Package leaflet: Information for the patient

Suvardio Plus, 40 mg + 10 mg, film-coated tablets
Rosuvastatinum + Ezetimibum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Suvardio Plus is and what it is used for
Important information before taking Suvardio Plus
How to take Suvardio Plus
Possible side effects
How to store Suvardio Plus
Contents of the packaging and other information

1. What Suvardio Plus is and what it is used for

Suvardio Plus contains two different active substances in one tablet. One of the active substances is rosuvastatin, belonging to a group of drugs known as statins, and the other active substance is ezetimibe.
Suvardio Plus is a medicine used to reduce blood levels of total cholesterol, so-called "bad" cholesterol (LDL cholesterol), and fat substances called "triglycerides", while also increasing levels of so-called "good" cholesterol (HDL cholesterol). The medicine reduces cholesterol levels by acting in two ways: by decreasing the amount of cholesterol absorbed in the gastrointestinal tract and by reducing the amount of cholesterol produced in the body.
In most people, high cholesterol levels do not affect well-being, as they do not cause any symptoms. However, if left untreated, fatty deposits may accumulate in the walls of blood vessels, leading to their narrowing.
As a result of this narrowing, blood vessels may become completely blocked, cutting off blood flow to the heart or brain, which may lead to myocardial infarction or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health problems can be reduced.
Suvardio Plus is used in patients in whom diet alone is insufficient to maintain normal cholesterol levels. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Your doctor may prescribe Suvardio Plus if you are already taking rosuvastatin and ezetimibe at the same doses as contained in the combination medicine.
The medicine is used in patients:

with elevated blood cholesterol levels (primary hypercholesterolemia)
with heart disease – Suvardio Plus reduces the risk of heart attack, stroke, need for surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.

Suvardio Plus does not help reduce body weight.

2. Important information before using Suvardio Plus

When not to use Suvardio Plus

if the patient is allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6)
if the patient has liver disease
if the patient has severe kidney function impairment
if the patient experiences recurrent, unexplained muscle pain (myopathy)
if the patient is taking a medicine containing cyclosporine (used, for example, after organ transplantation)
if the patient is pregnant or breastfeeding. If a patient becomes pregnant while taking Suvardio Plus, she should stop taking the medicine immediately and inform her doctor. Effective contraception must be used to avoid pregnancy while taking Suvardio Plus (see section "Pregnancy and breastfeeding").

If any of the above situations apply to the patient (or if the patient has any doubts),
the patient should consult a doctor.
Warnings and precautions
Before taking Suvardio Plus, discuss with a doctor or pharmacist if:
the patient has kidney function impairment;
the patient has liver function impairment;
the patient has experienced recurrent or unexplained muscle pain, or previously had muscle disorders, either personally or in family members, or had muscle problems related to taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially when accompanied by malaise or fever, the patient should contact a doctor immediately. The patient should also inform the doctor or pharmacist about persistent muscle weakness;
if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms or trigger the onset of myasthenia (see section 4);
the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine the appropriate dose of Suvardio Plus for the patient;
the patient is taking antiviral medicines, including those used to treat HIV infection or hepatitis C virus, e.g. ritonavir with lopinavir and (or) atazanavir or simeprevir (see section "Suvardio Plus and other medicines");
the patient has severe respiratory insufficiency;
the patient is taking other medicines (so-called fibrates) to lower cholesterol levels (see section "Suvardio Plus and other medicines");
the patient regularly consumes large amounts of alcohol;
the patient has been diagnosed with thyroid dysfunction (hypothyroidism);
the patient is over 70 years of age (as the doctor will need to select an appropriate dose of Suvardio Plus);
the patient is receiving or has received within the last 7 days, orally or by injection, a medicine called fusidic acid (used to treat bacterial infections). Concomitant use of fusidic acid and Suvardio Plus may lead to serious muscle disorders (rhabdomyolysis);
the patient has ever experienced a severe skin rash, skin peeling, blisters, and (or) oral ulcers after taking rosuvastatin or similar medicines.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin use. If any of the symptoms described in section 4 occur, treatment with Suvardio Plus should be discontinued immediately and the patient should contact a doctor without delay.
If any of the above situations apply to the patient (or if there is any doubt whether such a situation exists), the patient should consult a doctor or pharmacist again before starting Suvardio Plus.
Statins may affect liver function in a small number of people. This can be detected by a simple blood test measuring increased liver enzyme activity. Therefore, the doctor will recommend regular blood tests during treatment with Suvardio Plus. It is important that the patient attends appointments for these tests.
While taking this medicine, the doctor will closely monitor patients with diabetes or risk factors for developing diabetes. There is a high risk of developing diabetes if the patient has high blood sugar and lipid levels, overweight, and high blood pressure.
If the patient is admitted to hospital or is being treated for another condition, he or she should inform medical staff about taking Suvardio Plus.
Children and adolescents
Suvardio Plus is not recommended for use in children and adolescents under 18 years of age.
Suvardio Plus and other medicines
The patient should inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.
The patient should inform the doctor about taking any of the following medicines:

