Rosulip plus

PACKAGE LEAFLET: 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
Rosuvastatin + Ezetimibe
Rosulip Plus and Delipid Plus are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Rosulip Plus is and what it is 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 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, belonging 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 fat-like 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 cholesterol production 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 accumulate in the walls of blood vessels, leading to narrowing of the vessels.
Sometimes these narrowed vessels may become blocked, which can interrupt 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 reduce body weight.

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 impairment
• if the patient experiences recurrent, unexplained muscle symptoms or muscle pain (myopathy)
• if the patient is taking sofosbuvir/wepinavir/voxilaprevir (medicines used in viral hepatitis C infection)
• 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 immediately stop taking the medicine 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 mucosal 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 doubt 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 previously 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. The patient should also report to the doctor or pharmacist if persistent muscle weakness occurs.
• if the patient has or has had myasthenia gravis (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 – please refer to the section “Rosulip Plus with other medicines”.
• if the patient has severe respiratory failure
• if the patient is taking other medicines called fibrates to reduce cholesterol levels. Please refer to the section “Rosulip Plus with 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 in 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 doubt whether such a
situation exists), the patient should consult again with the doctor or pharmacist 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 rosuvastatin use. If any of the symptoms described in section 4 occur, the patient must stop taking Rosulip Plus and contact a doctor immediately.
In a small number of people, statins may affect the liver. To confirm such an 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. There is a high probability of developing diabetes if the patient has high blood sugar and fat 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 or has recently taken, as well as any medicines the patient plans to take.
Tell 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 increased). Do not take Rosulip Plus while taking cyclosporine.
• Blood-thinning medicines, e.g. warfarin, acenocoumarol or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken together 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 with these medicines, the effect of rosuvastatin is increased.
• Colestyramine (a medicine also used to lower cholesterol levels), because this medicine 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.
• 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 taking 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 restart Rosulip Plus. 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). 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 blood uric acid levels).
• Teriflunomide (used to treat multiple sclerosis).

If the patient is admitted to hospital or receiving treatment for another condition, the patient should
inform 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
immediately stop taking the medicine 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 not known whether the medicine passes into human 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 consult a 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 as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Rosulip Plus is available in the following strengths: 5 mg + 10 mg, 10 mg + 10 mg, and 20 mg

• 10 mg.
  While taking Rosulip Plus, you should continue a cholesterol-lowering diet and maintain
  regular 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.
  This 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.
  Starting treatment or adjusting doses, if necessary, should only be done using the active substances
  in the form of separate medicines. Only after the appropriate doses have been established should
  switching to Rosulip Plus be considered.
  Your doctor may decide to use the lowest strength (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 moderate to 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 check-ups 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
There is no cause for concern. 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
It is important for the patient to be aware of which adverse effects may occur.
The patient should stop taking Rosulip Plus immediately 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 rash, joint disorders and effects on blood cells).
• Muscle rupture.

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

• Red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and inside the eyes. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high fever 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 effects
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 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 intestinal gas)
• 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, 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 platelet count

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
• Breast enlargement in men (gynecomastia)

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

• 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 hands or feet worsening after
periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects 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
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Rosulip Plus

Store below 30°C. Keep in the original packaging to protect from light and moisture.
The medicine should be stored out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices 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.
Each hard capsule contains 20 mg of rosuvastatin (as rosuvastatin zinc) and 10 mg of ezetimibe.

Other ingredients are:
Core
Silicified microcrystalline cellulose 90 (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:
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
A self-locking hard gelatin capsule of Coni-Snap type, unmarked, with a caramel-colored cap and a yellow body, containing two tablets: one white or almost white, round, flat tablet of Ezetimibe 10 mg with bevelled edges, marked with a stylized letter E on one side and code 612 on the other side, and one white or almost white, round tablet of Rosuvastatin 20 mg with an imprint on one side and no marking on the other side. The length of the capsule is approximately 21.7 mm (± 0.5 mm).

Pack sizes containing 30, 60, 90 hard capsules in cold-formed blisters made of OPA/Al/PVC//Al, packed in a cardboard box with an enclosed patient information leaflet.

For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, 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
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation number in the Czech Republic, country of export: 31/355/14-C
Parallel Import Authorisation number: 78/24

This medicinal product is authorised in the European Economic Area member states under the following names: