Suvezen neo

Package leaflet: Information for the user

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
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• 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 other people. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What SUVEZEN NEO is and what it is 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 SUVEZEN NEO is and what it is 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 a medicine used to lower the levels of total cholesterol in the blood, "bad" cholesterol (LDL cholesterol), and fat substances called triglycerides.
Additionally, SUVEZEN NEO increases the level of "good" cholesterol (HDL cholesterol).
SUVEZEN NEO lowers cholesterol levels in two ways. It reduces the amount of cholesterol absorbed from the gastrointestinal tract and also decreases the amount of cholesterol produced by the body.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol.
This medicine is used in patients in whom diet alone is not sufficient to maintain normal cholesterol levels. While taking this medicine, you must always follow a cholesterol-lowering diet.
SUVEZEN NEO is used as an addition to a cholesterol-lowering diet in cases of elevated blood cholesterol levels due to:

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

when previous treatment with a statin alone has not sufficiently reduced blood cholesterol levels, or when the patient is already taking a statin and ezetimibe in separate tablets.
Other treatment methods may also be used in the patient.
If the patient has heart disease, SUVEZEN NEO reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.
SUVEZEN NEO has no effect on body weight reduction.
In most people, high cholesterol levels do not affect well-being, as they cause no symptoms. However, if left untreated, fatty deposits can accumulate in the walls of blood vessels and cause narrowing.
Sometimes these narrowed blood vessels may become blocked, cutting off blood supply to the heart or brain, leading to a heart attack or stroke. When cholesterol levels return to normal, the risk of heart attack, stroke, or similar health problems is reduced.
You should continue taking SUVEZEN NEO even if your cholesterol levels become normal. This helps prevent cholesterol levels from rising again and further accumulation of fatty deposits.
However, treatment should be discontinued if your doctor decides so, or if you become 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 pregnancy occurs while taking SUVEZEN NEO, treatment should be stopped immediately and the doctor informed. Women of childbearing potential should avoid becoming pregnant by using effective contraceptive methods during treatment with SUVEZEN NEO.
• If the patient has severe kidney disease.
• If the patient has recurrent or unexplained muscle pain or aches (myopathy).
• If the patient has previously experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after taking SUVEZEN NEO or other medicines containing rosuvastatin.
• If the patient is taking cyclosporine (used, for example, after organ transplantation). If any of the above apply to the patient (or if the patient has any doubts), consult the doctor.

Additionally, do not take SUVEZEN NEO 40 mg + 10 mg (the highest dose):
If the patient has moderate kidney disease (in case of doubt, consult the doctor).
If the patient has thyroid dysfunction (hypothyroidism).
If the patient has any recurrent or unexplained muscle pain or aches, or if the patient or family members have a history of muscle problems, or if the patient previously experienced muscle problems while taking other cholesterol-lowering medicines.
If the patient regularly consumes large amounts of alcohol.
If the patient is of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
If the patient is taking other cholesterol-lowering medicines called fibrates (see section “SUVEZEN NEO and other medicines”).
If any of the above apply to the patient (or if in doubt), consult the doctor.

Warnings and precautions
Before starting SUVEZEN NEO, discuss with the 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 appropriate medicine.
If the patient has recurrent or unexplained muscle pain or aches, or if the patient or family members have a history of muscle problems, or if the patient previously experienced muscle problems while taking other cholesterol-lowering medicines. Immediately inform the doctor if unexplained muscle pain or aches occur, especially if the patient feels unwell or has fever. Also inform the doctor or pharmacist if persistent muscle weakness occurs.
If the patient has thyroid dysfunction.
If the patient has severe respiratory insufficiency.
If the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), because statins may worsen an existing condition or lead to the development of myasthenia (see section 4).
If the patient is taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and/or atazanavir; see section “SUVEZEN NEO and other medicines”.
If the patient is over 70 years of age (because the doctor must determine the appropriate starting dose of SUVEZEN NEO for the patient).
If the patient is taking other cholesterol-lowering medicines called fibrates (see section “SUVEZEN NEO and other medicines”).
If the patient has planned surgery. Treatment with SUVEZEN NEO may need to be temporarily discontinued.
If the patient is of Asian descent – Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. The doctor should determine the appropriate starting dose of SUVEZEN NEO for the patient.
If the patient is taking or has taken orally or by injection fusidic acid (used to treat bacterial infections) within the last 7 days. Concomitant use of fusidic acid and SUVEZEN NEO may cause serious muscle problems (rhabdomyolysis).

