Inegy 10 mg/20 mg tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

INEGY 10mg/20mg tablets

INEGY 10mg/40mg tablets

Ezetimibe and Simvastatin

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 others, 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 INEGY is and what it is used for

2. What you need to know before taking INEGY

3. How to take INEGY

4. Possible side effects

5. How to store INEGY

6. Contents of the pack and other information

1. What INEGY is and what it is used for

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

INEGY 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 medicines known as "statins", inhibits the body's own production of cholesterol.

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 interruption in blood flow may 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.

INEGY 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.

INEGY 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 disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.

• heart disease; INEGY reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

INEGY does not help you lose weight.

2. What you need to know before starting to take INEGY

Do not take INEGY if

• you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other components of this medicine (listed in section 6. Package contents and additional information),

• 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).

• you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and INEGY may cause serious muscle problems (rhabdomyolysis).

Do not take more than 10/40 mg of INEGY if you are taking lomitapide (used to treat rare, serious 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 consume large amounts of alcohol or have ever had liver disease. INEGY may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking INEGY 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), since 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 INEGY and also if you develop any symptoms of liver problems while taking INEGY. 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 INEGY.

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 INEGY and fibrates (certain medicines to lower cholesterol) should be avoided, as the combination of INEGY and fibrates 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 INEGY, 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 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

• INEGY is not recommended for children under 10 years of age.

Taking INEGY with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines containing any of the following active substances. Taking INEGY 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 INEGY 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 advise you when you can restart treatment with INEGY. Using INEGY 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, serious genetic cholesterol disorders),
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). The adverse effects affecting muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., INEGY). Your doctor may decide that you should stop taking INEGY temporarily,
• 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 INEGY works,
• fenofibrate (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis),
• ticagrelor (an antiplatelet medicine).

You should also inform any doctor prescribing a new medicine that you are taking INEGY.

Taking INEGY with food and drink

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

Pregnancy and breastfeeding

Do not take INEGY if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking INEGY, stop taking it immediately and inform your doctor. Do not take INEGY 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

INEGY is not expected to affect your ability to drive or use machines. However, you should be aware that some people may experience dizziness after taking INEGY.

INEGY contains lactose

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

INEGY contains sodium

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

3. How to take INEGY

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

The tablets are not scored and must not be divided.

Always follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

• Before starting to take INEGY, you must already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking INEGY.

Adults: the dose is 1 tablet of INEGY once daily by oral administration.

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

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

Take INEGY in the evening. You may take it with or without food.

If your doctor has prescribed INEGY together with another cholesterol-lowering medicine containing the active ingredient cholestyramine or any other bile acid sequestrant, you must take INEGY at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more INEGY 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 INEGY

• Do not take a double dose to make up for forgotten doses. Take your usual dose of INEGY at the usual time.

If you stop taking INEGY

• 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 (see section 2. What you need to know before you start taking INEGY).

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

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

The following adverse effects have been reported as uncommon (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; bloating; 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 disorders; difficulty sleeping.

The following adverse effects have been reported with unknown frequency (frequency cannot be estimated from the available data):

• 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 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 patients taking INEGY 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,
• inflammation of the liver 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 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 visual 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 reactions which may include: allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty 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 severe allergic reaction may very rarely occur (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,
• 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.

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 sugars and fats in the 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 INEGY (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 breakdown leading to kidney damage; and very rarely, deaths have occurred.

Reporting of adverse effects:

If you experience any 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 INEGY

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or container following [EXP].
• Do not store INEGY tablets above 30°C.

Blister packs: Keep in the original packaging to protect from moisture and light.
Bottles: Keep bottles tightly closed to protect from moisture and light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of INEGY

The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 20 mg or 40 mg of simvastatin.

The other components are: butyl hydroxyanisole, citric acid monohydrate, sodium croscarmellose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and propyl gallate.

Appearance of the product and contents of the pack

INEGY tablets are capsule-shaped, white to off-white, with the code “312” on one side for INEGY 10 mg/20 mg tablets or “313” for INEGY 10 mg/40 mg tablets. The tablets do not have a break line and must not be divided.

Pack sizes:

7, 10, 14, 28, 30, 50, 56, 84, 90, 98, multiple pack containing 98 tablets (2 packs of 49), 100, or 300 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Or

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

INEGY in: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.

VYTORIN in: Germany, Italy, Portugal and Spain.

GOLTOR in: Germany and Italy.

Date of the latest revision of this leaflet: 07/2023.

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/)