ROSUMIBE 5 mg/10 mg Tablets

Зміст інструкції

1. ROSUMIBE 20 mg/10 mg, tablets, 10 mg/10 mg, tablets, 5 mg/10 mg, tablets
   1. What is ROSUMIBE tablets and what is it used for
   2. What you need to know before taking ROSUMIBE tablets
   3. How to take ROSUMIBE tablets
   4. Possible side effects
   5. How to store ROSUMIBE tablets
   6. Package Contents and Other Information
2. ROSUMIBE 15 mg/10 mg, tablets, 30 mg/10 mg, tablets, 40 mg/10 mg, tablets
   1. What is ROSUMIBE tablets and what is it used for
   2. What you need to know before taking ROSUMIBE tablets
   3. How to take ROSUMIBE tablets
   4. Possible side effects
   5. How to store ROSUMIBE tablets
   6. Contents of the pack and other information

ROSUMIBE 20 mg/10 mg, tablets, 10 mg/10 mg, tablets, 5 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 ROSUMIBE tablets are and what they are used for
• 2. What you need to know before you take ROSUMIBE tablets
• 3. How to take ROSUMIBE tablets
• 4. Possible side effects
• 5. How to store ROSUMIBE tablets
• 6. Contents of the pack and other information

1. What is ROSUMIBE tablets and what is it used for

ROSUMIBE tablets contains two different active ingredients in one tablet. One active ingredient is
rosuvastatin, belonging to the group of medicines called statins, the other is ezetimibe.
ROSUMIBE tablets 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: by reducing the amount absorbed from the digestive tract and by reducing the
amount produced by the body itself.
For most people, high cholesterol levels do not cause any symptoms. However, if left untreated, fat deposits
can build up 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, it can reduce the risk of a heart attack, stroke or other health problems related to it.
ROSUMIBE tablets 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 ROSUMIBE tablets if you are already taking rosuvastatin and ezetimibe at the same doses.
ROSUMIBE tablets is used if you have:

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

ROSUMIBE tablets does not help with weight loss.

2. What you need to know before taking ROSUMIBE tablets

Do not take ROSUMIBE tablets if:

• you are allergic to rosuvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6);
• you have a liver disease;
• you have severe kidney problems;
• you have recurrent or unexplained muscle pain or tenderness (myopathy);
• you are taking a combination of medicines containing sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C);
• you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
• you are pregnant or breastfeeding. If you become pregnant during treatment with ROSUMIBE tablets, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with ROSUMIBE tablets by using appropriate contraceptive measures (see below: Pregnancy and breastfeeding);
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking ROSUMIBE or other related medicines.

If any of these apply to you (or if you are unsure), talk to your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking ROSUMIBE tablets if:

• you have kidney problems;
• you have liver problems;
• you have had recurrent or unexplained muscle pain or tenderness, a personal or family history of muscle problems, or if you have previously experienced muscle problems while taking other medicines that lower cholesterol. Tell your doctor or pharmacist immediately if you experience unexplained muscle pain or tenderness, especially if you feel unwell or have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness;
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor may need to choose the correct dose of ROSUMIBE tablets for you;
• you are taking medicines used to fight infections, including HIV or hepatitis C, such as lopinavir/ritonavir and/or atazanavir or simeprevir, see “Other medicines and ROSUMIBE tablets”;
• you have severe lung problems;
• you are taking other medicines called fibrates to lower cholesterol. See “Other medicines and ROSUMIBE tablets”;
• you regularly drink large amounts of alcohol;
• you have a thyroid gland that is not working properly (hypothyroidism);
• you are over 70 years old (your doctor may need to establish the correct dose of ROSUMIBE tablets for you);
• you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine used for bacterial infections), by mouth or by injection. The combination of fusidic acid and ROSUMIBE tablets can lead to serious muscle problems (rhabdomyolysis).

If any of these apply to you (or if you have any doubts): talk to your doctor or pharmacist before
actually starting to take any dose of ROSUMIBE tablets.
Statins can alter liver function in a small number of people. This is detected with
a simple test, which allows monitoring of increased levels of liver enzymes in the blood. For
this reason, your doctor will usually request this blood test (liver function test) during
treatment with ROSUMIBE tablets. It is important to go to your doctor for the prescribed laboratory
tests.
During treatment with this medicine, your doctor will carefully 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 sugars and fats in
your blood, if you are overweight and have high blood pressure.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with ROSUMIBE.
Stop using ROSUMIBE and seek immediate medical attention if you notice any of the symptoms
described in section 4.

Children and adolescents
The use of ROSUMIBE tablets is not recommended in children and adolescents under 18 years of age.

Other medicines and ROSUMIBE tablets
Tell 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 rejection of the transplanted organ). The effect of rosuvastatin is increased when used at the same time as this medicine). Do not take ROSUMIBE tablets in combination with cyclosporine;
• Anticoagulants such as warfarin, acenocoumarol, fluindione or ticagrelor (their anticoagulant effect and the risk of bleeding may increase if taken with ROSUMIBE tablets), or clopidogrel;
• Other medicines to lower cholesterol levels called fibrates, which also correct triglyceride levels (e.g. gemfibrozil or other fibrates). During concomitant use with fibrates, the effect of rosuvastatin is increased;
• Cholestyramine (a medicine to lower cholesterol levels), as it alters the functioning of ezetimibe;
• Darolutamide, Regorafenib (used for the treatment of tumors);
• One 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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
• Antacids containing aluminium and magnesium (used to neutralize stomach acid; these metals decrease the levels of rosuvastatin in the blood). This effect may be mitigated by administering this type of medicine 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 should temporarily stop taking this medicine. Your doctor will tell you when it is safe to start taking ROSUMIBE tablets again. Taking ROSUMIBE tablets with fusidic acid can rarely cause weakness, fatigue or muscle pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4;
• An oral contraceptive (the pill). They increase the levels of hormones absorbed by the pill;
• Hormone replacement therapy (increases hormone levels in the blood).

If you are admitted to hospital or are being treated for another condition, tell the medical staff
that you are taking ROSUMIBE tablets.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take ROSUMIBE tabletsif you are pregnant, suspect you are pregnant or are planning a
pregnancy. If you become pregnant during treatment with ROSUMIBE tablets, stop
taking it immediatelyand inform your doctor. Women must always use contraceptive measures during treatment with ROSUMIBE tablets.

Breastfeeding
Do not take ROSUMIBE tabletswhile breastfeeding, as it is not known whether the medicine is excreted
in breast milk.

Driving and using machines
ROSUMIBE tablets should not interfere with your ability to drive or use machines. However,
you should consider that some people may experience dizziness after taking
ROSUMIBE tablets. If you experience dizziness, consult your doctor before driving or using machines.
ROSUMIBE contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
ROSUMIBE contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. “essentially sodium-free”.

3. How to take ROSUMIBE tablets

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 during
the use of ROSUMIBE tablets.
The recommended daily dose for adults is one tablet of the specific dose.

Take ROSUMIBE tablets once a day.
It can be taken at any time of day with or without food. Swallow each tablet
whole with a glass of water. Take the medicine at the same time each day.
ROSUMIBE tablets are not suitable for initial therapy.
The start of treatment or dose adjustment, if necessary, must be carried out only
by administering the active substances separately and after setting the appropriate doses, it is possible to
switch to ROSUMIBE tablets.

Regular cholesterol checks
It is important to return to your doctor for regular cholesterol level checks and to ensure that they are
reached and maintained within normal values.

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

If you forget to take ROSUMIBE tablets
Do not worry, skip the missed dose and take the next dose at the right time. Do not take a double
dose to make up for a missed dose.

If you stop taking ROSUMIBE tablets
Talk to your doctor if you want to stop taking ROSUMIBE tablets. Cholesterol levels
may increase again if you stop taking ROSUMIBE tablets.
If you have further questions about the use of the medicine, you can contact 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.

