Ezetimibe and simvastatin Teva B.V.: detailed information

Package leaflet: Information for the user

Ezetimibe and Simvastatin Teva B.V. 10 mg/10 mg tablets

Ezetimibe and Simvastatin Teva B.V. 10 mg/20 mg tablets
Ezetimibe and Simvastatin Teva B.V. 10 mg/40 mg tablets
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 other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Ezetimibe and Simvastatine Teva B.V. is and what it is used for

Ezetimibe and Simvastatine Teva B.V. contains the active substances ezetimibe and simvastatin. Ezetimibe and Simvastatine Teva B.V. is a medicine used to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and blood fats known as triglycerides. In addition, Ezetimibe and Simvastatine Teva B.V. increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe and Simvastatine Teva B.V. works in two ways to lower cholesterol. The active substance ezetimibe reduces cholesterol absorbed in the gastrointestinal 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 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 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. This blockage of blood flow may 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 can increase the risk of heart disease.

Ezetimibe and Simvastatine Teva B.V. 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 Simvastatine Teva B.V. 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):
that are not well controlled by a statin alone
for which you have previously been treated with a statin and ezetimibe as separate tablets
an inherited disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also be receiving other treatments.
heart disease; Ezetimibe and Simvastatine Teva B.V. reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe and Simvastatine Teva B.V. does not help with weight loss.

2. What you should know before taking Ezetimibe and SimvastatinTeva B.V.

Do not use Ezetimibe and SimvastatinTeva B.V.:

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(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
- gemfibrozil (used to lower cholesterol)
- cyclosporine (often used in patients who have undergone organ transplantation)
- 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, orally or by injection, a medicine called fusidic acid (used to treat bacterial infections). The combination of fusidic acid and Ezetimibe and SimvastatinTeva B.V. can cause serious muscle problems (rhabdomyolysis). Do not take more than 10 mg/40 mg of Ezetimibe and SimvastatinTeva B.V. if you are taking lomitapide (used to treat a rare, serious genetic condition characterized by high cholesterol levels).

Ask your doctor for advice if you are unsure whether the medicine you are taking is among those listed above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ezetimibe and SimvastatinTeva B.V.:

and inform them about all your medical conditions, including allergies.
if you consume large amounts of alcohol or have ever had liver disease. In this case, Ezetimibe and SimvastatinTeva B.V. may not be suitable for you.
if you are scheduled for surgery. You may need to temporarily stop taking Ezetimibe and SimvastatinTeva B.V.
if you are of Asian descent, as you may require a different dose. Your doctor should perform a blood test before you start taking Ezetimibe and SimvastatinTeva B.V. This test is performed to assess whether your liver is functioning properly.

Your doctor may also prescribe blood tests to monitor liver function after you start treatment with Ezetimibe and SimvastatinTeva B.V.

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 use of Ezetimibe and SimvastatinTeva B.V. with fibrates (a type of medicine used to lower cholesterol) should be avoided, as the combination of Ezetimibe and SimvastatinTeva B.V. with fibrates has not been studied.

Contact your doctor immediately if you experience muscle pain, tenderness, or weakness without a specific cause, as muscle problems can, rarely, be severe and lead to muscle tissue damage causing kidney damage; very rarely, cases of death have occurred.

The risk of muscle damage is higher at higher doses of ezetimibe and simvastatin, 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 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. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

The use of Ezetimibe and SimvastatinTeva B.V. is not recommended in children under 10 years of age.

Other medicines and Ezetimibe and SimvastatinTeva B.V.

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 SimvastatinTeva B.V. 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 use Ezetimibe and SimvastatinTeva B.V."):

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 tell you when it is safe to restart Ezetimibe and SimvastatinTeva B.V. Taking Ezetimibe and SimvastatinTeva B.V. with fusidic acid can rarely cause muscle weakness, soreness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in 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 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)
antiviral agents for hepatitis C 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 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, serious genetic condition characterized by high cholesterol levels)
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. 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 SimvastatinTeva B.V. 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 SimvastatinTeva B.V.

