Rosulip Plus

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Rosulip Plus (Delipid Plus)

20 mg + 10 mg, hard capsules

Rosuvastatinum + Ezetimibum
Rosulip Plus and Delipid Plus are different trade names for the same drug.

The patient should carefully read the contents of the leaflet before taking the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Rosulip Plus and what is it used for
• 2. Important information before taking Rosulip Plus
• 3. How to take Rosulip Plus
• 4. Possible side effects
• 5. How to store Rosulip Plus
• 6. Package contents and other information

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

Rosulip Plus contains two different active substances in one capsule. One of the active substances is rosuvastatin, which belongs to a group of so-called statins, and the other active substance is ezetimibe.
Rosulip Plus is a drug used to reduce blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides.
It also increases the levels of "good" cholesterol (HDL cholesterol). The drug reduces cholesterol levels by acting in two ways: it reduces the amount of cholesterol absorbed in the gut and the amount of cholesterol produced in the body.
In most people, high cholesterol levels do not affect how they feel, as they do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, leading to narrowing of the vessels.
Sometimes, these narrowed vessels can become blocked, which can block blood flow to the heart or brain, causing a heart attack or stroke. By reducing cholesterol levels, the risk of heart attack, stroke, or other similar health problems can be reduced.
Rosulip Plus is used in patients who have not been able to achieve adequate cholesterol control using a cholesterol-lowering diet alone. During treatment with the drug, a low-cholesterol diet should still be followed.
A doctor may prescribe Rosulip Plus if the patient is already taking rosuvastatin and ezetimibe in the same doses.
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Rosulip Plus is used in patients with heart disease. Rosulip 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.
Rosulip Plus does not help with weight loss.

2. Important information before taking Rosulip Plus

When not to take Rosulip Plus:

• if the patient is allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this drug (listed in section 6)
• if the patient has liver disease
• if the patient has severe kidney impairment
• if the patient experiences recurring, unexplained muscle pain or weakness (myopathy)
• if the patient is taking sofosbuvir/velpatasvir/voxilaprevir (drugs used to treat viral hepatitis C infection) at the same time
• if the patient is taking a drug called cyclosporine (used, for example, after organ transplantation)
• if the patient is pregnant or breastfeeding. If a woman becomes pregnant while taking Rosulip Plus, she should stop taking the drug immediately and consult a doctor. Women should avoid becoming pregnant while taking Rosulip Plus by using appropriate birth control methods
• if the patient has ever experienced a severe skin rash or skin peeling, blisters, and (or) ulcers in the mouth after taking Rosulip Plus or other drugs containing rosuvastatin.

If any of the above situations apply to the patient (or if there is any doubt as to whether such a situation exists), the patient should consult a doctor.

Warnings and precautions

Before taking Rosulip Plus, the patient should discuss the following with their doctor or pharmacist:

• if the patient has kidney problems
• if the patient has liver problems
• if the patient experiences recurring or unexplained muscle pain or weakness, or if the patient or their family members have had muscle diseases in the past, or if muscle disorders have occurred in the past when taking other cholesterol-lowering drugs. The patient should consult a doctor immediately if they experience unexplained muscle pain or weakness, especially if accompanied by general malaise or fever. The patient should also report any persistent muscle weakness to their doctor or pharmacist.
• if the patient has myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenia gravis (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor will determine the appropriate dose of Rosulip Plus for the patient.
• if the patient is taking drugs used to treat infections, including HIV or hepatitis C virus infections, such as lopinavir/ritonavir and/or atazanavir, the patient should refer to the section "Rosulip Plus and other drugs".
• if the patient has severe respiratory failure
• if the patient is taking other cholesterol-lowering drugs called fibrates. The patient should refer to the section "Rosulip Plus and other drugs".
• if the patient regularly consumes large amounts of alcohol
• if the patient has thyroid function disorders (hypothyroidism)

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• if the patient is over 70 years old (as the doctor should determine the appropriate dose of Rosulip Plus for the patient).
• if the patient is taking or has taken within the last 7 days an oral or injectable drug containing fusidic acid (an antibiotic). Taking fusidic acid with Rosulip Plus can lead to severe muscle damage (rhabdomyolysis).

If any of the above situations apply to the patient (or if there is any doubt as to whether such a situation exists), the patient should consult a doctor or pharmacist again before starting treatment with Rosulip Plus.
In connection with the use of rosuvastatin, severe skin reactions have been reported, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms described in section 4 occur, the patient should stop taking Rosulip Plus and contact their doctor immediately.
In a small number of people, statins can affect the liver. To confirm this effect, a simple blood test is performed to detect increased liver enzyme activity in the blood. For this reason, the doctor will regularly prescribe such a blood test (liver function tests) during treatment with Rosulip Plus. It is essential to attend the doctor's appointments for the recommended laboratory tests.
If the patient has diabetes or is at risk of developing diabetes, they will be closely monitored by their doctor during treatment with this drug. There is a high risk of developing diabetes if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure.

Children and adolescents

Rosulip Plus should not be used in children and adolescents under 18 years of age.

Rosulip Plus and other drugs

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

• Cyclosporine (used, for example, after organ transplantation to prevent rejection of the transplanted organ. When taken with rosuvastatin, the effect of rosuvastatin is enhanced). Rosulip Plus should not be taken while taking cyclosporine.
• Blood thinners, such as warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken with Rosulip Plus), ticagrelor, or clopidogrel.
• Other cholesterol-lowering drugs called fibrates, which also lower triglyceride levels (e.g., gemfibrozil and other fibrates). When taken with these drugs, the effect of rosuvastatin is enhanced.
• Cholestyramine (a drug also used to lower cholesterol levels), as it affects the action of ezetimibe.
• Regorafenib (used to treat cancer).
• Darolutamide (used to treat cancer).
• Any of the following drugs used to treat viral infections, including HIV or hepatitis C virus infections, taken alone or in combination with other drugs (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Drugs for indigestion containing aluminum and magnesium (used to neutralize stomach acid; these drugs reduce the level of rosuvastatin in the blood.) This effect can be reduced by taking this type of drug 2 hours after taking rosuvastatin.

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• Erythromycin (an antibiotic). The effect of rosuvastatin is reduced when taken with this drug.
• Fusidic acid. If the patient needs to take fusidic acid orally or by injection to treat a bacterial infection, they should temporarily stop taking Rosulip Plus. The doctor will inform the patient when they can safely restart taking Rosulip Plus. Taking Rosulip Plus with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• Oral contraceptives (the pill). The levels of sex hormones absorbed from the pill increase.
• Kapmatinib (used to treat cancer).
• Hormone replacement therapy (increased hormone levels in the blood).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high levels of uric acid in the blood),
• Teriflunomide (used to treat multiple sclerosis).

If the patient is hospitalized or receives treatment for another disease, they should tell the medical staff that they are taking Rosulip Plus.

Pregnancy and breastfeeding

Rosulip Plus should not be taken if the patient is pregnant, trying to become pregnant, or suspects they may be pregnant. If a woman becomes pregnant while taking Rosulip Plus, she should stop taking the drug immediately and consult a doctor. During treatment with Rosulip Plus, women should use appropriate birth control methods to avoid becoming pregnant.
Rosulip Plus should not be taken during breastfeeding, as it is not known whether the drug passes into breast milk.

Driving and using machines

Rosulip Plus should not affect the patient's ability to drive or use machines.
However, the patient should be aware that some people may experience dizziness after taking Rosulip Plus. If the patient experiences dizziness, they should consult their doctor before driving or using machines.

Rosulip Plus contains sodium

This drug contains less than 1 mmol (23 mg) of sodium per hard capsule, which means the drug is considered "sodium-free".

3. How to take Rosulip Plus

This drug should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
During treatment with Rosulip Plus, the patient should continue to follow a low-cholesterol diet and maintain physical activity.
The drug is available in the following strengths: Rosulip Plus 5 mg + 10 mg, Rosulip Plus 10 mg + 10 mg, and Rosulip Plus 20 mg + 10 mg.
The recommended daily dose for adults is one capsule of the given strength once a day.

Rosulip Plus should be taken once a day.

The drug can be taken at any time of day, with or without food. The capsule should be swallowed whole and washed down with water.
The drug should be taken every day at the same time.
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Rosulip Plus is not suitable for initiating treatment.
Treatment initiation or dose changes, if necessary, should only be done using the individual active substances and only after determining the appropriate doses can the patient be switched to Rosulip Plus.
The doctor may decide to use the lowest dose (5 mg + 10 mg) as the starting dose if:

• the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• the patient is over 70 years old,
• the patient has moderate kidney disease,
• the patient is at risk of muscle disease (myopathy).

Regular cholesterol checks

It is essential to attend the doctor's appointments for regular cholesterol checks to ensure that cholesterol levels have reached and remain at a healthy level.

Taking more than the recommended dose of Rosulip Plus

The patient should contact their doctor or go to the emergency room of the nearest hospital, as medical attention may be necessary.

Missing a dose of Rosulip Plus

There is no need to worry; the patient should skip the missed dose and take the next scheduled dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Rosulip Plus

The patient should tell their doctor if they want to stop taking Rosulip Plus. Cholesterol levels may rise again if the patient stops taking Rosulip Plus.
If the patient has any further doubts about taking this drug, they should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, Rosulip Plus can cause side effects, although not everyone will experience them.
It is essential for the patient to know what side effects may occur.