Stop taking ROSUMIBE tablets and contact your doctor immediatelyif you experience any of the
following side effects:

• swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and swallowing;
• symptoms of a lupus-like illness (including rash, joint disorders and effects on blood cells);
• muscle breakdown;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers. These severe skin reactions 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 reaction with eosinophilia and systemic symptoms).

Contact your doctor immediately if you haveunexplained muscle pain, tenderness or weakness that lasts
longer than expected. These can rarely lead to fatal muscle damage known as
rhabdomyolysis, which leads to malaise, fever and kidney problems.
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;
• Constipation;
• Feeling unwell;
• Muscle pain;
• Feeling weak;
• Dizziness;
• Diabetes. You are at risk of developing diabetes if you have high blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Stomach pain;
• Diarrhoea;
• Flatulence (excess gas in the intestinal tract);
• Feeling tired;
• Increase in some blood tests related to liver function (transaminases).

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 rosuvastatin;
• Increases in some blood tests related to 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 the arms and legs;
• Swelling, especially of the hands and feet.

Rare side effects
Pancreatitis, which causes severe stomach pain that radiates to the back, reduced
platelet count.

Very rare side effects
Jaundice (yellowing of the skin and eyes), liver inflammation (hepatitis), traces of blood in the
urine, damage to the nerves 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 problems, persistent muscle weakness, gallstones or inflammation of the gallbladder (which can cause stomach pain, nausea, vomiting).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 ROSUMIBE tablets

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 which is reported on the box and on the 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
the medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What ROSUMIBE tablets contain
The active ingredients are rosuvastatin (as rosuvastatin calcium salt) and ezetimibe. The tablets
contain rosuvastatin calcium salt equivalent to 5 mg, 10 mg or 20 mg of rosuvastatin. Each tablet
contains 10 mg of ezetimibe.
The other ingredients are: Lactose monohydrate, Microcrystalline Cellulose, Sodium Croscarmellose,
Croscarpovidone type A, Povidone K-30, Sodium Lauryl Sulfate and Magnesium Stearate.

Description of the appearance of ROSUMIBE tablets and package contents
ROSUMIBE 20 mg/10 mg tablets: white to off-white, round, biconvex, uncoated tablet.
The diameter of the tablet is 11 mm.
ROSUMIBE 10 mg/10 mg tablets: white to off-white, oval, biconvex, uncoated tablet,
with E1 engraved on one side and 1 on the other side. The dimensions of the tablet are 15 mm x 7 mm.
ROSUMIBE 5 mg/10 mg tablets: white to off-white, round, flat, uncoated tablet, with E2
engraved on one side and 2 on the other side. The diameter of the tablet is 10 mm.
Packs of 7, 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 tablets in blisters (PA/AL/PVC//Al) inserted into the
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Piam Farmaceutici S.p.A.
Via Fieschi, 8/7

• 16121 - Genoa Italy

Manufacturer
Pabianickie Zakłady Farmaceutyczne Polfa S.A.
Marszałka J. Piłsudskiego Street 5,
95-200 Pabianice
Poland
Adamed Pharma S.A.
ul. Marszalka Józefa Pilsudskiego 5,
95-200 Pabianice
Poland

ROSUMIBE 15 mg/10 mg, tablets, 30 mg/10 mg, tablets, 40 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 they have the same symptoms as you, as it may 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 ROSUMIBE tablets are and what they are used for
• 2. What you need to know before you take ROSUMIBE tablets
• 3. How to take ROSUMIBE tablets
• 4. Possible side effects
• 5. How to store ROSUMIBE tablets
• 6. Contents of the pack and other information

1. What is ROSUMIBE tablets and what is it used for

ROSUMIBE tablets contains two different active ingredients in one tablet. One active ingredient is
rosuvastatin, belonging to the class of medicines known as statins, the other active ingredient is ezetimibe.
ROSUMIBE tablets 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: by reducing the amount absorbed from the digestive tract and by decreasing 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, it can reduce the risk of a heart attack, stroke, or other health problems related to it.
ROSUMIBE tablets is used for those patients whose cholesterol levels can no longer be controlled solely through a
low-cholesterol diet. You must continue to follow a diet to reduce cholesterol during therapy with this medicine.
Your doctor may prescribe ROSUMIBE tablets if you are already taking rosuvastatin and ezetimibe at the same
doses.
ROSUMIBE tablets is used if you have:

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

ROSUMIBE tablets does not help with weight loss.

