Rosulip plus

Package leaflet: Information for the patient

Rosulip Plus, 40 mg + 10 mg, hard capsules
Rosuvastatin + Ezetimibe
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 someone else even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Rosulip Plus is and what it is used for
2. What you need to know 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 Rosulip Plus is and what it is 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 medicines called statins; 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. Additionally, it increases levels of "good" cholesterol (HDL cholesterol). The medicine reduces cholesterol levels by acting in two ways: by decreasing the amount of cholesterol absorbed in the gastrointestinal tract and by reducing the amount of cholesterol produced in the body.
In most people, high cholesterol does not affect how they feel, as it causes no 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 may become blocked, which can stop blood flow to the heart or brain, causing a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health problems can be reduced.
Rosulip Plus is used in patients in whom adequate cholesterol control has not been achieved with diet alone. You should continue to follow a cholesterol-lowering diet while taking this medicine.
Your doctor may prescribe Rosulip Plus if you are already taking rosuvastatin and ezetimibe at the same doses.
Rosulip Plus is used in patients with heart disease. Rosulip Plus reduces the risk of heart attack, stroke, the need for a surgical procedure 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 moderate or severe kidney impairment
• if the patient experiences recurrent, unexplained muscle symptoms or muscle pain (myopathy)
• if the patient is concurrently taking sofosbuvir/velpatasvir/voxilaprevir (medicines used for viral hepatitis C infection)
• if the patient has experienced recurrent or unexplained muscle pain, or if the patient or their family members have previously had muscle disorders, or if muscle-related side effects occurred previously during treatment with other cholesterol-lowering medicines
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4)
• if the patient is taking a medicine called cyclosporine (e.g. 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 her doctor. Women should avoid becoming pregnant while taking Rosulip Plus by using appropriate contraceptive methods
• if the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after taking Rosulip Plus or other medicines containing rosuvastatin
• if the patient has thyroid dysfunction (hypothyroidism)
• if the patient regularly consumes large amounts of alcohol
• if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India)
• if the patient is taking other medicines called fibrates to lower cholesterol levels (see section “Rosulip Plus and other medicines”)

If any of the above situations apply to the patient (or if there is any uncertainty whether such a
situation exists), the patient should consult their doctor.
Warnings and precautions
Before taking Rosulip Plus, talk to your doctor or pharmacist:

• if the patient has kidney problems
• if the patient has liver problems
• if the patient experiences recurrent or unexplained muscle symptoms or muscle pain, or if the patient or their family members have previously had muscle disorders, or if muscle-related side effects occurred previously during treatment with other cholesterol-lowering medicines. The patient should contact their doctor immediately if unexplained muscle symptoms or muscle pain occur, especially if accompanied by general malaise or fever. The patient should also report to their doctor or pharmacist if persistent muscle weakness occurs
• 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, e.g. lopinavir/ritonavir and/or atazanavir; refer to section “Rosulip Plus and other medicines”
• if the patient has severe respiratory insufficiency
• if the patient is taking other medicines called fibrates to lower cholesterol levels. Refer to section “Rosulip Plus and other medicines”
• if the patient regularly consumes large amounts of alcohol
• if the patient has thyroid dysfunction (hypothyroidism)
• if the patient is over 70 years of age (because 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 medicine containing fusidic acid (used to treat bacterial infections). Taking 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 uncertainty whether such a
situation exists): do not take Rosulip Plus 40 mg + 10 mg hard capsules
(the highest dose), and consult your doctor or pharmacist again before
starting treatment with Rosulip Plus.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of rosuvastatin. If any of the symptoms described in section 4 occur, stop taking Rosulip Plus immediately and
contact your doctor without delay.
In a small number of people, statins may affect the liver. To detect such effects, a simple blood test is performed to identify increased liver enzyme activity in the blood. Therefore, your doctor will regularly order such blood tests (liver function tests) during treatment with Rosulip Plus. It is important to attend scheduled appointments for these 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. The risk of developing diabetes is higher if the patient has high blood sugar and lipid levels, overweight, and high blood pressure.
Children and adolescents
Rosulip Plus is not recommended for use in children and adolescents under 18 years of age.
Rosulip Plus and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Inform your doctor if the patient is taking any of the following medicines:

