Package leaflet: Information for the user

MAORIS 5 mg/10 mg tablets, 10 mg/10 mg tablets, 20 mg/10 mg tablets

Rosuvastatin and Ezetimibe
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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MAORIS is and what it is used for

MAORIS contains two different active substances in one tablet. One active substance is rosuvastatin, which belongs to a group of medicines called "statins", the other is ezetimibe.
MAORIS is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat 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. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health problems can be reduced.
MAORIS is 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 MAORIS to you if you are already taking rosuvastatin and ezetimibe at the same doses.
MAORIS is used if you have:

increased cholesterol levels in the blood (primary hypercholesterolemia);
heart disease; in such cases, MAORIS reduces the risk of heart attack, stroke, surgical intervention to improve blood flow to the heart, or hospitalization due to chest pain.

MAORIS does not help with weight loss.

2. What you should know before taking MAORIS

Do not take MAORIS

if you have previously had an allergic reaction to rosuvastatin, ezetimibe, or any of the other components of this medicine (listed in section 6);
if you are pregnant or breastfeeding. If you become pregnant while taking MAORIS, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking MAORIS by using appropriate contraceptive measures (see "Pregnancy and breastfeeding");
if you have liver disease;
if you have severe kidney impairment;
if you have unexplained, recurrent muscle pain or tenderness (myopathy);
if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking MAORIS or other medicines containing rosuvastatin.

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 MAORIS if:

you have kidney problems;
you have liver problems;
you have experienced unexplained, recurrent muscle pain or tenderness, 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 MAORIS";
you are taking medicines used to treat HIV infections, e.g. lopinavir/ritonavir and/or atazanavir. See "Other medicines and MAORIS";
you are over 70 years old (your doctor needs to choose the correct dosage suitable 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 suitable 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 MAORIS can lead to serious muscle problems (rhabdomyolysis);
severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with MAORIS. Stop using MAORIS and seek immediate medical attention if you notice any of the symptoms described in section 4;
you have or have had myasthenia (a disease characterized by generalized muscle weakness, sometimes including muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may occasionally worsen myasthenia or trigger its onset (see section 4).

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 MAORIS.
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 ask you to undergo this test (liver function test) during treatment with
MAORIS. It is important to attend your doctor's appointments for prescribed laboratory tests.
During treatment with this medicine, your doctor will carefully 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.
If you are hospitalized or undergoing treatment for other conditions, inform the medical staff that you
are taking MAORIS.
Children and adolescents
The use of MAORIS is not recommended in children and adolescents under 18 years of age.
Other medicines and MAORIS
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 MAORIS concomitantly with cyclosporine;
anticoagulants such as warfarin, acenocoumarol, fluindione (their anticoagulant effect and risk of bleeding may increase when taken with MAORIS), 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;
colestyramine (a medicine to lower cholesterol levels), as it alters the function of ezetimibe;
remedies 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 will need to temporarily stop taking MAORIS. Your doctor will advise you when it is safe to restart MAORIS. Taking MAORIS 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 hormonal levels absorbed from the pill;
hormone replacement therapy (increases hormone levels in the blood);
regorafenib (used to treat tumors);
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, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If you are hospitalized or undergoing treatment for other conditions, inform the medical staff
that you are taking MAORIS.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take MAORIS if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
If you become pregnant while taking MAORIS, stop taking it immediately and inform your doctor.
Women must always use effective contraceptive measures during treatment with MAORIS.
Breastfeeding
Do not take MAORIS during breastfeeding, as it is unknown whether the medicine passes into breast
milk.
Driving and using machines
MAORIS is not expected to affect your ability to drive or use machines. However, you should be aware
that some people may experience dizziness after taking MAORIS. If you experience dizziness, consult
your doctor before driving or using machines.
MAORIS contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before
taking this medicine.

3. How to take MAORIS

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and engage in physical activity while taking MAORIS.
The recommended daily dose for adults is one tablet of the specific strength prescribed by your doctor.
Take MAORIS once daily.
The MAORIS tablet can be taken at any time of day, with or without food.
Swallow the tablet whole with a glass of water.
Try to take the tablets at approximately the same time each day.
MAORIS is not suitable for initial therapy. Treatment initiation or dose adjustment, if necessary, must be performed only by administering the two active substances separately; switching to MAORIS is possible only after appropriate doses have been established.
Periodic cholesterol monitoring
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and remains within the normal range.
If you take more MAORIS than you should
Contact your doctor or the nearest hospital emergency department, as you may require medical attention.
If you forget to take MAORIS
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 MAORIS
Inform your doctor if you intend to stop taking MAORIS. If you discontinue MAORIS, your cholesterol levels may rise again.
If you have any questions about the use of 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.
Usually they are mild and disappear in a short time.
Stop taking MAORIS and seek immediate medical attention 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;
flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals, and eyes. These severe 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);
lupus-like illness (including skin rash, joint problems, and effects on blood cells);
muscle rupture.

Contact your doctor immediately if you have unusual muscle tenderness or pain that lasts longer than expected. Rarely, these symptoms may progress to 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 of weakness;
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 of tiredness;
diarrhoea;
flatulence (excess gas in the intestine);
increased transaminase levels in laboratory blood tests related to liver function.

Uncommon side effects

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

Rare side effects
Pancreatitis (inflammation of the pancreas), causing severe stomach pain radiating to the back, reduction in platelet count.
Very rare side effects
Jaundice (yellowing of the skin and eyes), liver inflammation (hepatitis), blood in the urine, nerve damage in the arms and legs (such as numbness), memory loss, breast enlargement in men (gynecomastia).
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).
Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing).
Ocular myasthenia (a disease causing weakness of the eye muscles).
Contact your doctor if you experience weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
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 the 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 MAORIS

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 no longer required. This will help protect the environment.

6. Package contents and other information

What MAORIS contains
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, sodium croscarmellose, crospovidone, povidone, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of MAORIS and contents of the pack
MAORIS 5 mg/10 mg tablets: white or almost white, round, flat tablet, imprinted with E2 on one side and 2 on the other side. The tablet diameter is 10 mm.
MAORIS 10 mg/10 mg tablets: white or almost white, oval, biconvex tablet, imprinted with E1 on one side and 1 on the other side. The tablet dimensions are 15 mm x 7 mm.
MAORIS 20 mg/10 mg tablets: white or almost white, round, biconvex tablet. 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.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo n. 15
20143 Milan, Italy

Manufacturer
Adamed Pharma
S.A. ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland