Rosuvastatin and ezetimibe Sandoz

Patient Information Leaflet

Rosuvastatin and 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

Please read this entire 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Rosuvastatina e Ezetimibe Sandoz contains two different active substances in one tablet. One of the active substances is rosuvastatin, belonging to the group of medicines known as statins; the other active substance is ezetimibe.
Rosuvastatina e 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. In addition, 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 and decreases the body's own production of cholesterol.
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 fatty deposits in the walls of blood vessels, causing them to narrow.
Sometimes these narrowed blood vessels can become blocked, interrupting blood flow to the heart or brain and causing a heart attack or stroke. By lowering cholesterol levels, it is possible to reduce the risk of having a heart attack, stroke, or related health problems.
Rosuvastatina e Ezetimibe Sandoz is used in patients whose cholesterol levels cannot be sufficiently controlled by a cholesterol-lowering diet alone. Such a cholesterol-lowering diet must be maintained while taking this medicine. Your doctor may prescribe Rosuvastatina e Ezetimibe Sandoz if you are already taking both rosuvastatin and ezetimibe at the same dosage.
Rosuvastatina e Ezetimibe Sandoz is used in cases where you have:

• Excess cholesterol in the blood (primary hypercholesterolaemia);
• Heart disease; Rosuvastatina e Ezetimibe Sandoz reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalisations due to chest pain.

Rosuvastatina e Ezetimibe Sandoz does not help with weight loss.

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

Do not take Rosuvastatin 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 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 the viral liver infection called hepatitis C).
• you are taking a medicine called cyclosporine (used, for example, after organ transplants).
• you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin and Ezetimibe Sandoz, stop taking it immediately and contact your doctor. Women must avoid pregnancy while using Rosuvastatin and Ezetimibe Sandoz by using adequate contraceptive measures.

In addition, do not take Rosuvastatin and Ezetimibe Sandoz 40 mg/10 mg (the highest dose):

• if you have moderately severe kidney problems (if in doubt, 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 a previous history of muscle problems during treatment with other cholesterol-lowering medicines.
• if you regularly consume large 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 Rosuvastatin and Ezetimibe Sandoz”). If any of the above apply to you (or if you are unsure), contact your doctor.

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

• you have kidney problems.
• you have liver problems.
• you have experienced repeated or unexplained muscle pain, a personal or family history of muscle problems, or previous muscle problems during treatment with other cholesterol-lowering medicines. Contact a doctor immediately if you experience repeated and unexplained muscle pain, especially if you feel unwell or have a fever. Also consult a doctor or pharmacist if you have persistent muscle weakness.
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In such cases, your doctor must choose the appropriate dose for you.
• you are taking medicines for infections, including HIV or hepatitis C (e.g. lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir and/or pibrentasvir). See section “Other medicines and Rosuvastatin and Ezetimibe Sandoz”.
• you have severe respiratory failure.
• you are taking other medicines called fibrates to lower cholesterol levels. See section “Other medicines and Rosuvastatin and Ezetimibe Sandoz”.
• you are about to undergo surgery. You may need to stop taking Rosuvastatin and Ezetimibe Sandoz for a short period.
• you regularly drink large amounts of alcohol.
• you have hypothyroidism, where the thyroid gland does not function properly.
• you are over 70 years of age (your doctor must determine the correct dose of Rosuvastatin and Ezetimibe Sandoz 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) by mouth or injection. The combination of fusidic acid and Rosuvastatin and Ezetimibe Sandoz may lead to serious muscle problems (rhabdomyolysis).
• you are taking regorafenib (a medicine used to treat cancer).
• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking rosuvastatin or related medicines. Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment. Stop using Rosuvastatin and Ezetimibe Sandoz and seek immediate medical help if you notice any of the symptoms described in section 4. If any of the above circumstances apply to you (or if you are in doubt), consult your doctor or pharmacist before taking any dose of this medicine.

Statins may cause liver problems in a small number of people. This condition can be easily detected with a simple blood test measuring liver enzyme levels. For this reason, your doctor must regularly perform this blood test (liver function test) during treatment with this medicine. It is important to attend your scheduled laboratory appointments.
While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is particularly high if you have high levels of sugar and fats in the blood, if you are overweight, or if you have high blood pressure.
Children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Rosuvastatin and Ezetimibe Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 is increased when used together with cyclosporine). Do not take Rosuvastatin and Ezetimibe Sandoz while taking cyclosporine.
• Anticoagulants, such as warfarin, acenocoumarol, or fluindione (their anticoagulant effect and 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 (e.g. gemfibrozil and other fibrates, niacin (nicotinic acid)).
• Colestipol (a medicine used to lower cholesterol levels), as it alters the action of ezetimibe.
• Regorafenib (used to treat tumours).
• Darolutamide (used to treat tumours).
• Any 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 aluminium and magnesium (used to neutralize stomach acids; these reduce rosuvastatin levels in the blood).
• Erythromycin (an antibiotic).
• Fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop treatment with this medicine. Your doctor will advise you when it is safe to restart Rosuvastatin and Ezetimibe Sandoz. The combination of Rosuvastatin and Ezetimibe Sandoz and fusidic acid may 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 hospitalized or undergoing treatment for another condition, inform the medical staff that you are taking Rosuvastatin and Ezetimibe Sandoz.
Pregnancy and breastfeeding
Do not take Rosuvastatin and Ezetimibe Sandoz if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant while taking this medicine, stop immediately and contact your doctor. Women must always use effective contraceptive measures during treatment with this medicine.
Do not take Rosuvastatin and Ezetimibe Sandoz while breastfeeding, as it is not known whether the medicine passes into breast milk.
Driving and using machines
This medicine is not expected to affect your ability to drive or operate machinery. However, you should consider that some people may experience dizziness after taking this medicine. If you feel dizzy, do not drive or operate machinery.
Rosuvastatin and Ezetimibe Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 Rosuvastatin and Ezetimibe Sandoz

