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 trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. 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, inform your doctor, pharmacist, or nurse. See section 4.

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 reduce 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 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 interrupt blood flow to the heart or brain, causing a heart attack or stroke. By reducing 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.
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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 in reducing 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/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 developed 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, speak with 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 previous 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 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 trigger the onset 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 insufficiency
• 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)

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• 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 to treat bacterial infections). Concomitant use of 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 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 the use of rosuvastatin. 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 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 tests as recommended.
If the patient has diabetes or is at risk of developing diabetes, close monitoring by the doctor will
be required 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 your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:

• Cyclosporine (used, for example, after organ transplantation to prevent organ rejection. The effect of rosuvastatin is enhanced when used concomitantly). Do not take Rosulip Plus while using cyclosporine.
• Anticoagulant medicines, e.g. warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when used together with Rosulip Plus), ticagrelor, or clopidogrel.
• Other cholesterol-lowering medicines called fibrates, also reducing triglyceride levels (e.g. gemfibrozil and other fibrates). When used concomitantly, the effect of rosuvastatin is enhanced.
• 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, 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 rosuvastatin.

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• Erythromycin (an antibiotic). The effect of rosuvastatin is reduced when used concomitantly with these medicines.
• Fusidic acid. If the patient needs to take oral or injectable fusidic acid 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. Concomitant use of 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 concentrations of sex hormones absorbed from the pill may increase.
• Capmatinib (used in cancer treatment).
• Hormone replacement therapy (increased blood hormone concentrations).
• 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 receives treatment for another condition, they should
inform healthcare 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 dizziness occurs, the
patient 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 prescribed 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 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 every day at the same time.
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  Rosulip Plus is not suitable for initiating treatment.
  Starting treatment or changing doses, if necessary, should only be done using the active substances
  in the form of separate medicines; only after determining the appropriate doses 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 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 need to worry; 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 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 experiences them.
It is important that the patient knows 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 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 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):

• Red, flat, disc-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, oral, throat, nose, genital and eye mucosal ulcers. These potentially 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 adverse reactions
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, is overweight and has 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 affect up to 1 in 100 patients)

• Rash, itching, urticaria
• Increased protein in urine may occur – levels usually return 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 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, 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 (may cause abdominal pain, nausea, vomiting)
• Myasthenia gravis (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 speak to their doctor if they experience weakness in 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, pharmacist or nurse. 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 to provide 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.
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 (as rosuvastatin zinc) and ezetimibe.
The capsules contain rosuvastatin zinc equivalent to 10 mg of rosuvastatin. Each capsule contains 10 mg of ezetimibe.
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The other ingredients are:
Microcrystalline cellulose silicon dioxide 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 Coni-Snap type, unmarked, with yellow cap and yellow body, containing two tablets: one white or almost white, round, flat tablet with bevelled edges, Ezetimibe 10 mg, marked with a stylized letter E on one side and code 612 on the other side, and one white or almost white, round, flat tablet of Rosuvastatin 10 mg marked with an imprint on one side and unmarked on the other side. The length of the capsule is approximately 21.7 mm (± 0.5 mm).
Packaging containing 30, 60, 90 hard capsules in cold-formed OPA/Al/PVC/Al blisters, in a cardboard box with patient information leaflet.
For further 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in the Czech Republic, country of export: 31/354/14-C
Parallel Import Authorisation number: 181/22
This medicinal product is authorised in the European Economic Area countries under the following names:

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