Ezetimibe/simvastatin Stada 10 mg/40 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ezetimibe/Simvastatin Stada 10 mg/20 mg tablets EFG

Ezetimibe/Simvastatin Stada 10 mg/40 mg tablets EFG

Please read all of this 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; do not pass it on 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Ezetimibe/Simvastatin Stada

3. How to take Ezetimibe/Simvastatin Stada

4. Possible side effects

5. How to store Ezetimibe/Simvastatin Stada

6. Contents of the pack and other information

1. What Ezetimiba/Simvastatina Stada 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. In addition, it 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 mainly composed 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 cause 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 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 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 cholesterol levels (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 treatment with separate tablets of a statin and ezetimibe has been used

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

• heart disease, in which case 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 lose weight.

2. What you need to know before taking Ezetimiba/Simvastatina Stada

Do NOT take Ezetimiba/Simvastatina Stada 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 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 tissue lining the uterus grows outside the uterus)

• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). The combination of fusidic acid with ezetimibe/simvastatin may lead to serious muscle problems (rhabdomyolysis)

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

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

Warnings and precautions

Tell your doctor:

• about all your medical conditions, including allergies
• if you drink 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 stop taking ezetimibe/simvastatin tablets for a short period
• if you are of Asian descent, as you may require a different dose
• 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)

Your doctor will perform a blood test before you start taking ezetimibe/simvastatin. 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 you for diabetes or risk of developing diabetes. This risk increases if you have high levels of sugar and fats in your 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 used 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, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

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.

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 increased 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 relatives have a hereditary muscle disorder

Children and adolescents

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

Other medicines and Ezetimiba/Simvastatina Stada

Tell 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 section above “Do NOT take Ezetimiba/Simvastatina Stada 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 it is safe to restart ezetimibe/simvastatin. The combination of ezetimibe/simvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.
• cyclosporine (often used in transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the tissue lining 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)
• antivirals for hepatitis C 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, serious genetic cholesterol disorders)
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting muscles may be increased 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, 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 lower cholesterol), as it affects how ezetimibe/simvastatin works
• fenofibrate (also used to lower 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 Stada 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 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 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, it should be noted that some people may experience dizziness after taking ezetimibe/simvastatin.

This medicine contains lactose and sodium

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

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

3. How to take Ezetimiba/Simvastatina Stada

Your doctor will determine the appropriate tablet dose 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 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 by oral administration.

Use in adolescents (10 to 17 years of age): the dose is 1 tablet of ezetimiba/simvastatina once daily by oral administration (a maximum dose of 10 mg/40 mg once daily must not be exceeded).

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 achieved their treatment goal with lower doses.

If optimal dosing cannot be achieved using ezetimiba/simvastatina 10 mg/40 mg, your doctor may prescribe other tablets containing ezetimiba/simvastatina.

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 substance 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 Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at phone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Ezetimiba/Simvastatina Stada

Do not take a double dose to make up for forgotten doses. Take your usual dose of ezetimiba/simvastatina at the usual time on the following day.

If you stop taking Ezetimiba/Simvastatina Stada

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them (see section 2).

The following frequent side effects have been reported (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 uncommon side 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; muscle pain, tenderness, weakness, or spasms; neck pain; arm and leg pain; back pain
• unusual tiredness or weakness; feeling tired; chest pain; swelling, especially of the hands and feet
• sleep disorders; difficulty sleeping

Additionally, the following side 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 counts, 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
• liver inflammation 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 gallbladder inflammation (which may cause abdominal pain, nausea, vomiting)
• hair loss; red, raised rash, sometimes with target-like lesions (erythema multiforme)
• blurred vision and vision deterioration (may affect up to 1 in 1,000 people)
• skin rash or mouth ulcers (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)); a very rare severe allergic reaction causing difficulty breathing or dizziness (anaphylaxis); joint pain or swelling; inflammation of blood vessels; atypical bruising; skin rashes and swelling; urticaria; skin sensitivity to sunlight; fever; hot flushes; breathing difficulties; 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
• myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing) (frequency not known: cannot be estimated from available data)*
• ocular myasthenia (a disease causing weakness of the eye muscles) (frequency not known: cannot be estimated from available data)*

* Consult your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

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, 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).

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 side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are possible side effects 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 side effects, you help provide more information on the safety of this medicine.

5. Storage of Ezetimibe/Simvastatin Stada

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

Do not use this medicine after the expiry date stated on the packaging 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 containers and unused medicines at the SIGRE Point at your pharmacy. 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 Stada

The active substances are ezetimibe and simvastatin.

10 mg/20 mg: Each tablet contains 10 mg of ezetimibe and 20 mg of simvastatin.

10 mg/40 mg: Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatin.

The other components are: Tablet core: monohydrate lactose, hypromellose, sodium croscarmellose, microcrystalline cellulose, ascorbic acid, citric acid, butylated hydroxyanisole, propyl gallate, magnesium stearate. Pigment mixture: monohydrate lactose, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the pack

10 mg/20 mg: Ezetimibe/Simvastatin Stada 10 mg/20 mg tablets are light brown, mottled, round, 8 mm in diameter, biconvex, and marked with “512” on one side.

10 mg/40 mg: Ezetimibe/Simvastatin Stada 10 mg/40 mg tablets are light brown, mottled, round, 10 mm in diameter, biconvex, and marked with “513” on one side.

Pack sizes:

Blister packs: 28, 30, 50, 90, 98 and 100 tablets.

HDPE bottles: 90 and 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitza 2600

Bulgaria

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de?Reijtstraat?31-E?

4814 NE Breda?

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Sanico N.V.

Veedijk 59

2300 Turnhout

Belgium

or

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of the most recent review of this leaflet: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/