ROSULIP 10 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. Read the leaflet carefully 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 contact your doctor 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 daily.
   2. Regular cholesterol checks
   3. Taking more than the recommended dose of Rosulip Plus
   4. Missing a dose of Rosulip Plus
   5. Stopping Rosulip Plus treatment
8. Possible side effects
   1. You should stop taking Rosulip Plus and seek medical help immediately if you 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 pack 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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 any not listed in this leaflet, please tell your 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 lower 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 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 how they feel, as it does 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 prevent blood from reaching the heart or brain, causing a heart attack or stroke. By lowering 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 achieved adequate cholesterol control with diet alone. While taking this medicine, you should continue to follow a low-cholesterol diet.
Your doctor may prescribe Rosulip Plus if you are 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 any of the above applies to you (or if you are unsure), you should consult your doctor.

Warnings and precautions

Before taking Rosulip Plus, you should talk to your doctor or pharmacist:

If any of the above applies to you (or if you are unsure), you should consult your doctor or pharmacist again before starting Rosulip Plus.
With rosuvastatin, serious skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported. If you experience any of the symptoms described in section 4, you should stop taking Rosulip Plus and contact your doctor immediately.

Plus and contact your doctor immediately.

In a small number of people, statins may affect the liver. To check for this, a simple blood test is done to detect increased liver enzyme activity in the blood. For this reason, your doctor will regularly order this blood test (liver function tests) while you are taking Rosulip Plus. It is essential to attend your doctor's appointments for the recommended laboratory tests.
If you have diabetes or are at risk of developing diabetes, you will be closely monitored by your doctor while taking this medicine. There is a high risk of developing diabetes if you have high sugar and fat levels in your blood, are overweight, and have 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Tell your doctor if you are taking any of the following medicines:

• Cyclosporin (used, for example, after organ transplantation to prevent rejection of the transplanted organ. Rosuvastatin's effect is increased when taken with cyclosporin). Do not take Rosulip Plus 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), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, which also lower triglyceride levels (e.g., gemfibrozil and other fibrates). Rosuvastatin's effect is increased when taken with these medicines.
• Cholestyramine (a medicine also used to lower cholesterol levels), as it affects ezetimibe's action.
• 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 rosuvastatin levels in the blood). This effect can be reduced by taking this type of medicine 2 hours after taking rosuvastatin.
• Erythromycin (an antibiotic). Rosuvastatin's effect is reduced when taken with this medicine.
• Fusidic acid. If you need to take fusidic acid orally or by injection to treat a bacterial infection, you should temporarily stop taking Rosulip Plus. Your doctor will tell you when you can safely start taking Rosulip Plus again. 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.
• 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 uric acid levels in the blood),
• Teriflunomide (used to treat multiple sclerosis).

If you are going to be hospitalized or receive treatment for another condition, you should tell the medical staff that you are taking Rosulip Plus.

Pregnancy and breastfeeding

Rosulip Plus should not be taken if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Rosulip Plus, you should stop taking the medicine and consult your doctor. While taking Rosulip Plus, women should use appropriate birth control methods 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 your ability to drive or use machines.
However, remember that some people may experience dizziness after taking Rosulip Plus. If you experience dizziness, you should consult your 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
While taking Rosulip Plus, you 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 with water.
The medicine should be taken at the same time every day.
Rosulip Plus is not suitable for initiating treatment.
Treatment initiation or dose adjustments, if needed, should be done using the individual active substances and only after determining the appropriate doses can you switch to Rosulip Plus.
Your doctor may decide to use the lowest dose (5 mg + 10 mg) as the starting dose if:

• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• you are over 70 years old,
• you have moderate kidney disease,
• you are at risk of muscle disease (myopathy).

Regular cholesterol checks

It is essential to attend your doctor's appointments for regular cholesterol checks to ensure that your cholesterol levels have reached and are maintained at the correct levels.

Taking more than the recommended dose of Rosulip Plus

You should contact your doctor or go to the emergency department of your nearest hospital, as medical attention may be necessary.

Missing a dose of Rosulip Plus

Do not worry, just skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Rosulip Plus treatment

You should tell your doctor if you want to stop taking Rosulip Plus. Your cholesterol levels may rise again if you stop taking Rosulip Plus.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is essential to know what side effects can occur.

You should stop taking Rosulip Plus and seek medical help immediately if you 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, which can last longer than expected. Rarely, this can lead to a potentially life-threatening muscle injury called rhabdomyolysis, which causes general malaise, fever, and kidney damage.
• A 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)
Frequency not known)

• Red, flat, plate-like, or round patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

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

• Toxic epidermal necrolysis (a life-threatening allergic reaction affecting 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 you have high sugar and fat levels in your blood, are overweight, and have high blood pressure. Your doctor will monitor you for this while you are taking this medicine.
• Stomach pain (abdominal pain)
• Diarrhea
• Bloating (excessive gas in the intestines)
• Feeling tired
• Increased results of some laboratory blood tests that check 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 stopping rosuvastatin treatment
• Increased results of some laboratory blood tests that check 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 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 stomach pain that can radiate to the back
• Low 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 (cannot be estimated from the available data)
Frequency not known)

• 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 stomach 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).

You should talk to your doctor if you experience muscle 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 any not listed in this leaflet, you should tell your doctor or pharmacist. 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,
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.
Reporting side effects will help to gather more information on the safety of this medicine.

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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rosulip Plus contains

The active substances are rosuvastatin (in the form of rosuvastatin zinc) and ezetimibe.
The capsules contain rosuvastatin zinc equivalent to 5 mg, 10 mg, or 20 mg of rosuvastatin. Each capsule contains 10 mg of ezetimibe.
The other ingredients are:
Core
Microcrystalline cellulose silanized (microcrystalline cellulose (E 460) and colloidal silicon dioxide (E 551)), colloidal 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 white body, filled with two tablets: one white or almost white, round, flat tablet of Ezetimibe 10 mg with a stylized "E" on one side and code "612" on the other, and one white or almost white, round, biconvex tablet of Rosuvastatin 5 mg with "5" on one side and no markings on the other. 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 yellow body, filled with two tablets: one white or almost white, round, flat tablet of Ezetimibe 10 mg with a stylized "E" on one side and code "612" on the other, and one white or almost white, round tablet of Rosuvastatin 10 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).
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 yellow body, filled with two tablets: one white or almost white, round, flat tablet of Ezetimibe 10 mg with a stylized "E" on one side and code "612" on the other, and one white or almost white, round 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).
5 mg + 10 mg: Packs containing 28, 30, 60, 90 hard capsules in a cold-formed blister pack of OPA/Aluminum/PVC/Aluminum.
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 of OPA/Aluminum/PVC/Aluminum, in a cardboard box 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 get more detailed information on this medicine, please 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