Ezateros

Package leaflet: Information for the user

EZATEROS 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets

Rosuvastatin and Ezetimibe
Please read this leaflet carefully before you start 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, as 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:

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

1. What EZATEROS is and what it is used for

EZATEROS contains two different active substances in one tablet. One active substance is rosuvastatin,
belonging to a group of medicines called “statins”, the other is ezetimibe.
EZATEROS tablets is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances in the blood called triglycerides. In addition, it increases levels of “good” cholesterol (HDL cholesterol). This medicine reduces cholesterol in two ways: by reducing the amount absorbed from the digestive tract and by decreasing the body's own production of cholesterol.
For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow. Sometimes, this narrowing of blood vessels can block blood flow to the heart or brain, leading to heart attack or stroke. Lowering cholesterol levels may reduce the risk of heart attack, stroke, or other health problems related to high cholesterol.
EZATEROS tablets are used for patients whose cholesterol levels cannot be controlled by a low-cholesterol diet alone. You must continue to follow a cholesterol-lowering diet during treatment with this medicine. Your doctor may prescribe EZATEROS tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
EZATEROS tablets are used if you have:

• increased cholesterol levels in the blood (primary hypercholesterolaemia);
• heart disease; EZATEROS reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalisation due to chest pain.

EZATEROS tablets do not help with weight loss.

2. What you need to know before taking EZATEROS tablets

Do not take EZATEROS tablets

• if you have previously had an allergic reaction to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding. If you become pregnant while taking EZATEROS, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with EZATEROS by using appropriate contraceptive measures (see below: Pregnancy and breastfeeding);
• if you have liver disease;
• if you have severe kidney impairment;
• if you have repeated or unexplained muscle pain or tenderness (myopathy);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If any of these apply to you (or if you have any doubts), consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking EZATEROS if:

• you have kidney problems;
• you have liver problems;
• you have experienced unexplained muscle pain or tenderness, or have a personal or family history of muscle disorders, or have previously experienced muscle problems while taking other cholesterol-lowering medicines. Inform your doctor or pharmacist immediately if you experience unexplained muscle pain or tenderness, especially if accompanied by malaise or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
• you regularly consume large amounts of alcohol;
• you have an underactive thyroid (hypothyroidism);
• you are taking other cholesterol-lowering medicines called fibrates. See “Other medicines and EZATEROS tablets”;
• you are taking medicines used to treat HIV infections, e.g. lopinavir/ritonavir and/or atazanavir. See “Other medicines and EZATEROS tablets”;
• you are over 70 years of age (your doctor needs to choose the correct dosage for you);
• you have severe respiratory failure;
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the correct dosage for you;
• you are currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) taken orally or by injection. The combination of fusidic acid and EZATEROS may lead to serious muscle problems (rhabdomyolysis).

If any of these apply to you (or if you have any doubts): consult your doctor or pharmacist before
starting to take any dose of EZATEROS tablets.
In a small number of people, statins may affect liver function, which can be detected
by a simple blood test showing increased levels of liver enzymes. For this reason,
your doctor will request this test (liver function test) during treatment with
EZATEROS tablets. It is important to attend your doctor’s appointments for prescribed laboratory tests.
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 the blood, are overweight, and have high blood pressure.
If you are hospitalized or undergoing treatment for another condition, inform the medical staff
that you are taking EZATEROS tablets.
Children and adolescents
The use of EZATEROS tablets is not recommended in children and adolescents under 18 years of age.
Other medicines and EZATEROS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
Inform your doctor if you are taking any of the following medicines:

• cyclosporine (used, for example, after organ transplantation to prevent organ rejection). The effect of rosuvastatin increases when used together with this medicine. Do not take EZATEROS concomitantly with cyclosporine;
• anticoagulants such as warfarin, acenocoumarol, or phenindione (their anticoagulant effect and risk of bleeding may increase if taken together with EZATEROS or clopidogrel);
• other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). The effect of rosuvastatin is increased during concomitant use;
• colestyramine (a medicine to lower cholesterol levels), as it may alter the function of ezetimibe;
• antacids containing aluminium and magnesium (used to neutralize stomach acids; these metals reduce rosuvastatin levels in the blood). This effect may be minimized by taking this type of medicine 2 hours after rosuvastatin;
• erythromycin (an antibiotic). Concomitant use of this antibiotic reduces the effect of rosuvastatin;
• fusidic acid. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart EZATEROS tablets. Taking EZATEROS tablets with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). See section 4 for more information on rhabdomyolysis;
• oral contraceptives (the pill). These increase the absorbed hormone levels from the pill;
• hormone replacement therapy (increases hormone levels in the blood);
• regorafenib (used for the treatment of tumours);
• any of the following medicines used to treat viral infections, including HIV or Hepatitis C, used alone or in combination (see “Warnings and precautions”): ritonavir, lopinavir, atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If you are hospitalized or undergoing treatment for another condition, inform the medical staff
that you are taking EZATEROS tablets.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take EZATEROS tablets if you are pregnant, suspect you may be pregnant, or are planning a
pregnancy. If you become pregnant while taking EZATEROS, stop taking it immediately and
inform your doctor. Women must always use effective contraceptive measures during treatment with
EZATEROS tablets.
Breastfeeding
Do not take EZATEROS tablets during breastfeeding, as it is not known whether the medicine is
excreted in breast milk.
Driving and using machines
EZATEROS tablets should not affect your ability to drive or use machines. However,
it should be considered that some people may experience dizziness after taking
EZATEROS tablets. If you experience dizziness, consult your doctor before driving or using
machinery.
EZATEROS contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.

