Rosulip plus

Package leaflet: Information for the patient

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
Please read 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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 known as 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 may 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 cannot be achieved with a cholesterol-lowering diet alone. A low-cholesterol diet should still be followed during treatment.
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 reduction.

2. Important information before using Rosulip Plus

When not to use 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 function impairment
• if the patient experiences recurrent, unexplained muscle symptoms or muscle pain (myopathy)
• if the patient is taking sofosbuvir/velpatasvir/voxilaprevir (medicines used to treat viral hepatitis C)
• if the patient is taking a medicine 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 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 or skin peeling, blisters, and/or oral ulcers after taking Rosulip Plus or other medicines containing rosuvastatin.

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 a 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 family members have previously had muscle disorders, or if muscle-related side effects occurred during treatment with other cholesterol-lowering medicines. The patient should contact the doctor immediately if unexplained muscle symptoms or muscle pain occur, especially if accompanied by general malaise or fever. Persistent muscle weakness should also be reported to the doctor or pharmacist.
• 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 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, e.g. lopinavir/ritonavir and/or atazanavir; 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 reduce cholesterol levels. Refer to the 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 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 medicine containing fusidic acid (a medicine 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), the patient should consult a doctor or pharmacist again before starting
treatment with Rosulip Plus.
Serious 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, treatment with Rosulip Plus must be discontinued and the
patient should seek immediate medical advice.
In a small number of people, statins may 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 order such blood tests (liver function tests) during treatment with Rosulip Plus. It is
important to attend scheduled laboratory appointments.
If the patient has diabetes or is at risk of developing diabetes, the patient will be closely monitored
by the doctor during treatment with this medicine. The risk of developing diabetes is high 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
Inform your doctor or pharmacist about all medicines the patient is currently taking or has
recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

• Cyclosporine (used, for example, after organ transplantation to prevent organ rejection. When taken together, the effect of rosuvastatin is enhanced). 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). When taken together, the effect of rosuvastatin is enhanced.
• Colestyramine (a medicine also used to lower cholesterol levels), as it affects 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, administered alone or in combination with other medicines (see: Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• Antacid medicines 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 together with these medicines.
• 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 resume taking 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). Plasma concentrations of sex hormones absorbed from the pill may increase.
• Capmatinib (used in cancer treatment).
• Hormone replacement therapy (increased hormone concentrations in blood).
• Fostamatinib (used to treat low platelet count).
• Febuxostat (used to treat and prevent high uric acid levels in blood).
• Teriflunomide (used to treat multiple sclerosis).

If the patient is admitted to hospital or receiving treatment for another illness, the patient should
inform the medical staff that they are taking Rosulip Plus.
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.
Rosulip Plus should not be used during breastfeeding, as it is unknown whether the medicine is
excreted in human milk.
Driving and operating machinery
Rosulip Plus is not expected to affect the ability to drive or operate machinery.
However, it should be remembered that dizziness may occur in some patients after taking Rosulip
Plus. If the patient experiences dizziness, they should consult 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.
Rosulip Plus 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 every day at the same time.
Rosulip Plus is not suitable for initiating treatment.
Starting treatment or changing doses, if necessary, should only be done using the active substances as separate medicines. Only after the appropriate doses have been established should you switch to Rosulip Plus.
Your 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 of age,
• the patient has moderately severe kidney disease,
• the patient is at risk of developing muscle disorders and muscle pain (myopathy).

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 than the recommended dose of Rosulip Plus
Contact your doctor or go to the nearest hospital emergency department, as medical assistance may be required.
Missing a dose of Rosulip Plus
Do not be concerned. 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
Tell your doctor if you wish to stop taking Rosulip Plus. Cholesterol levels may rise again if you stop taking 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 should immediately stop taking Rosulip Plus and seek medical help
if any of the following symptoms occur:
Rare (may occur in 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 and 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 skin rash, joint disorders, and effects on blood cells).
• Muscle rupture.

