Rosulip Plus

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is 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 medicine.

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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. Contents of the pack 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 medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood.
It also increases the levels of "good" cholesterol (HDL cholesterol). The medicine 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 the flow of blood 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 by diet alone. During treatment with this medicine, 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.
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 medicine (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 (medicines used to treat viral hepatitis C infection)
• if the patient is taking a medicine called cyclosporin (used, for example, after organ transplantation to prevent rejection of the transplanted organ)
• if the patient is pregnant or breastfeeding. If a woman becomes pregnant while taking Rosulip Plus, she should stop taking the medicine and consult a doctor. Women should avoid becoming pregnant while taking Rosulip Plus by using appropriate methods of contraception
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, or ulcers in the mouth after taking Rosulip Plus or other medicines containing rosuvastatin.

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 a doctor.

Warnings and precautions

Before taking Rosulip Plus, the patient should talk to 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 while taking other cholesterol-lowering medicines. 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 a disease that causes muscle weakness (myasthenia), or myasthenia of the eye, as statins can sometimes worsen the symptoms of the disease or cause myasthenia (see section 4).
• if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine the appropriate dose of Rosulip Plus for the patient.
• if the patient is taking medicines used to treat infections, including HIV or hepatitis C virus, such as lopinavir/ritonavir and/or atazanavir, the patient should refer to the section "Rosulip Plus and other medicines".
• if the patient has severe respiratory failure
• if the patient is taking other medicines called fibrates to lower cholesterol levels. The patient should refer to the section "Rosulip Plus and other medicines".
• if the patient regularly consumes large amounts of alcohol
• if the patient has thyroid function disorders (hypothyroidism)
• 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 fusidic acid orally or by injection in the last 7 days. The use of 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 whether such a situation exists), the patient should consult their 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 rash 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.

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, which allows for the detection of increased liver enzyme activity in the blood. For this reason, the doctor will regularly order 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 medicine. There is a high risk of developing diabetes if the patient has high sugar and fat levels in the blood, 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 medicines

The patient should tell 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 tell their doctor if they are taking any of the following medicines:

• Cyclosporin (used, for example, after organ transplantation to prevent rejection of the transplanted organ. When taken together, the effect of rosuvastatin is increased). Rosulip Plus should not be taken while taking cyclosporin.
• Blood thinners, such as warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken with Rosulip Plus) tikagrelor or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also lower triglyceride levels (e.g., gemfibrozil and other fibrates). When taken together, the effect of rosuvastatin is increased.
• Cholestyramine (a medicine 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 medicines used to treat viral infections, including HIV or hepatitis C virus, taken alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Antacids containing aluminum and magnesium (used to neutralize stomach acid; these medicines reduce the level of rosuvastatin in the blood). This effect can be reduced by taking this type of medicine 2 hours after taking rosuvastatin.
• Erythromycin (an antibiotic). The effect of rosuvastatin is reduced when taken with this medicine.
• 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 may 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 condition, 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 thinks they may be pregnant. If a woman becomes pregnant while taking Rosulip Plus, she should stop taking the medicine and consult a doctor. During treatment with Rosulip Plus, women should use appropriate methods of contraception to avoid becoming pregnant.
Rosulip Plus should not be taken while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Rosulip Plus is unlikely to affect the 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 medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which means it is essentially "sodium-free".

3. How to take Rosulip Plus

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

Rosulip Plus should be taken once daily.

The medicine can be taken at any time of day, with or without food. The capsule should be swallowed whole and washed down with water.
The medicine should be taken every day at the same time.
Rosulip Plus is not suitable for initiating treatment.
Treatment initiation or dose changes, if necessary, should only be performed 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 (Japan, China, Philippines, Vietnam, Korea, or India),
• 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 been reduced to and are maintained at a suitable level.

Taking a higher dose of Rosulip Plus than recommended

The patient should contact their doctor or go to the emergency department 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 medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rosulip Plus can cause side effects, although not everybody gets them.
It is essential for the patient to know what side effects can occur.

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

Rare (may affect up to 1 in 1,000 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 potentially life-threatening muscle injury called rhabdomyolysis, which causes general malaise, fever, and kidney impairment.
• A disease-like condition similar to lupus (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.

Frequency not known from the available data, and it is not possible to estimate the frequency
of occurrence)

• Red, flat, plate-like, or round patches on the torso, often with blisters in the center, peeling of the skin, 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 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 sugar and fat levels in the blood, is overweight, and has high blood pressure. The doctor will monitor the patient for this during treatment with this medicine.
• 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
• Increased protein 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 spasms
• Neck pain
• Loss of appetite
• Pain
• Chest pain
• Hot flashes
• High blood pressure
• Numbness or 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 1,000 people)

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

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

• Jaundice (yellowing of the skin and eyes)
• 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 from the available data, and it is not possible to estimate the frequency
of occurrence)

• 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 of the eye (a disease that causes weakness of the eye muscles).

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 the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal 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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Rosulip Plus

Store in a temperature below 30°C. Store in the original packaging to protect from light and moisture.
The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via 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 pack and other information

What Rosulip Plus contains

The active substances of the medicine are rosuvastatin (in the form of rosuvastatin zinc) and ezetimibe.
Each hard capsule contains 20 mg of rosuvastatin (in the form of rosuvastatin zinc) and 10 mg of ezetimibe.
The other ingredients are:
Core
Microcrystalline cellulose silanized 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)
Hydroxypropylcellulose low-substituted (E 463)
Capsule shell:
Iron oxide red (E 172)
Titanium dioxide (E 171)
Iron oxide yellow (E 172)
Gelatin

What Rosulip Plus looks like and contents of the pack

Self-locking hard gelatin capsule of Coni Snap type, without markings, with a caramel-colored cap and a yellow body, filled with two tablets: one white or almost white, round, flat tablet of Ezetimibe 10 mg with beveled edges, with a stylized "E" sign on one side of the tablet and code "612" on the other, and one white or almost white, round, flat tablet of Rosuvastatin 20 mg with marking on one side and without marking on the other side. The length of the capsule is approximately 21.7 mm (± 0.5 mm).
Packaging containing 30, 60, 90 hard capsules in a cold-formed blister pack with OPA/Al/PVC//Al, in a cardboard box with a patient information leaflet.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in the Czech Republic, the country of export: 31/355/14-C
Parallel import authorization number: 78/24

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

Date of approval of the leaflet: 04.12.2024

[Information about the trademark]