Rosuvastatin and ezetimibe EG: detailed information

Patient Information Leaflet

Rosuvastatin and Ezetimibe EG, 5 mg/10 mg hard capsules, 10 mg/10 mg hard capsules, 20 mg/10 mg hard capsules

Rosuvastatin/Ezetimibe

Please read all of 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on 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, inform your doctor, pharmacist, or nurse. See section 4.

What is in this leaflet:

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

1. What Rosuvastatina and Ezetimibe EG is and what it is used for

Rosuvastatina and Ezetimibe EG capsules contain two different active substances in one capsule.
One active substance is rosuvastatin, belonging to a group of medicines called “statins”,
the other is ezetimibe.
Rosuvastatina and Ezetimibe EG is a medicine used to lower total cholesterol levels,
“bad” cholesterol (LDL cholesterol), and blood fats 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,
leading to their narrowing. Sometimes, this narrowing of blood vessels can block blood flow to the heart or brain, resulting in heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health problems can be reduced.
Rosuvastatina and Ezetimibe EG capsules are used for patients whose cholesterol levels can no longer 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 Rosuvastatina and Ezetimibe EG capsules if you are already taking rosuvastatin and ezetimibe at the same doses.
Rosuvastatina and Ezetimibe EG capsules are used if you have:

increased cholesterol levels in the blood (primary hypercholesterolaemia);
heart disease, in which case Rosuvastatina and Ezetimibe EG reduces the risk of heart attack, stroke, surgical intervention to improve blood flow to the heart, or hospitalisation due to chest pain.

Rosuvastatina and Ezetimibe EG capsules do not help with weight loss.

2. What you should know before taking Rosuvastatin and Ezetimibe EG

Do not take Rosuvastatin and Ezetimibe EG:

If you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6).
If you have liver disease.
If you have severe kidney impairment.
If you have unexplained, repeated muscle pain or tenderness (myopathy).
If you are taking a medicine called cyclosporine (used, for example, after an organ transplant).
If you are taking the combination medicine sofosbuvir/velpatasvir/voxilaprevir (used for viral liver infection known as hepatitis C).
If you are pregnant or breastfeeding.
If you become pregnant while taking Rosuvastatin and Ezetimibe EG capsules, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking Rosuvastatin and Ezetimibe EG by using appropriate contraceptive measures (see "Pregnancy and breastfeeding").
If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Rosuvastatin and Ezetimibe EG or other related medicines. 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 Rosuvastatin and Ezetimibe EG if:

You have kidney problems.
You have liver problems.
You have experienced unexplained, repeated 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 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 are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must choose the appropriate dose of Rosuvastatin and Ezetimibe EG capsules for you.
You are taking medicines used to treat infections, including HIV or hepatitis C infection, e.g., lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir and/or pibrentasvir; see “Other medicines and Rosuvastatin and Ezetimibe EG capsules”.
You suffer from severe respiratory insufficiency.
You are taking other medicines called fibrates to lower cholesterol. See “Other medicines and Rosuvastatin and Ezetimibe EG capsules”.
You regularly consume large amounts of alcohol.
You have an underactive thyroid (hypothyroidism).
You are over 70 years old (as your doctor must choose the appropriate dose of Rosuvastatin and Ezetimibe EG capsules for you).
You are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection.
The combination of fusidic acid and Rosuvastatin and Ezetimibe EG capsules may lead to serious
muscle problems (rhabdomyolysis).
If any of these situations apply to you (or if you have any doubts), consult your doctor or pharmacist
before starting to take any dose of Rosuvastatin and Ezetimibe EG capsules.
In a small number of people, statins may affect liver function. This can be detected by a simple blood test that measures increased levels of liver enzymes. For this reason, your doctor will ask you to have this test (liver function test) during treatment with Rosuvastatin and Ezetimibe EG capsules. 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 your blood, if you are overweight, or if you have high blood pressure.
If you are hospitalized or undergoing treatment for other medical conditions, inform the medical staff that you are taking Rosuvastatin and Ezetimibe EG capsules.
Serious skin reactions, including Stevens-Johnson syndrome and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported in association with treatment with rosuvastatin/ezetimibe. Stop taking Rosuvastatin and Ezetimibe EG and contact a doctor immediately if you notice any of the symptoms described in section 4.