• Cyclosporine (e.g. used after organ transplantation to prevent organ rejection. The effect of rosuvastatin may be enhanced when taken concurrently). Do not take Rosulip Plus while taking cyclosporine.
• Anticoagulant medicines, e.g. 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 reduce triglyceride levels (e.g. gemfibrozil and other fibrates). The effect of rosuvastatin may be enhanced when taken concurrently. Do not take Rosulip Plus 40 mg + 10 mg hard capsules while taking a fibrate.
• Colestyramine (a medicine also used to lower cholesterol levels), as it may affect the action of ezetimibe
• Regorafenib (used in cancer treatment)
• Darolutamide (used in cancer treatment)
• 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 aluminium and magnesium (used to neutralize stomach acid; these medicines reduce rosuvastatin plasma concentrations). This effect can be minimized by taking such antacids 2 hours after rosuvastatin
• Erythromycin (an antibiotic). The effect of rosuvastatin may be reduced when taken concurrently
• Fusidic acid. If the patient needs to take fusidic acid orally or by injection to treat a bacterial infection, Rosulip Plus should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Rosulip Plus. Taking Rosulip Plus with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4
• Oral contraceptives (the pill). Blood levels of sex hormones absorbed from the pill may increase
• Capmatinib (used in cancer treatment)
• Hormone replacement therapy (increased blood hormone levels)
• Fostamatinib (used to treat low platelet count)
• Febuxostat (used to treat and prevent high blood uric acid levels)
• Teriflunomide (used to treat multiple sclerosis)

If the patient is admitted to hospital or receiving treatment for another condition,
they should inform medical staff that they are taking Rosulip Plus.
Rosulip Plus and alcohol
Do not take Rosulip Plus 40 mg + 10 mg hard capsules (the highest dose) if the patient
regularly consumes large amounts of alcohol.
Pregnancy and breastfeeding
Rosulip Plus should not be used if the patient is pregnant, trying to become pregnant, or suspects she may be pregnant. If a woman becomes pregnant while taking Rosulip Plus,
she should stop taking the medicine immediately and consult her doctor. Women should use appropriate contraceptive methods during treatment with Rosulip Plus.
Do not take Rosulip Plus while breastfeeding, as it is not known whether the medicine passes into breast milk.
Driving and operating machinery
Rosulip Plus is not expected to affect the ability to drive or operate machinery.
However, dizziness may occur in some patients after taking Rosulip Plus. If the patient experiences dizziness, they should contact their doctor before driving or operating machinery.
Rosulip Plus contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, meaning the medicine is considered "sodium-free".

3. How to take Rosulip Plus

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
While taking Rosulip Plus, you should continue a cholesterol-lowering diet and maintain
physical activity.
The recommended daily dose for adults is one capsule of a given strength taken 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 taken with water.
The medicine should be taken daily at the same time.
Rosulip Plus is not intended for initiating treatment. Starting treatment or changing doses, if necessary,
should be done only by using the active substances as separate medicines. Only after the appropriate doses have been established should switching to Rosulip Plus be considered.
The maximum daily dose of rosuvastatin is 40 mg. This dose is intended only for
patients with high cholesterol levels and high risk of heart attack or stroke, in whom the 20 mg dose does not provide sufficient cholesterol reduction.
Regular cholesterol monitoring
It is important to visit your doctor for regular cholesterol checks to ensure that cholesterol levels have reached and remain at the desired level.
Taking more Rosulip Plus than prescribed
Contact your doctor or go to the nearest hospital emergency department, as medical assistance may be required.
Missing a dose of Rosulip Plus
There is no cause for concern. Simply skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Rosulip Plus
Inform your doctor if you wish to stop taking Rosulip Plus. Cholesterol levels may rise again if you discontinue treatment with Rosulip Plus.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important for the patient to be aware of which adverse reactions may occur.
The patient must immediately stop taking Rosulip Plus and seek medical help
if any of the following symptoms occur:
Rare (may affect less than 1 in 1,000 patients):

• Allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing.
• Unusual muscle pain or discomfort lasting longer than expected. Rarely, this may lead to potentially life-threatening muscle damage called rhabdomyolysis, which causes malaise, fever and impaired kidney function.
• Lupus-like syndrome (including rash, joint disorders and effects on blood cells).
• Muscle rupture.

