Ezetimibe and simvastatin Doc Generici: detailed information

Patient Information Leaflet

EZETIMIBE AND SIMVASTATIN DOC Generics 10 mg/10 mg tablets, mg/20 mg tablets, mg/40 mg tablets, mg/80 mg tablets

Generic medicine
Please read this leaflet carefully before 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, because it may be harmful to them.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What EZETIMIBE AND SIMVASTATIN DOC Generics is and what it is used for
What you need to know before taking EZETIMIBE AND SIMVASTATIN DOC Generics
How to take EZETIMIBE AND SIMVASTATIN DOC Generics
Possible side effects
How to store EZETIMIBE AND SIMVASTATIN DOC Generics
Contents of the pack and other information

1. What EZETIMIBE and SIMVASTATIN DOC Generici is and what it is used for

EZETIMIBE and SIMVASTATIN DOC Generici is a medicine used to lower
levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat-like substances
called triglycerides in the blood. In addition, EZETIMIBE and SIMVASTATIN DOC Generici increases
levels of "good" cholesterol (HDL cholesterol).
EZETIMIBE and SIMVASTATIN DOC Generici contains the active substances ezetimibe and simvastatin.
EZETIMIBE and SIMVASTATIN DOC Generici works in two ways to lower cholesterol. The active
substance ezetimibe reduces 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 is made up 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 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 form of fat in the blood that may increase the risk of heart disease.
EZETIMIBE and SIMVASTATIN DOC Generici 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 DOC Generici is used as an add-on to diet to lower cholesterol when 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
a hereditary disease (homozygous familial hypercholesterolemia) that increases your blood cholesterol levels. You may also be receiving other treatments.
heart disease; EZETIMIBE and SIMVASTATIN DOC Generici reduces the risk of heart attack, stroke, surgical procedures to improve blood flow, or hospitalization due to chest pain.

EZETIMIBE and SIMVASTATIN DOC Generici does not help with weight loss.

2. What you need to know before taking EZETIMIBE and SIMVASTATIN DOC Generics

Do not take EZETIMIBE and SIMVASTATIN DOC Generics:

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 or gemfibrozil (used to lower cholesterol); cyclosporine (often used in organ transplant patients); or danazol (a synthetic 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, or have been prescribed fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and EZETIMIBE and SIMVASTATIN DOC Generics may lead to a serious muscle problem (rhabdomyolysis)
do not take more than 10 mg/40 mg of EZETIMIBE and SIMVASTATIN DOC Generics 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

Tell your doctor or pharmacist before taking EZETIMIBE and SIMVASTATIN DOC Generics:

if you have any medical condition, including allergies
if you drink large amounts of alcohol or have ever had liver disease. In this case, EZETIMIBE and SIMVASTATIN DOC Generics may not be suitable for you
if you are due to undergo surgery. You may need to stop taking EZETIMIBE and SIMVASTATIN DOC Generics for a short time
if you are of Asian descent, as you may require a different dose

Your doctor will perform a blood test before starting EZETIMIBE and SIMVASTATIN DOC Generics. This test checks how well your liver is functioning.
Your doctor may also perform further blood tests to monitor liver function after you start taking EZETIMIBE and SIMVASTATIN DOC Generics.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high blood sugar and fat levels, being overweight, and having high blood pressure.
Inform your doctor if you have a serious lung disease.

The combined use of EZETIMIBE and SIMVASTATIN DOC Generics with fibrates (a class of cholesterol-lowering medicines) should be avoided, as the combination has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness.
Muscle problems can, rarely, be serious and lead to muscle tissue damage causing kidney damage; very rarely, fatal cases have occurred.
Always inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatment may be required.

The risk of muscle injury is higher at higher doses of EZETIMIBE and SIMVASTATIN DOC Generics, particularly with the 10 mg/80 mg dose. The risk of muscle injury 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 previously experienced muscle problems during treatment with cholesterol-lowering medicines known as "statins" (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil and bezafibrate)
you or your close family members have a hereditary muscle disorder.

Children and adolescents

The use of EZETIMIBE and SIMVASTATIN DOC Generics is not recommended in children under 10 years of age.

Other medicines and EZETIMIBE and SIMVASTATIN DOC Generics

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 DOC Generics with any of the following medicines may increase the risk of muscle problems (some have already been mentioned in the section "Do not take EZETIMIBE and SIMVASTATIN DOC Generics"):

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 DOC Generics.
Taking EZETIMIBE and SIMVASTATIN DOC Generics with fusidic acid may, in rare cases, lead to muscle weakness or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4 of this leaflet
cyclosporine (often used in patients receiving 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)
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, have recently taken, or might take any other medicines, including those without a prescription. In particular, tell your doctor if you are taking any of the following:

medicines containing an active substance to prevent blood clots, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants)
colestyramine (also used to lower cholesterol), as it may affect how EZETIMIBE and SIMVASTATIN DOC Generics works
fenofibrate (also used to lower cholesterol)
rifampicin (used to treat tuberculosis)

You must also inform any doctor who is prescribing you a new medicine that you are taking EZETIMIBE and SIMVASTATIN DOC Generics.