Take this medicine exactly as your doctor or pharmacist 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 Rosuvastatin and Ezetimibe Sandoz.
The recommended daily dose for adults is one tablet per day.
Take the tablet at any time of day, with or without food. Swallow each tablet whole with a glass of water.
Take the tablet at the same time every day to help you remember.
This medicine is not suitable for initiating treatment. Treatment initiation or, if necessary,
a dose adjustment, must only be done by administering the active substances
separately; only after the correct dose has been established may you switch to Rosuvastatin and
Ezetimibe Sandoz at the appropriate dose.
If your doctor has prescribed Rosuvastatin and Ezetimibe Sandoz together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take Rosuvastatin 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 ensure
that cholesterol reaches and maintains the correct level.
If you take more Rosuvastatin and Ezetimibe Sandoz than you should
Contact your doctor or the nearest hospital emergency department, as you may
require medical attention.
If you forget to take Rosuvastatin and Ezetimibe Sandoz
Do not worry. Skip the missed dose and take the next scheduled dose at the usual time.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Rosuvastatin and Ezetimibe Sandoz
Talk to your doctor if you want to stop treatment with this medicine. Keep in mind that your cholesterol levels may rise again if you stop taking this medicine.
If you have any doubts about how to use this medicine, consult 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 the possible side effects.
Stop taking Rosuvastatin 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 muscle breakdown, can lead to kidney damage, which may be serious and potentially fatal (rhabdomyolysis). This is rare (may affect up to 1 in 1,000 people)
• in case of muscle breakdown.
• if you develop a lupus-like syndrome (including skin rash, joint problems and effects on blood cells).
• severe allergic reaction (angioedema). Signs include: swelling of the face, lips, tongue and/or throat, difficulty breathing and swallowing, and severe skin itching (with appearance of lumps). This is rare (may affect up to 1 in 1,000 people)
• severe skin ulcers or blisters on the skin, mouth, eyes and genitals. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). Frequency is unknown (cannot be estimated from 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 of weakness
• dizziness
• diabetes. This is much more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will need to monitor you during treatment.
• stomach pain
• diarrhoea
• flatulence (excess gas in the intestinal tract)
• feeling of tiredness
• increase in certain blood tests related to liver function (transaminases)
• increased amount of protein in the urine – usually values return to normal on their own without needing to stop taking Rosuvastatin and Ezetimibe Sandoz (only for rosuvastatin 40 mg)

Uncommon (may affect up to 1 in 100 people)

• skin rashes, itching, hives
• increase in certain blood tests related to muscle function (Creatine Kinase test)
• cough
• indigestion
• heartburn
• joint pain
• muscle spasms
• neck pain
• decreased appetite
• pain
• chest pain
• hot flushes
• high blood pressure
• tingling sensation
• dry mouth
• inflammation of the stomach
• back pain
• muscle weakness
• pain in arms and legs
• swelling, especially in hands and feet
• increased amount of protein in the urine – usually values return to normal on their own without needing to stop taking Rosuvastatin and Ezetimibe Sandoz (only for rosuvastatin 10 and 20 mg)

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

• inflammation of the pancreas, causing severe stomach pain radiating to the back
• reduction in platelets in the blood, which could 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
• nerve damage in arms and legs (such as numbness)
• joint pain
• memory loss
• breast enlargement in men (gynaecomastia)

Not known (frequency cannot be estimated from available data)

• diarrhoea (watery stools)
• cough
• shortness of breath
• oedema (swelling)
• sleep disorders, including insomnia and nightmares
• sexual problems
• depression
• breathing problems, 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 may cause stomach pain, nausea, vomiting)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at
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 special storage temperature.
Keep in the original packaging 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 stated on the carton and on the blister after "Exp.". 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Rosuvastatina e Ezetimibe Sandoz contains
The active substances 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 components are:
Tablet core
Monohydrate lactose, Croscarmellose sodium, Povidone, Sodium lauryl sulfate, Microcrystalline cellulose 102, Hypromellose 2910, Anhydrous colloidal silica, Magnesium stearate.

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

Description of the appearance of Rosuvastatina e Ezetimibe Sandoz and pack sizes
Rosuvastatina e Ezetimibe Sandoz 5 mg/10 mg film-coated tablets
Film-coated, round, biconvex tablets, light yellow in colour, approximately 10 mm in diameter, with "EL 5" imprinted on one side.
Rosuvastatina e Ezetimibe Sandoz 10 mg/10 mg film-coated tablets
Film-coated, round, biconvex tablets, beige in colour, approximately 10 mm in diameter, with "EL 4" imprinted on one side.
Rosuvastatina e Ezetimibe Sandoz 20 mg/10 mg film-coated tablets
Film-coated, round, biconvex tablets, yellow in colour, approximately 10 mm in diameter, with "EL 3" imprinted on one side.
Rosuvastatina e Ezetimibe Sandoz 40 mg/10 mg film-coated tablets
Film-coated, round, biconvex tablets, white in colour, approximately 10 mm in diameter, with "EL 2" imprinted on one side.

Blister OPA/Alu/PVC-aluminium containing 10, 30, 90 and 100 film-coated tablets
Blister OPA/Alu/PVC-aluminium, unit dose divisible, 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 authorized in the Member States of the European Economic Area under 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