Patients with diabetes or those at risk of developing diabetes will be closely monitored during treatment with this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at increased risk of developing diabetes.

In a small number of patients, statins may affect liver function. To confirm this, a blood test to check liver enzyme activity may be performed. Therefore, the doctor will prescribe regular blood tests (liver function tests) during treatment with SUVEZEN NEO. It is important to visit the doctor for these laboratory tests.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of SUVEZEN NEO. If any of the symptoms described in section 4 occur, discontinue SUVEZEN NEO and contact the doctor immediately.

SUVEZEN NEO and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, inform the doctor about the use of the following medicines:

• Cyclosporine (a medicine commonly used in patients after organ transplantation). Do not take SUVEZEN NEO while being treated with cyclosporine.
• Anticoagulants such as warfarin, acenocoumarol, phenprocoumon, or fluindione (their blood-thinning effect and risk of bleeding may be increased when used concomitantly with this medicine), ticagrelor, or clopidogrel.
• Colestyramine (a medicine used to reduce cholesterol levels), as it may affect 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 concomitantly with fibrates.
• Antacids containing aluminium 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 required to treat a bacterial infection, treatment with SUVEZEN NEO should be temporarily discontinued. The doctor will advise when to resume taking SUVEZEN NEO. Concomitant use of SUVEZEN NEO and fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See also additional information on rhabdomyolysis in section 4 of this leaflet. The patient taking SUVEZEN NEO should inform every doctor prescribing a new medicine about its use.

Use of 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, planning to become pregnant, or suspects she may be pregnant. If pregnancy occurs during treatment with SUVEZEN NEO, the patient should stop taking the medicine immediately and contact the doctor.
Do not take SUVEZEN NEO during breastfeeding, as it is unknown whether the medicine passes into breast milk.

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

Driving and operating machinery
SUVEZEN NEO is not expected to affect the ability to drive or operate machinery. However, consider that dizziness may occur in some individuals after taking SUVEZEN NEO.

SUVEZEN NEO contains lactose (a type of sugar) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, consult the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to use the medicine SUVEZEN NEO

This medicine should always be taken as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

• Before starting treatment with SUVEZEN NEO, a cholesterol-lowering diet should be initiated.
• The cholesterol-lowering diet should be continued during treatment with SUVEZEN NEO.

The recommended dose is one tablet of SUVEZEN NEO once daily.
SUVEZEN NEO is not suitable for initiating treatment.
If the patient's cholesterol level is not adequately controlled, the doctor will determine the appropriate dose
based on current treatment and individual cardiovascular risk.
Initiation of therapy or dose adjustment should be performed using the individual active substances separately.
Only after the appropriate doses have been established may the fixed-combination medicine SUVEZEN NEO
be used at the determined strength.
The maximum daily dose of rosuvastatin is 40 mg. This dose should be used only in patients with high cholesterol
levels and high risk of heart attack or stroke, in whom a 20 mg dose was insufficient to reduce cholesterol levels.
Try to take the tablet at the same time each day, as this will help you remember when to take it.
SUVEZEN NEO can be taken independently of meals. Swallow each tablet whole with water.
If your doctor has prescribed SUVEZEN NEO to be taken together with colestyramine or any other bile acid sequestrant
(medicines that lower cholesterol), SUVEZEN NEO should be taken at least 2 hours before or 4 hours after the bile acid
sequestrant.

Regular cholesterol monitoring
To ensure that cholesterol levels have decreased and remain within the target range, regular check-ups with your doctor
and blood tests are necessary. Your doctor may decide to increase the dose of the medicine to suit your individual needs.

If you take more SUVEZEN NEO than prescribed
Contact your doctor or pharmacist immediately.

If you miss a dose of SUVEZEN NEO
Do not take a double dose to make up for the missed dose.

Stopping SUVEZEN NEO
Consult your doctor or pharmacist before stopping, as cholesterol levels may rise again.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking SUVEZEN NEO and contact your doctor immediately
if the patient experiences any of the following symptoms:

• Unexplained muscle pain, tenderness or muscle weakness, particularly if these symptoms persist longer than expected. This is because muscle-related disorders, including muscle breakdown leading to kidney damage, can be serious and progress to a potentially life-threatening condition (rhabdomyolysis). This occurs rarely (may affect up to 1 in 1,000 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 lumps present). This occurs rarely (may affect up to 1 in 1,000 people);
• Red, flat, disc-shaped or circular skin lesions on the trunk, often with blisters in the center, peeling of the skin, and ulcers in the mouth, throat, nose, genital organs, and around the eyes. These potentially life-threatening skin rashes 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 hypersensitivity syndrome);
• Drug-induced lupus-like syndrome (including rash, joint disorders, and blood cell abnormalities);
• Muscle rupture.

Other known adverse reactions:
Common (may affect up to 1 in 10 people):
Diarrhea; flatulence; feeling of fatigue; increased blood laboratory test values indicating liver function (liver aminotransferases); headache; abdominal pain; constipation; nausea; muscle pain; feeling of weakness; dizziness; increased protein in urine – usually resolves spontaneously without the need to discontinue SUVEZEN NEO (this reaction occurred with a rosuvastatin dose of 40 mg); diabetes – more likely if the patient has high blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people):
Increased parameters in certain tests indicating muscle function (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; tingling sensation; dry mouth; gastritis; itching; rash; urticaria or other skin reactions; back pain; muscle weakness; pain in arms and legs; swelling, particularly in hands and feet; increased protein in urine – usually resolves spontaneously without the need to discontinue SUVEZEN NEO (with rosuvastatin 10 mg or 20 mg only).

Rare (may affect up to 1 in 1,000 people):
Reduced number of blood cells, which may cause bruising/bleeding (thrombocytopenia); severe abdominal pain (which may indicate pancreatitis).

Very rare (may affect up to 1 in 10,000 people):
Jaundice (yellowing of the skin and eyes); hepatitis; presence of trace amounts of blood in urine; nerve damage in arms and legs (such as numbness); memory loss; gynecomastia (enlargement of breasts in men).

Adverse reactions with unknown frequency (cannot be estimated from available data):
Shortness of breath; swelling; sleep disorders, including insomnia and nightmares; sexual dysfunction; depression; breathing problems, including persistent cough and/or shortness of breath or fever; tendon injury; persistent muscle weakness; raised red rash, sometimes with characteristic lesion patterns (erythema multiforme); muscle tenderness; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); myasthenia (a disease causing general muscle weakness, including in some cases the muscles used for breathing); ocular myasthenia (a disease causing weakness of the eye muscles). You should contact your doctor if you experience worsening weakness in arms or legs after periods of physical activity, double vision, drooping eyelid, difficulty swallowing, or shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store SUVEZEN NEO

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and blister, following the abbreviation "EXP". The expiry date refers to the last day of the indicated month.
Store the medicine below 30°C, in the original packaging, to protect it from light and moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What SUVEZEN NEO contains

• The active substances 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: monohydrate lactose, microcrystalline cellulose, sodium lauryl sulphate, povidone 25, anhydrous colloidal silicon dioxide, 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
Film-coated tablets (tablets) SUVEZEN NEO 10 mg + 10 mg are white to off-white in colour,
round, biconvex, with a diameter of approximately 9.1 mm.
Film-coated tablets (tablets) SUVEZEN NEO 20 mg + 10 mg are yellow to light yellow in colour,
round, biconvex, with a diameter of approximately 9.9 mm.
Film-coated tablets (tablets) SUVEZEN NEO 40 mg + 10 mg are pink in colour, round,
biconvex, with a diameter of approximately 11.1 mm.
The film-coated tablets are packed in blisters and cardboard cartons.
Pack sizes: 30, 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi-Aventis Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Poland

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 medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Zenon Neo
Belgium and Ireland: SUVEZEN
Romania: Suvezen
Greece, Norway and Portugal: Zenon
Poland: SUVEZEN NEO

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Sanofi-Aventis Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 280 00 00