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

• Red, flat, disc-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 body temperature, and enlarged 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 occur in up to 1 in 10 patients)

• Headache
• Constipation
• Nausea
• Muscle pain
• Feeling of weakness
• Dizziness
• Diabetes. This is more likely if the patient has high levels of sugars and fats in the blood, overweight, and high blood pressure. The doctor will monitor the patient for this during treatment with this medicine.
• Abdominal pain (stomach pain)
• Diarrhea
• Bloating (excessive gas in the intestines)
• Feeling of fatigue
• Increased results of certain blood laboratory tests assessing liver function (aminotransferases)

Uncommon (may occur in up to 1 in 100 patients)

• Rash, skin itching, urticaria
• Increased amount of protein in the urine may occur – the level usually returns to normal spontaneously, without the need to discontinue rosuvastatin treatment
• Increased results of certain blood laboratory 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
• Back pain
• Muscle weakness
• Pain in hands and feet
• Swelling, particularly of hands and feet

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

• Pancreatitis, causing severe abdominal pain radiating to the back
• Decreased number of blood platelets

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

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

Frequency unknown (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 eye muscles).

Patients should talk to their doctor if they experience weakness in the arms or legs worsening
after periods of activity, double vision or drooping eyelids, difficulty swallowing, or
shortness of breath.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 to 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 to protect from light and moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the cardboard box and blister pack.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Rosulip Plus contains
The active substances are: rosuvastatin (as rosuvastatin zinc) and ezetimibe.
The capsules contain rosuvastatin zinc salt equivalent to 5 mg, 10 mg or 20 mg of rosuvastatin.
Each capsule contains 10 mg of ezetimibe.
Other ingredients:
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
Rosulip Plus, 5 mg +10 mg, hard capsules:
Cap: titanium dioxide (E 171), iron oxide yellow (E 172), gelatin
Body: titanium dioxide (E 171), gelatin
Rosulip Plus, 10 mg +10 mg, hard capsules:
Cap and body: iron oxide yellow (E 172), titanium dioxide (E 171), gelatin
Rosulip Plus, 20 mg +10 mg, hard capsules:
Cap: 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
Rosulip Plus, 5 mg +10 mg, hard capsules: a self-locking hard gelatin capsule of Coni Snap type, unmarked, 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 bevelled edges, marked with a stylized "E" on one side and code "612" on the other side, and one white or almost white, round, biconvex tablet of Rosuvastatin 5 mg marked with "5" on one side and unmarked on the other. The capsule length is approximately 21.7 mm (± 0.5 mm).

Rosulip Plus, 10 mg +10 mg, hard capsules: a self-locking hard gelatin capsule of Coni Snap type, unmarked, 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 bevelled edges, marked with a stylized "E" on one side and code "612" on the other side, and one white or almost white, round tablet of Rosuvastatin 10 mg marked on one side and unmarked on the other. The capsule length is approximately 21.7 mm (± 0.5 mm).

Rosulip Plus, 20 mg +10 mg, hard capsules: a self-locking hard gelatin capsule of Coni Snap type, unmarked, with a caramel-coloured cap and a yellow body, filled with two tablets: one white or almost white, round, flat tablet of Ezetimibe 10 mg with bevelled edges, marked with a stylized "E" on one side and code "612" on the other side, and one white or almost white, round tablet of Rosuvastatin 20 mg marked on one side and unmarked on the other. The capsule length is approximately 21.7 mm (± 0.5 mm).

5 mg + 10 mg: Packs containing 28, 30, 60 or 90 hard capsules in cold-formed blisters made of OPA/Aluminium/PVC/Aluminium foil.
10 mg + 10 mg and 20 mg + 10 mg: Packs containing 10, 28, 30, 56, 60, 84 or 90 hard capsules in cold-formed blisters made of OPA/Aluminium/PVC/Aluminium foil, in a cardboard outer 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 for marketing.

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 for marketing in the European Economic Area under the following names:

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