cyclosporine (a medicine used, for example, after organ transplantation to prevent transplant rejection. Cyclosporine enhances the effect of concomitantly administered rosuvastatin). Suvardio Plus must not be taken during cyclosporine treatment.
anticoagulant medicines, e.g. warfarin, acenocoumarol, or fluindione (concomitant use with Suvardio Plus may enhance anticoagulant effect, increasing the risk of bleeding), ticagrelor, or clopidogrel;
other cholesterol-lowering medicines, so-called fibrates, which also regulate blood triglyceride levels (e.g. gemfibrozil and other medicines in this group). Concomitant use increases the effect of rosuvastatin;
colestyramine (a medicine used to lower cholesterol levels), as it affects the way ezetimibe works;
medicines used to treat indigestion, containing aluminium and magnesium (used to neutralize stomach acid). These medicines reduce rosuvastatin plasma concentration. This interaction can be minimized by taking these medicines 2 hours after rosuvastatin;
erythromycin (an antibiotic). Concomitant use reduces the effect of rosuvastatin;
fusidic acid. If the patient needs to take oral fusidic acid to treat a bacterial infection, temporary discontinuation of Suvardio Plus will be necessary. The doctor will advise when it is safe to resume taking the medicine. Concomitant use of Suvardio Plus and fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis is provided in section 4;
oral contraceptives (birth control pills). Concomitant use increases the concentration of sex hormones released from the pill;
medicines used in hormone replacement therapy (increased hormone levels in blood);
regorafenib (used in cancer treatment);
any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, administered alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If the patient is admitted to hospital or is being treated for another illness, he or she should
inform medical staff about taking Suvardio Plus.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Suvardio Plus must not be used if the patient is pregnant, trying to become pregnant, or suspects she may be pregnant. If a patient becomes pregnant while taking Suvardio Plus, she should stop taking the medicine immediately and inform her doctor. Effective contraception must be used by patients while taking Suvardio Plus.
Breastfeeding
Suvardio Plus must not be used during breastfeeding, as it is unknown whether the medicine passes into breast milk.
Driving and using machines
Suvardio Plus is not expected to affect the ability to drive or operate machinery.
However, it should be noted that Suvardio Plus may cause dizziness in some patients. In such a case, the patient should consult a doctor before driving or operating machinery.
Suvardio Plus contains sodium and lactose
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".
If the patient has been previously diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

3. How to use Suvardio Plus

This medicine should always be taken as directed by the physician or pharmacist. In case of
doubt, consult your physician or pharmacist.
While taking Suvardio Plus, a low-cholesterol diet should be continued and physical activity maintained.
The recommended daily dose for adults is one tablet of a given strength.
Suvardio Plus should be taken once daily.
The medicine can be taken at any time of day, with or without food. Tablets should be swallowed
whole with water.
The medicine should be taken at the same time each day.
Suvardio Plus is not suitable for initiating treatment. If starting treatment or if a dose adjustment is
required, each active substance should be administered separately as individual medicines, and only
after determining the appropriate doses should the switch be made to Suvardio Plus at a specified strength.
Regular monitoring of cholesterol levels
It is important to visit your physician regularly to monitor cholesterol levels, to ensure that the
appropriate target level has been achieved and maintained.
Taking more Suvardio Plus than recommended
In case of overdose, contact your physician or the emergency department of the nearest hospital,
as medical assistance may be necessary.
Missing a dose of Suvardio Plus
If a dose is missed, take the next tablet at the usual time. Do not take a double dose to make up for
the missed dose.
Stopping Suvardio Plus
Inform your physician if you wish to discontinue taking Suvardio Plus. After stopping Suvardio Plus,
cholesterol levels may increase again.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important that the patient is aware of the possible adverse reactions associated with the use of this medicine.
If the patient experiences any of the following reactions, treatment with Suvardio Plus must be discontinued
and immediate medical help sought:

