Ezetimibe and simvastatin Sandoz

Package leaflet: Information for the user

Ezetimibe and simvastatin Sandoz 10 mg/10 mg tablets, mg/20 mg tablets, mg/40 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine as 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 give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ezetimibe and Simvastatin Sandoz is and what it is used for

Ezetimibe and Simvastatin Sandoz is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and blood fats known as triglycerides. In addition, Ezetimibe and Simvastatin Sandoz increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe and Simvastatin Sandoz contains the active substances ezetimibe and simvastatin.
Ezetimibe and Simvastatin Sandoz works in two ways to lower cholesterol. The active substance ezetimibe reduces cholesterol absorbed from the digestive tract. The active substance simvastatin, which belongs to a class of medicines called "statins", inhibits the body's production of cholesterol.
Cholesterol is one of several types of fat found in the bloodstream. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage of blood flow can cause 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 form of fat in the blood that may increase the risk of heart disease.
Ezetimibe and Simvastatin Sandoz is used for patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Ezetimibe and Simvastatin Sandoz is used as an additional therapy to diet to lower cholesterol if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or elevated levels of fats in the blood (mixed hyperlipidemia):
• that are not well controlled by a statin alone
• for which you have previously been treated with separate tablets containing a statin and ezetimibe
• a hereditary condition (homozygous familial hypercholesterolemia) that increases your blood cholesterol levels. You may also be receiving other treatments.
• heart disease; in such cases, Ezetimibe and Simvastatin Sandoz reduces the risk of heart attack, stroke, surgical procedures to improve blood flow, or hospitalization due to chest pain. Ezetimibe and Simvastatin Sandoz does not help with weight loss.

2. What you should know before taking Ezetimibe and Simvastatin Sandoz

Do not take Ezetimibe and Simvastatin Sandoz:

• 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 a medicine 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 infections)
  • nefazodone (used to treat depression)
  • cobicistat
  • gemfibrozil (used to lower cholesterol)
  • cyclosporine (often used in patients who have had an organ transplant)
  • danazol (a synthetic male hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and Ezetimibe and Simvastatin Sandoz can cause serious muscle problems (rhabdomyolysis).
• Do not take more than 10 mg/40 mg of Ezetimibe and Simvastatin Sandoz if you are taking lomitapide (used to treat a rare, severe genetic cholesterol condition).

Ask your doctor for advice if you are unsure whether the medicine you are taking is among those listed above.
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Warnings and precautions
Talk to your doctor or pharmacist before taking Ezetimibe and Simvastatin Sandoz if:

• you have any medical condition, including allergies.
• you consume large amounts of alcohol or have ever had liver disease. Ezetimibe and Simvastatin Sandoz may not be suitable for you.
• you are scheduled for surgery. You may need to stop taking Ezetimibe and Simvastatin Sandoz temporarily.
• you are of Asian origin, as you may require a different dose.

Your doctor will perform a blood test before starting Ezetimibe and Simvastatin Sandoz. This test is to check whether your liver is functioning properly.
Your doctor may also order blood tests to monitor liver function after you start taking Ezetimibe and Simvastatin Sandoz.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.
Inform your doctor if you have a serious lung disease.
The combined use of Ezetimibe and Simvastatin Sandoz with fibrates (certain types of cholesterol-lowering medicines) should be avoided, as the use of Ezetimibe and Simvastatin Sandoz with fibrates has not been studied.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, as muscle problems can rarely be serious and lead to muscle tissue damage causing kidney injury; very rarely, cases of death have occurred.
Always inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.
The risk of muscle damage is higher at higher doses of Ezetimibe and Simvastatin Sandoz, particularly with the 10 mg/80 mg dose. The risk of muscle damage is also increased in certain patients. Inform your doctor if any of the following apply to you:

• you have kidney problems
• you have thyroid problems
• you are 65 years of age or older
• you are female
• 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 and bezafibrate)
• you or your close family members have a hereditary muscle disease.

Children and adolescents
The use of Ezetimibe and Simvastatin Sandoz is not recommended in children under 10 years of age.
Other medicines and Ezetimibe and Simvastatin Sandoz
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Inform your doctor if you are taking, have recently taken, or might take any other medicine containing any of the following active substances. Taking Ezetimibe and Simvastatin Sandoz with any of the following medicines may increase the risk of muscle problems (some of which have already been mentioned in the section "Do not take Ezetimibe and Simvastatin Sandoz"):

• if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Ezetimibe and Simvastatin Sandoz. Taking Ezetimibe and Simvastatin Sandoz with fusidic acid may rarely lead to muscle weakness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see also section 4.
• cyclosporine (often used in patients who have received an organ transplant)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the 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 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)
• antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infections)
• nefazodone (used to treat depression)
• medicines containing 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 a rare, severe genetic cholesterol condition)
• high doses (1 g or more per day) of niacin or nicotinic acid (also used to lower cholesterol)
• colchicine (used to treat gout).

In addition to the medicines listed above, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those without a prescription. In particular, tell 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 and Simvastatin Sandoz works
• fenofibrate (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis).

You should also inform any doctor who prescribes you a new medicine that you are taking Ezetimibe and Simvastatin Sandoz.
Ezetimibe and Simvastatin Sandoz with food and drink
Grapefruit juice contains one or more substances that alter the metabolism of certain medicines, including Ezetimibe and Simvastatin Sandoz. Consumption of grapefruit juice should be avoided, as it may increase the risk of muscle problems.
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Pregnancy and breastfeeding
Do not take Ezetimibe and Simvastatin Sandoz if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant while taking Ezetimibe and Simvastatin Sandoz, stop treatment immediately and contact your doctor. Do not take Ezetimibe and Simvastatin Sandoz if you are breastfeeding, as it is not known whether the medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ezetimibe and Simvastatin Sandoz is not expected to affect your ability to drive or use machines. However, bear in mind that some people have experienced dizziness after taking Ezetimibe and Simvastatin Sandoz.
Ezetimibe and Simvastatin Sandoz contains lactose
Ezetimibe and Simvastatin Sandoz tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ezetimibe and Simvastatin Sandoz

Your doctor will determine the appropriate tablet strength for you based on your current treatment and individual risk profile.
The tablets do not have a break line and must not be divided.
Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

• Before starting treatment with Ezetimibe and Simvastatin Sandoz, you must already be following a cholesterol-lowering diet.
• While taking Ezetimibe and Simvastatin Sandoz, you must continue to follow this cholesterol-lowering diet.

Adults: The dose is 1 tablet taken orally once daily.
Adolescents (aged 10 to 17 years): The dose is 1 tablet taken orally once daily (a maximum dose of 10 mg/40 mg once daily must not be exceeded).
The 10 mg/80 mg dose of Ezetimibe and Simvastatin Sandoz is recommended only for adult patients with very high cholesterol levels and a high risk of heart disease who have not reached their target cholesterol levels with lower doses.
If the optimal dose cannot be achieved with Ezetimibe and Simvastatin Sandoz, your doctor may prescribe other tablets containing ezetimibe/simvastatin.
Take Ezetimibe and Simvastatin Sandoz in the evening. It can be taken with or without food.
If your doctor has prescribed Ezetimibe and Simvastatin Sandoz together with another cholesterol-lowering medicine containing the active ingredient cholestyramine or any other bile acid sequestrant, you must take Ezetimibe and Simvastatin Sandoz at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe and Simvastatin Sandoz than you should
Contact your doctor or pharmacist immediately.

If you forget to take Ezetimibe and Simvastatin Sandoz
Do not take a double dose to make up for the missed tablet. Take only your usual dose at the regular time the next day.

If you stop taking Ezetimibe and Simvastatin Sandoz
Consult your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them (see section 2).
The following common side effects have been reported (may affect up to 1 in 10 people):

• muscle pain
• increases in blood laboratory test values related to liver function (transaminases) and/or muscle (CK)

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

• increases in blood test values related to liver function; increases in blood uric acid levels; prolonged blood clotting time; presence of protein in urine; decrease in body weight
• dizziness; headache; tingling sensation
• abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhoea; dry mouth; heartburn
• skin rash; itching; hives
• joint pain; muscle pain; tenderness; weakness or spasms; neck pain; pain in arms and legs; back pain
• unusual tiredness or weakness; feeling of fatigue; chest pain; swelling, especially of the hands and feet
• sleep disorders; difficulty falling asleep

In addition, the following side effects have been reported in patients taking either Ezetimibe and simvastatin Sandoz or medicines containing the active substances ezetimibe or simvastatin:

• reduced number of red blood cells (anaemia); decreased number of blood cells, which may cause bruising/bleeding (thrombocytopenia)
• loss of sensation or weakness in arms and legs; poor memory; memory loss; confusion
• breathing problems including persistent cough and/or shortness of breath 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 of tiredness or weakness; loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea and vomiting)
• hair loss; red raised skin rash, sometimes with target-like lesions with Ezetimibe and simvastatin Sandoz (erythema multiforme)
• hypersensitivity reaction including some of the following features: hypersensitivity (allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing and requires immediate treatment (angioedema), severe allergic reaction causing difficulty in breathing or dizziness (anaphylaxis, which may affect up to 1 in 10,000 people, and anaphylactic reactions), joint pain, inflammation of blood vessels, abnormal bruising, skin rashes and swelling, hives, skin sensitivity to sunlight, fever, hot flushes, shortness of breath and feeling unwell, lupus-like symptoms (including skin rash, joint problems, and effects on white blood cells))
• muscle pain; tenderness; weakness or muscle cramps; muscle injury; tendon problems, sometimes complicated by tendon rupture
• decreased appetite
• hot flushes; high blood pressure
• pain
• erectile dysfunction
• depression
• changes in certain blood test values related to liver function

