MAORIS 5 mg/10 mg Coated Tablet

Зміст інструкції

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

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

Rosuvastatin and Ezetimibe

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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MAORIS is and what it is used for

MAORIS contains two different active ingredients in one tablet. One active ingredient is rosuvastatin, belonging to a group of medicines called “statins”, the other is ezetimibe.
MAORIS is a medicine used to lower total cholesterol levels, “bad” cholesterol (LDL cholesterol) and fats in the blood called triglycerides. It also increases levels of “good” cholesterol (HDL cholesterol). This medicine reduces cholesterol in two ways: it reduces the amount absorbed from the digestive tract and decreases its production by the body itself.
For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fat deposits can accumulate in the walls of blood vessels causing them to narrow. Sometimes, this narrowing of the blood vessels can cause a blockage of blood flow to the heart or brain resulting in a heart attack or stroke. By lowering cholesterol levels, the risk of a heart attack, stroke or other health problems can be reduced.
MAORIS is used for those patients whose cholesterol levels can no longer be controlled by diet alone. You should continue to follow a low-cholesterol diet during treatment with this medicine. Your doctor may prescribe MAORIS if you are already taking rosuvastatin and ezetimibe at the same doses.
MAORIS is used if you have:

• an elevated blood cholesterol level (primary hypercholesterolemia);
• heart disease, MAORIS reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

MAORIS does not help with weight loss.

2. What you need to know before taking MAORIS

Do not take MAORIS

• 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 MAORIS, stop taking it immediately and inform your doctor. Women must avoid pregnancy while taking MAORIS, using appropriate contraceptive measures (see “Pregnancy and breastfeeding”);
• if you have a liver disease;
• if you have severe kidney damage;
• if you have recurrent or unexplained muscle aches or pains (myopathy);
• if you are taking a medicine called cyclosporine (used, for example, after an organ transplant);
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking MAORIS or other medicines containing rosuvastatin.

If you fall into any of these categories (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 had recurrent or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol. Tell your doctor or pharmacist immediately if you have unexplained muscle aches or pains, especially if accompanied by feeling unwell or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness;
• you regularly consume large amounts of alcohol;
• your thyroid gland is not functioning properly (hypothyroidism);
• you are taking other medicines to lower cholesterol called fibrates. See “Other medicines and MAORIS”;
• you are taking medicines used to treat HIV infections, such as lopinavir/ritonavir and/or atazanavir. See “Other medicines and MAORIS”;
• you are over 70 years of age (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 and Indian). Your doctor needs to choose the correct dosage suitable for you;
• you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections), 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 in association with 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 including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to occur (see section 4).

If any of these situations apply to you (or if you have any doubts), consult your doctor or pharmacist
before actually starting to take any dose of MAORIS.
In a small number of people, statins can alter liver function, which can
be identified with a simple test that detects increased levels of liver enzymes in the blood.
For this reason, your doctor will ask you to have this test (liver function test) during treatment with MAORIS. It is important to go to your doctor for the prescribed laboratory tests.
During treatment with this medicine, your doctor will carefully check that you do not 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 the blood, if you are overweight and have high blood
pressure.
If you are hospitalized or undergoing treatments to cure 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking any of the following medicines:

• cyclosporine (used, for example, after organ transplantation to prevent rejection of the transplanted organ). The effect of rosuvastatin increases if used at the same time with this medicine. Do not take MAORIS in combination with cyclosporine;
• anticoagulants such as warfarin, acenocoumarol, fluindione (their anticoagulant effect and the risk of bleeding may increase if taken in combination with MAORIS), ticagrelor or clopidogrel;
• other medicines to lower cholesterol levels called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). During concomitant use, the effect of rosuvastatin is increased;
• cholestyramine (a medicine to lower cholesterol levels), as it alters the functioning of ezetimibe;
• remedies or medicines for indigestion containing aluminum and magnesium (used to neutralize stomach acids; these metals decrease the levels of rosuvastatin in the blood). This effect may be mitigated by administering these types of remedies or medicines 2 hours after taking rosuvastatin;
• erythromycin (an antibiotic). Concomitant use of this antibiotic decreases 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 using MAORIS. Your doctor will tell you when to safely start taking MAORIS again. Taking MAORIS with fusidic acid can, rarely, cause weakness, aching or muscle pain (rhabdomyolysis). See section 4 for more information regarding rhabdomyolysis;
• oral contraceptives (the pill). They increase the levels of hormones absorbed by the pill;
• hormone replacement therapy (increases hormone levels in the blood);
• regorafenib (used to treat tumors);
• one of the following medicines used to treat viral infections, including HIV or Hepatitis C infections, 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 or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take MAORISif you are pregnant, suspect you may be pregnant or are planning to become pregnant.
If you become pregnant while taking MAORIS, stop taking it immediatelyand inform
your doctor. Women should always use contraceptive measures during treatment with
MAORIS.

