Ezetimibe/simvastatin Normon 10 mg/40 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Ezetimibe/Simvastatin Normon 10 mg/40 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 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

This medicine contains the active substances ezetimibe and simvastatin. It is used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain 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 "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. 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 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 levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or high levels of fatty substances in the blood (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; 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 Normon

Do not take Ezetimibe/Simvastatin Normon if:

• you are allergic to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in section 6, "Contents of the pack and other 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)

• if you are taking or have taken within the last 7 days, or have been given a medicine called fusidic acid (used to treat bacterial infections) by mouth or 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

Tell 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.

Your doctor will perform a blood test before you start taking ezetimibe/simvastatin and may also do so if you develop symptoms of liver problems while taking it. This is to monitor 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 factors for developing diabetes. This risk is higher if you have high levels of sugars 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 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, 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 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 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
• if you have or have had myasthenia (a disease causing 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 or 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 Normon

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 listed in the section above “Do not take Ezetimibe/Simvastatin Normon 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 Ezetimibe/Simvastatin Normon. Using Ezetimibe/Simvastatin Normon 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, 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)

• 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, tell your doctor if you are taking any of the following:

• medicines containing active substances used 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).

You should also inform any doctor prescribing a new medicine that you are taking ezetimibe/simvastatin.

Taking Ezetimibe/Simvastatin Normon 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 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

Ezetimibe/simvastatin is not expected to affect your ability to drive or operate machinery. However, bear in mind that some people may experience dizziness after taking ezetimibe/simvastatin.

Ezetimibe/Simvastatin Normon contains lactose and sodium

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

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 provided by your doctor. If in doubt, please 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, taken orally.

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

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 complications who have not achieved treatment goals with lower doses.

Take ezetimiba/simvastatina in the evening. It may be taken with or without food.

If your doctor has prescribed ezetimiba/simvastatina together with another cholesterol-lowering medicine containing the active ingredient cholestyramine 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 Normon 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 Ezetimiba/Simvastatina Normon

• Do not take a double dose to make up for missed doses. Take your usual amount of Ezetimiba/Simvastatina Normon at the regular time.

If you stop taking Ezetimiba/Simvastatina Normon

• 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 may cause adverse effects, although not everybody will experience them (see section 2. What you need to know before you start taking Ezetimiba/Simvastatina Normon).

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

• elevated 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

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 counts, which may cause bruising/bleeding (thrombocytopenia)
• numbness or weakness in arms and legs; poor memory, 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 lesions (erythema multiforme)
• blurred vision and deterioration of vision (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 reaction which may include the following: hypersensitivity (allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing and requires immediate treatment, joint pain or swelling, inflammation of blood vessels, atypical bruising, skin rashes and swelling, urticaria, skin sensitivity to sunlight, fever, hot flushes, difficulty breathing and 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; elevated 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 sugars 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)

Adverse reactions with unknown frequency:

• 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.

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 type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Normon

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

Do not use this medicine after the expiry date which appears on the carton or container after EXP.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba/Simvastatina Normon

• 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, pregelatinized corn starch (1500), crospovidone type B, hypromellose 3 CPS, sodium lauryl sulfate, microcrystalline cellulose (E460i), butylated hydroxyanisole, citric acid, ascorbic acid, lactose, sodium croscarmellose, sodium stearyl fumarate, magnesium stearate (E470b).

Appearance of the product and contents of the pack

White to off-white, capsule-shaped tablets, engraved with "14" on one side and smooth on the other.

Ezetimiba/Simvastatina Normon 10 mg/40 mg is available in blisters, in pack sizes of 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: April 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/