Package leaflet: Information for the patient

Suvardio Plus, 5 mg + 10 mg, tablets
Suvardio Plus, 10 mg + 10 mg, tablets
Suvardio Plus, 20 mg + 10 mg, tablets
Rosuvastatin + Ezetimibe
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Suvardio Plus is and what it is used for
What you need to know before taking Suvardio Plus
How to take Suvardio Plus
Possible side effects
How to store Suvardio Plus
Contents of the pack 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 medicines known as statins, and the other active substance is ezetimibe.
Suvardio Plus is a medicine used to lower 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: it decreases the amount of cholesterol absorbed in the gastrointestinal tract and reduces the amount of cholesterol produced in the body.
In most people, high cholesterol does not affect well-being, as it causes no symptoms. However, if left untreated, fatty deposits may accumulate in the walls of blood vessels, causing them to narrow. This narrowing may lead to complete blockage of the blood vessel, cutting off blood supply to the heart or brain, resulting in a heart attack 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 must 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 those contained in the combination medicine.
This medicine is used in patients:

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

Suvardio Plus does not help with weight reduction.

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 cyclosporine (used, for example, after organ transplantation)
if the patient is pregnant or breastfeeding. If pregnancy occurs during treatment with Suvardio Plus, the patient should stop taking the medicine immediately and inform her doctor. Effective contraception should be used during treatment with Suvardio Plus to avoid pregnancy (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 impaired kidney function;
the patient has impaired liver function;
the patient has experienced recurrent or unexplained muscle pain, or if there was a history of muscle disorders in the patient or in their family, or previous muscle-related problems associated with 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;
the patient has or has had myasthenia gravis (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, such as 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 oral or injectable 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 severe skin rash, skin peeling, blisters and/or oral ulcers after taking rosuvastatin or similar medicines. Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin. If any of the symptoms described in section 4 occur, the patient should stop taking Suvardio Plus and contact a doctor immediately.
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 again with a doctor or pharmacist before starting treatment with Suvardio Plus.
In a small number of people, statins may affect liver function. This is 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 scheduled doctor’s appointments for test referrals.
During treatment with 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, they 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, recently taken, or planned for use.
The patient should inform the doctor if they are taking any of the following medicines:

cyclosporine (a medicine used, for example, after organ transplantation to prevent transplant rejection. Cyclosporine enhances the effect of rosuvastatin when used concomitantly). Suvardio Plus must not be taken during cyclosporine treatment.
anticoagulants, e.g. warfarin, acenocoumarol or fluindione (concomitant use with Suvardio Plus may increase 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 hydrochloric acid). These medicines may 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 treatment. Concomitant use of Suvardio Plus and fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
oral contraceptives. Concomitant use increases the concentration of sex hormones released from the pill.
medicines used in hormone replacement therapy (increased hormone concentrations in blood).
regorafenib (used in cancer treatment).
any of the following antiviral medicines used to treat viral infections, including HIV or hepatitis C virus, used 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 condition, they 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 become pregnant, she should consult her 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 pregnancy occurs during treatment with Suvardio Plus, the patient must stop taking the medicine immediately and inform her doctor. Patients should use effective contraception during treatment with Suvardio Plus.
Breastfeeding
Suvardio Plus must not be used during breastfeeding, as it is unknown whether the medicine passes into breast milk.
Driving and operating machinery
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. the medicine is considered "sodium-free".
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Suvardio Plus

This medicine should always be taken exactly as directed by the doctor or pharmacist.
If in doubt, consult the doctor or pharmacist.
While taking Suvardio Plus, continue to follow a cholesterol-lowering diet and maintain
physical activity.
The recommended daily dose for adults is one tablet of the prescribed 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 therapy or if a dose adjustment
is required, each active substance should be administered separately as individual medicines.
Only after the appropriate doses have been established should the patient switch to Suvardio
Plus of the appropriate strength.
Regular monitoring of cholesterol levels
It is important to visit the doctor regularly to monitor cholesterol levels, to ensure that
the desired level has been achieved and is being maintained.
Taking more Suvardio Plus than recommended
In case of overdose, contact a doctor 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 the doctor if the patient wishes to discontinue taking Suvardio Plus. After stopping
Suvardio Plus, 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.
It is important that the patient knows which adverse reactions may be associated with the use of this medicine.
If the patient experiences any of the following reactions, treatment with Suvardio Plus must be discontinued immediately and medical help must be sought without delay:

swelling of the face, lips, tongue, and/or throat, which may make breathing or swallowing difficult,
lupus-like syndrome (including rash, joint disorders, and effects on blood cells),
muscle rupture,
red, flat, round or target-shaped spots on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs, and eyes. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
extensive rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Seek immediate medical advice if the patient experiences any unusual, persistent muscle pain.
This condition may rarely progress to life-threatening muscle damage (known as rhabdomyolysis), causing malaise, fever, and kidney dysfunction.

For the purpose of classifying the frequency of adverse reactions, the following categories are used:

very common (may affect more than 1 in 10 people)
common (may affect less than 1 in 10 people)
uncommon (may affect less than 1 in 100 people)
rare (may affect less than 1 in 1,000 people)
very rare (may affect less than 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 the urine, which usually resolves spontaneously without the need to discontinue Suvardio Plus tablets
increased levels of certain tests assessing muscle status (creatine kinase, CK activity)
cough
indigestion
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 (inflammation of the liver)
trace amounts of blood in the urine
nerve damage in arms and legs (e.g. numbness)
memory loss
breast enlargement in men (gynecomastia)

Adverse reactions with unknown frequency
shortness of breath
swelling
sleep disorders, including insomnia and nightmares
sexual dysfunction
depression
breathing 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, which worsens 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 those not listed in this leaflet, inform your doctor or pharmacist. 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
tel.: +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 to provide more information on the safety of this medicine.

5. How to store Suvardio Plus

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the stated month.
Store the medicine in the original packaging to protect it from light.
There are no special requirements regarding storage temperature.
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
The active substances in this medicinal product are rosuvastatin (in the form of calcium salt) and ezetimibe.
Suvardio Plus, 5 mg + 10 mg
Each tablet contains calcium rosuvastatin equivalent to 5 mg of rosuvastatin and 10 mg of ezetimibe.
Suvardio Plus, 10 mg + 10 mg
Each tablet contains calcium rosuvastatin equivalent to 10 mg of rosuvastatin and 10 mg of ezetimibe.
Suvardio Plus, 20 mg + 10 mg
Each tablet contains calcium rosuvastatin equivalent to 20 mg of rosuvastatin and 10 mg of ezetimibe.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
crospovidone type A, povidone K-30, sodium lauryl sulfate and magnesium stearate.

What Suvardio Plus looks like and contents of the pack
Suvardio Plus, 5 mg + 10 mg
White or almost white, round, flat, uncoated tablets with the imprint “E2” on one side and “2” on the other side, 10 mm in diameter.
Suvardio Plus, 10 mg + 10 mg
White or almost white, oval, biconvex, uncoated tablets with the imprint “E1” on one side and “1” on the other side, measuring 15 mm x 7 mm.
Suvardio Plus, 20 mg + 10 mg
White or almost white, round, biconvex, uncoated tablets, 11 mm in diameter.
The tablets are packed in blisters made of PA/Aluminium/PVC/Aluminium foil and placed in a cardboard box.
Pack sizes:
30 or 60 tablets

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

Manufacturers
Adamed Pharma S.A.
ul. Marsz. Józefa Piłsudskiego 5
95-200 Pabianice, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For further information about this medicinal product and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel. 22 209 70 00