swelling of the face, lips, tongue and (or) throat, which may cause difficulty breathing and swallowing,
drug reaction with eosinophilia and systemic symptoms (DRESS) (including rash, joint disorders and effects on blood cells),
muscle rupture,
red, flat, circular or target-like lesions on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin reactions 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).

Immediate medical advice should be sought if the patient experiences any unusual, persistent muscle pain.
In rare cases, this condition may progress to life-threatening muscle damage (known as rhabdomyolysis), causing malaise, fever and kidney dysfunction.
To describe the frequency of adverse reactions, the following classification is used:

very common (may affect more than 1 in 10 people)
common (may affect up to 1 in 10 people)
uncommon (may affect up to 1 in 100 people)
rare (may affect up to 1 in 1,000 people)
very rare (may affect up to 1 in 10,000 people), including isolated cases

Common adverse reactions
headache
constipation
nausea
muscle pain
feeling of weakness
dizziness
diabetes – more likely in patients with high levels of sugar and fats in the blood, overweight and high blood pressure. The doctor will monitor the patient’s condition during treatment with this medicine.
stomach pain
diarrhea
flatulence (excess gas in the intestines)
feeling of fatigue
increased results of certain blood tests assessing liver function (aminotransferase activity)

Uncommon adverse reactions
rash, itching, urticaria
increased protein in urine, which usually resolves spontaneously without the need to discontinue Suvardio Plus tablets
increased results of certain tests assessing muscle status (creatine kinase, CK activity)
cough
dyspepsia
heartburn
joint pain
muscle cramps
neck pain
decreased appetite
pain
chest pain
hot flushes
high blood pressure
tingling
dry mouth
gastritis (inflammation of the stomach lining)
back pain
muscle weakness
pain in arms and legs
swelling, especially of hands and feet

Rare adverse reactions
pancreatitis causing severe abdominal pain, which may radiate to the back
decreased platelet count

Very rare adverse reactions
jaundice (yellowing of the skin and eyes)
hepatitis (liver inflammation)
trace amounts of blood in urine
nerve damage in arms and legs (e.g. numbness)
memory loss
breast enlargement in men (gynaecomastia)

Adverse reactions with unknown frequency
shortness of breath
oedema
sleep disorders, including insomnia and nightmares
sexual dysfunction
depression
respiratory disorders, including persistent cough and/or shortness of breath or fever
tendon injury
persistent muscle weakness
gallstones or cholecystitis (which may cause abdominal pain, nausea, vomiting)
myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
ocular myasthenia (a disease causing weakness of eye muscles).

Talk to your doctor if the patient experiences weakness in the arms or legs, worsening after periods of activity, double vision or drooping eyelids, 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions may 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 Suvardio Plus

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Store the medicine in its original packaging to protect it from light and moisture.
No special temperature storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Suvardio Plus contains
Each coated tablet contains rosuvastatin (as calcium salt) equivalent to 40 mg of rosuvastatin and 10 mg of ezetimibe.
Other ingredients: monohydrate lactose, sodium croscarmellose, povidone K29/32, sodium lauryl sulfate, microcrystalline cellulose (type 102), hypromellose 2910 (E464), colloidal anhydrous silica, magnesium stearate.
Coating: Opadry White OY-L-28900: monohydrate lactose, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521).

What Suvardio Plus looks like and contents of the pack
Each coated tablet contains rosuvastatin (as calcium rosuvastatin) equivalent to 40 mg of rosuvastatin and 10 mg of ezetimibe.
Blisters made of OPA/Aluminium/PVC/Aluminium in cardboard packaging.
Blisters: 30 coated tablets.
Single-dose blisters: 30x1 coated tablet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia
Elpen Pharmaceutical Co. Inc.
Marathonos 95
190 09 Pikermi
Greece

For more detailed information about the medicine and its names in the countries of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00