Ezetimibe and SimvastatinTeva B.V. with food and drink

Grapefruit juice contains one or more substances that alter the metabolism of certain medicines, including Ezetimibe and SimvastatinTeva B.V. Grapefruit juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not take Ezetimibe and SimvastatinTeva B.V. during pregnancy. If you become pregnant while taking Ezetimibe and SimvastatinTeva B.V., stop taking it immediately and contact your doctor. Ezetimibe and SimvastatinTeva B.V. should not be used during breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

No effects of Ezetimibe and SimvastatinTeva B.V. on the ability to drive or use machines are expected. However, you should consider that some people may experience dizziness after taking Ezetimibe and SimvastatinTeva B.V.

Ezetimibe and SimvastatinTeva B.V. contains lactose.

Ezetimibe and SimvastatinTeva B.V. tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Ezetimibe and Simvastatin Teva B.V.

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

Before starting treatment with Ezetimibe and Simvastatin Teva B.V., you must already be following a cholesterol-lowering diet.
During treatment with Ezetimibe and Simvastatin Teva B.V., 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 (the maximum dose must not exceed 10 mg/40 mg once daily).

The ezetimibe and simvastatin 10 mg/80 mg dose is recommended only for adult patients with very high cholesterol levels and at high risk for heart disease who have not reached their target cholesterol levels with lower doses.
Take Ezetimibe and Simvastatin Teva B.V. in the evening. It may be taken with or without food.
If your doctor has prescribed Ezetimibe and Simvastatin Teva B.V. together with another cholesterol-lowering medicine containing the active substance colestyramine or any other bile acid sequestrant, you must take Ezetimibe and Simvastatin Teva B.V. at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe and Simvastatin Teva B.V. than you should
Contact your doctor or pharmacist.

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

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

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ezetimibe and Simvastatin Teva BV
may cause side effects, although not everyone gets them.

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

muscle pain
increases in blood 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 the urine; decrease in body weight
dizziness; headache; tingling sensation
abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; 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 in hands and feet
sleep disorders; difficulty falling asleep

In addition, the following side effects have been reported in people taking the combination of ezetimibe and simvastatin 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; memory impairment; 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 in breathing or swallowing and requires immediate treatment (angioedema), severe allergic reaction causing breathing difficulties 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, 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))
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 which may not resolve after stopping treatment with Ezetimibe and Simvastatin Teva B.V. (frequency not known: cannot be estimated from available data).

Contact your doctor immediately if you experience muscle pain, tenderness and weakness without a
specific cause, as muscle problems can, rarely, be serious and lead to muscle tissue damage causing
kidney damage; very rarely, cases of death have occurred.
Reporting of side effects
If you experience 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 Simvastatina Teva B.V.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cardboard box, on the bottle or on the blisters after "Exp". The expiry date refers to the last day of that month.
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 Teva B.V. contains
The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 10 mg,
20 mg, or 40 mg of simvastatin.
The other components are:
Tablet core: monohydrate lactose, hypromellose, sodium croscarmellose, microcrystalline
cellulose, ascorbic acid, anhydrous citric acid, butylated hydroxyanisole, propyl gallate, magnesium
stearate.
Pigment mixture: monohydrate lactose, yellow iron oxide (E172), red iron oxide (E172), and
black iron oxide (E172).

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

Pack sizes:
Blister packs:
10 mg/10 mg
14, 28, 30, 98 and 100 tablets
10 mg/20 mg
28, 30, 90, 98 and 100 tablets
10 mg/40 mg
28, 30, 90, 98 and 100 tablets

HDPE tablet containers:
10 mg/10 mg
30 and 100 tablets
10 mg/20 mg
30, 90 and 100 tablets
10 mg/40 mg
30 and 90 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V.,
Swensweg 5,
2031 GA Haarlem,
The Netherlands

Manufacturer
Balkanpharma-Dupnitsa AD,
3 Samokovsko Shosse Street, Dupnitsa, 2600,
Bulgaria