Ezetimibe/simvastatin Cinfamed 10 mg/40 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

ezetimibe/simvastatin cinfamed 10 mg/40 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 other people, 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 cinfamed is and what it is used for
2. What you need to know before taking ezetimibe/simvastatin cinfamed
3. How to take ezetimibe/simvastatin cinfamed
4. Possible side effects
5. How to store ezetimibe/simvastatin cinfamed
6. Contents of the pack and other information

1. What ezetimibe/simvastatin cinfamed is and what it is used for

This medicine contains the active substances ezetimibe and simvastatin. It is used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. 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 in the gastrointestinal 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 cause 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 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 them from 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 disease (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 lose weight.

2. What you need to know before taking ezetimibe/simvastatin cinfamed

Do not take ezetimibe/simvastatin cinfamed

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

• If you currently have liver problems.

• If you are pregnant or breastfeeding.

• If 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) taken 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 ezetimibe/simvastatin cinfamed.

Inform your doctor:

• about all your medical conditions, including allergies,
• 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 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 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).

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 you for diabetes or 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 severe 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 or a close family member has 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 ezetimibe/simvastatin cinfamed

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking ezetimibe/simvastatin with any of the following medicines may increase the risk of muscle problems (some of these are already listed in the section above “Do not take ezetimibe/simvastatin cinfamed”).

• 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 advise you when you can restart ezetimibe/simvastatin treatment. The use of ezetimibe/simvastatin with fusidic acid rarely may 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 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),

• ribociclib (used to treat breast cancer),

• palbociclib (used to treat breast cancer).

As well as the medicines listed above, especially inform your doctor if you are taking any of the following:

• medicines containing active substances to prevent blood clots, such as warfarin, fluindione, 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 ezetimibe/simvastatin cinfamed 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine if you are pregnant, trying to become pregnant, or think you could 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, bear in mind that some people may experience dizziness after taking ezetimibe/simvastatin.

ezetimibe/simvastatin cinfamed contains lactose

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

ezetimibe/simvastatin cinfamed contains sodium

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

3. How to take ezetimibe/simvastatin cinfamed

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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.

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

Adults: The dose is 1 tablet of ezetimibe/simvastatin once daily by oral administration.

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

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 problems who have not achieved treatment goals with lower doses.

Take this medicine 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 cinfamed than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take ezetimibe/simvastatin cinfamed

• Do not take a double dose to make up for the missed dose. Take your usual dose of ezetimibe/simvastatin at the regular time.

If you stop taking ezetimibe/simvastatin cinfamed

• 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

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; diarrhea; 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 disorder; difficulty sleeping.

The following adverse effects have been reported 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).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additionally, the following adverse effects have been reported in patients taking ezetimibe/simvastatin or medicines containing the active substances ezetimibe or simvastatin:

• low red blood cell count (anemia), reduced blood cell count, which may cause bruising/bleeding (thrombocytopenia),
• numbness or weakness of 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 urine or pale 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 worsening of vision (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 reactions which may include: 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, blood vessel inflammation, 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) causing difficulty breathing or dizziness, 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,
• gynecomastia (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 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 blood sugar and fats, 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 ezetimibe/simvastatin treatment (frequency unknown: cannot be estimated from available data).

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.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ezetimibe/simvastatin cinfamed

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

Do not use this medicine after the expiry date stated on the packaging or blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of ezetimibe/simvastatin cinfamed

The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatin.

The other components are: monohydrate lactose, hypromellose, sodium croscarmellose, microcrystalline cellulose, ascorbic acid, citric acid, butylhydroxyanisole, propyl gallate and magnesium stearate. Pigment mixture: monohydrate lactose, yellow iron oxide (E-172), red iron oxide (E-172) and black iron oxide (E-172).

Nature of the product and pack sizes

Round, biconvex tablets, white to bone-coloured, mottled, 10 mm in diameter, marked with "513" on one side.

OPA/Aluminum/PVC blisters sealed with an aluminum foil.

Pack sizes:

10, 14, 28, 30, 50, 56, 90, 98 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Balkanpharma-Dupnitsa AD,

3 Samokovsko Shosse Street,

Dupnitsa, 2600,

Bulgaria

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

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 Medical Devices (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 in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82800/P_82800.html

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