid levels; prolonged blood clotting time; protein in urine; weight loss
• dizziness; headache; tingling sensation
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhoea; dry mouth; heartburn
• rash; itching; urticaria
• joint pain; pain, tenderness, weakness, or muscle 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 disorder; difficulty sleeping

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 skin lesions (erythema multiforme)
• blurred vision and vision impairment (may affect up to 1 in 1,000 people)
• rash which 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 which may include the following: allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing and require immediate treatment (angioedema), joint pain or inflammation, inflammation of blood vessels, atypical bruising, skin rashes and swelling, urticaria, skin sensitivity to sunlight, fever, hot flushes, breathing difficulties and general malaise, 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) may occur, causing difficulty in breathing or dizziness, and requiring immediate treatment (anaphylaxis)
• muscle pain, tenderness, weakness or cramps; muscle breakdown; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture
• gynaecomastia (enlargement of the breast 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 liver function blood tests

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 fats in your blood, are overweight, or 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).

Contact 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 breakdown leading to kidney damage; and very rarely, deaths have occurred.

• myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• 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.

Reporting of adverse effects:

If you experience any adverse effect, consult 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 Teva-ratio

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

Do not use this medicine after the expiry date stated on the carton, bottle, or blisters after [EXP]. The expiry date refers to 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe/Simvastatin Teva-ratio 10 mg/20 mg

• The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 20 mg of simvastatin.
• The other components are: Tablet core: lactose monohydrate, hypromellose, sodium croscarmellose, microcrystalline cellulose, ascorbic acid, citric acid, butylated hydroxyanisole, propyl gallate and magnesium stearate. Coating pigment mixture: lactose monohydrate, yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

Appearance of the product and contents of the pack

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

Pack sizes:

Blister pack:

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

HDPE bottle:

28, 30, 90 and 100 tablets.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11. Edificio Albatros B, 1st floor.

Alcobendas, 28108, Madrid (Spain)

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 most recent revision of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. 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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