Rosulip plus

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Rosulip Plus (Delipid Plus), 10 mg + 10 mg, hard capsules
Rosuvastatin + Ezetimibe
Rosulip Plus and Delipid Plus are different brand names of the same medicinal product.
Please read the entire leaflet carefully before using 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 doubts, 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, 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, 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: it reduces the amount of cholesterol absorbed in the gastrointestinal tract and the amount of cholesterol produced in the body.
In most people, high cholesterol levels do not affect how they feel, as they cause 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 similar 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 pain or discomfort (myopathy)
• if the patient is taking sofosbuvir/velpatasvir/voxilaprevir (medicines used for 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 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 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 uncertainty whether such a
situation exists), the patient should consult a doctor.
Warnings and precautions
Before taking Rosulip Plus, speak with a doctor or pharmacist:

• if the patient has kidney problems
• if the patient has liver problems
• if the patient experiences recurrent or unexplained muscle pain or discomfort, or if the patient or family members have previously had muscle disorders, or if muscle-related problems occurred during treatment with other cholesterol-lowering medicines. The patient should contact the doctor immediately if unexplained muscle symptoms or pain occur, especially if accompanied by general malaise or fever. The patient should also inform the doctor or pharmacist if persistent muscle weakness occurs.
• 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), as 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 with other medicines”.
• if the patient has severe respiratory insufficiency
• if the patient is taking other medicines called fibrates to reduce cholesterol levels. 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 (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, orally or by injection, a 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 uncertainty whether such a
situation exists), the patient should consult again with a 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, treatment with Rosulip Plus must be discontinued and the patient must
contact a doctor immediately.
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, 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 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
Inform the doctor or pharmacist about all medicines currently taken or 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 increased). Rosulip Plus must not be taken during cyclosporine treatment.
• Anticoagulants, 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 increased.
• Colestyramine (a medicine also used to lower cholesterol levels), as 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, 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 concentration). 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 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 on rhabdomyolysis can be found in section 4.
• Oral contraceptives (the pill). The levels of sex hormones absorbed from the pill are increased.
• Hormone replacement therapy (increased hormone levels in the blood).

If the patient is admitted to hospital or receives treatment for another condition, the patient should
inform medical staff that they are taking Rosulip Plus.
Pregnancy and breastfeeding
Rosulip Plus must 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 must not be used during breastfeeding, as it is unknown 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 use Rosulip Plus

This medicine should always be taken exactly as instructed 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 medicine is available in the following strengths: Rosulip Plus 5 mg + 10 mg, Rosulip Plus 10 mg + 10 mg,
and Rosulip Plus 20 mg + 10 mg.
The recommended daily dose for adults is one capsule of a given 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 every day at the same time.
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 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 moderate renal impairment,
• the patient is at risk of developing muscle diseases and muscle pain (myopathy).

Regular cholesterol monitoring
It is important to visit your doctor regularly for cholesterol tests 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 alarmed. 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 stop taking Rosulip Plus.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
It is important for the patient to be aware of the possible side effects.
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 skin rash, joint disorders and effects on blood cells).
• Muscle rupture.

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

• 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 around the eyes. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Erythema multiforme (life-threatening allergic reactions affecting the skin and mucous membranes).

Other possible side effects
Common (may affect 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 ache)
• Diarrhea
• Bloating (excessive intestinal gas)
• Feeling of tiredness
• Increased results of certain laboratory blood tests assessing liver function (aminotransferases)

Uncommon (may affect up to 1 in 100 patients)

• Rash, itching, urticaria
• Increased amount of protein in urine may occur – the level usually returns to normal spontaneously, without the need to discontinue rosuvastatin treatment
• Increased results of certain laboratory 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
• Back pain
• Muscle weakness
• Pain in arms and legs
• 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
• Trace amounts of blood in urine
• Nerve damage in arms and legs (numbness)
• Memory loss
• Breast enlargement in men (gynecomastia)

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

• 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 arms or legs worsening
with periods of activity, double vision or drooping eyelids, difficulty swallowing or
shortness of breath.
Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed
in the leaflet, the patient 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Rosulip Plus

Store below 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 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. 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.
Each capsule contains rosuvastatin zinc equivalent to 10 mg of rosuvastatin. Each capsule also contains 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
Cap and body: iron oxide yellow (E 172), titanium dioxide (E 171), gelatin.

What Rosulip Plus looks like and contents of the pack
A self-closing hard gelatin capsule of the Coni Snap type, unmarked, with a yellow cap and a yellow body.
Pack sizes of 30, 60, and 90 hard capsules, formed in cold-form blisters OPA/Aluminium/PVC/Aluminium, in a cardboard carton with a patient information leaflet.
For further detailed information, please contact the responsible party 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 31/354/14-C
Parallel Import Authorisation Number: 298/21

This medicinal product is authorised in the Member States of the European Economic Area under the following names: