EZETIMIBE/SIMVASTATIN VISO FARMACEUTICA 10 mg/20 mg TABLETS

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 components of this medication (listed in section 6. Contents of the pack and further information)
• you currently have liver problems
• you are pregnant or breastfeeding
• you are taking medications with one or more of the following active ingredients:

• 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 reduce cholesterol)
• cyclosporine (used in organ transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus)

• you are taking or have taken in the last 7 days a medication that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and ezetimibe/simvastatin can 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 and severe genetic cholesterol disorders).

Consult your doctor if you are not sure if your medication is mentioned above.

Warnings and precautions

Tell your doctor:

• about all your medical problems, including allergies.
• if you consume large amounts of alcohol or if you 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 Asian, as you may need a different dose.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

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

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

While you are taking this medication, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the 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-reducing medications) should be avoided, as the combined use of ezetimibe/simvastatin and fibrates has not been studied.

Tell your doctor immediately if you experience muscle pain, tenderness, or weakness that cannot be explained. 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.

The risk of muscle failure is higher with high doses of ezetimibe/simvastatin, especially the 10/80 mg dose. The risk of muscle failure is also higher 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-reducing medications called "statins" (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate).
• you or close relatives have a hereditary muscle problem

Also, tell your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Children and adolescents

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

Other medications and Ezetimibe/Simvastatin Viso Pharmaceutical

Tell your doctor if you are taking, have recently taken, or may need to take any other medication with any of the following active ingredients. Taking ezetimibe/simvastatin with any of the following medications can increase the risk of muscle problems (some of these are already included in the previous section "Do not take Ezetimibe/Simvastatin Viso Pharmaceutical if").

• cyclosporine (often used in transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus)
• medications with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
• fibrates with an active ingredient such as gemfibrozil and bezafibrate (used to reduce 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)
• medications with the active ingredient 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 diseases)
• lomitapide (used to treat rare and severe genetic cholesterol disorders)
• daptomycin (a medication used to treat skin and skin structure infections with complications and bacteremia). The adverse effects that affect the muscles may be greater when this medication 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 reduce cholesterol)
• colchicine (used to treat gout).

As well as the medications indicated above, tell your doctor or pharmacist if you are taking or have recently taken other medications, even those purchased without a prescription. In particular, inform your doctor if you are taking any of the following:

• medications with an active ingredient to prevent blood clot formation, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants)
• cholestyramine (also used to reduce cholesterol), as it affects how ezetimibe/simvastatin works
• fenofibrate (also used to reduce cholesterol)
• rifampicin (used to treat tuberculosis).
• ticagrelor (antiplatelet medication)

You should also inform any doctor who prescribes you a new medication that you are taking ezetimibe/simvastatin.

Taking Ezetimibe/Simvastatin Viso Pharmaceutical with food and drinks

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

Pregnancy and breastfeeding

Do not take this medication 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 inform your doctor. Do not take ezetimibe/simvastatin if you are breastfeeding, as it is unknown whether this medication passes into breast milk.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Ezetimibe/simvastatin is not expected to interfere with 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 medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Ezetimibe/Simvastatin Viso Pharmaceutical contains sodium

This medication 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 determine the appropriate dose per tablet for you, depending on your current treatment and personal risk situation.

The tablets have no score line and should not be divided.

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimibe/simvastatin, you should be following a cholesterol-reducing diet.
• You should continue with this cholesterol-reducing 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 disease who have not reached the treatment goal with lower doses.

Take ezetimibe/simvastatin at night. You can take it with or without food.

If your doctor has prescribed ezetimibe/simvastatin along with another cholesterol-reducing medication that contains the active ingredient cholestyramine 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, consult 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 may increase again.

If you have any other questions about 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-colored urine or pale-colored stools, feeling tired or weak, loss of appetite; liver failure; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting)
• Hair loss; reddened and swollen rash, sometimes with target-like 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, 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) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis) may occur.
• Muscle pain, pressure sensitivity, weakness, or muscle cramps; muscle failure; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture
• Gynecomastia (breast enlargement in men) (may affect up to 1 in 10,000 people)
• Decreased appetite
• Hot flashes; high blood pressure
• Pain
• Erectile dysfunction
• Depression
• Alterations in some liver function blood tests

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 fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.
• Persistent muscle pain, sensitivity, 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 your 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, pressure sensitivity, or weakness. This is because, in rare cases, muscle problems can be severe, 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 it 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 SIGRE point in the pharmacy. In case of 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/