ROSUVASTATINA 5 mg/10 mg Tabletki Powlekane

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1. Rosuvastatina e Ezetimibe Sandoz 5 mg/10 mg film-coated tablets, 10 mg/10 mg film-coated tablets, 20 mg/10 mg film-coated tablets, 40 mg/10 mg film-coated tablets
   1. What is Rosuvastatina and Ezetimibe Sandoz and what is it used for
   2. What you need to know before taking Rosuvastatina and Ezetimibe Sandoz
   3. How to take Rosuvastatina and Ezetimibe Sandoz
   4. Possible side effects
   5. How to store Rosuvastatina e Ezetimibe Sandoz
   6. Package contents and other information

Rosuvastatina e Ezetimibe Sandoz 5 mg/10 mg film-coated tablets, 10 mg/10 mg film-coated tablets, 20 mg/10 mg film-coated tablets, 40 mg/10 mg film-coated tablets

Read this leaflet carefully before 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 Rosuvastatina e Ezetimibe Sandoz is and what it is used for
• 2. What you need to know before you take Rosuvastatina e Ezetimibe Sandoz
• 3. How to take Rosuvastatina e Ezetimibe Sandoz
• 4. Possible side effects
• 5. How to store Rosuvastatina e Ezetimibe Sandoz
• 6. Contents of the pack and other information

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

Rosuvastatina and Ezetimibe Sandoz contains two different active ingredients in one tablet. One of the
active ingredients is rosuvastatin, belonging to the group of medicines called statins, the other active
ingredient is ezetimibe.
Rosuvastatina and Ezetimibe Sandoz is a medicine used in adult patients to lower levels of
total cholesterol, so-called "bad" cholesterol (LDL cholesterol) and other fatty substances
called triglycerides in the blood. It also increases levels of "good" cholesterol (HDL cholesterol). This medicine works by reducing cholesterol in two ways: it reduces both cholesterol
absorbed from the digestive tract, as well as decreases the production of cholesterol by the
body itself.
For most people, high cholesterol levels do not affect how they feel,
as it produces no symptoms. However, if left untreated, it can lead to the accumulation of deposits of
fat in the walls of blood vessels, causing them to narrow.
Sometimes these narrowed blood vessels can become blocked and block the flow of blood to the heart or
brain causing a heart attack or stroke. By reducing cholesterol levels, it is possible to reduce
the risk of having a heart attack, stroke or related health problems.
Rosuvastatina and Ezetimibe Sandoz is used in patients whose cholesterol levels can no longer be
controlled by diet alone to lower cholesterol. This cholesterol-lowering diet must necessarily be maintained while taking the medicine. Your doctor may
prescribe Rosuvastatina and Ezetimibe Sandoz if you are already taking both rosuvastatin and
ezetimibe at the same dosage.
Rosuvastatina and Ezetimibe Sandoz is used in cases where you have:

• An excess of cholesterol in the blood (primary hypercholesterolemia);
• Heart disease, Rosuvastatina and Ezetimibe Sandoz reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalizations for chest pain.

Rosuvastatina and Ezetimibe Sandoz does not help with weight loss.

2. What you need to know before taking Rosuvastatina and Ezetimibe Sandoz

Do not take Rosuvastatina and Ezetimibe Sandoz 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 repeated and unexplained muscle pain (myopathy).
• you are taking the combination sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C)
• you are taking a medicine called ciclosporin (used for example after organ transplants).
• you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatina and Ezetimibe Sandoz, stop taking the medicine immediately and consult your doctor. Women must avoid pregnancy while using Rosuvastatina and Ezetimibe Sandoz by using adequate contraceptive measures.

Also, do not take Rosuvastatina and Ezetimibe Sandoz 40 mg/10 mg (the highest dose):

• if you have moderate kidney problems (if you are unsure, consult your doctor).
• if you have an underactive thyroid gland (hypothyroidism).
• if you have had repeated or unexplained muscle pain, a personal or family history of muscle problems, or if you have previously experienced muscle problems while taking other medicines that lower cholesterol.
• if you regularly consume significant amounts of alcohol.
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• if you are taking other medicines called fibrates to lower cholesterol (see section “Other medicines and Rosuvastatina and Ezetimibe Sandoz”). If any of these situations apply to you (or if you are unsure), contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rosuvastatina and Ezetimibe Sandoz if:

