EZETIMIBE 10 mg/10 mg Tablets

Зміст інструкції

1. Ezetimibe and Simvastatina Tecnigen 10 mg/10 mg tablets, mg/20 mg tablets
   1. What is Ezetimibe and Simvastatina Tecnigen and what it is used for
   2. What you need to know before taking Ezetimibe and Simvastatina Tecnigen
   3. How to take Ezetimibe and Simvastatina Tecnigen
   4. Possible side effects
   5. How to store Ezetimibe and Simvastatina Tecnigen
   6. Contents of the pack and other information

Ezetimibe and Simvastatina Tecnigen 10 mg/10 mg tablets, mg/20 mg tablets

Generic medicine

Read 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Ezetimibe and Simvastatina Tecnigen and what it is used for

Ezetimibe and Simvastatina Tecnigen contains the active ingredients ezetimibe and simvastatin. Ezetimibe and
Simvastatina Tecnigen is a medicine that is used to decrease the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood.
In addition, Ezetimibe and Simvastatina Tecnigen increases the levels of "good" cholesterol (HDL cholesterol).
Ezetimibe and Simvastatina Tecnigen works in two ways to lower cholesterol. The active ingredient
ezetimibe reduces the cholesterol absorbed in the digestive tract. The active ingredient simvastatin, which
belongs to the class of "statins", inhibits the production of cholesterol synthesized
by the body.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is composed mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of the
arteries forming plaques. Over time, this buildup in the form of plaque can
lead to a narrowing of the arteries. This narrowing can slow down or block the flow of
blood to vital organs such as the heart and brain. This 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 accumulating in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that can increase the risk of heart
disease.
Ezetimibe and Simvastatina Tecnigen is used for patients who cannot control their cholesterol levels with diet alone. While taking this medicine you should still
follow a diet to lower cholesterol.
Ezetimibe and Simvastatina Tecnigen is used as an adjunct to diet to lower
cholesterol if you have:

• increased levels of cholesterol in the blood (primary hypercholesterolemia [familial and non-familial heterozygous]) or high levels of fats in the blood (mixed hyperlipidemia): which are not well controlled by a statin alone for whom you have taken treatment with a statin and ezetimibe in separate tablets
• an inherited disease (familial homozygous hypercholesterolemia) that increases your cholesterol levels in the blood. You may also be receiving other treatments.
• heart disease, Ezetimibe and Simvastatina Tecnigen reduces the risk of heart attack, stroke, surgery to increase blood flow or hospitalization for chest pain.

Ezetimibe and Simvastatina Tecnigen does not help with weight loss.

2. What you need to know before taking Ezetimibe and Simvastatina Tecnigen

Do not take Ezetimibe and Simvastatina Tecnigen if:
you are allergic 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 any 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 for the treatment of 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 for the treatment of depression)
• cobicistat
• gemfibrozil (used to lower cholesterol levels)
• cyclosporine (often used in patients who have had an organ transplant)
• 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, a medicine called fusidic acid (used for the treatment of bacterial infections) orally or by injection. The combination of fusidic acid and Ezetimibe and Simvastatina Tecnigen can cause serious muscle problems (rhabdomyolysis).

Do not take more than 10 mg/40 mg of Ezetimibe and Simvastatina Tecnigen if you are taking lomitapide
(used to treat a serious and rare genetic condition of cholesterol).
Ask your doctor for advice if you are not sure whether the medicine you are taking is among those
listed above.

Warnings and precautions
Talk to your doctor:

• about all your medical conditions, including allergies
• if you drink large amounts of alcohol or if you have ever had a liver disease. Ezetimibe and Simvastatina Tecnigen may not be suitable for you.
• If you are going to have surgery. You may need to stop taking Ezetimibe and Simvastatina Tecnigen tablets for a short period of time
• If you are Asian, as a different dose may be appropriate for you.

Your doctor should have a blood test before you start treatment with Ezetimibe and
Simvastatina Tecnigen and if you develop any symptoms of liver problems while taking Ezetimibe and
Simvastatina Tecnigen. This is to check if your liver is functioning properly.
Your doctor may also prescribe a blood test to check your liver function after
starting treatment with Ezetimibe and Simvastatina Tecnigen.
While you are taking this medicine, your doctor will carefully monitor you if you have diabetes or are at
risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars and
fats in your blood, if you are overweight or suffer from high blood pressure.
Tell your doctor if you have a serious lung disease.
The combined use of Ezetimibe and Simvastatina Tecnigen and fibrates (some medicines that lower
cholesterol levels) should be avoided as the combined use of ezetimibe/simvastatin and fibrates has not
been studied.

Contact your doctor immediately if you experience muscle pain, tenderness or weakness
that is unexplained. This is because, in rare cases, muscle problems can be
serious and lead to muscle damage that causes kidney damage; very rarely, deaths have occurred.
The risk of muscle damage is greater at high doses of Ezetimibe and Simvastatina Tecnigen,
especially with the 10/80 mg dose. The risk of muscle damage is also greater in some
patients. Talk to your doctor if any of the following conditions apply to you:

• If you have kidney problems
• If you have thyroid problems
• If you are 65 years of age or older
• If you are female
• If you have ever had muscle problems while taking medicines that lower cholesterol levels, called “statins” (such as simvastatin, atorvastatin and rosuvastatin) or fibrates (such as gemfibrozil and bezafibrato)
• If you or a close family member have a hereditary muscle disease.

Talk to your doctor or pharmacist even if you experience persistent muscle weakness. Further
tests or medicines may be needed to diagnose and treat this disorder.

Children and adolescents
Ezetimibe and Simvastatina Tecnigen is not recommended in children under 10 years of age.

Other medicines and Ezetimibe and Simvastatina Tecnigen
Tell your doctor if you are taking, have recently taken or might take any other
medicine with any of the following active substances. Taking Ezetimibe and Simvastatina Tecnigen
with any of the following medicines may increase the risk of muscle problems (some are
already listed in the section above "Do not take Ezetimibe and Simvastatina Tecnigen"):

• if you need fusidic acid orally to treat a bacterial infection you will need to temporarily stop taking this medicine. Your doctor will tell you when you can safely start taking Ezetimibe and Simvastatina Tecnigen again. Taking Ezetimibe and Simvastatina Tecnigen with fusidic acid can, in rare cases, lead to muscle weakness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• 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 with an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections)
• fibrates with active substances such as gemfibrozil and bezafibrato (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 such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infections)
• nefazodone (used to treat depression)
• medicines with the active substance cobicistat
• amiodarone (used to treat an 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 serious and rare genetic condition of cholesterol)
• 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, tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including those available without a prescription. In
particular, tell your doctor if you are taking any of the following medicines:

• medicines with an active substance used to prevent blood clots, such as warfarin, fluindione, phenprocoumone or acenocoumarol (anticoagulants)
• cholestyramine (also used to lower cholesterol) as it affects the way Ezetimibe and Simvastatina Tecnigen works
• fenofibrate (also used to lower cholesterol)
• rifampicin (used to treat tuberculosis).You should also tell any doctor who is prescribing you a new medicine that you are taking Ezetimibe and Simvastatina Tecnigen.

Ezetimibe and Simvastatina Tecnigen with food, drinks and alcohol
Grapefruit juice contains one or more substances that alter the metabolism of some medicines, including
Ezetimibe and Simvastatina Tecnigen. Consumption of grapefruit juice should be avoided, as it may
increase the risk of muscle problems.

Pregnancy and breastfeeding
Do not take Ezetimibe and Simvastatina Tecnigen if you are pregnant, if you suspect you might be
pregnant or if you are planning to become pregnant. If you become pregnant during treatment with Ezetimibe and Simvastatina
Tecnigen, stop taking it immediately and contact your doctor.
Do not take Ezetimibe and Simvastatina Tecnigen 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 Simvastatina Tecnigen 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 Simvastatina Tecnigen.

Ezetimibe and Simvastatina Tecnigen contains lactose
Ezetimibe and Simvastatina Tecnigen tablets contain a sugar, called lactose. If you
have been diagnosed with intolerance to some sugars, contact your doctor before taking this
medicine.

Ezetimibe and Simvastatina Tecnigen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per , that is to say, it is essentially ‘sodium-free’

3. How to take Ezetimibe and Simvastatina Tecnigen

Your doctor will determine the appropriate tablet dosage for you, based on your current treatment and your
personal risk profile.
The score line is not designed to divide the tablets.
Always take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.
Before starting to take Ezetimibe and Simvastatina Tecnigen you should start following a diet to
lower your cholesterol levels.
During treatment with Ezetimibe and Simvastatina Tecnigen you should continue to follow this diet
to lower cholesterol.

Adults: the dose is 1 tablet orally once a day.

