Suvezen Neo

Leaflet accompanying 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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 packaging 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 lower the level of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. Additionally, 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 and also lowers the amount of cholesterol produced by the body.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of LDL cholesterol and HDL cholesterol.
The medicine is used in patients for whom diet alone is not enough to control cholesterol levels. While taking this medicine, you should always follow a cholesterol-lowering diet.
SUVEZEN NEO is used in addition to a cholesterol-lowering diet in cases of high cholesterol in the blood due to:

• primary hypercholesterolemia (heterozygous familial or non-familial),
• inherited disorder (homozygous familial hypercholesterolemia),

in cases where previous treatment with a statin alone has not sufficiently lowered 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 well-being, as it does not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels and cause them to narrow.
Sometimes these narrowed blood vessels can become blocked, which can cut off blood flow 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 will be reduced.
Patients should continue taking SUVEZEN NEO even if their cholesterol levels are normal. This prevents cholesterol levels from rising again and, as a result, the buildup 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 the patient is allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6).
• If the patient currently has liver disease.
• If the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking SUVEZEN NEO, they should stop taking the medicine immediately and consult their doctor. While taking SUVEZEN NEO, women should avoid becoming pregnant by using effective methods of contraception.
• If the patient has severe kidney disease.
• If the patient has recurring or unexplained muscle pain or weakness (myopathy).
• If the patient has 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 the patient is taking cyclosporin (e.g., after organ transplantation). If any of the above applies to the patient (or if the patient is in doubt), they should consult their doctor again.

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

If the patient has moderately severe kidney disease (if in doubt, consult a doctor).
If the patient's thyroid gland does not function properly (hypothyroidism).
If the patient has any recurring or unexplained muscle pain or weakness, or if the patient or their family members have had muscle problems, or if the patient has had muscle problems while taking other cholesterol-lowering medicines.
If the patient regularly consumes large amounts of alcohol.
If the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
If the patient is taking other cholesterol-lowering medicines called fibrates (see "SUVEZEN NEO and other medicines").
If any of the above applies to the patient (or if in doubt), they should consult their doctor again.

Warnings and precautions

Before starting to take SUVEZEN NEO, the patient should discuss it with their doctor or pharmacist:
If the patient has kidney disease.
If the patient consumes large amounts of alcohol or has ever had liver disease. SUVEZEN NEO may not be the right medicine.
If the patient has recurring or unexplained muscle pain or weakness, or if the patient or their family members have had muscle problems, or if they have had muscle problems while taking other cholesterol-lowering medicines. The patient should inform their doctor immediately if they experience unexplained muscle pain or weakness, especially if they feel unwell or have a fever.
The patient should also inform their doctor or pharmacist if they experience persistent muscle weakness.
If the patient's thyroid gland does not function properly.
If the patient has severe respiratory failure.
If the patient has or has had myasthenia (a disease that causes general muscle weakness, including muscles used for breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may worsen the condition or cause myasthenia (see section 4).
If the patient is taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and (or) atazanavir, see "SUVEZEN NEO and other medicines".
If the patient is over 70 years old (as the doctor must determine the appropriate initial dose of SUVEZEN NEO for the patient).
If the patient is taking other cholesterol-lowering medicines called fibrates (see "SUVEZEN NEO and other medicines").
If the patient is scheduled for surgery. The treatment with SUVEZEN NEO may need to be interrupted for a short time.
If the patient is of Asian origin - Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. The doctor should determine the appropriate initial dose of SUVEZEN NEO for the patient.
If the patient is taking or has 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).
Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.
In rare cases, statins may affect liver function. To confirm this effect, a blood test is performed to check liver enzyme activity. Therefore, the doctor will prescribe regular blood tests (liver function tests) during treatment with SUVEZEN NEO. It is essential to visit the 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 the patient experiences any of the symptoms described in section 4, they should stop taking SUVEZEN NEO and contact their doctor immediately.

SUVEZEN NEO and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should tell their doctor about taking 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 necessary to treat a bacterial infection, the treatment with SUVEZEN NEO should be temporarily interrupted. The doctor will advise when to resume 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 treatment.

Taking SUVEZEN NEO with alcohol

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

Pregnancy and breastfeeding

Do not take SUVEZEN NEO if the patient is pregnant, plans to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking SUVEZEN NEO, they should stop taking the medicine immediately and consult their 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

It is unlikely that SUVEZEN NEO will affect the ability to drive or use machines. However, the patient should consider that some people may experience dizziness after taking SUVEZEN NEO.

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

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take SUVEZEN NEO

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is in doubt, they should consult their doctor or pharmacist.

• Before starting to take SUVEZEN NEO, the patient should follow a cholesterol-lowering diet.
• While taking SUVEZEN NEO, the patient should continue to follow a cholesterol-lowering diet. The recommended dose is one SUVEZEN NEO tablet per day.

SUVEZEN NEO is not intended for initial treatment.
If the patient's cholesterol levels are not normal, the doctor will determine the appropriate dose based on the current treatment and individual risk level.
Treatment should be started or 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, for whom the 20 mg dose was not sufficient to lower cholesterol levels.
The patient should try to take the tablet at the same time every day, which will help them remember to take the medicine. The medicine can be taken with or without food. Each tablet should be swallowed whole with a glass of water.
If the doctor has prescribed SUVEZEN NEO to be taken with colestyramine or any other bile acid sequestrant (cholesterol-lowering medicines), SUVEZEN NEO should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular cholesterol testing

To ensure that cholesterol levels have decreased and are normal, the patient should regularly visit their doctor and have blood tests. The doctor may decide to increase the dose of the medicine to make it suitable for the patient.

Taking a higher dose of SUVEZEN NEO than recommended

The patient should consult their doctor or pharmacist.

Missing a dose of SUVEZEN NEO

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

Stopping treatment with SUVEZEN NEO

The patient should consult their doctor or pharmacist, as their cholesterol levels may rise again.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking SUVEZEN NEO and contact their doctor immediately if they 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, or rounded patches on the trunk, 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 drug 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 - this is more likely if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor the patient 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 cramps; neck pain; decreased appetite; pain; chest pain; sudden flushing of the face; high blood pressure; feeling of tingling; dry mouth; gastritis; itching; rash or other skin reactions; back pain; muscle weakness; pain in the arms and legs; swelling, especially in 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 cholecystitis (which can cause abdominal pain, nausea, vomiting); myasthenia (a disease that causes general muscle weakness, including muscles used for breathing); ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient should consult their doctor if they experience muscle weakness in the 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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.
Reporting side effects will help to gather 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 take 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging 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.
• 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.
Package sizes: 30, 90 film-coated tablets.
Not all package 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, the patient 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