• you have kidney problems.
• you have liver problems.
• you have had repeated or unexplained muscle pain, a personal or family history of muscle problems, or a previous experience of muscle problems while taking other medicines that lower cholesterol. Contact your doctor immediately if you have repeated and unexplained muscle pain, especially if you feel unwell or have a fever. Contact your doctor or pharmacist also if you have constant muscle fatigue.
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). In these cases, your doctor may need to choose the right dose for you.
• you are taking medicines against infections, including HIV or hepatitis C (for example lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir and/or pibrentasvir). See section “Other medicines and Rosuvastatina and Ezetimibe Sandoz”.
• you have severe breathing difficulties.
• you are taking other medicines called fibrates to lower cholesterol levels. See section “Other medicines and Rosuvastatina and Ezetimibe Sandoz”.
• you are about to undergo surgery. You may need to stop taking Rosuvastatina and Ezetimibe Sandoz for a short period of time.
• you drink regularly large amounts of alcohol.
• you suffer from hypothyroidism, where the thyroid gland does not work properly.
• you are over 70 years of age (your doctor must establish the right dose of Rosuvastatina and Ezetimibe Sandoz that suits 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 Rosuvastatina and Ezetimibe Sandoz can lead to serious muscle problems (rhabdomyolysis).
• if you are taking regorafenib (a medicine used to treat cancer)
• if you have ever developed a severe skin rash or blistering, blisters and/or ulcers in the mouth after taking rosuvastatin or other related medicines. Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with rosuvastatin treatment. Stop using Rosuvastatina and Ezetimibe Sandoz and seek immediate medical attention if you notice any of the symptoms described in section 4. If any of the above circumstances apply to you (or if you are unsure), consult your doctor or pharmacist before taking any dose of this medicine.

Statins can cause liver problems in a small number of people. This situation can
be easily identified with a simple test that analyzes the levels of liver enzymes in the blood.
For this reason, your doctor must regularly perform this blood test (liver function test) during treatment with this medicine. It is important to go to the doctor
for the prescribed laboratory tests.
While you are taking this medicine, your doctor will monitor you carefully if you have diabetes or if you
are at risk of developing diabetes. The risk of developing diabetes is very high if you have high levels of
sugar and fats in your blood, if you are overweight or if you have high blood pressure.

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

Other medicines and Rosuvastatina and Ezetimibe Sandoz
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:

• Ciclosporin (used, for example, after an organ transplant to prevent rejection of the transplanted organs. The effect of rosuvastatin is increased if used concurrently with ciclosporin). Do not take Rosuvastatina and Ezetimibe Sandoz while takingciclosporin.
• Anticoagulants, for example warfarin, acenocoumarol or fluindione (their anticoagulant effect and the risk of bleeding may increase if taken together with this medicine), ticagrelor or clopidogrel.
• Other medicines used to lower cholesterol levels, called fibrates, which also correct triglyceride levels (for example gemfibrozil and other fibrates, niacin (nicotinic acid)).
• Cholestyramine (medicine used to lower cholesterol levels), as it alters the functioning of ezetimibe.
• Regorafenib (used to treat tumors).
• Darolutamide (used to treat tumors).
• Each of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see section “Warnings and precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Antacids containing aluminum and magnesium (used to neutralize stomach acids; these decrease the levels of rosuvastatin in the blood).
• Erythromycin (an antibiotic).
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop treatment with this medicine. Your doctor will tell you when it is safe to resume treatment with Rosuvastatina and Ezetimibe Sandoz. The combination of Rosuvastatina and Ezetimibe Sandoz and fusidic acid can, rarely, cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis see section 4.
• Oral contraceptives (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 Rosuvastatina and Ezetimibe Sandoz

Pregnancy and breastfeeding
Do not take Rosuvastatina and Ezetimibe Sandoz if you are pregnant, if you suspect or
are planning a pregnancy. If you become pregnant while taking this medicine,
stop taking it immediately and consult your doctor. Women must always use
contraceptive measures during treatment with this medicine.
Do not take Rosuvastatina and Ezetimibe Sandoz while breastfeeding, as it is not known
whether the medicine passes into breast milk.

Driving and using machines
It is not expected that this medicine will interfere with your ability to drive vehicles or use
machinery. However, you should consider that some people
may experience dizziness after taking this medicine. If you feel dizzy, do not drive
vehicles or use machinery.

Rosuvastatina and Ezetimibe Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Rosuvastatina and Ezetimibe Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
You should continue to follow a low-cholesterol diet and exercise
while taking Rosuvastatina and Ezetimibe Sandoz.
The recommended daily dose for adults is one tablet a day.
Take the tablet at any time of day, on an empty stomach or with food. Take each tablet
whole with a glass of water.
Take the tablet at the same time each day to help you remember.
This medicine is not suitable for starting treatment. The start of treatment or, if necessary,
a dosage adjustment, must be done only by administering the active substances
separately, and only after the correct dosage has been established can you switch to Rosuvastatina and
Ezetimibe Sandoz at the appropriate dosage.
If your doctor has prescribed Rosuvastatina and Ezetimibe Sandoz together with another medicine for
reducing cholesterol containing colestyramine as the active ingredient or any other medicine
containing a bile acid sequestrant, you must take Rosuvastatina and Ezetimibe Sandoz
at least 2 hours before or at least 4 hours after taking the bile acid sequestrant.

Regular cholesterol checks
It is important to have your cholesterol levels checked regularly by your doctor, to make sure
that your cholesterol reaches and maintains the correct level.

If you take more Rosuvastatina and Ezetimibe Sandoz than you should
Contact your doctor or the nearest hospital emergency room as you may
need medical attention.

If you forget to take Rosuvastatina and Ezetimibe Sandoz
Do not worry, skip the missed dose and take your next dose as scheduled at the
same time. Do not take a double dose to make up for a missed dose.

If you stop taking Rosuvastatina and Ezetimibe Sandoz
Talk to your doctor if you want to stop taking this medicine. Keep in
mind that your cholesterol levels may rise again if you stop taking this
medicine
If you have any further questions on 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 everybody gets them. It is important to be aware of possible side effects.

Stop taking Rosuvastatina and Ezetimibe Sandoz and seek immediate medical help if you experience any of the following symptoms:

• if you experience unusual muscle pain, tenderness or weakness that lasts longer than expected, as muscle problems including breakdown can lead to kidney damage, which can be serious and potentially life-threatening (rhabdomyolysis). This is rare (may affect up to 1 in 1,000 people)
• in case of muscle breakdown.
• if you have a lupus-like syndrome (including skin rash, joint disorders and effects on blood cells).
• severe allergic reaction (angioedema). The signs include: swelling of the face, lips, tongue and/or throat, difficulty breathing and swallowing and severe skin itching (with the appearance of bumps). This is rare (may affect up to 1 in 1,000 people)
• severe skin ulcers or blisters, mouth, eyes and genitals. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). Frequency not known (cannot be estimated from the available data).
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Other known side effects
Common (may affect up to 1 in 10 people)

• headache
• constipation
• feeling unwell
• muscle pain
• feeling weak
• dizziness
• diabetes. This is much more likely if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure. Your doctor will need to check you during treatment.
• stomach pain
• diarrhoea
• flatulence (excess gas in the intestinal tract)
• feeling tired
• increase in some blood tests related to liver function (transaminases)
• an increase in the amount of protein in the urine - usually the values return to normal on their own without having to stop taking Rosuvastatina and Ezetimibe Sandoz (only for rosuvastatin 40 mg)

Uncommon (may affect up to 1 in 100 people)

• skin rashes, itching, hives
• increase in some blood tests related to muscle function (Creatine Kinase test)
• 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 in the hands and feet
• an increase in the amount of protein in the urine - usually the values return to normal on their own without having to stop taking Rosuvastatina and Ezetimibe Sandoz (only for rosuvastatin 10 and 20 mg)

Rare (may affect up to 1 in 1,000 people)

• inflammation of the pancreas, which causes severe stomach pain that spreads to the back
• reduction in platelets in the blood, which may cause bruising/bleeding (thrombocytopenia)
• increase in liver enzymes in the blood.

Very rare (may affect up to 1 in 10,000 people)

• jaundice (yellowing of the skin and eyes)
• inflammation of the liver (hepatitis)
• traces of blood in the urine
• damage to the nerves of legs and arms (such as numbness)
• joint pain
• memory loss
• breast enlargement in men (gynaecomastia)

Not known (frequency cannot be estimated from the available data)

• diarrhoea (loose stools)
• cough
• shortness of breath
• oedema (swelling)
• sleep disorders, including insomnia and nightmares
• sexual problems
• depression
• problems with breathing, including persistent cough and/or shortness of breath or fever
• tendon injury
• persistent muscle weakness
• red skin rash, sometimes with target-shaped lesions (erythema multiforme)
• muscle tenderness
• 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, pharmacist or nurse. 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 Rosuvastatina e Ezetimibe Sandoz