Breastfeeding
Do not take MAORISwhile breastfeeding, as it is not known whether the medicine passes into breast
milk.

Driving and using machines
MAORIS should not interfere with your ability to drive or use machines. However,
it should be considered that some people may experience dizziness
after taking MAORIS. If you experience dizziness, consult your doctor before driving vehicles or
using machines.
MAORIS contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take MAORIS

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
You must continue to follow a low-cholesterol diet and exercise
while taking MAORIS.
The recommended daily dose for adults is one tablet of the specific dosage
prescribed by your doctor.

Take MAORIS once a day.
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 every day at approximately the same time.
MAORIS is not suitable for initial therapy. The start of treatment or dose adjustment,
if necessary, must be carried out only by administering the two active substances separately and
after setting the appropriate doses, it is possible to switch to MAORIS.

Periodic cholesterol checks
It is important to return to your doctor to periodically check cholesterol levels, to
ensure that cholesterol has reached and maintains values within the normal range.

If you take moreMAORIS than you should
Contact your doctor or the nearest hospital emergency room as you may need
medical assistance.

If you forget to take MAORIS
Do not worry, take the next dose at the usual time. Do not take a double dose to
compensate for missing the dose.

If you stop taking MAORIS
Tell your doctor if you intend to stop taking MAORIS. If you stop
taking MAORIS, your cholesterol levels may increase again.
If you have any doubts about the use of 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 to be aware of possible side effects. They are usually mild and disappear in a short time.

Stop taking MAORIS and see a doctor immediatelyif you experience:

• one of the following allergic reactions: swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and swallowing;
• reddish, non-raised spots, target-shaped or circular on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, and

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);
• a lupus-like illness (including rash, joint disorders and effects on blood cells);
• muscle tearing.

Contact your doctor immediately if you have unusual muscle soreness or painthat
lasts longer than expected. These can 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 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 fat in your blood, if you 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 intestines);
• increased transaminases during laboratory blood tests related to liver function.

Uncommon side effects

• skin rash, itching, hives;
• an increase in the amount of protein in the urine may occur, which usually returns to normal without having to stop taking MAORIS;
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• hot flushes;
• high blood pressure;
• feeling of pins and needles;
• dry mouth;
• inflammation of the stomach;
• back pain;
• muscle weakness;
• pain in the arms and legs;
• swelling, especially of the hands and feet.

Rare side effects
Pancreatitis, which causes severe stomach pain that extends to the back,
decreased platelets.

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

Not known
Shortness of breath, edema (swelling), sleep disorders, including difficulty sleeping and nightmares, sexual difficulties, 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 can cause stomach pain, nausea, vomiting).
Myasthenia gravis (a disease that causes generalized muscle weakness including, in
some cases, the muscles used for breathing).
Ocular myasthenia (a disease that causes weakness of the eye muscles).
See a doctor if you experience weakness in your arms or legs that gets worse after periods of
activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at
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

Store in the original package to protect the medicine from light.
This medicine does not require any particular 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 package and blister.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or 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 MAORIS contains
The active ingredients 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 ingredients are: lactose monohydrate, 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, with
E2 imprinted on one side and 2 on the other side. The diameter of the tablet is 10 mm.
MAORIS 10 mg/10 mg tablets: white or almost white, oval, biconvex tablet, with
E1 imprinted on one side and 1 on the other side. The dimensions of the tablet are 15 mm x 7 mm.
MAORIS 20 mg/10 mg tablets: white or almost white, round, biconvex tablet.
The diameter of the tablet is 11 mm.
Packs of 28 tablets in blisters (PA/Al/PVC-Al) placed in a cardboard box with the package
leaflet.
Not all pack sizes may be marketed.

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

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