The patient should stop taking Rosulip Plus and seek medical attention immediately if they experience any of the following symptoms:

Rare (may affect up to 1 in 1000 people)

• Allergic reactions, such as swelling of the face, lips, tongue, and (or) throat, which can cause difficulty breathing and swallowing.
• Unusual muscle pain or weakness that persists longer than expected. Rarely, this can lead to a life-threatening muscle injury called rhabdomyolysis, which causes general malaise, fever, and kidney damage.
• A disease-like condition similar to lupus (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.

Frequency not known (cannot be estimated from the available data)

• Red, flat, plate-like, or round 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).

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A widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

• Polymorphic erythema (life-threatening allergic reactions involving the skin and mucous membranes).

Other possible side effects

Common (may affect up to 1 in 10 people)

• Headache
• Constipation
• Nausea
• Muscle pain
• Feeling weak
• Dizziness
• Diabetes. This is more likely if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor the patient for this during treatment with the drug.
• Stomach pain (abdominal pain)
• Diarrhea
• Bloating (excessive gas in the intestines)
• Feeling tired
• Increased results of some laboratory blood tests that assess liver function (aminotransferases)

Uncommon (may affect up to 1 in 100 people)

• Rash, itching, hives
• Protein may be present in the urine - this usually returns to normal without the need to stop treatment with rosuvastatin
• Increased results of some laboratory blood tests that assess muscle function (CK)
• Cough
• Indigestion
• Heartburn
• Joint pain
• Muscle cramps
• Neck pain
• Loss of appetite
• Pain
• Chest pain
• Hot flashes
• High blood pressure
• Feeling of tingling
• Dry mouth
• Gastritis
• Back pain
• Muscle weakness
• Pain in the arms and legs
• Swelling, especially of the hands and feet

Rare (may affect up to 1 in 1000 people)

• Pancreatitis, which can cause severe abdominal pain that radiates to the back
• Decreased platelet count

Very rare (may affect up to 1 in 10,000 people)

• Jaundice (yellowing of the skin and eyes)

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• Hepatitis
• Traces of blood in the urine
• Nerve damage in the arms and legs (numbness)
• Memory loss
• Enlargement of the breasts in men (gynecomastia)

Frequency not known (cannot be estimated from the available data)

• Shortness of breath
• Swelling (edema)
• Sleep disorders, including insomnia and nightmares
• Sexual disorders
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon injury
• Persistent muscle weakness
• Gallstones or cholecystitis (which can cause abdominal pain, nausea, vomiting)
• Myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• Myasthenia gravis (a disease that causes muscle weakness in the eyes).

The patient should talk to their doctor if they experience weakness in their arms or legs, worsening 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 this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Reporting side effects can help gather more information on the safety of the drug.

5. How to store Rosulip Plus

Store at a temperature below 30°C.
Store in the original packaging to protect from light and moisture.
The drug should be stored out of sight and reach of children.
The drug should not be taken after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Drugs should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Rosulip Plus contains

The active substances of the drug are rosuvastatin (in the form of rosuvastatin zinc) and ezetimibe.
Each hard capsule contains zinc rosuvastatin equivalent to 20 mg of rosuvastatin. Each capsule contains 10 mg of ezetimibe.
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The other ingredients are:
Microcrystalline cellulose silicified 90 (microcrystalline cellulose (E 460) and silicon dioxide (E 551)), silicon dioxide (E 551), magnesium stearate (E 572), povidone (E 1201), sodium croscarmellose (E 468), microcrystalline cellulose (E 460), mannitol (E 421), sodium lauryl sulfate (E 514), hypromellose (E 463).

• Capsule shell

Capsule shell
Lid: iron oxide red (E 172), titanium dioxide (E 171), iron oxide yellow (E 172), gelatin.
Body: iron oxide yellow (E 172), titanium dioxide (E 171), gelatin.

What Rosulip Plus looks like and contents of the pack

A self-locking hard gelatin capsule of the Coni Snap type, without markings, with a caramel-colored lid and a yellow body, filled with two tablets: one white or almost white, round, flat tablet of Ezetimibe 10 mg with a beveled edge, with a stylized letter E on one side and code 612 on the other, and one white or almost white, round, flat tablet of Rosuvastatin 20 mg with markings on one side and no markings on the other. The length of the capsule is approximately 21.7 mm (± 0.5 mm).
Packaging containing 30, 60, 90 hard capsules in cold-formed OPA/Al/PVC/Al blisters, in a cardboard box with a patient information leaflet.

Marketing authorization holder in the Czech Republic, the country of export:

Egis Pharmaceuticals PLC, Keresztúri út 30-38., H-1106 Budapest, Hungary

Manufacturer:

Egis Pharmaceuticals PLC, Bökényföldi út 118-120, H-1165 Budapest, Hungary
Egis Pharmaceuticals PLC, Mátyás király utca 65, H-9900 Körmend, Hungary

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 31/355/14-C

Parallel import authorization number: 176/22

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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Date of approval of the leaflet: 24.10.2024

[Information about the trademark]
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