2. What you need to know before taking ROSUMIBE tablets

Do not take ROSUMIBE tablets if:

• you are allergic to rosuvastatin, ezetimibe or any of the other ingredients of this medicine (listed in section 6);
• you have a liver disease;
• you have severe kidney problems;
• you have recurrent or unexplained muscle pain or tenderness (myopathy);
• you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medicines (used for a viral liver infection called hepatitis C);
• you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
• you are pregnant or breastfeeding. If you become pregnant during treatment with ROSUMIBE tablets, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with ROSUMIBE tablets by using appropriate contraceptive measures (see below: Pregnancy and breastfeeding);
• you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking ROSUMIBE or other related medicines.

If any of these apply to you (or if you are unsure), consult your doctor.

Also, do not take ROSUMIBE 40 mg/10 mg (the highest dose) if

• you have moderate kidney problems (if in doubt, ask your doctor);
• your thyroid gland is not working properly (hypothyroidism);
• you have had recurrent or unexplained muscle pain, a personal or family history of muscle problems, or a previous history of muscle problems while taking other medicines to lower cholesterol;
• you regularly drink large amounts of alcohol;
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
• you are taking other medicines called fibrates to lower cholesterol (see section “Other medicines and ROSUMIBE tablets”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ROSUMIBE tablets if:

• you have kidney problems;
• you have liver problems;
• you have had recurrent or unexplained muscle pain or tenderness, a personal or family history of muscle problems, or if you have had a previous history of muscle problems while taking other medicines that lower cholesterol. Tell your doctor immediately if you have unexplained muscle pain or tenderness, especially if you feel unwell or have a fever. Also tell your doctor or pharmacist if you have persistent muscle weakness;
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor may need to choose the correct dose of ROSUMIBE tablets for you;
• you are taking medicines used to fight infections, including HIV or hepatitis C infections, such as lopinavir/ritonavir and/or atazanavir, see “Other medicines and ROSUMIBE tablets”;
• you have severe breathing difficulties;
• you are taking other medicines called fibrates to lower cholesterol. Please read this leaflet carefully, even if you have previously taken other medicines for high cholesterol. See “Other medicines and ROSUMIBE tablets”;
• you regularly consume significant amounts of alcohol;
• your thyroid gland is not working properly (hypothyroidism);
• you are over 70 years old (your doctor must determine the correct dose of ROSUMIBE tablets for you);
• you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used for bacterial infections), orally or by injection. The combination of fusidic acid and ROSUMIBE tablets can lead to serious muscle problems (rhabdomyolysis);
• you have or have had myasthenia (a disease with general muscle weakness including in some cases the muscles used for breathing), or ocular myasthenia (a disease that causes weakness of the

muscles of the eyes) because statins can sometimes worsen the condition or lead to the onset of
myasthenia (see section 4).

• you have ever developed a severe skin rash or peeling of the skin, formation of blisters and/or ulcers in the mouth after taking rosuvastatin or other related medicines.

If any of these apply to you (or if you have any doubts): do not take ROSUMIBE 40 mg/10 mg (the highest dose) and consult your doctor or pharmacist before actually starting to take any dose of
ROSUMIBE tablets.
Statins can alter liver function in a small number of people. This is detected with a
simple test, which allows monitoring of increased levels of liver enzymes in the blood. For this
reason, your doctor will usually request this blood test (liver function test) during
treatment with ROSUMIBE tablets. It is important to go to your doctor for the prescribed laboratory tests.
During treatment with this medicine, your doctor will carefully check 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 and have high blood pressure.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with the treatment with
ROSUMIBE. Stop using
ROSUMIBE and seek immediate medical attention if you notice any of the symptoms described in section 4.

Children and adolescents
The use of ROSUMIBE tablets is not recommended in children and adolescents under the age of 18 years.

Other medicines and ROSUMIBE tablets
Tell 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 rejection of the transplanted organ. The effect of rosuvastatin is increased when used at the same time with this medicine). Do not take ROSUMIBE tablets in combination with cyclosporine;
• Anticoagulants such as warfarin, acenocoumarol, fluindione, ticagrelor or clopidogrel (their anticoagulant effect and the risk of bleeding may be increased if taken with ROSUMIBE tablets);
• Other medicines to lower cholesterol levels called fibrates, which also correct triglyceride levels (for example gemfibrozil or other fibrates). During concomitant use with fibrates, the effect of rosuvastatin is increased. Do not take ROSUMIBE 40 mg/10 mg tablets withconcomitant use of a fibrate.
• Cholestyramine (a medicine to lower cholesterol levels), as it alters the functioning of ezetimibe;
• Darolutamide, regorafenib, capmatinib (used for cancer treatment);
• 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, sofosbuvir, velpatasvir, ombitasvir, paritaprevir, dasabuvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. See the Warnings and precautions section;
• Antacids containing aluminium and magnesium (used to neutralise stomach acid; these metals decrease the levels of rosuvastatin in the blood). This effect may be mitigated by administering this type of medicine 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 should temporarily stop taking this medicine. Your doctor will tell you when it is safe to start taking ROSUMIBE tablets again. Taking ROSUMIBE tablets with

fusidic acid can rarely cause weakness, tenderness or pain in the muscles (rhabdomyolysis).
See more information regarding rhabdomyolysis in section 4;

• An oral contraceptive (the pill). They increase the levels of hormones absorbed by the pill;
• Hormone replacement therapy (increases hormone levels in the blood) ;
• Fostamatinib (used to treat low platelet count);
• Febuxostat (used to treat and prevent high levels of uric acid in the blood);
• Teriflunomide (used to treat multiple sclerosis)

If you are admitted to hospital or are being treated for another condition, tell the medical staff
that you are taking ROSUMIBE tablets.

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 ROSUMIBE tabletsif you are pregnant, suspect you may be pregnant or are planning to
become pregnant. If you become pregnant during treatment with ROSUMIBE tablets, stop
taking it immediatelyand inform your doctor. Women must always use contraceptive measures
during treatment with ROSUMIBE tablets.

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

Driving and using machines
ROSUMIBE tablets should not interfere with your ability to drive or operate machinery. However,
you should be aware that some people experience dizziness after taking
ROSUMIBE tablets. If you feel dizzy, talk to your doctor before driving or operating machinery.

ROSUMIBE tablets contains lactose monohydrate
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

ROSUMIBE tabletscontains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially
’sodium-free’.

3. How to take ROSUMIBE tablets

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor
or pharmacist.
You must continue to follow a low-cholesterol diet and exercise during
the use of ROSUMIBE tablets.
The recommended daily dose for adults is one tablet of the indicated dose.

Take ROSUMIBE tablets once a day.
It can be taken at any time of the day with or without food. Swallow each tablet whole
with a glass of water.
Always take the medicine at the same time each day.
ROSUMIBE tablets are not suitable for initial therapy.
The start of treatment or dose adjustment, if necessary, must be carried out only
by administering the active substances separately and after the appropriate doses have been set, it is possible to
switch to ROSUMIBE tablets.
The maximum daily dose of rosuvastatin is 40 mg. It is only indicated for patients with high cholesterol levels and a high risk of heart attack or stroke whose cholesterol levels are not sufficiently lowered with 30
mg.

Regular cholesterol checks
It is important to return to your doctor for regular cholesterol checks and to ensure that they are
reached and maintained within normal values.

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

If you forget to take ROSUMIBE tablets
Do not worry, skip the missed dose and take the next dose at the right time. Do not take a double
dose to make up for a missed dose.

If you stop taking ROSUMIBE tablets
Talk to your doctor if you want to stop taking ROSUMIBE tablets. Cholesterol levels
may increase again if you stop taking ROSUMIBE tablets.
If you have further questions about the use of the medicine, you can contact 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.

Stop taking ROSUMIBE tablets and contact your doctor immediatelyif you experience any of the following:

• allergic reactions: swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and swallowing, severe skin itching (with raised bumps). These are rare possible side effects;
• syndrome resembling lupus disease (including skin rash, joint disorders and effects on blood cells). This is a rare possible side effect;
• muscle breakdown. This is a rare possible side effect;
• reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). The frequency of this possible side effect is not known;
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). The frequency of this possible side effect is not known.

Contact your doctor immediately if you haveunexplained muscle pain or weakness that lasts longer than expected. These can rarely lead to fatal muscle damage known as
rhabdomyolysis, which causes 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;
• constipation;
• feeling unwell;
• muscle pain;
• tenderness;
• feeling of weakness;
• dizziness;
• an increase in the amount of protein in urine - these usually return to normal on their own without stopping ROSUMIBE (only with rosuvastatin 40 mg);
• diabetes. You are at risk of developing diabetes if you have high blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• stomach pain;
• diarrhoea;
• flatulence (excess gas in the intestines);
• feeling tired;
• increased in some blood tests related to liver function (transaminases).

Uncommon side effects:

• skin rash, itching, hives
• an increase in the amount of protein in urine may occur - which usually returns to normal, without stopping rosuvastatin (only with rosuvastatin 10 mg and 20 mg);
• increases in some blood tests related to muscle function (CK);
• cough;
• indigestion;
• heartburn;
• nausea;
• 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 the arms and legs;
• swelling, especially of the hands and feet.

Rare side effects:

• inflammation of the pancreas, causing severe stomach pain that extends to the back;
• bleeding or bruising more easily than usual due to low platelet levels.

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

Side effects with unknown frequency:
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, red raised skin rash, sometimes with target-shaped lesions (erythema multiforme), muscle tenderness, gallstones or inflammation of the gallbladder
(which can cause stomach pain, nausea, vomiting).
Myasthenia gravis (a disease that causes general muscle weakness, including in some cases the muscles
used during breathing), ocular myasthenia (a disease that causes weakness of the eye muscles). See
your doctor if you experience weakness in your arms or legs that worsens 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 http://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 ROSUMIBE tablets

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 which is reported on the package and on the blister. 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 the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ROSUMIBE tablets contain
The active ingredients are rosuvastatin (as rosuvastatin calcium salt) and ezetimibe. The tablets
contain rosuvastatin calcium salt equivalent to 15 mg, 30 mg or 40 mg of rosuvastatin. Each tablet
contains 10 mg of ezetimibe.
The other ingredients are: Lactose monohydrate, Microcrystalline Cellulose, Sodium croscarmellose,
Croscarpovidone type A, Povidone K-30, Sodium lauryl sulfate and Magnesium stearate.

Description of the appearance of ROSUMIBE tablets and contents of the pack
ROSUMIBE 15mg/10mg tablets: uncoated, hexagonal, biconvex tablet, from white to
whitish in colour, approximately 9 x 8 mm in size and with “E3” engraved on both sides.
ROSUMIBE 30mg/10mg tablets: uncoated, biconvex tablet, from white to whitish in colour,
rectangular in shape, 12 x 6 mm in size and with “X” engraved on both sides.
ROSUMIBE 40mg/10mg tablets: uncoated, elliptical, biconvex tablet, from white to
whitish in colour, approximately 13 x 6 mm in size and with "E6" engraved on both sides.
Packs of 28, 30, 56, 60, 90 and 100 tablets in blisters (PA/AL/PVC//Al) inserted in the cardboard box
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Piam Farmaceutici S.p.A.
Via Fieschi, 8/7

• 16121 - Genoa Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszalka Józefa Pilsudskiego 5,
95-200 Pabianice
Poland