EZETIMIBE/SIMVASTATIN VISO FARMACEUTICA 10 mg/40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ezetimibe/Simvastatin Viso Pharmaceutical 10 mg/10 mg tablets EFG

Ezetimibe/Simvastatin Viso Pharmaceutical 10 mg/20 mg tablets EFG

Ezetimibe/Simvastatin Viso Pharmaceutical 10 mg/40 mg tablets EFG

Ezetimibe/Simvastatin Viso Pharmaceutical 10 mg/80 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 further 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet

1. What is Ezetimibe/Simvastatin Viso Pharmaceutical and what is it used for
2. What you need to know before you take Ezetimibe/Simvastatin Viso Pharmaceutical
3. How to take Ezetimibe/Simvastatin Viso Pharmaceutical
4. Possible side effects
5. Storage of Ezetimibe/Simvastatin Viso Pharmaceutical

1. Contents of the pack and further information

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

This medicine contains the active substances ezetimibe and simvastatin. It is used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and substances called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/simvastatin works by reducing cholesterol in two ways. The active substance ezetimibe reduces the amount of cholesterol absorbed from the gut. The active substance simvastatin, which belongs to a group of medicines known as "statins", inhibits the production of cholesterol made by the body.

Cholesterol is one of the fatty substances that can be found in the blood. Your total cholesterol level 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 can lead to a narrowing of the arteries, which can reduce or block blood flow to important organs such as the heart and brain. This blocking of 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 the blood that can increase the risk of heart disease.

Ezetimibe/simvastatin is used in patients who cannot control their cholesterol levels by diet alone. While you are taking this medicine, you should also follow a low-cholesterol diet.

Ezetimibe/simvastatin is used, along with a low-cholesterol diet, in patients with:

• high blood levels of cholesterol (primary hypercholesterolaemia [heterozygous familial and non-familial]) or high blood levels of fats (mixed hyperlipidaemia):
• that are not well controlled with a statin alone
• for whom a statin and ezetimibe have been taken as separate tablets

• a rare inherited cholesterol disorder (homozygous familial hypercholesterolaemia). You may also receive other treatments.

• heart disease, ezetimibe/simvastatin reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain.

This medicine does not help to lose weight.

2. What you need to know before you take Ezetimibe/Simvastatin Viso Pharmaceutical

Do not take Ezetimibe/Simvastatin Viso Pharmaceutical if:

• you are allergic to ezetimibe (hypersensitive), simvastatin or any of the other ingredients of this medicine (listed in section 6. Contents of the pack and further information)
• you currently have liver problems
• you are pregnant or breast-feeding
• you are taking medicines with 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)
• cyclosporin (used in organ transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)

• you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and ezetimibe/simvastatin can cause muscle problems (rhabdomyolysis)

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

Ask your doctor if you are not sure if your medicine is mentioned above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions, including allergies.
• if you drink large amounts of alcohol or if you have ever had liver disease. Ezetimibe/Simvastatin may not be suitable for you.
• if you are going to have an operation. You may need to stop taking the ezetimibe/simvastatin tablets for a short time.
• if you are Asian, as you may need a different dose.
• If you have or have had myasthenia (a disease that causes muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes make this condition worse or trigger myasthenia (see section 4).

Your doctor will do a blood test before you start taking ezetimibe/simvastatin and may also do a blood test if you have symptoms of liver problems while taking ezetimibe/simvastatin. This is to check how well your liver is working.

Your doctor may also want to do blood tests to check how well your liver is working after you start treatment with ezetimibe/simvastatin.

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. Your risk of diabetes increases if you have high levels of sugars and fats in your blood, are overweight, and 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 use of ezetimibe/simvastatin with fibrates has not been studied.

Tell your doctor immediately if you experience muscle pain, tenderness or weakness that you cannot explain. This is because, on rare occasions, muscle problems can be serious, including muscle breakdown that can cause kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is greater with higher doses of ezetimibe/simvastatin, especially the 10/80 mg dose. The risk of muscle breakdown is also greater in certain patients. Tell 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).
• you or your close relatives have a hereditary muscle disorder

Also, tell your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be needed to diagnose and treat this condition.

