ROSULIP 20 mg + 10 Mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Rosulip Plus, 5 mg + 10 mg, hard capsules
3. Rosulip Plus, 10 mg + 10 mg, hard capsules
4. Rosulip Plus, 20 mg + 10 mg, hard capsules
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is Rosulip Plus and what is it used for
6. Important information before taking Rosulip Plus
   1. When not to take Rosulip Plus:
   2. Warnings and precautions
   3. Plus and seek medical attention immediately.
   4. Children and adolescents
   5. Rosulip Plus and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Rosulip Plus contains sodium
7. How to take Rosulip Plus
   1. Rosulip Plus should be taken once a day.
   2. Regular cholesterol checks
   3. Taking a higher dose of Rosulip Plus than recommended
   4. Missing a dose of Rosulip Plus
   5. Stopping treatment with Rosulip Plus
8. Possible side effects
   1. The patient should stop taking Rosulip Plus immediately and seek medical attention if they experience any of the following symptoms:
   2. Rare (may affect up to 1 in 1,000 people):
   3. Other possible side effects
   4. Common (may affect up to 1 in 10 people)
   5. Uncommon (may affect up to 1 in 100 people)
   6. Rare (may affect up to 1 in 1,000 people)
   7. Very rare (may affect up to 1 in 10,000 people)
   8. Reporting side effects
9. How to store Rosulip Plus
10. Contents of the packaging and other information
    1. What Rosulip Plus contains
    2. What Rosulip Plus looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: patient information

Rosulip Plus, 5 mg + 10 mg, hard capsules

Rosulip Plus, 10 mg + 10 mg, hard capsules

Rosulip Plus, 20 mg + 10 mg, hard capsules

Rosuvastatin + Ezetimibe

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 necessary.
• In case of any doubts, you 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 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 packaging 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.
Additionally, it 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 may 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 reduce body weight.

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) at the same time
• if the patient is taking a medicine called cyclosporin (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 medicine immediately and consult a doctor. Women should avoid becoming pregnant while taking Rosulip Plus by using appropriate methods of contraception
• 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 medicines 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 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 in the past 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 or has had 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 (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 infection, such as lopinavir/ritonavir and/or atazanavir, the patient should consult section "Rosulip Plus and other medicines".
• if the patient has severe respiratory failure
• if the patient is taking other cholesterol-lowering medicines called fibrates. The patient should consult 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 a medicine containing fusidic acid (an antibiotic) orally or by injection within the last 7 days. The use of fusidic acid with Rosulip Plus may 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 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 seek medical attention immediately.

In a small number of people, statins may 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 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 medicine. 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.

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 with rosuvastatin, 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 the risk of bleeding may be increased when taken with Rosulip Plus), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also lower triglyceride levels (e.g., gemfibrozil and other fibrates). When taken together with these medicines, 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 infection, 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 start taking Rosulip Plus again. Taking Rosulip Plus with fusidic acid may 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.
• Capmatinib (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 to be hospitalized or receive treatment for another condition, they should inform 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 medicine immediately and consult a doctor. During treatment with Rosulip Plus, women should use appropriate methods of contraception.
Rosulip Plus should not be taken during breastfeeding, as it is not known whether the medicine 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 medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which means that the medicine is considered "sodium-free".

3. How to take Rosulip Plus

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient 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 recommended daily dose for adults is one capsule of the given strength once a day.

Rosulip Plus should be taken once a day.

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 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 initial 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 moderately severe kidney disease,
• the patient is at risk of muscle diseases (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 normal 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 immediately and seek medical attention 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 may 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 based on available data (frequency cannot be estimated)

• 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).

Rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• Extensive rash, toxic epidermal necrolysis (a life-threatening allergic reaction 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 levels of sugar and fat in the blood, is overweight, and has high blood pressure. The doctor will monitor the patient for this during treatment with Rosulip Plus.
• 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 on its own 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 flushes
• 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 1,000 people)

• Pancreatitis, which causes severe abdominal pain that may radiate 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
• Breast enlargement in men (gynecomastia)

Frequency not known based on available data (frequency cannot be estimated)

• 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 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, Phone: +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.

5. How to store Rosulip Plus

Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton and blister. 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 packaging and other information

What Rosulip Plus contains

The active substances of the medicine are rosuvastatin (in the form of rosuvastatin zinc) and ezetimibe.
The capsules contain the zinc salt of rosuvastatin in an amount equivalent to 5 mg, 10 mg, or 20 mg of rosuvastatin. Each capsule contains 10 mg of ezetimibe.
Other ingredients are:
Core
Microcrystalline cellulose silanized (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
Rosulip Plus, 5 mg +10 mg, hard capsules:
Cap: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin
Body: titanium dioxide (E 171), gelatin
Rosulip Plus, 10 mg +10 mg, hard capsules:
Cap and body: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
Rosulip Plus, 20 mg +10 mg, hard capsules:
Cap: red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin
Body: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin

What Rosulip Plus looks like and contents of the pack

Rosulip Plus, 5 mg +10 mg, hard capsules: a hard, self-locking gelatin capsule of the Coni Snap type, without markings, with a yellow cap and a white body, filled with two tablets: one white or almost white, round, flat tablet of Ezetimibe 10 mg with a beveled edge, with a stylized "E" on one side of the tablet and the code "612" on the other side, and one white or almost white, round, biconvex tablet of Rosuvastatin 5 mg with the marking "5" on one side of the tablet and no marking on the other side. The length of the capsule is approximately 21.7 mm (± 0.5 mm).
Rosulip Plus, 10 mg +10 mg, hard capsules: a hard, self-locking gelatin capsule of the Coni Snap type, without markings, with a yellow cap 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 "E" on one side of the tablet and the code "612" on the other side, and one white or almost white, round tablet of Rosuvastatin 10 mg with a marking on one side of the tablet and no marking on the other side. The length of the capsule is approximately 21.7 mm (± 0.5 mm).
Rosulip Plus, 20 mg +10 mg, hard capsules: a hard, self-locking gelatin capsule of the Coni Snap type, without markings, with a caramel cap 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 "E" on one side of the tablet and the code "612" on the other side, and one white or almost white, round tablet of Rosuvastatin 20 mg with a marking on one side of the tablet and no marking on the other side. The length of the capsule is approximately 21.7 mm (± 0.5 mm).
5 mg + 10 mg: Packs containing 28, 30, 60, 90 hard capsules in a cold-formed blister pack with OPA/Aluminum/PVC/Aluminum foil.
10 mg + 10 mg and 20 mg + 10 mg: Packs containing 10, 28, 30, 56, 60, 84, 90 hard capsules in a cold-formed blister pack with OPA/Aluminum/PVC/Aluminum foil, in a carton with a patient information leaflet.
Not all pack sizes may be marketed.
In Poland, only packs of 30, 60, and 90 hard capsules are authorized.

Marketing authorization holder

EGIS Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

EGIS Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary
EGIS Pharmaceuticals PLC
9900 Körmend, Mátyás király u. 65
Hungary

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

To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00
Date of last revision of the leaflet:02.05.2024