EZETIMIBE and SIMVASTATIN DOC Generics with food and drink

Grapefruit juice contains one or more substances that alter the metabolism of certain medicines, including EZETIMIBE and SIMVASTATIN DOC Generics. Consumption of grapefruit juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

Do not take EZETIMIBE and SIMVASTATIN DOC Generics if you are pregnant, suspect you may be pregnant, or are planning to become pregnant. If you become pregnant while taking EZETIMIBE and SIMVASTATIN DOC Generics, stop taking it immediately and contact your doctor. Do not take EZETIMIBE and SIMVASTATIN DOC Generics 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 DOC Generics 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 DOC Generics.

EZETIMIBE and SIMVASTATIN DOC Generics contains lactose

EZETIMIBE and SIMVASTATIN DOC Generics tablets contain a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

EZETIMIBE and SIMVASTATIN DOC Generics contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take EZETIMIBE AND SIMVASTATIN DOC Generici

Your doctor will determine the appropriate tablet dose for you, based on your current treatment and individual risk profile.
The tablets have no 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 DOC Generici, you must already be following a cholesterol-lowering diet.
During treatment with EZETIMIBE AND SIMVASTATIN DOC Generici, you must continue to follow this cholesterol-lowering diet.

Adults: The dose is 1 tablet of EZETIMIBE AND SIMVASTATIN DOC Generici taken orally once daily.
Adolescents (aged 10 to 17 years): The dose is 1 tablet of EZETIMIBE AND SIMVASTATIN DOC Generici taken orally once daily (the maximum dose must not exceed 10 mg/40 mg once daily).
The EZETIMIBE AND SIMVASTATIN DOC Generici 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.
If optimal dosing cannot be achieved with EZETIMIBE AND SIMVASTATIN DOC Generici, your doctor may prescribe other tablets containing ezetimibe/simvastatin.
Take EZETIMIBE AND SIMVASTATIN DOC Generici in the evening. It can be taken with or without food.
If your doctor has prescribed EZETIMIBE AND SIMVASTATIN DOC Generici together with another cholesterol-lowering medicine containing the active ingredient cholestyramine or any other bile acid sequestrant, you must take EZETIMIBE AND SIMVASTATIN DOC Generici at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more EZETIMIBE AND SIMVASTATIN DOC Generici than you should:
Contact your doctor or pharmacist.

If you forget to take EZETIMIBE AND SIMVASTATIN DOC Generici:
Do not take a double dose to make up for the forgotten tablet. Take only the next normal dose at the usual time the following day.

If you stop taking EZETIMIBE AND SIMVASTATIN DOC Generici:
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, What you should know before taking EZETIMIBE and SIMVASTATINA DOC Generici).

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

In addition, the following side effects have been reported in people taking the combination of ezetimibe/simvastatin or medicines containing the active substances ezetimibe or simvastatin:
o reduced number of red blood cells (anaemia); reduced number of blood cells, which may cause bruising/bleeding (thrombocytopenia)
o loss of sensation or weakness in arms and legs; memory impairment; memory loss; confusion
o breathing problems including persistent cough and/or shortness of breath or fever
o constipation
o inflammation of the pancreas, often with severe abdominal pain
o liver inflammation 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)
o hair loss; red raised skin rash, sometimes with target-like lesions (erythema multiforme)
o 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), a severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis, which may affect up to 1 in 10,000 people, and anaphylactic reactions), joint pain or inflammation, 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)
o muscle pain; tenderness; weakness or cramps; muscle damage; tendon problems, sometimes complicated by tendon rupture
o decreased appetite
o hot flushes; high blood pressure
o pain
o erectile dysfunction
o depression
o changes in certain blood test values related to liver function

Additional possible side effects reported with some statins:
o sleep disorders, including nightmares
o sexual difficulties
o 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.
o persistent muscle pain, tenderness or weakness that does not resolve after stopping treatment with EZETIMIBE and SIMVASTATINA DOC Generici (frequency not known: cannot be estimated from 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 experience any side effect, 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 DOC Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the word "EXP". The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EZETIMIBE AND SIMVASTATIN DOC Generici 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. Each tablet contains 10 mg of ezetimibe and 80 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. 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 DOC Generici and contents of the pack
EZETIMIBE and SIMVASTATIN DOC Generici 10 mg/10 mg tablets: light brown, mottled, round, 6 mm in diameter, biconvex tablets, smooth on one side and engraved with “511” on the other side.
EZETIMIBE and SIMVASTATIN DOC Generici 10 mg/20 mg tablets: light brown, mottled, round, 8 mm in diameter, biconvex tablets, smooth on one side and engraved with “512” on the other side.
EZETIMIBE and SIMVASTATIN DOC Generici 10 mg/40 mg tablets: light brown, mottled, round, 10 mm in diameter, biconvex tablets, smooth on one side and engraved with “513” on the other side.
EZETIMIBE and SIMVASTATIN DOC Generici 10 mg/80 mg tablets: light brown, mottled, capsule-shaped, sized 17.5x7.55 mm, biconvex tablets, smooth on one side and engraved with “515” on the other side.
Pack sizes: blisters containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl
Via Turati 40
20121 Milano
Italy

Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitza 2600
Bulgaria
Special Product’s Line S.p.A
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Denmark: Ezetimib/Simvastatin Doc Generici
Italy: EZETIMIBE and SIMVASTATIN DOC Generici