Children and adolescents

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

Other medicines and Ezetimibe/Simvastatin Viso Pharmaceutical

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Taking ezetimibe/simvastatin with any of the following medicines can increase the risk of muscle problems (some of these are already included in the "Do not take Ezetimibe/Simvastatin Viso Pharmaceutical if" section).

• cyclosporin (often used in transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)
• medicines with an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
• fibrates with an active substance 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 with the active substance cobicistat
• amiodarone (used to treat irregular heartbeat)
• 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 and serious genetic cholesterol disorders)
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteremia). The risk of side effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., Ezetimibe/Simvastatin Viso Pharmaceutical). Your doctor may decide that you should stop taking Ezetimibe/Simvastatin for a while.
• high doses (1 gram or more per day) of niacin or nicotinic acid (also used to lower cholesterol)
• colchicine (used to treat gout)

As well as the medicines mentioned above, tell 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 with an active substance to prevent blood clots, such as warfarin, fludione, phenprocoumon, or acenocoumarol (anticoagulants)
• cholestyramine (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 tell any doctor who prescribes you a new medicine that you are taking ezetimibe/simvastatin.

Taking Ezetimibe/Simvastatin Viso Pharmaceutical with food and drink

Grapefruit juice contains one or more components that alter the metabolism of some medicines, including ezetimibe/simvastatin. You should avoid drinking grapefruit juice, as it can increase the risk of muscle problems.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, if you are trying to become pregnant, or if you think you may be pregnant. If you become pregnant while taking ezetimibe/simvastatin, stop taking it immediately and tell your doctor. Do not take ezetimibe/simvastatin if you are breast-feeding, as it is not known whether this medicine passes into breast milk.

Ask your doctor or pharmacist for advice before taking 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 experience dizziness after taking ezetimibe/simvastatin.

Ezetimibe/Simvastatin Viso Pharmaceutical contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Ezetimibe/Simvastatin Viso Pharmaceutical contains sodium

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

3. How to take Ezetimibe/Simvastatin Viso Pharmaceutical

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

The tablets are not scored and should not be divided.

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

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

Adults: the dose is 1 tabletof ezetimibe/simvastatin once a day by mouth.

Use in adolescents(10 to 17 years of age): the dose is 1 tabletof ezetimibe/simvastatin once a day by mouth (do not exceed a maximum dose of 10 mg/40 mg once a day).

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

Take ezetimibe/simvastatin in the evening. You can take it with or without food.

If your doctor has prescribed ezetimibe/simvastatin along with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you should take ezetimibe/simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe/Simvastatin Viso Pharmaceutical than you should

• In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone: 91 562 04 20, consult your doctor or pharmacist.

If you forget to take Ezetimibe/Simvastatin Viso Pharmaceutical

• Do not take a double dose to make up for forgotten doses, take your normal dose of Ezetimibe/Simvastatin Viso Pharmaceutical at the usual time

If you stop taking Ezetimibe/Simvastatin Viso Pharmaceutical

• Talk to your doctor or pharmacist because your cholesterol levels may increase again.

If you have any further questions on 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 all people suffer from them (see section 2. What you need to know before taking Ezetimibe/Simvastatin Viso Farmaceutica).

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

• Muscle pain
• Elevations in blood test results for liver function (transaminases) and/or muscle (CK)

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

• Elevation of liver function in blood tests; elevations of uric acid in the blood; elevations in the time it takes for blood to clot; protein in urine; weight loss
• Dizziness; headache; tingling sensation
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; heartburn
• Rash; itching; hives
• Joint pain; pain, hypersensitivity, weakness, or muscle spasms; neck pain; pain in the arms and legs; back pain
• Unusual fatigue 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 medications containing the active ingredients ezetimibe or simvastatin:

• Low red blood cell count (anemia), reduced blood cell count, which can cause bruising/bleeding (thrombocytopenia)
• Numbness or weakness of the arms and legs; poor memory, memory loss, confusion
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Constipation
• Pancreatitis, 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 can cause abdominal pain, nausea, vomiting)
• Hair loss; red, swollen rash, sometimes with target-shaped lesions (erythema multiforme)
• Blurred vision and vision loss (may affect up to 1 in 1000 people)
• Skin rash or mouth ulcers (lichenoid rash) (may affect up to 1 in 10,000 people)
• Hypersensitivity reaction that may include the following: hypersensitivity (allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing and requires immediate treatment (angioedema), joint pain or inflammation, blood vessel inflammation, unusual bruising, skin rashes, and swelling, hives, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, pseudo-lupus 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) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis).
• 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
• Gynecomastia (enlargement of the breasts in men) (may affect up to 1 in 10,000 people)
• Decreased appetite
• Hot flashes; high blood pressure
• Pain
• Erectile dysfunction
• Depression
• Abnormalities in some liver function blood tests

