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)
10 mg + 10 mg, hard capsules
Rosuvastatinum + Ezetimibum
Rosulip Plus and Delipid Plus are different brand 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, as you may need to read it again.
• If you have any questions, 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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 fatty substances called triglycerides.
Additionally, it increases levels of "good" cholesterol (HDL cholesterol). The medicine reduces cholesterol levels by acting in two ways: by reducing 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 control of cholesterol levels cannot be achieved with 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 loss.

2. Important information before taking 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 must stop taking the medicine immediately and consult her doctor. Women of childbearing potential should use appropriate contraceptive methods to avoid pregnancy while taking Rosulip Plus
• if the patient has previously experienced severe skin rash or skin peeling, blistering, 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, 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 a history of 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 pain occur, especially if accompanied by malaise or fever. Persistent muscle weakness should also be reported to the doctor or pharmacist.
• if the patient has or has had myasthenia gravis (a disease causing generalized 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 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, such as 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 lipid-lowering medicines called fibrates. 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 (as the doctor should determine the appropriate dose of Rosulip Plus)
• if the patient is currently 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 uncertainty), 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, the patient must stop taking Rosulip Plus and seek immediate medical advice.
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, 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 the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Inform the doctor if the patient is taking any of the following medicines:

• Cyclosporine (used, for example, after organ transplantation to prevent organ rejection. Concurrent use increases the effect of rosuvastatin). Rosulip Plus must not be taken during treatment with cyclosporine.
• Anticoagulants, such as 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). Concurrent use increases the effect of rosuvastatin.
• 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, used 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 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 used concomitantly.
• Fusidic acid. If the patient needs to take fusidic acid orally or by injection for bacterial infection treatment, Rosulip Plus should be temporarily discontinued. The doctor will inform the patient when it is safe to resume Rosulip Plus. Concomitant use of Rosulip Plus with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis is provided in section 4.
• Oral contraceptives (birth control pills). 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 receives treatment for another illness, they should inform the 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 must stop taking the medicine immediately and consult her doctor. Women of childbearing potential 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 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 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 exactly 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, a low-cholesterol diet and regular physical activity should be maintained.
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 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 treatment with Rosulip Plus be initiated.
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 regularly for 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 immediately, 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 intend 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
It is important for the patient to be aware of which side effects may occur.
You should stop taking Rosulip Plus immediately and seek medical help
if any of the following symptoms occur:
Rare (may affect up to 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
from the data available):

• Reddish flat, disc-shaped or round spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, 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 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 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. Your doctor will monitor you 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 laboratory tests assessing liver function (aminotransferases)
• Uncommon (may affect up to 1 in 100 patients)
• Rash, itching, urticaria
• Increased amount of protein in the urine may occur – this 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 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
from the data available)

• 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).

You should talk to your doctor if you experience weakness in arms or legs worsening after
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 side effects not listed
in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported
directly to the Department for 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 side effects 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.
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 measures 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 hard capsule contains 10 mg rosuvastatin (in the form of rosuvastatin zinc) and 10 mg ezetimibe.
The 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 Coni Snap type, unmarked, with yellow cap and yellow body, filled with two tablets: one white or almost white, round, flat tablet of Ezetimibe 10 mg with bevelled edges, marked with stylized letter E on one side and code 612 on the other side, and one white or almost white, round tablet

Rosuvastatin 10 mg marked on one side of the tablet and unmarked on the other side.
The length of the capsule is approximately 21.7 mm (± 0.5 mm).
Packaging containing 30, 60, or 90 hard capsules in cold-formed blisters of OPA/Al/PVC//Al, in a cardboard box with a patient information leaflet.
For more 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing Authorisation number in the Czech Republic, country of export: 31/354/14-C
Parallel Import Authorisation number: 264/23

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