Ezetimibe and simvastatin Sun: detailed information

Patient Information Leaflet

Ezetimibe and Simvastatin SUN 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg tablets

Ezetimibe and simvastatin
Generic medicine
Please read this leaflet carefully before 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ezetimibe and Simvastatin SUN is and what it is used for
What you need to know before taking Ezetimibe and Simvastatin SUN
How to take Ezetimibe and Simvastatin SUN
Possible side effects
How to store Ezetimibe and Simvastatin SUN
Contents of the pack and other information

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

Ezetimibe and Simvastatin SUN contains the active substances ezetimibe and simvastatin.
Ezetimibe and Simvastatin SUN is used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and blood fats known as triglycerides. In addition, Ezetimibe and Simvastatin SUN increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe and Simvastatin SUN works in two ways to lower cholesterol. The active substance ezetimibe reduces the amount of cholesterol absorbed in the digestive tract. The active substance simvastatin, which belongs to the class of drugs known as "statins", inhibits the body's production of cholesterol.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate 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 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 type of fat in the blood that may increase the risk of heart disease.
Ezetimibe and Simvastatin SUN is used for patients who cannot control their cholesterol levels through diet alone. While taking this medicine, you must still follow a cholesterol-lowering diet.
Ezetimibe and Simvastatin SUN is used as an add-on 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): either not adequately controlled by a statin alone; or for which you have previously been treated with separate tablets containing a statin and ezetimibe;
an inherited condition (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also be receiving other treatments.
heart disease: Ezetimibe and Simvastatin SUN reduces the risk of heart attack, stroke, surgical intervention to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe and Simvastatin SUN does not help with weight loss.

2. What you need to know before taking Ezetimibe and Simvastatin SUN

Do not take Ezetimibe and Simvastatin SUN if

you are allergic (hypersensitive) 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 a medicine(s) 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 or gemfibrozil (used to lower cholesterol); cyclosporine (often used in patients who have undergone organ transplantation); or 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 within the last 7 days, or have been administered fusidic acid (used to treat bacterial infection) orally or by injection. The combination of fusidic acid and Ezetimibe and Simvastatin SUN may lead to serious muscle problems (rhabdomyolysis). Do not take more than 10 mg/40 mg of Ezetimibe and Simvastatin SUN 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 one of those listed above.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ezetimibe and Simvastatin SUN.

If you are taking or have taken within the last 7 days fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Ezetimibe and Simvastatin SUN may lead to serious muscle problems (rhabdomyolysis).

Inform your doctor:

about all your medical conditions, including allergies.
if you consume large amounts of alcohol or have ever had liver disease. In such cases, Ezetimibe and Simvastatin SUN may not be suitable for you.
if you are scheduled for surgery. You may need to temporarily stop taking Ezetimibe and Simvastatin SUN.
if you are of Asian origin, as you may require a different dose.

Your doctor should perform a blood test before starting Ezetimibe and Simvastatin SUN
and if you develop symptoms of liver problems while taking Ezetimibe and Simvastatin SUN. This
test is performed to determine whether your liver is functioning properly.
Your doctor may also order blood tests to monitor liver function after starting therapy with
Ezetimibe and Simvastatin SUN.
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 concomitant use of Ezetimibe and Simvastatin SUN with fibrates (certain types of medicines to lower cholesterol) should be avoided, as the use of Ezetimibe and Simvastatin SUN 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 severe and lead to muscle tissue damage causing kidney damage;
very rare cases of death have occurred.
The risk of muscle damage is higher at higher doses of Ezetimibe and Simvastatin SUN,
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 conditions apply to you:

you have kidney problems
you have thyroid problems
you are 65 years of age or older
you are female
you have previously experienced 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.

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed to diagnose and treat this condition.
Children and adolescents
The use of Ezetimibe and Simvastatin SUN is not recommended in children under 10 years of age.
Other medicines and Ezetimibe and Simvastatin SUN
Inform your doctor if you are taking, have recently taken, or might take any other
medicine.
If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to resume treatment with Ezetimibe and Simvastatin SUN. Taking Ezetimibe and Simvastatin SUN with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
It is especially important to inform your doctor if you are taking medicines containing any of the following active substances. Taking Ezetimibe and Simvastatin SUN 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 SUN if”):

cyclosporine (often used in patients who have received an organ transplant)
danazol (an artificial 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, telithromycin, or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine. See also section 4 of this leaflet.
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS)
boceprevir or telaprevir (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 or have recently taken 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 used 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 SUN 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 SUN.
Ezetimibe and Simvastatin SUN with food and drink
Grapefruit juice contains one or more substances that alter the metabolism of certain medicines,
including Ezetimibe and Simvastatin SUN. Consumption of grapefruit juice should be avoided, as it
may increase the risk of muscle problems.
Pregnancy and breastfeeding
Do not use Ezetimibe and Simvastatin SUN during pregnancy, if you are planning a pregnancy,
or if you suspect you may be pregnant. If you become pregnant while taking Ezetimibe and Simvastatin SUN,
stop treatment immediately and contact your doctor. Ezetimibe and Simvastatin SUN should not
be used during breastfeeding, as it is not known whether the medicine passes into human milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ezetimibe and Simvastatin SUN is not expected to affect your ability to drive or use machines. However, you should be aware that some people have experienced dizziness after taking Ezetimibe and Simvastatin SUN.
Ezetimibe and Simvastatin SUN contains lactose
Ezetimibe and Simvastatin SUN tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ezetimibe and Simvastatin SUN

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

Before starting treatment with Ezetimibe and Simvastatin SUN, you should already be following a cholesterol-lowering diet.
During treatment with Ezetimibe and Simvastatin SUN, you must continue to follow this cholesterol-lowering diet.

Adults: the dose is 1 tablet taken orally once daily.
Use in 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 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 level with lower doses.
Take Ezetimibe and Simvastatin SUN in the evening. It may be taken with or without food.
If your doctor has prescribed Ezetimibe and Simvastatin SUN together with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you must take Ezetimibe and Simvastatin SUN at least 2 hours before or 4 hours after taking the bile acid sequestrant.

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

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

If you stop taking Ezetimibe and Simvastatin SUN
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, Ezetimibe and Simvastatina SUN may cause side effects, although not everybody gets them (see Section 2 What you should know before taking Ezetimibe and Simvastatina SUN).
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness.
Muscle problems can, in rare cases, be serious, including muscle breakdown which can lead to
kidney damage; and very rarely, deaths have occurred.

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; urticaria
joint pain; muscle pain; tenderness; weakness or spasms; neck pain; arm or leg pain; back pain
unusual tiredness or weakness; feeling of fatigue; chest pain; swelling, especially of the hands and feet
sleep disturbance; difficulty falling asleep

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

reduction in red blood cell count (anaemia); decrease in blood cells, which may lead to 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 urine or pale 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 (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 breathing or swallowing and requires immediate treatment (angioedema), joint pain or inflammation, inflammation of blood vessels, unusual bruising, skin rashes and swelling, urticaria, 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). A very rare severe allergic reaction (may affect up to 1 in 10,000 people) causing breathing difficulties or dizziness and requiring immediate treatment (anaphylaxis) may occur.
muscle pain; tenderness; weakness or 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 fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
persistent muscle pain, tenderness or weakness that does not resolve after stopping treatment with Ezetimibe and Simvastatina SUN (frequency not known).

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 SUN

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 blister pack after the word EXP.
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 Simvastatina SUN contains

The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and either 10 mg, 20 mg, or 40 mg of simvastatin.
The other excipients are: butylhydroxyanisole (E320), monohydrate citric acid (E330), sodium croscarmellose (E468), hypromellose (E464), monohydrate lactose, magnesium stearate (E470b), microcrystalline cellulose (E460i), and propyl gallate (E310).

Description of the appearance of Ezetimibe and Simvastatina SUN and the contents of the pack
Ezetimibe and Simvastatina SUN are uncoated, capsule-shaped tablets, white to almost white, with the code “L”, “I”, “F” imprinted on one side and smooth on the other side. Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, or 40 mg of simvastatin.
Ezetimibe and Simvastatina SUN 10 mg/10 mg: The tablets have a length of approximately 8.50 mm and a width of approximately 4.30 mm.
Ezetimibe and Simvastatina SUN 10 mg/20 mg: The tablets have a length of approximately 10.70 mm and a width of approximately 5.40 mm.
Ezetimibe and Simvastatina SUN 10 mg/40 mg: The tablets have a length of approximately 13.80 mm and a width of approximately 6.00 mm.
Ezetimibe and Simvastatina SUN tablets are packaged in unit dose blisters (OPA/Al/PVC/Al).
Pack: 30 tablets
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Legal Representative in Italy:
Ranbaxy Italia S.p.A.
Viale Giulio Richard, 1/B
20143 Milano
Italy

Manufacturer
Alkaloida Chemical Company Zrt
Kabay János u.29 - Tiszavasvári H-4440
Hungary
Terapia SA
Str. Fabricii nr. 124 - Cluj-Napoca, 400 632
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 - 2132JH, Hoofddorp
The Netherlands