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 sugar and fat 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 that may not disappear after stopping treatment with ezetimibe/simvastatin (frequency not known).
• Severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

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

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 failure, which can cause kidney damage; and very rarely, deaths have occurred.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines:

https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ezetimibe/Simvastatin Viso Farmaceutica

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

Do not use this medicine after the expiration date that appears on the box or bottle after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Blister: keep the blister in the outer packaging to protect it from moisture.

Bottles: keep the bottle tightly closed and store in the outer packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ezetimibe/Simvastatin Viso Farmaceutica

The active ingredients are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 10 mg, 20, 40 mg, or 80 mg of simvastatin.

The other ingredients are: lactose monohydrate, microcrystalline cellulose (E 460), hypromellose, sodium croscarmellose (E 468), propyl gallate (E 310), butylated hydroxyanisole (E 320), citric acid monohydrate (E 330), sodium lauryl sulfate, magnesium stearate (E 470b).

See also section 2 "What you need to know before taking Ezetimibe/Simvastatin Viso Farmaceutica"

Appearance of Ezetimibe/Simvastatin Viso Farmaceutica and Package Contents

10 mg/ 10 mg:

White to off-white, uncoated, capsule-shaped tablets with "G" engraved on one side and "321" on the other side, approximately 8.5 mm long and 4.25 mm wide.

10 mg/ 20 mg:

White to off-white, uncoated, capsule-shaped tablets with "G" engraved on one side and "322" on the other side, approximately 10.7 mm long and 5.3 mm wide.

10 mg/ 40 mg:

White to off-white, uncoated, capsule-shaped tablets with "G" engraved on one side and "323" on the other side, approximately 14.0 mm long and 6.0 mm wide.

10 mg/ 80 mg:

White to off-white, uncoated, capsule-shaped tablets with "G" engraved on one side and "324" on the other side, approximately 17.5 mm long and 7.5 mm wide.

Ezetimibe/Simvastatin Viso Farmaceutica 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg are presented in PVC-Aluminum-OPA/Aluminum blisters of 7, 10, 14, 28, 30, 49, 50, 56, 84, 90, 98, multiple packaging containing 98 (2 boxes of 49), 100, 196, 300, or 392 tablets, and HDPE bottles of 90 tablets (only Ezetimibe/Simvastatin Viso Farmaceutica 10 mg/40 mg). The tablets packaged in HDPE bottles include a desiccant that protects the tablets from moisture. The desiccant should not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola PLA3000

Malta

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands:Ezetimibe/Simvastatine Glenmark 10 mg/10 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/20 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/40 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/80 mg tablets

Germany:Ezetimibe/Simvastatine Glenmark 10 mg/10 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/20 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/40 mg tablets

Ezetimibe/Simvastatine Glenmark 10 mg/80 mg tablets

Czech Republic:Glezisim

Slovakia:Glezisim 10 mg/10 mg tablets

Glezisim 10 mg/20 mg tablets

Glezisim 10 mg/40 mg tablets

Glezisim 10 mg/80 mg tablets

Norway:Ezetimib/Simvastatin Glenmark 10 mg/20 mg tablets

Ezetimib/Simvastatin Glenmark 10 mg/40 mg tablets

Spain:Ezetimiba/Simvastatina Viso Farmacéutica 10 mg/20 mg tablets EFG

Ezetimiba/Simvastatina Viso Farmacéutica 10 mg/40 mg tablets EFG

Denmark:Ezetimib/Simvastatin Glenmark

Sweden:Ezetimib/Simvastatin Glenmark 10 mg/10 mg tablets

Ezetimib/Simvastatin Glenmark 10 mg/20 mg tablets

Ezetimib/Simvastatin Glenmark 10 mg/40 mg tablets

Ezetimib/Simvastatin Glenmark 10 mg/80 mg tablets

Date of the last revision of this prospectus:June 2023

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/