3. How to take EZATEROS tablets

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
You must continue to follow a low-cholesterol diet and engage in physical activity while taking
EZATEROS tablets.
The recommended daily dose for adults is one tablet of the specific strength.
Take EZATEROS tablets once daily.
It can be taken at any time of day, with or without food. Swallow each tablet whole with a glass of water.
Try to take the tablets at approximately the same time each day.
EZATEROS tablets are not suitable for initial therapy. Treatment initiation or dose adjustment, if needed,
must only be performed by administering the active substances separately; after appropriate doses have been established, switching to EZATEROS tablets is possible.
Periodic cholesterol checks
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and remains within normal limits.
If you take more EZATEROS tablets than you should
Contact your doctor or the nearest hospital emergency department, as you may require medical assistance.
If you forget to take EZATEROS tablets
Do not panic; take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking EZATEROS tablets
Inform your doctor if you intend to stop taking EZATEROS tablets. If you stop taking EZATEROS tablets, 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 everyone experiences them. It is important to be aware of the possible side effects. They are usually mild and disappear in a short time.

Stop taking EZATEROS tablets and go to a doctor immediately if you experience any of the following allergic reactions:

• swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and swallowing;
• a set of symptoms similar to those of lupus (including skin rash, joint disorders and effects on blood cells);
• muscle breakdown.

Contact your doctor immediately if you have unusual muscle tenderness or pain that lasts longer than expected. These may rarely develop into a fatal muscle damage known as rhabdomyolysis, which leads to malaise, fever and kidney dysfunction.

The following terms are used to describe how often the side effects have been reported:

• very common (may affect more than 1 in 10 people)
• common (may affect up to 1 in 10 people)
• uncommon (may affect up to 1 in 100 people)
• rare (may affect up to 1 in 1,000 people)
• very rare (may affect up to 1 in 10,000 people, including isolated cases).

Common side effects

• headache;
• stomach pain;
• constipation;
• feeling unwell;
• muscle pain;
• feeling weak;
• dizziness;
• diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine;
• feeling tired;
• diarrhoea;
• flatulence (excess gas in the intestine);
• increased transaminase levels in laboratory blood tests assessing liver function.

Uncommon side effects

• skin rash, itching, hives;
• increase in the amount of protein in the urine – this usually returns to normal without needing to stop taking rosuvastatin;
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• loss of appetite;
• pain;
• chest pain;
• hot flushes;
• high blood pressure;
• tingling sensation;
• dry mouth;
• inflammation of the stomach;
• back pain;
• muscle weakness;
• pain in arms and legs;
• swelling, especially of hands and feet.

Rare side effects
Inflammation of the pancreas, causing severe stomach pain spreading to the back, reduction in platelets.

Very rare side effects
Jaundice (yellowing of the skin and eyes), liver inflammation (hepatitis), presence of blood in the urine, nerve damage in the arms and legs (such as numbness), memory loss, breast enlargement in men (gynaecomastia).

Not known
Shortness of breath, oedema (swelling), sleep disorders including difficulty sleeping and nightmares, sexual problems, depression, breathing problems including persistent cough and/or shortness of breath or fever, tendon disorders, persistent muscle weakness, gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting).

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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EZATEROS tablets

Keep in the original packaging to protect the medicine from light.
This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister.
The expiry date refers to the last day of that month.
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 EZATEROS tablets contain
The active substances are rosuvastatin (as rosuvastatin calcium salt) and ezetimibe. The tablets contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg and 20 mg of rosuvastatin and 10 mg of ezetimibe.
The other components are: monohydrate lactose, microcrystalline cellulose type 101, microcrystalline cellulose type 102, croscarmellose sodium, cross-linked povidone, povidone, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of EZATEROS tablets and pack contents
EZATEROS 5 mg/10 mg tablets: white or almost white, round, flat tablets, imprinted with "E2" on one side and "2" on the other side. The tablet diameter is 10 mm.
EZATEROS 10 mg/10 mg tablets: white or almost white, oval, biconvex tablets, imprinted with "E1" on one side and "1" on the other side. The tablet dimensions are 15 mm x 7 mm.
EZATEROS 20 mg/10 mg tablets: white or almost white, round, biconvex tablets. The tablet diameter is 11 mm.
Pack size: 28 tablets in blisters (PA/AL/PVC//Al), contained in a cardboard box with the package leaflet.
Not all pack sizes may be marketed.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy

Marketing Authorization Holder for Sale:
Istituto Luso Farmaco D’Italia SpA
Milanofiori - Strada 6 - Edificio L
Rozzano (MI)
Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy