Suvezen Neo

Leaflet attached to the packaging: patient information

SUVEZEN NEO, 10 mg + 10 mg, film-coated tablets

SUVEZEN NEO, 20 mg + 10 mg, film-coated tablets

SUVEZEN NEO, 40 mg + 10 mg, film-coated tablets

rosuvastatin + ezetimibe

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is SUVEZEN NEO and what is it used for
• 2. Important information before taking SUVEZEN NEO
• 3. How to take SUVEZEN NEO
• 4. Possible side effects
• 5. How to store SUVEZEN NEO
• 6. Contents of the pack and other information

1. What is SUVEZEN NEO and what is it used for

SUVEZEN NEO contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins, and the other active substance is ezetimibe.
SUVEZEN NEO is used to reduce the level of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. In addition, SUVEZEN NEO increases the level of "good" cholesterol (HDL cholesterol).
SUVEZEN NEO lowers cholesterol in two ways. It reduces the amount of cholesterol absorbed in the gut, as well as lowering the amount of cholesterol produced by the body.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol includes mainly LDL cholesterol and HDL cholesterol.
The medicine is used in patients whose diet alone is not enough to control their cholesterol levels. While taking this medicine, you should also follow a low-cholesterol diet.
SUVEZEN NEO is used in addition to a low-cholesterol diet in patients with high levels of cholesterol in the blood due to:

• primary hypercholesterolaemia (heterozygous familial or non-familial),
• a hereditary disorder (homozygous familial hypercholesterolaemia),

in cases where the patient's previous use of a statin alone did not sufficiently lower cholesterol levels or when the patient is already taking a statin and ezetimibe in separate tablets.
Other treatments may also be used in patients.
If the patient has heart disease, SUVEZEN NEO reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain.
SUVEZEN NEO does not affect weight loss.
In most people, high cholesterol does not affect how they feel, as it does not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.
Sometimes, these narrowed blood vessels can become blocked, which can cut off the blood supply to the heart or brain, leading to a heart attack or stroke. If cholesterol levels return to normal, the risk of heart attack, stroke, or similar health problems is reduced.
You should continue to take SUVEZEN NEO even if your cholesterol levels are normal. This prevents the cholesterol level from rising again and, as a result, the accumulation of fatty deposits.
However, treatment should be discontinued if the doctor decides to do so or if the patient becomes pregnant.

2. Important information before taking SUVEZEN NEO

When not to take SUVEZEN NEO:

• If you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6).
• If you currently have liver disease.
• If you are pregnant or breastfeeding. If you become pregnant while taking SUVEZEN NEO, you should stop taking the medicine immediately and tell your doctor. While taking SUVEZEN NEO, women should avoid becoming pregnant by using effective methods of contraception.
• If you have severe kidney disease.
• If you have recurring or unexplained muscle pain or weakness (myopathy).
• If you have ever had a severe skin rash or skin peeling, blisters, and (or) ulcers in the mouth after taking SUVEZEN NEO or other medicines containing rosuvastatin.
• If you are taking cyclosporin (used, for example, after organ transplantation). If any of the above applies to you (or if you are unsure), you should consult your doctor again.

In addition, do not take SUVEZEN NEO 40 mg + 10 mg (the highest dose):

If you have moderately severe kidney disease (if in doubt, ask your doctor).
If your thyroid gland does not function properly (hypothyroidism).
If you have recurring or unexplained muscle pain or weakness, or if you or a family member have had muscle problems, or if you have had muscle problems in the past while taking other cholesterol-lowering medicines.
If you regularly drink large amounts of alcohol.
If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
If you are taking other cholesterol-lowering medicines called fibrates (see "SUVEZEN NEO and other medicines").
If any of the above applies to you (or if you are unsure), you should consult your doctor again.

Warnings and precautions

Before starting to take SUVEZEN NEO, you should discuss this with your doctor or pharmacist:
If you have kidney disease.
If you drink large amounts of alcohol or have ever had liver disease. SUVEZEN NEO may not be the right medicine for you.
If you have recurring or unexplained muscle pain or weakness, or if you or a family member have had muscle problems, or if you have had muscle problems in the past while taking other cholesterol-lowering medicines. You should tell your doctor immediately if you experience unexplained muscle pain or weakness, especially if you feel unwell or have a fever.
You should also tell your doctor or pharmacist if you experience persistent muscle weakness.
If your thyroid gland does not function properly.
If you have severe respiratory failure.
If you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles used for breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may worsen the condition or lead to the development of myasthenia (see section 4).
If you are taking medicines used to treat HIV infection, such as ritonavir, lopinavir, and (or) atazanavir, see "SUVEZEN NEO and other medicines".
If you are over 70 years old (as your doctor will need to determine the appropriate starting dose of SUVEZEN NEO for you).
If you are taking other cholesterol-lowering medicines called fibrates (see "SUVEZEN NEO and other medicines").
If you are scheduled to have surgery. You may need to stop taking SUVEZEN NEO for a short time.
If you are of Asian origin - Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor should determine the appropriate starting dose of SUVEZEN NEO for you.
If you are taking or have taken fusidic acid orally or by injection in the last 7 days (used to treat bacterial infections). Taking fusidic acid and SUVEZEN NEO at the same time may cause serious muscle problems (rhabdomyolysis).
People with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. People with high blood sugar and fat levels, being overweight, and having high blood pressure may be at risk of developing diabetes.
In a small number of patients, statins may affect liver function. To check for this, a blood test is done to check liver enzyme activity. Therefore, your doctor will prescribe regular blood tests (liver function tests) while taking SUVEZEN NEO. It is important to go to your doctor, who will order the necessary laboratory tests.
Severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with SUVEZEN NEO. If you experience any of the symptoms described in section 4, you should stop taking SUVEZEN NEO and contact your doctor immediately.

SUVEZEN NEO and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. In particular, tell your doctor about the following medicines:

• cyclosporin (a medicine often used in patients after organ transplantation).

Do not take SUVEZEN NEO while being treated with cyclosporin.

• blood thinners, such as warfarin, acenocoumarol, phenprocoumon, or fluindion (their blood-thinning effect and risk of bleeding may be increased when taken with this medicine), ticagrelor, or clopidogrel.
• colestyramine (a medicine used to lower cholesterol levels), as it affects the action of SUVEZEN NEO.
• fibrates, such as gemfibrozil, fenofibrate (a medicine used to lower cholesterol levels). Do not take SUVEZEN NEO 40 mg + 10 mg tablets at the same time as fibrates.
• antacids containing aluminum and magnesium (used to neutralize stomach acid).
• erythromycin (an antibiotic).
• oral contraceptives (the "pill").
• hormone replacement therapy.
• regorafenib (a medicine used to treat cancer).
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, alone or in combination (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• fusidic acid - if fusidic acid is needed to treat a bacterial infection, you should temporarily stop taking SUVEZEN NEO. Your doctor will advise when to restart taking SUVEZEN NEO. Taking SUVEZEN NEO and fusidic acid at the same time may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See also additional information on rhabdomyolysis in section 4 of this leaflet. Patients taking SUVEZEN NEO should inform any doctor who prescribes them a new medicine about their use of SUVEZEN NEO.

Taking SUVEZEN NEO with alcohol

Do not take SUVEZEN NEO 40 mg + 10 mg tablets (the highest dose) if you regularly drink large amounts of alcohol.

Pregnancy and breastfeeding

Do not take SUVEZEN NEO if you are pregnant, plan to become pregnant, or think you may be pregnant. If you become pregnant while taking SUVEZEN NEO, you should stop taking it immediately and contact your doctor.
Do not take SUVEZEN NEO while breastfeeding, as it is not known whether the medicine passes into breast milk.

Children and adolescents

SUVEZEN NEO is not intended for use in children and adolescents under 18 years of age.

Driving and using machines

You should not expect SUVEZEN NEO to affect your ability to drive or use machines. However, you should take into account that some people may experience dizziness after taking SUVEZEN NEO.

SUVEZEN NEO contains lactose (a type of sugar) and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially "sodium-free".

3. How to take SUVEZEN NEO

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are unsure, you should ask your doctor or pharmacist.

• Before starting to take SUVEZEN NEO, you should follow a low-cholesterol diet.
• While taking SUVEZEN NEO, you should continue to follow a low-cholesterol diet. The recommended dose is one SUVEZEN NEO tablet, once a day.

SUVEZEN NEO is not intended for initial treatment.
If your cholesterol levels are not normal, your doctor will determine the appropriate dose, depending on your current treatment and individual risk level.
Treatment should be started or, if necessary, the dose adjusted by administering the active substances separately. Only after determining the appropriate doses can the combined SUVEZEN NEO medicine be used.
The maximum daily dose of rosuvastatin is 40 mg. It is used only in patients with very high cholesterol levels and a high risk of heart attack or stroke, in whom the 20 mg dose was not sufficient to lower cholesterol levels.
You should try to take the tablet at the same time every day, as this will help you remember when to take the medicine. The medicine can be taken with or without food. You should swallow each tablet whole, with a glass of water.
If your doctor has prescribed that you take SUVEZEN NEO with colestyramine or any other bile acid sequestrant (cholesterol-lowering medicines), you should take SUVEZEN NEO at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular cholesterol testing

To ensure that your cholesterol levels have decreased and are normal, you should regularly visit your doctor for check-ups and have blood tests. Your doctor may decide to increase the dose of the medicine to make it suitable for you.

Taking a higher dose of SUVEZEN NEO than recommended

You should contact your doctor or pharmacist.

