Suvardio Plus

Leaflet attached to the packaging: patient information

Suvardio Plus, 5 mg + 10 mg, tablets

Suvardio Plus, 10 mg + 10 mg, tablets

Suvardio Plus, 20 mg + 10 mg, tablets

Rosuvastatin + Ezetimibe

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 packaging 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 known as statins, and the other active substance is ezetimibe. Suvardio Plus is used to reduce the level of cholesterol in the blood, specifically "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides, and 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 cause fatty deposits to build up in the walls of blood vessels, leading to their narrowing. 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, which can lead 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. During treatment with this medicine, the patient should continue to follow a cholesterol-lowering diet. The doctor may prescribe Suvardio Plus if the patient is 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)
• 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 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 problems
• if the patient experiences recurring, unexplained muscle pain (myopathy)
• if the patient is taking a medicine containing cyclosporin (used, for example, after organ transplantation)
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Suvardio Plus, they should stop taking the medicine immediately and inform their doctor. During treatment with Suvardio Plus, the patient should avoid becoming pregnant, using effective methods of contraception (see "Pregnancy and breastfeeding").

If any of the above situations apply to the patient (or if the patient has any doubts), they should consult their doctor.

Warnings and precautions

Before taking Suvardio Plus, the patient should discuss it with their doctor or pharmacist if:

the patient has kidney problems; the patient has liver problems; the patient has experienced recurring or unexplained muscle pain, has a history of muscle disorders, or has had previous muscle problems related to taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially if accompanied by a feeling of illness or fever, the patient should immediately consult their doctor. The patient should also inform their doctor or pharmacist about persistent muscle weakness; if the patient has or has had myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing) or myasthenia gravis (a disease that causes muscle weakness, including eye muscles), as statins can sometimes exacerbate the symptoms of the disease or lead to the development 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 or hepatitis C, such as ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir (see "Suvardio Plus and other medicines"); the patient has severe respiratory failure; the patient is taking other cholesterol-lowering medicines (fibrates) (see "Suvardio Plus and other medicines"); the patient regularly consumes large amounts of alcohol; the patient has been diagnosed with hypothyroidism (underactive thyroid); the patient is over 70 years old (as the doctor will need to choose an appropriate dose of Suvardio Plus for the patient); the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. 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; if the patient has 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 the patient experiences any of the symptoms described in section 4, they should stop taking Suvardio Plus and seek medical attention immediately. If any of the above situations apply to the patient (or if the patient has any doubts), they should consult their doctor or pharmacist before starting treatment with Suvardio Plus. In a small number of people, statins can affect liver function. This can be detected by a simple blood test that checks for increased liver enzyme activity. Therefore, the doctor will recommend regular blood tests during treatment with Suvardio Plus. It is essential for the patient to attend these tests as scheduled. During treatment with this medicine, the doctor will closely monitor the condition of patients with diabetes or at risk of developing diabetes. There is a high risk of developing diabetes if the patient has high levels of sugar and fat in the blood, is overweight, and has high blood pressure. If the patient is hospitalized or treated for another condition, they should inform the medical staff about their treatment with 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

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should inform their doctor about taking any of the following medicines:

• cyclosporin (a medicine used, for example, after organ transplantation to prevent rejection of the transplanted organ. Cyclosporin increases the effect of rosuvastatin taken at the same time). During treatment with cyclosporin, Suvardio Plus should not be taken.
• anticoagulant medicines, such as warfarin, acenocoumarol, or fluindion (concomitant use with Suvardio Plus may increase the anticoagulant effect, with an increased risk of bleeding), ticagrelor, or clopidogrel.
• other cholesterol-lowering medicines (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 may decrease the level of rosuvastatin in the blood. This effect can be reduced by taking these medicines 2 hours after taking rosuvastatin.
• erythromycin (an antibiotic). Concomitant use decreases the effect of rosuvastatin.
• fusidic acid. If the patient needs to take fusidic acid orally to treat a bacterial infection, it may be necessary to temporarily stop taking Suvardio Plus. The doctor will inform the patient when it is safe to resume taking the medicine. 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 from the pill.
• hormone replacement therapy (increased 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 the patient is to be hospitalized or treated for another condition, they should inform the medical staff about their treatment with Suvardio Plus.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Pregnancy Suvardio Plus should not be takenif the patient is pregnant, trying to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Suvardio Plus, they should stop taking the medicine immediatelyand inform their doctor. During treatment with Suvardio Plus, female patients should use effective methods of contraception (see "Pregnancy and breastfeeding"). Breastfeeding Suvardio Plus should not be takenduring breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Suvardio Plus is unlikely to affect the ability to drive or use machines. However, the patient should be aware that Suvardio Plus may cause dizziness. In such cases, the patient should consult their 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 considered "sodium-free". If the patient has previously been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Suvardio Plus

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. During treatment with Suvardio Plus, the patient should continue to follow a cholesterol-lowering 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. The tablets should be swallowed whole, with a glass of water. The medicine should be taken at the same time every day. Suvardio Plus is not suitable for starting treatment. If treatment is started or the dose needs to be changed, the patient should take each active substance separately and only switch to Suvardio Plus after the doses have been established.

Regular cholesterol level checks

It is essential for the patient to attend regular check-ups with their doctor to monitor their cholesterol levels and ensure they are within a healthy range.

Taking a higher dose of Suvardio Plus than recommended

In case of overdose, the patient should consult their doctor or the emergency department of the nearest hospital, as medical attention may be necessary.

Missing a dose of Suvardio Plus

If a dose is missed, the next tablet should be taken at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Suvardio Plus

The patient should inform their doctor if they want to stop taking Suvardio Plus. After stopping Suvardio Plus, cholesterol levels may increase again. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Suvardio Plus can cause side effects, although not everyone gets them. It is essential for the patient to know which side effects may be associated with taking the medicine. If the patient experiences any of the following reactions, they should stop taking the medicine and seek medical attention immediately

Suvardio Plus and:

• 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, or round patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, or 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).

The patient should consult their doctor immediatelyif they experience any unusual, persistent muscle pain. This condition can rarely progress to a life-threatening muscle injury (known as rhabdomyolysis), causing a feeling of illness, fever, and kidney problems. To determine the frequency of side effects, the following classification has been used:

• very common (may occur more frequently than in 1 in 10 people)
• common (may occur less frequently than in 1 in 10 people)
• uncommon (may occur less frequently than in 1 in 100 people)
• rare (may occur less frequently than in 1 in 1000 people)
• very rare (may occur less frequently than in 1 in 10,000 people), including isolated cases

Common side effects

headache
constipation
nausea
muscle pain
feeling of weakness
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. The doctor will monitor the patient's condition during treatment with this medicine.
stomach pain
diarrhea
bloating (excess gas in the intestines)
feeling of fatigue
increased results of some blood tests that assess liver function (aminotransferase activity)

Uncommon side effects

rash, itching, hives
increased amount of protein in the urine, which usually resolves on its own without the need to stop taking Suvardio Plus tablets
increased results of certain tests that assess muscle condition (creatine kinase activity, CK)
cough
indigestion
heartburn
joint pain
muscle cramps
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, which can cause severe stomach pain that radiates to the back
decreased platelet count

Very rare side effects

jaundice (yellowing of the skin and eyes)
liver inflammation
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 muscles involved in breathing).
myasthenia gravis (a disease that causes muscle weakness, including eye muscles).
The patient should talk to their doctor if they experience weakness in their arms or legs, which worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Suvardio Plus

The medicine should be stored out of sight and reach of children. The medicine should not be used after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the specified month. The medicine should be stored in its original packaging to protect it from light. There are no special storage temperature recommendations. Medicines should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Suvardio Plus contains

The active substances of the medicine 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 packaging

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. Packaging 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

For more information about the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, tel. 22 209 70 00. Date of last update of the leaflet:04/2023. Sandoz logo