Suvardio Plus

Package Leaflet: Information for the Patient

Suvardio Plus, 40 mg + 10 mg, Film-Coated Tablets

Rosuvastatin + Ezetimibe

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

• Keep this leaflet, as 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 others. 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.

Table of Contents of the Package Leaflet:

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

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

Suvardio Plus 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. Suvardio Plus is used to lower the level of cholesterol in the blood, so-called "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides, and also to increase the level of "good" cholesterol (HDL cholesterol). The medicine works by reducing the amount of cholesterol absorbed in the gut and the amount of cholesterol produced by the body.

In most people, high cholesterol does not affect their well-being, as it does not cause any symptoms. However, if left untreated, it can lead to the accumulation of fatty deposits in the walls of blood vessels, causing them to narrow.

As a result of the narrowing, it is possible for the blood vessel to become blocked, cutting off blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other similar health problems can be reduced.

Suvardio Plus is used in patients for whom diet alone is not enough to maintain a healthy cholesterol level. While taking this medicine, it is essential to continue following a low-cholesterol diet.

Your doctor may prescribe Suvardio Plus if you are already taking rosuvastatin and ezetimibe in the same doses as in the combination medicine.

The medicine is used in patients:

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

Suvardio Plus does not help with weight loss.

2. Important information before taking Suvardio Plus

When not to take Suvardio Plus

• if you are allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6)
• if you have liver disease
• if you have severe kidney problems
• if you have recurring, unexplained muscle pain (myopathy)
• if you are taking a medicine called ciclosporin (used, for example, after organ transplantation)
• if you are pregnant or breastfeeding. If you become pregnant while taking Suvardio Plus, you must stop taking the medicine and inform your doctor. While taking Suvardio Plus, women should use effective contraceptive methods (see "Pregnancy and breastfeeding").

If any of the above applies to you (or if you are unsure), consult your doctor.

Warnings and precautions

Before taking Suvardio Plus, discuss with your doctor or pharmacist if:

you have kidney problems;

you have liver problems;

you have had recurring or unexplained muscle pain, or if you or your family members have had muscle problems, or if you have had previous muscle problems related to taking other cholesterol-lowering medicines. If you experience unexplained muscle pain, especially if accompanied by malaise or fever, contact your doctor immediately. You should also tell your doctor or pharmacist about persistent muscle weakness;

you have had a condition called myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenia gravis (a condition that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms or lead to myasthenia (see section 4);

you are of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). Your doctor will determine the appropriate dose of Suvardio Plus for you;

you are taking antiviral medicines, including those used to treat HIV or hepatitis C, such as ritonavir with lopinavir and/or atazanavir or simeprevir (see "Suvardio Plus and other medicines");

you have severe respiratory failure;

you are taking other cholesterol-lowering medicines (fibrates) (see "Suvardio Plus and other medicines");

you regularly consume large amounts of alcohol;

you have been diagnosed with hypothyroidism (underactive thyroid);

you are over 70 years old (as your doctor will need to choose a suitable dose of Suvardio Plus for you);

you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). The concurrent use of fusidic acid and Suvardio Plus may rarely cause muscle weakness, muscle tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4;

you have ever had a severe skin rash or skin peeling, blisters, or ulcers in the mouth after taking rosuvastatin or other similar medicines.

Rosuvastatin has been associated with severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any of the symptoms described in section 4, stop taking Suvardio Plus and contact your doctor immediately.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking Suvardio Plus.

In rare cases, statins may affect liver function. This can be detected by a simple blood test that checks for increased liver enzyme activity. Therefore, your doctor may recommend regular blood tests while taking Suvardio Plus. It is essential to attend these tests as scheduled by your doctor.

While taking this medicine, your doctor will closely monitor your condition if you have diabetes or are at risk of developing it. There is a high risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

If you are hospitalized or treated for another condition, inform the medical staff that you are 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Inform your doctor about taking any of the following medicines:

• ciclosporin (a medicine used, for example, after organ transplantation to prevent rejection. Ciclosporin increases the effect of rosuvastatin taken at the same time). Do not take Suvardio Plus while taking ciclosporin.
• anticoagulants, such as warfarin, acenocoumarol, or fluindione (concomitant use with Suvardio Plus may increase the anticoagulant effect, increasing the risk of bleeding) ticagrelor or clopidogrel.
• other cholesterol-lowering medicines, such as fibrates, which also regulate triglyceride levels in the blood (e.g., gemfibrozil and other medicines in this class). 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 aluminum and magnesium (used to neutralize stomach acid). These medicines reduce the level of rosuvastatin in the blood. This effect can be mitigated by taking these medicines 2 hours after taking rosuvastatin.
• erythromycin (an antibiotic). Concomitant use reduces the effect of rosuvastatin.
• fusidic acid. If you need to take fusidic acid orally to treat a bacterial infection, it may be necessary to temporarily stop taking Suvardio Plus. Your doctor will inform you when it is safe to resume taking it. Concomitant use of Suvardio Plus and fusidic acid may rarely cause muscle weakness, muscle tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• oral contraceptives (birth control pills). Concomitant use increases the level of sex hormones released by the pill.
• hormone replacement therapy (increasing hormone levels in the blood).
• regorafenib (used to treat cancer).
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, taken alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If you are to be hospitalized or treated for another condition, inform the medical staff that you are taking Suvardio Plus.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Suvardio Plusif you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Suvardio Plus, you must stop taking the medicine immediatelyand inform your doctor. While taking Suvardio Plus, women should use effective contraceptive methods (see "Pregnancy and breastfeeding").