Missing a dose of SUVEZEN NEO

You should not take a double dose to make up for a missed dose.

Stopping treatment with SUVEZEN NEO

You should consult your doctor or pharmacist, as this may lead to your cholesterol levels rising again.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, SUVEZEN NEO can cause side effects, although not everybody gets them.

You should stop taking SUVEZEN NEO and contact your doctor immediately if you experience any of the following symptoms:

• unexplained muscle pain, tenderness, or weakness, if these symptoms persist longer than expected. This is because muscle problems, including muscle breakdown leading to kidney damage, can be serious and potentially life-threatening (rhabdomyolysis). This occurs rarely (may affect up to 1 in 1000 people);
• severe allergic reaction (angioedema) - symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing or breathing, and persistent itching of the skin (with raised bumps). This occurs rarely (may affect up to 1 in 1000 people);
• red, flat, round, or oval patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• widespread rash, high fever, and enlarged lymph nodes (DRESS or hypersensitivity syndrome);
• drug-induced lupus-like syndrome (including rash, joint disorders, and blood cell disorders);
• muscle rupture.

Other known side effects:

Common (may affect up to 1 in 10 people):
diarrhea; bloating; feeling tired; increased values of some blood test results that assess liver function (liver transaminases); headache; abdominal pain; constipation; nausea; muscle pain; feeling weak; dizziness; increased protein in the urine - usually returns to normal without the need to stop taking SUVEZEN NEO (this effect occurred with rosuvastatin 40 mg); diabetes - is more likely if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you while taking this medicine.
Uncommon (may affect up to 1 in 100 people):
increased parameters of some muscle function tests (CK, creatine kinase); cough; indigestion; heartburn; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; sudden flushing of the face; high blood pressure; feeling of tingling; dry mouth; stomach inflammation; itching; rash; hives or other skin reactions; back pain; muscle weakness; pain in the arms and legs; swelling, especially of the hands and feet; increased protein in the urine - usually returns to normal without the need to stop taking SUVEZEN NEO (only rosuvastatin 10 mg or 20 mg).
Rare (may affect up to 1 in 1000 people):
decreased number of blood cells, which can cause bruising/bleeding (thrombocytopenia); severe abdominal pain (may indicate pancreatitis).
Very rare (may affect up to 1 in 10,000 people):
jaundice (yellowing of the skin and eyes); liver inflammation; presence of trace amounts of blood in the urine; nerve damage in the legs and arms (such as numbness); memory loss; gynecomastia (breast enlargement in men).
Side effects with unknown frequency (cannot be estimated from the available data):
shortness of breath; swelling; sleep disorders, including insomnia and nightmares; sexual disorders; depression; breathing problems, including persistent cough and (or) shortness of breath or fever; tendon injury; persistent muscle weakness; raised red rash, sometimes with a characteristic shape (erythema multiforme); muscle tenderness; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting); myasthenia (a disease that causes general muscle weakness, including in some cases muscles used for breathing); ocular myasthenia (a disease that causes muscle weakness in the eyes). You should contact your doctor if you experience muscle weakness in your arms or legs that worsens after periods of physical activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SUVEZEN NEO

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and blister after the "EXP" abbreviation. The expiry date refers to the last day of the month.
Store the medicine at a temperature below 30°C, in the original packaging to protect it from light and moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What SUVEZEN NEO contains

• The active substances of SUVEZEN NEO are rosuvastatin and ezetimibe. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.
• The other ingredients are:
• Tablet core:lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, povidone 25, colloidal anhydrous silica, sodium croscarmellose, magnesium stearate.
• Coating:hypromellose 2910/5 (E464), macrogol 6000, titanium dioxide (E171), talc (E553). SUVEZEN NEO 20 mg + 10 mg also contains yellow iron oxide (E172). SUVEZEN NEO 40 mg + 10 mg also contains red iron oxide (E172).

What SUVEZEN NEO looks like and contents of the pack

SUVEZEN NEO 10 mg + 10 mg film-coated tablets are white to off-white, round, biconvex, approximately 9.1 mm in diameter.
SUVEZEN NEO 20 mg + 10 mg film-coated tablets are yellow to light yellow, round, biconvex, approximately 9.9 mm in diameter.
SUVEZEN NEO 40 mg + 10 mg film-coated tablets are pink, round, biconvex, approximately 11.1 mm in diameter.
The tablets are packaged in blisters and a cardboard box.
Pack sizes: 30, 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sanofi-Aventis Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw

Manufacturer/Importer

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Sanofi Winthrop Industrie-Tours
30-36 avenue Gustave Eiffel
37100 Tours
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Zenon Neo
Belgium and Ireland: SUVEZEN
Romania: Suvezen
Greece, Norway, and Portugal: Zenon
Poland: SUVEZEN NEO
To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder in Poland:
Sanofi-Aventis Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 280 00 00
Date of last revision of the leaflet:May 2023