Use in adolescents(10 to 17 years of age): the dose is 1 tablet orally once a day
(you should not exceed the maximum dose of 10 mg/40 mg once a day).
The 10 mg/80 mg dose of Ezetimibe and Simvastatina Tecnigen is recommended only in adult patients
with very high cholesterol levels and at high risk for heart disease who have not reached their ideal cholesterol level with lower doses.
Take Ezetimibe and Simvastatina Tecnigen in the evening. You can take it with or without food.
If your doctor has prescribed Ezetimibe and Simvastatina Tecnigen with another medicine to lower
cholesterol containing the active ingredient colestiramina or any other bile acid sequestrant, you should take Ezetimibe and Simvastatina Tecnigen at least 2 hours before or 4 hours after taking
the bile acid sequestrant.

If you take more Ezetimibe and Simvastatina Tecnigen than you should
Contact your doctor or pharmacist.

If you forget to take Ezetimibe and Simvastatina Tecnigen
Do not take a double dose to make up for a missed tablet, just take your usual dose of Ezetimibe and Simvastatina Tecnigen the next day at the usual time.

If you stop taking Ezetimibe and Simvastatina Tecnigen
Contact your doctor or pharmacist as your cholesterol may increase again. If you have any
doubts about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them
(see section 2, What you need to know before you take Ezetimibe and
Simvastatina Tecnigen).
The following undesirable effects have been reported as common (may affect more than 1 in 10 people):

• Muscle pain
• Increases in blood test values regarding liver function (transaminases) and/or muscles (CK)

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

• increases in blood test values regarding liver function; increases in uric acid levels in the blood; increases in the time it takes for the blood to clot; 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; hives
• joint pain; muscle pain; sensitivity; weakness or spasms; neck pain; arm and leg pain; back pain
• unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet
• sleep disorder; difficulty falling asleep

In addition, the following undesirable effects have been reported in people taking the ezetimibe/simvastatin combination or medicines containing the active ingredients ezetimibe or simvastatin:

• lowering of the number of red blood cells (anaemia); decrease in the number of blood cells, which can cause bruising/bleeding (thrombocytopenia)
• loss of sensitivity or weakness in the 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 tired or weak; loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea and vomiting)
• hair loss; raised, red skin rash, sometimes with target-like lesions (erythema multiforme)
• a hypersensitivity reaction that included some of the following manifestations: allergic reactions including swelling of the face, lips, tongue and/or throat that can cause difficulty breathing or swallowing and requires immediate treatment (angioedema), pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin rashes and swelling, skin sensitivity to the sun, fever, hot flushes, shortness of breath and feeling unwell, a collection of symptoms like lupus (which includes skin rash, joint problems, and effects on white blood cells)). A very rare serious allergic reaction (which can affect up to 1 in 10000 people) can occur causing breathing problems and dizziness and requires immediate treatment (anaphylaxis).
• muscle pain; sensitivity; weakness or muscle cramps; muscle injury; tendon problems, sometimes complicated by tendon rupture
• decreased appetite
• hot flushes; high blood pressure
• pain
• erectile dysfunction
• depression
• alteration of some values of the blood analysis regarding the function of the liver

Further possible side effects reported with some statins:

• sleep disturbances, including nightmares
• sexual problems
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• muscle pain, tenderness or weakness that does not go away after stopping treatment with Ezetimibe and Simvastatina Tecnigen (frequency not known).

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects
directly through 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 Tecnigen

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date that is reported on the label after "Scad.". The
expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ezetimibe and Simvastatina Tecnigen contains
The active ingredients 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.
The other ingredients are lactose monohydrate, anhydrous lactose, hypromellose, butylated hydroxytoluene,
sodium croscarmellose, sodium stearyl fumarate.

Description of the appearance of Ezetimibe and Simvastatina Tecnigen and contents of the pack
Ezetimibe and Simvastatina Tecnigen 10 mg/10 mg tablets are white, oblong, with
length of 8.0 mm ± 0.2 mm and width of 4.4 mm ± 0.2 mm.
Ezetimibe and Simvastatina Tecnigen 10 mg/20 mg tablets are white, oblong, with a
score line on one side, with length of 10.0 mm ± 0.2 mm and width of 5.5 mm ± 0.2
mm.
Ezetimibe and Simvastatina Tecnigen 10 mg/10 mg is available in packs of 30 tablets.
Ezetimibe and Simvastatina Tecnigen 10 mg/20 mg is available in packs of 28 and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira
2710-089 Sintra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations
Portugal: Sinvastatina + Ezetimiba Tecnigen
Italy: Ezetimibe e Simvastatina Tecnigen
Spain: Ezetimiba/Simvastatina TecniGen 10 mg/20 mg comprimidos EFG