Breastfeeding

Do not take Suvardio Pluswhile breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Suvardio Plus is unlikely to affect your ability to drive or use machines. However, keep in mind that some patients taking Suvardio Plus may experience dizziness. In such cases, consult your 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, which means it is essentially "sodium-free".

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Suvardio Plus

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

While taking Suvardio Plus, continue to follow a low-cholesterol diet and maintain physical activity.

The recommended daily dose for adults is one tablet of the given strength.

Take Suvardio Plus once a day.

You can take the medicine at any time of day, with or without food. Swallow the tablets whole with water.

Take the medicine at the same time every day.

Suvardio Plus is not suitable for initiating treatment. If you are starting treatment or need to change your dose, you should take each active substance separately and only switch to Suvardio Plus once the doses have been established.

Regular cholesterol level checks

It is essential to attend regular check-ups with your doctor to monitor your cholesterol levels and ensure that you have achieved and maintained a healthy level.

Taking more than the recommended dose of Suvardio Plus

If you have taken more than the recommended dose, contact your doctor or the nearest hospital emergency department, as medical attention may be necessary.

Missing a dose of Suvardio Plus

If you miss a dose, take the next tablet at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping Suvardio Plus treatment

Tell your doctor if you want to stop taking Suvardio Plus. After stopping Suvardio Plus, your cholesterol levels may rise again.

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

4. Possible side effects

Like all medicines, Suvardio Plus can cause side effects, although not everybody gets them.

It is essential to know what side effects may occur when taking Suvardio Plus.

If you experience any of the following reactions, stop taking the medicine and seek medical help immediately:

Suvardio Plus and

• swelling of the face, lips, tongue, and/or throat, which may make breathing and swallowing difficult,
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells),
• muscle rupture
• 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 drug hypersensitivity syndrome).

Seek medical help immediatelyif you experience any unusual, persistent muscle pain. This condition can rarely progress to life-threatening muscle damage (known as rhabdomyolysis), causing malaise, fever, and kidney problems.

To determine the frequency of side effects, the following classification is used:

• very common (may occur in more than 1 in 10 people)
• common (may occur in less than 1 in 10 people)
• uncommon (may occur in less than 1 in 100 people)
• rare (may occur in less than 1 in 1,000 people)
• very rare (may occur in less than 1 in 10,000 people), including single cases

Common side effects

headache

constipation

nausea

muscle pain

feeling weak

dizziness

diabetes - this is more likely in patients with high blood sugar and fat levels, who are overweight, and have high blood pressure. Your doctor will monitor your condition while taking this medicine.

stomach pain

diarrhea

bloating (excess gas in the intestines)

feeling tired

increased results of some blood tests that assess liver function (aminotransferase activity)

Uncommon side effects

rash, itching, hives

increased protein in the urine, which usually resolves on its own without the need to stop taking the tablets

increased results of some blood tests that assess muscle condition (creatine kinase activity)

cough

indigestion

heartburn

joint pain

muscle spasms

neck pain

decreased appetite

pain

chest pain

hot flushes

high blood pressure

tingling

dry mouth

gastritis

back pain

muscle weakness

pain in the arms and legs

swelling, especially of the hands and feet

Rare side effects

pancreatitis, causing severe stomach pain that may radiate to the back

decreased platelet count

Very rare side effects

jaundice (yellowing of the skin and eyes)

hepatitis

trace amounts of blood in the urine

nerve damage in the legs and arms (e.g., numbness)

memory loss

breast enlargement in men (gynecomastia)

Side effects with unknown frequency

shortness of breath

swelling

sleep disorders, including insomnia and nightmares

sexual disorders

depression

breathing difficulties, including persistent cough and/or shortness of breath or fever

tendon damage

persistent muscle weakness

gallstones or cholecystitis (which can cause stomach pain, nausea, vomiting)

myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)

myasthenia gravis (a condition that causes muscle weakness in the eyes).

Consult your doctor if you experience muscle weakness in your arms or legs, worsening after periods of 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, tell your doctor or pharmacist. 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

tel.: +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 gather more information on the safety of this medicine.

5. How to store Suvardio Plus

Keep this 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 month stated.

Store the medicine in its original packaging to protect it from light and moisture.

There are no special storage instructions.

Medicines should not be disposed of via wastewater or household waste. 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 Suvardio Plus contains

Each film-coated tablet contains rosuvastatin (in the form of rosuvastatin calcium) equivalent to 40 mg of rosuvastatin and 10 mg of ezetimibe.

The other ingredients are: lactose monohydrate, croscarmellose sodium, povidone K29/32, sodium lauryl sulfate, microcrystalline cellulose (type 102), hypromellose 2910 (E464), silicon dioxide, magnesium stearate, Coating: Opadry White OY-L-28900: lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521).

What Suvardio Plus looks like and contents of the pack

Each film-coated tablet contains rosuvastatin (in the form of rosuvastatin calcium) equivalent to 40 mg of rosuvastatin and 10 mg of ezetimibe.

Blister packs of 30 tablets.

Single-dose blister packs: 30x1 film-coated tablet.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova Ulica 57

1526 Ljubljana

Slovenia

Elpen Pharmaceutical Co. Inc.

Marathonos 95

190 09 Pikermi

Greece

For more information about this medicine and its authorized names in the European Economic Area, contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. 22 209 70 00

Date of last revision of the leaflet:04/2023

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