Suvardio Plus

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

Read the package 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the 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 in 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 with a cholesterol-lowering 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 levels of cholesterol in the blood (primary hypercholesterolemia)
• 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 experience recurring, unexplained muscle pain (myopathy)
• if you are taking a medicine containing cyclosporin (used, for example, after organ transplantation)
• if you are pregnant or breastfeeding. If you become pregnant while taking Suvardio Plus, you should stop taking the medicine immediately and inform your doctor. While taking Suvardio Plus, you should avoid becoming pregnant, using effective methods of contraception (see "Pregnancy and breastfeeding").

If any of the above situations apply to you (or if you are in doubt), consult your doctor.

Warnings and precautions

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

you have kidney problems;

you have liver problems;

you have experienced recurring or unexplained muscle pain, or if you or your family members have had muscle disorders, or if previous muscle problems were related to taking other cholesterol-lowering medicines. If you experience unexplained muscle pain, especially if accompanied by a feeling of illness or fever, seek medical attention immediately. You should also inform your doctor or pharmacist about persistent muscle weakness;

you have or have had myasthenia (a disease that causes general muscle weakness, including, in some cases, muscles involved in breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes exacerbate symptoms of the disease or lead to the development of 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, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir (see "Suvardio Plus and other medicines");

you have severe respiratory failure;

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

you regularly consume large amounts of alcohol;

you have been diagnosed with thyroid dysfunction (hypothyroidism);

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 fusidic acid orally or by injection in the last 7 days. It may be necessary to temporarily stop taking Suvardio Plus. Your doctor will inform you when it is safe to resume taking it. Taking Suvardio Plus and fusidic acid at the same time can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis).

you have ever experienced a severe skin rash or skin peeling, blisters, or ulcers in the mouth, after taking rosuvastatin or other similar medicines. Severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin. If you experience any of the symptoms described in section 4, stop taking Suvardio Plus and seek medical attention immediately.

If any of the above situations apply to you (or if you are in doubt), consult your doctor or pharmacist before starting to take 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 will recommend regular blood tests while you are taking Suvardio Plus. It is essential to attend these tests as scheduled.

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 levels of sugar and fat in your blood, 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 should not be used in children and adolescents under 18 years of age.

Suvardio Plus and other medicines

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

Inform your doctor about taking any of the following medicines:

• cyclosporin (a medicine used, for example, after organ transplantation to prevent rejection of the transplant. Cyclosporin increases the effect of rosuvastatin taken at the same time). Do not take Suvardio Plus while taking cyclosporin.
• anticoagulant medicines, such as warfarin, acenocoumarol, or fluindion (taking Suvardio Plus at the same time may increase the anticoagulant effect, with an increased risk of bleeding), ticagrelor, or clopidogrel.
• other cholesterol-lowering medicines, so-called fibrates, which also regulate triglyceride levels in the blood (e.g., gemfibrozil and other medicines in this class). Taking them at the same time 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 can reduce the level of rosuvastatin in the blood. This effect can be reduced by taking these medicines 2 hours after taking rosuvastatin.
• erythromycin (an antibiotic). Taking it at the same time 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. Taking Suvardio Plus and fusidic acid at the same time can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis).
• oral contraceptives (birth control pills). Taking them at the same time increases the level of sex hormones released from 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

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

Breastfeeding

Suvardio Plus must not be takenwhile 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 using machines.

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 not sure, consult your doctor or pharmacist.

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

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

Suvardio Plus should be taken once a day.

The medicine can be taken at any time of day, with or without food. Swallow the tablets whole with a glass of water.

Take the medicine at the same time every day.

Suvardio Plus is not suitable for starting 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 they are within a healthy range.

Taking more than the recommended dose of Suvardio Plus

If you have taken more than the recommended dose, consult your doctor or the emergency department of your nearest hospital, 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 treatment with Suvardio Plus

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 can be associated with taking Suvardio Plus.

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

Suvardio Plus and

• swelling of the face, lips, tongue, and/or throat, which may make swallowing or breathing 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, or eyes. The onset of these serious skin rashes 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).

Consult your doctor immediatelyif you experience any unusual, persistent muscle pain. This condition can rarely progress to a life-threatening muscle injury (known as rhabdomyolysis), causing illness, fever, and kidney problems.

To determine the frequency of side effects, 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 single cases

Common side effects

headache

constipation

nausea

muscle pain

feeling weak

dizziness

diabetes - this is more likely in patients with high levels of sugar and fat in the blood, 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 Suvardio Plus tablets

increased results of certain blood tests that assess muscle condition (creatine kinase activity, CK)

cough

indigestion

heartburn

joint pain

muscle spasms

neck pain

decreased appetite

pain

chest pain

hot flashes

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)

ocular myasthenia (a disease that causes weakness of the eye muscles)

Consult your doctor if you experience 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. There are no special storage temperature requirements.

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

The active substances of Suvardio Plus are rosuvastatin (in the form of calcium salt) and ezetimibe.

Suvardio Plus, 5 mg + 10 mg

Each tablet contains rosuvastatin calcium equivalent to 5 mg of rosuvastatin and 10 mg of ezetimibe.

Suvardio Plus, 10 mg + 10 mg

Each tablet contains rosuvastatin calcium equivalent to 10 mg of rosuvastatin and 10 mg of ezetimibe.

Suvardio Plus, 20 mg + 10 mg

Each tablet contains rosuvastatin calcium equivalent to 20 mg of rosuvastatin and 10 mg of ezetimibe.

The other ingredients are lactose monohydrate, 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 inscription "E2" on one side and "2" on the other side, with a diameter of 10 mm.

Suvardio Plus, 10 mg + 10 mg

White or almost white, oval, biconvex uncoated tablets with the inscription "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 with a diameter of 11 mm.

The tablets are packaged in blisters made of PA/Aluminum/PVC/Aluminum foil and placed in a cardboard box.

Package sizes:

30 or 60 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl, Austria

Manufacturer

Adamed Pharma S.A.

ul. Marsz. Józefa Piłsudskiego 5

95-200 Pabianice

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana, Slovenia