This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from light and moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister after
“Exp.”. 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
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rosuvastatina and Ezetimibe Sandoz contains
The active ingredients are rosuvastatin (as rosuvastatin calcium) and ezetimibe.
Rosuvastatina e Ezetimibe Sandoz 5 mg/10 mg: each film-coated tablet contains
rosuvastatin calcium equivalent to 5 mg of rosuvastatin and 10 mg of ezetimibe.
Rosuvastatina e Ezetimibe Sandoz 10 mg/10 mg: each film-coated tablet contains
rosuvastatin calcium equivalent to 10 mg of rosuvastatin and 10 mg of ezetimibe.
Rosuvastatina e Ezetimibe Sandoz 20 mg/10 mg: each film-coated tablet contains
rosuvastatin calcium equivalent to 20 mg of rosuvastatin and 10 mg of ezetimibe.
Rosuvastatina e Ezetimibe Sandoz 40 mg/10 mg: each film-coated tablet contains
rosuvastatin calcium equivalent to 40 mg of rosuvastatin and 10 mg of ezetimibe.
The other ingredients are:

Tablet core
Lactose monohydrate, Sodium croscarmellose, Povidone, Sodium lauryl sulfate, Microcrystalline
cellulose 102, Hypromellose 2910, Anhydrous colloidal silica, Magnesium stearate.

Tablet coating
Rosuvastatina e Ezetimibe Sandoz 5mg/10mg – Opadry Yellow 02F220026 which consists of:
Hypromellose 2910 (E464), Titanium dioxide (E171), Yellow iron oxide (E172), Talc (E553b),
Red iron oxide (E172), Macrogol 4000 (E1521)
Rosuvastatina e Ezetimibe Sandoz 10mg/10mg – Opadry Beige 02F270003 which consists of:
Hypromellose 2910 (E464), Titanium dioxide (E171), Yellow iron oxide (E172), Macrogol 4000
(E1521), Talc (E553b)
Rosuvastatina e Ezetimibe Sandoz 20mg/10mg – VIVACOAT PC-2P-308 which consists of:
Hypromellose 6 (E464), Titanium dioxide (E171), Talc (E553b), Macrogol 4000 (E1521), Yellow iron
oxide (E172)
Rosuvastatina e Ezetimibe Sandoz 40mg/10mg – Opadry White 0Y-L-28900 which consists of:
Lactose monohydrate, Hypromellose 2910 (E464), Titanium dioxide (E171), Macrogol 4000 (E1521)

Description of the appearance of Rosuvastatina e Ezetimibe Sandoz and contents of the pack
Rosuvastatina e Ezetimibe Sandoz 5 mg/10 mg film-coated tablets
Film-coated tablets, round, biconvex, light yellow in color, with an approximate diameter
of 10 mm and “EL 5” imprinted on one side
Rosuvastatina e Ezetimibe Sandoz 10 mg/10 mg film-coated tablets
Film-coated tablets, round, biconvex, beige in color, with an approximate diameter
of 10 mm and “EL 4” imprinted on one side
Rosuvastatina e Ezetimibe Sandoz 20 mg/10 mg film-coated tablets
Film-coated tablets, round, biconvex, yellow in color, with an approximate diameter
of 10 mm and “EL 3” imprinted on one side
Rosuvastatina e Ezetimibe Sandoz 40 mg/10 mg film-coated tablets
Film-coated tablets, round, biconvex, white in color, with an approximate diameter
of 10 mm and “EL 2” imprinted on one side
OPA/Alu/PVC-aluminum blisters containing 10, 30, 90 and 100 film-coated tablets
OPA/Alu/PVC-aluminum divisible blisters for unit dosage containing 10x1, 30x1, 90x1 and
100x1 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
ELPEN Pharmaceutical Co. Inc.
Marathonos Ave. 95
Pikermi Attiki 19009
Greece
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
Belgium Ezetimibe/Rosuvastatin Sandoz 10
mg/10 mg filmomhulde tabletten
Ezetimibe/Rosuvastatin Sandoz 10
mg/20 mg filmomhulde tabletten
Ezetimibe/Rosuvastatin Sandoz 10
mg/40 mg filmomhulde tabletten
Croatia Coupet Combi 5 mg/ 10 mg filmom
obložene tablete
Coupet Combi 10 mg/ 10 mg filmom
obložene tablete
Coupet Combi 20 mg/ 10 mg filmom
obložene tablete
Coupet Combi 40 mg/ 10 mg filmom
obložene tablete
Greece Rosuvastatin/Ezetimibe Sandoz
Italy Rosuvastatina e Ezetimibe Sandoz
Latvia Rosuvastatin/Ezetimibe Sandoz 10
mg/10 mg apvalkotās tabletes
Rosuvastatin/Ezetimibe Sandoz 20
mg/10 mg apvalkotās tabletes
Portugal Rosuvastatina + Ezetimiba Sandoz
Czech Republic Rosuvastatin/Ezetimib Sandoz