Children and adolescents
The use of Rosuvastatin and Ezetimibe EG is not recommended in children and adolescents under 18 years of age.

Other medicines and Rosuvastatin and Ezetimibe EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell 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 Rosuvastatin and Ezetimibe EG capsules concomitantly with cyclosporine.
Blood thinners, e.g., warfarin, acenocoumarol, or phenindione (their blood-thinning effect and risk of bleeding may increase when taken together with Rosuvastatin and Ezetimibe EG capsules), ticagrelor, or clopidogrel.
Other cholesterol-lowering medicines called fibrates, which also correct triglyceride levels (e.g., gemfibrozil or other fibrates). Concomitant use increases the effect of rosuvastatin.
Colestipol (a medicine to lower cholesterol levels), as it interferes with the action of ezetimibe.
Regorafenib (used for cancer treatment).
Darolutamide (used for cancer treatment).
Any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see “Warnings and precautions”): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
Antacids or medicines for indigestion containing aluminium and magnesium (used to neutralize stomach acid; these metals reduce rosuvastatin levels in the blood). This effect may be minimized by taking these remedies or medicines 2 hours after taking 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 Rosuvastatin and Ezetimibe EG capsules. Your doctor will advise you when it is safe to restart taking Rosuvastatin and Ezetimibe EG. Taking Rosuvastatin and Ezetimibe EG 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 hormonal levels from the pill.
Hormone replacement therapy (increases hormone levels in the blood).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take Rosuvastatin and Ezetimibe EG if you are pregnant, suspect you may be pregnant,
or are planning to become pregnant. If you become pregnant while taking Rosuvastatin and
Ezetimibe EG, stop taking it immediately and inform your doctor. Women must always use
appropriate contraceptive measures during treatment with Rosuvastatin and Ezetimibe EG.

Breastfeeding
Do not take Rosuvastatin and Ezetimibe EG during breastfeeding, as it is not known whether
the medicine passes into breast milk.

Driving and using machines
Rosuvastatin and Ezetimibe EG should not affect your ability to drive or use machines. However,
you should be aware that some people may experience dizziness after taking Rosuvastatin and
Ezetimibe EG capsules. If you experience dizziness, consult your doctor before driving or using
machinery.

Rosuvastatin and Ezetimibe EG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before
taking this medicine.

Rosuvastatin and Ezetimibe EG contains sodium
Rosuvastatin and Ezetimibe EG contains less than 1 mmol of sodium (23 mg) per capsule, i.e.,
essentially "sodium-free".

3. How to take Rosuvastatin and Ezetimibe EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You must continue to follow a cholesterol-lowering diet and maintain physical activity while taking Rosuvastatin and Ezetimibe EG capsules.
The recommended daily dose for adults is one capsule of the specific strength prescribed by your doctor.
Take Rosuvastatin and Ezetimibe EG once daily.
The Rosuvastatin and Ezetimibe EG capsule can be taken at any time of day, with or without food. Swallow the capsule whole with a glass of water.
Try to take the capsules at approximately the same time each day.
Rosuvastatin and Ezetimibe EG capsules are not suitable for initial therapy. Treatment initiation or dose adjustment, if necessary, must only be performed by administering the two active substances separately; once the appropriate doses have been established, switching to Rosuvastatin and Ezetimibe EG may be considered.
If your doctor has prescribed Rosuvastatin and Ezetimibe EG together with another cholesterol-lowering medicine containing the active ingredient cholestyramine or any other medicine containing a bile acid sequestrant, you must take Rosuvastatin and Ezetimibe EG at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular cholesterol monitoring
It is important to return to your doctor regularly to check your cholesterol levels, to ensure that cholesterol has reached and remains within the normal range.

If you take more Rosuvastatin and Ezetimibe EG than you should
Contact your doctor or go to the nearest hospital emergency department, as you may require medical attention.

If you forget to take Rosuvastatin and Ezetimibe EG
Do not be alarmed; 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 Rosuvastatin and Ezetimibe EG
Inform your doctor if you intend to stop treatment with Rosuvastatin and Ezetimibe EG. If you stop taking Rosuvastatin and Ezetimibe EG capsules, your cholesterol levels may rise again.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. It is important that you are aware of what these side effects may be.
Stop taking Rosuvastatin and Ezetimibe EG capsules and seek
immediate medical help if you experience any of the following allergic reactions:

swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing;
severe itching of the skin (with raised lumps);
red, non-elevated spots shaped like targets or rings on the trunk, often with central blisters, peeling of the skin, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking Rosuvastatin and Ezetimibe EG and contact your doctor immediately
if you have:

any unusual muscle pain or pain that lasts longer than expected. Rarely, this may progress to a potentially life-threatening muscle damage known as rhabdomyolysis, which can lead to malaise, fever, and kidney failure;
lupus-like illness syndrome (including skin rash, joint problems, and effects on blood cells);
muscle breakdown.

The following terms are used to describe how frequently 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 reports).

Common side effects:

headache;
constipation;
feeling unwell;
muscle pain;
feelings of weakness;
dizziness;
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 while you are taking this medicine;
stomach ache;
diarrhoea;
flatulence (excess gas in the digestive tract);
feeling tired;
increases in liver function tests in blood laboratory tests (transaminases).

Uncommon side effects:

rash, itching, hives;
increased amount of protein in the urine, which usually returns to normal on its own without stopping rosuvastatin;
increases in blood laboratory tests of muscle function (CK);
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 in hands and feet.

Rare side effects:
Inflammation of the pancreas, causing severe stomach pain that may spread to the back, reduction in platelets in the blood.
Very rare side effects:
Jaundice (yellowing of the skin and eyes), inflammation of the liver (hepatitis), traces of blood in the urine, nerve damage in arms and legs (such as numbness), memory loss, breast enlargement in men (gynaecomastia).
Not known (frequency cannot be estimated from the available data):
Shortness of breath, oedema (swelling), sleep disorders including insomnia and nightmares, sexual difficulties, depression, breathing problems including persistent cough and/or shortness of breath or fever, tendon injuries, persistent muscle weakness, gallstones or inflammation of the gallbladder (which may cause stomach pain, nausea, vomiting).
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
https://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 Rosuvastatin and Ezetimibe EG

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 packaging and on the blister after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Rosuvastatina e Ezetimibe EG contains
The active substances are rosuvastatin (as rosuvastatin calcium) and ezetimibe.
Each hard capsule contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of
ezetimibe.
Each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of
ezetimibe.
Each hard capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of
ezetimibe.
The other ingredients are:

Capsule content: monohydrate lactose, hypromellose, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose, sodium stearyl fumarate, lactose (anhydrous), crospovidone, talc (E553b), anhydrous colloidal silica, titanium dioxide (E171), triacetin (E1518), red iron oxide (E172).
Composition of the 5 mg/10 mg capsule: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
Composition of the 10 mg/10 mg capsule: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Composition of the 20 mg/10 mg capsule: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), indigotine (E132).

Description of the appearance of Rosuvastatina e Ezetimibe EG and package contents
Rosuvastatina e Ezetimibe EG 5 mg/10 mg capsules are hard gelatin capsules with orange cap and body, filled with 1 pink film-coated tablet and 2 white tablets.
Rosuvastatina e Ezetimibe EG 10 mg/10 mg capsules are hard gelatin capsules with yellow cap and body, filled with 2 pink film-coated tablets and 2 white tablets.
Rosuvastatina e Ezetimibe EG 20 mg/10 mg capsules are hard gelatin capsules with green cap and white body, filled with 4 pink film-coated tablets and 2 white tablets.
Rosuvastatina e Ezetimibe EG 5 mg/10 mg hard capsules are available in packages containing 10 and 30 capsules in blisters.
Rosuvastatina e Ezetimibe EG 10 mg/10 mg hard capsules are available in packages containing 30 capsules in blisters.
Rosuvastatina e Ezetimibe EG 20 mg/10 mg hard capsules are available in packages containing 30 capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.P.A.
VIA PAVIA, 6
20136 MILANO
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2 Abrunheira,
2710-089 Sintra
Portugal.
This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: Rosuvastatina e Ezetimibe EG.
Portugal: Rosuvastatina + Ezetimiba Tecnimede
Spain: Rosuvastatina/ezetimiba Normon 5mg/10mg cápsulas duras
Rosuvastatina/ezetimiba Normon 10mg/10mg cápsulas duras
Rosuvastatina/ezetimiba Normon 20mg/10mg cápsulas duras