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

• Flat, red, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Erythema multiforme. (life-threatening allergic reactions affecting the skin and mucous membranes).

Other possible adverse reactions
Common (may affect up to 1 in 10 patients)

• Headache
• Constipation
• Nausea
• Muscle pain
• Feeling of weakness
• Dizziness
• Increased protein levels in urine may occur – these levels usually return to normal spontaneously, without the need to discontinue rosuvastatin treatment
• Diabetes. This is more likely if the patient has high levels of blood sugar and fats, overweight and high blood pressure. The doctor will monitor the patient for this during treatment with this medicine.
• Abdominal pain (stomach pain)
• Diarrhea
• Flatulence (excessive gas in the intestines)
• Feeling of fatigue
• Increased results of certain blood tests assessing liver function (aminotransferases)

Uncommon (may affect up to 1 in 100 patients)

• Rash, itching, urticaria (hives)
• Increased results of certain blood tests assessing muscle function (CK)
• Cough
• Indigestion
• Heartburn
• Joint pain
• Muscle cramps
• Neck pain
• Decreased appetite
• Pain
• Chest pain
• Hot flushes
• High blood pressure
• Tingling sensation
• Dry mouth
• Gastritis (inflammation of the stomach)
• Back pain
• Muscle weakness
• Pain in hands and feet
• Swelling, particularly of hands and feet

Rare (may affect up to 1 in 1,000 patients)

• Pancreatitis, causing severe abdominal pain radiating to the back
• Decreased platelet count

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

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (inflammation of the liver)
• Trace amounts of blood in urine
• Nerve damage in arms and legs (numbness)
• Memory loss
• Breast enlargement in men (gynecomastia)

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

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

Patients should speak to their doctor if they experience weakness in the arms or legs worsening with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Rosulip Plus

Do not store above 30°C.
Store in the original packaging, protected from light and moisture.
Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date (EXP) stated on the carton and
blister. The expiry date refers to the last day of the stated 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 40 mg of rosuvastatin. Each capsule contains 10 mg of ezetimibe.
Other components are:
Core
Silicified microcrystalline cellulose (microcrystalline cellulose (E 460) and colloidal anhydrous silica
(E 551)), colloidal anhydrous silica (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),
low-substituted hydroxypropylcellulose (E 463)
Capsule shell
Cap: iron oxide red (E 172), titanium dioxide (E 171), iron oxide yellow (E 172), gelatin
Body: gelatin, iron oxide yellow (E 172), titanium dioxide (E 171)
What Rosulip Plus looks like and contents of the pack
A self-closing hard gelatin capsule of Coni Snap type, unmarked, with a red cap and a yellow body,
containing three tablets: one white or almost white, round, flat, bevelled tablet of Ezetimibe 10 mg with a
stylized "E" on one side and code 612 on the other side; two white or almost white, round tablets of
Rosuvastatin 20 mg with a mark on one side and no mark on the other side. The length of the capsule is
approximately 21.7 mm (± 0.5 mm).
Packs containing 10, 28, 30, 56, 60, 84, 90 hard capsules, formed in cold-forming blisters made of OPA/
Aluminium/PVC/Aluminium, packed in a cardboard box with a patient information leaflet.
In Poland, only packs containing 30, 60, and 90 hard capsules are authorized for sale.
Not all pack sizes may be available on the market.
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 medicinal product is authorized in the European Economic Area countries under the
following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
45D Komitetu Obrony Robotników Street
02-146 Warsaw
Phone: +48 22 417 92 00