Additional possible side effects reported with some statins:

• sleep disorders, including nightmares
• sexual difficulties
• 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 during treatment with this medicine.
• muscle pain, tenderness or weakness that is persistent and may not resolve after stopping treatment with Ezetimibe and simvastatin Sandoz (frequency not known: cannot be estimated from the available data).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness.
This is because muscle problems can, rarely, be serious and lead to muscle tissue damage causing kidney damage; very rare cases of death have occurred.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ezetimibe and Simvastatin Sandoz

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 after "Exp.". The expiry date refers to the last day of that month.
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Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ezetimibe and Simvastatin Sandoz contains
The active substances are ezetimibe and simvastatin.
Each tablet contains 10 mg of ezetimibe and 10 mg of simvastatin.
Each tablet contains 10 mg of ezetimibe and 20 mg of simvastatin.
Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatin.
The other excipients are: Tablet core: monohydrate lactose, hypromellose, sodium croscarmellose, microcrystalline cellulose, ascorbic acid, anhydrous citric acid, butylhydroxyanisole, propyl gallate, magnesium stearate. Colouring mixture: monohydrate lactose, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Description of the appearance of Ezetimibe and Simvastatin Sandoz and the contents of the pack
Ezetimibe and Simvastatin Sandoz 10 mg/10 mg are light brown, mottled, round, 6 mm in diameter, biconvex tablets, engraved with “511” on one side.
Ezetimibe and Simvastatin Sandoz 10 mg/20 mg are light brown, mottled, round, 8 mm in diameter, biconvex tablets, engraved with “512” on one side.
Ezetimibe and Simvastatin Sandoz 10 mg/40 mg are light brown, mottled, round, 10 mm in diameter, biconvex tablets, engraved with “513” on one side.

Pack sizes
Blister packs:
Packs of: 10, 14, 28, 30, 50, 90 and 100 tablets
HDPE bottle:
100 tablets
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitza 2600
Bulgaria
Lek Pharmaceuticals d.d.
Verovskova ulica 57,
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
Sachsen-Anhalt, 39179 Barleben
Germany

This medicinal product is authorized in the European Economic Area countries under the
following names:
Austria Ezetimib/Simvastatin Sandoz 10 mg/10 mg – Tablets
Ezetimib/Simvastatin Sandoz 10 mg/20 mg – Tablets
Ezetimib/Simvastatin Sandoz 10 mg/40 mg – Tablets
Ezetimib/Simvastatin Sandoz 10 mg/80 mg – Tablets

Belgium Ezetimibe/Simvastatine Sandoz 10mg/10mg tabletten
Ezetimibe/Simvastatine Sandoz 10mg/20mg tabletten
Ezetimibe/Simvastatine Sandoz 10mg/40mg tabletten
Ezetimibe/Simvastatine Sandoz 10mg/80mg tabletten

Denmark Ezetimib/Simvastatin Sandoz

France Ezétimibe/Simvastatine Sandoz 10 mg/20 mg, comprimé
Ezétimibe/Simvastatine Sandoz 10 mg/40 mg, comprimé

Germany SimvaHEXAL plus Ezetimib 10 mg/10 mg Tablets
SimvaHEXAL plus Ezetimib 10 mg/20 mg Tablets
SimvaHEXAL plus Ezetimib 10 mg/40 mg Tablets
SimvaHEXAL plus Ezetimib 10 mg/80 mg Tablets

Greece Ezetimibe+Simvastatin/Sandoz

Ireland Ezetimibe/Simvastatin Rowex 10 mg/20 mg Tablets
Ezetimibe/Simvastatin Rowex 10 mg/40 mg Tablets
Ezetimibe/Simvastatin Rowex 10 mg/80 mg Tablets

Italy Ezetimibe and Simvastatin Sandoz

Luxembourg Ezetimibe/Simvastatine Sandoz 10mg/10mg comprimés
Ezetimibe/Simvastatine Sandoz 10mg/20mg comprimés
Ezetimibe/Simvastatine Sandoz 10mg/40mg comprimés
Ezetimibe/Simvastatine Sandoz 10mg/80mg comprimés

Norway Ezetimib/Simvastatin Sandoz

Netherlands Ezetimibe/Simvastatine Sandoz 10 mg/10 mg, tabletten
Ezetimibe/Simvastatine Sandoz 10 mg/20 mg, tabletten
Ezetimibe/Simvastatine Sandoz 10 mg/40 mg, tabletten
Ezetimibe/Simvastatine Sandoz 10 mg/80 mg, tabletten

Portugal Sinvastatina + Ezetimiba Sandoz

Spain Eztimiba/Simvastatina Sandoz 10 mg/10 mg comprimidos EFG
Eztimiba/Simvastatina Sandoz 10 mg/20 mg comprimidos EFG
Eztimiba/Simvastatina Sandoz 10 mg/40 mg comprimidos EFG
Eztimiba/Simvastatina Sandoz 10 mg/80 mg comprimidos EFG

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