Crosuvo Plus

Package Leaflet: Information for the Patient

Crosuvo Plus, 5 mg + 10 mg, Film-Coated Tablets

Crosuvo Plus, 10 mg + 10 mg, Film-Coated Tablets

Crosuvo Plus, 20 mg + 10 mg, Film-Coated Tablets

Crosuvo Plus, 40 mg + 10 mg, Film-Coated Tablets

Rosuvastatinum + Ezetimibum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Crosuvo Plus and what is it used for
• 2. Important information before taking Crosuvo Plus
• 3. How to take Crosuvo Plus
• 4. Possible side effects
• 5. How to store Crosuvo Plus
• 6. Contents of the pack and other information

1. What is Crosuvo Plus and what is it used for

Crosuvo Plus contains two different active substances in one film-coated tablet. One of the active substances is calcium rosuvastatin, which belongs to a group of medications called statins, and the other active substance is ezetimibe.
Crosuvo Plus is used to lower the level of cholesterol in the blood, including "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides. Additionally, it increases the level of "good" cholesterol (HDL cholesterol).
This medication lowers cholesterol levels by acting in two ways: it reduces the amount of cholesterol absorbed in the digestive tract and the amount of cholesterol produced in the body.
In most people, high cholesterol levels do not affect their well-being, as they do not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, leading to their narrowing.
Sometimes, these narrowed blood vessels can become blocked, which can cut off blood flow to the heart or brain, leading to a heart attack or stroke. Lowering cholesterol levels can help reduce the risk of heart attack, stroke, or other similar health problems.
Crosuvo Plus is used in patients for whom diet alone is not enough to maintain a healthy cholesterol level. While taking this medication, patients should follow a cholesterol-lowering diet.
A doctor may prescribe Crosuvo Plus if the patient is already taking rosuvastatin and ezetimibe in the same dose.

• high cholesterol levels in the blood (primary hypercholesterolemia).

Crosuvo Plus does not affect weight loss.

2. Important information before taking Crosuvo Plus

When not to take Crosuvo Plus:

• if the patient is allergic to ezetimibe, rosuvastatin, or any of the other ingredients of this medication (listed in section 6);
• if the patient has liver disease;
• if the patient has severe kidney problems;
• if the patient has recurring, unexplained muscle pain or weakness (myopathy);
• if the patient is taking a medication called cyclosporin (used, for example, after organ transplantation to prevent rejection);
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral infection called hepatitis C);
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Crosuvo Plus, they should stop taking the medication and consult a doctor. Women of childbearing age should avoid becoming pregnant while taking Crosuvo Plus and use effective birth control methods. Additionally, rosuvastatin should not be taken at a dose of 40 mg (the highest dose):
• if the patient has moderate kidney problems (in case of doubt, consult a doctor);
• if the patient has thyroid problems (hypothyroidism);
• if the patient regularly consumes large amounts of alcohol;
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian);
• if the patient is taking other cholesterol-lowering medications called fibrates (see "Crosuvo Plus and other medications");
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, and (or) ulcers in the mouth after taking Crosuvo Plus or similar medications. If any of the above applies to the patient (or in case of doubt), they should consult a doctor.

Warnings and precautions

Before starting to take Crosuvo Plus, the patient should discuss the following with their doctor or pharmacist:

• if the patient has kidney disease;
• if the patient has liver disease;
• if the patient has recurring or unexplained muscle pain or weakness, or if they have had muscle problems in the past or have a family history of muscle problems. The patient should contact their doctor immediately if they experience unexplained muscle pain or weakness, especially if it is accompanied by a general feeling of being unwell or fever. The patient should also inform their doctor or pharmacist if they experience persistent muscle weakness;
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the symptoms of the disease or cause myasthenia (see section 4).
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor will determine the appropriate dose of Crosuvo Plus for the patient;
• if the patient is taking medications used to treat viral infections, including HIV or hepatitis C, such as lopinavir/ritonavir and (or) atazanavir; see "Crosuvo Plus and other medications";
• if the patient has severe respiratory failure;
• if the patient is taking other cholesterol-lowering medications called fibrates. See "Crosuvo Plus and other medications";
• if the patient regularly consumes large amounts of alcohol;
• if the patient has thyroid problems (hypothyroidism);
• if the patient is over 70 years old (as the doctor should determine the appropriate initial dose of Crosuvo Plus for the patient;
• if the patient is currently taking or has taken within the last 7 days a medication called fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Crosuvo Plus may cause serious muscle problems (rhabdomyolysis).

There have been reports of severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), in patients taking Crosuvo Plus. If the patient experiences any of the symptoms described in section 4, they should stop taking Crosuvo Plus and contact their doctor immediately.
If any of the above applies to the patient (or in case of doubt), they should consult their doctor or pharmacist before taking Crosuvo Plus.
In rare cases, statins may affect liver function. To check for this, a simple blood test is performed to detect increased liver enzyme activity in the blood. Therefore, the doctor will regularly order this blood test (liver function test) during treatment with Crosuvo Plus. It is essential to visit the doctor who ordered the test.
Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medication. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

Crosuvo Plus is not recommended for children and adolescents under 18 years of age.

Crosuvo Plus and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those available without a prescription.
The patient should inform their doctor if they are taking any of the following medications:

• cyclosporin (used, for example, after organ transplantation to prevent rejection. The effect of rosuvastatin may be increased when taken with cyclosporin). Crosuvo Plus should not be taken while taking cyclosporin;
• blood thinners, such as warfarin, acenocoumarol, or fluindione (their effect and the risk of bleeding may be increased when taken with Crosuvo Plus, ticagrelor, or clopidogrel;
• darolutamide (used to treat cancer);
• other cholesterol-lowering medications called fibrates, which also lower triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). The effect of rosuvastatin may be increased when taken with these medications;
• colestyramine (a cholesterol-lowering medication), as it affects the way ezetimibe works;
• any of the following medications used to treat viral infections, including HIV or hepatitis C, taken alone or in combination with other medications (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
• antacids containing aluminum and magnesium (used to neutralize stomach acid; they can lower rosuvastatin levels in the blood). This effect can be avoided by taking these medications 2 hours after taking rosuvastatin;
• erythromycin (an antibiotic). The effect of rosuvastatin may be decreased when taken with erythromycin;
• fusidic acid. If the patient needs to take fusidic acid to treat a bacterial infection, they should temporarily stop taking Crosuvo Plus. The doctor will advise when it is safe to restart Crosuvo Plus. Taking Crosuvo Plus with fusidic acid can cause serious muscle problems (rhabdomyolysis) in rare cases.
• oral contraceptives (the "pill"). The levels of sex hormones absorbed from the pill may increase;
• hormone replacement therapy (increased levels of sex hormones in the blood);
• regorafenib (used to treat cancer). If the patient is hospitalized or treated for another condition, they should inform the medical staff that they are taking Crosuvo Plus.

Crosuvo Plus and alcohol

Crosuvo Plus should not be taken at a dose of 40 mg + 10 mg (the highest dose) if the patient regularly consumes large amounts of alcohol.

Pregnancy and breastfeeding

Crosuvo Plus should not be taken if the patient is pregnant, plans to become pregnant, or suspects they may be pregnant. If the patient becomes pregnant while taking Crosuvo Plus, they should stop taking the medication immediately and inform their doctor. During treatment with Crosuvo Plus, women should use effective birth control methods.
Crosuvo Plus should not be taken during breastfeeding, as it is not known whether the medication passes into breast milk.

Driving and using machines

Crosuvo Plus is not expected to affect the ability to drive or use machines.
However, the patient should consider that Crosuvo Plus may cause dizziness. If the patient experiences dizziness after taking Crosuvo Plus, they should contact their doctor before driving or using machines.

Crosuvo Plus contains lactose

Crosuvo Plus tablets contain a sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medication.

3. How to take Crosuvo Plus

This medication should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
While taking Crosuvo Plus, the patient should follow a cholesterol-lowering diet and engage in physical activity.
The recommended daily dose for adults is one tablet of the prescribed strength.

Crosuvo Plus should be taken once a day.

The medication can be taken at any time of day, with or without food. Each tablet should be swallowed whole with water.
The patient should take Crosuvo Plus at the same time every day.
Crosuvo Plus is not suitable for initiating treatment. The initiation of treatment or any changes to the dose, if necessary, should be done with the individual active substances.
Only after the appropriate doses have been established can Crosuvo Plus be used at the appropriate dose.
The maximum daily dose of rosuvastatin is 40 mg. It is used only in patients with high cholesterol levels and a high risk of heart attack or stroke, for whom a dose of 20 mg was not sufficient to lower cholesterol levels.

Regular cholesterol checks

To ensure that cholesterol levels have decreased and are being maintained at a healthy level, the patient should have regular check-ups with their doctor and undergo blood tests.

Taking a higher dose of Crosuvo Plus than recommended

The patient should contact their doctor or go to the emergency room, as medical attention may be necessary.

Missing a dose of Crosuvo Plus

The patient should skip the missed dose and take the next scheduled dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Crosuvo Plus

If the patient wants to stop taking Crosuvo Plus, they should consult their doctor. After stopping Crosuvo Plus, cholesterol levels may rise again.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Crosuvo Plus can cause side effects, although not everyone will experience them.
It is essential for the patient to know which side effects can occur.

The patient should stop taking Crosuvo Plus and contact their doctor immediately if they experience any of the following symptoms:

• swelling of the face, lips, tongue, and (or) throat, which may cause difficulty breathing and swallowing;
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells);
• muscle rupture;
• red, flat, round, or oval patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome). If the patient experiences unusual muscle pain that persists longer than expected, they should contact their doctor immediately. In rare cases, these symptoms can lead to a potentially life-threatening muscle injury called rhabdomyolysis, which is characterized by a general feeling of being unwell, fever, and impaired kidney function.

The following terms are used to describe the frequency of side effects:

• very common (may occur in more than 1 in 10 people);
• common (may occur in up to 1 in 10 people);
• uncommon (may occur in up to 1 in 100 people);
• rare (may occur in up to 1 in 1,000 people);
• very rare (may occur in up to 1 in 10,000 people, including single reports).

Common side effects:

• headache;
• constipation;
• nausea;
• muscle pain;
• weakness;
• dizziness;
• diabetes. Its occurrence is more likely if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor the patient's condition while taking this medication;
• abdominal pain;
• diarrhea;
• bloating (excess gas in the digestive tract);
• fatigue;
• increased levels of certain liver enzymes in the blood (aminotransferases).

Uncommon side effects:

• rash, itching, hives;
• increased protein in the urine - usually resolves on its own without the need to stop taking rosuvastatin;
• increased levels of certain blood tests for muscle function (CK);
• cough;
• indigestion;
• heartburn;
• joint pain;
• muscle spasms;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• hot flashes;
• high blood pressure;
• tingling sensation;
• dry mouth;
• gastritis;
• back pain;
• muscle weakness;
• pain in the arms and legs;
• swelling, especially of the hands and feet.

Rare side effects:

pancreatitis, which can cause severe abdominal pain that radiates to the back, decreased platelet count.

Very rare side effects:

jaundice (yellowing of the skin and eyes), liver inflammation (hepatitis), presence of blood in the urine, nerve damage in the arms and legs (e.g., numbness), memory loss, breast enlargement in men (gynecomastia).

Frequency not known:

shortness of breath, swelling, sleep disturbances, including insomnia and nightmares, sexual disorders, depression, breathing problems, including persistent cough and (or) shortness of breath or fever, tendon injury, persistent muscle weakness, gallstones or cholecystitis (which can cause abdominal pain, nausea, vomiting), myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing), ocular myasthenia (a disease that causes weakness of the eye muscles).
The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301 Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medication.

5. How to store Crosuvo Plus

Store the medication in its original packaging to protect it from moisture and light. There are no special storage temperature requirements.
Keep the medication out of sight and reach of children.
Do not use the medication after the expiration date stated on the carton and blister pack after the abbreviation "EXP". The expiration date refers to the last day of the specified month.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Crosuvo Plus contains

• The active substances of Crosuvo Plus are rosuvastatin (in the form of rosuvastatin calcium) and ezetimibe. Crosuvo Plus 5 mg + 10 mg: Each tablet contains 5.20 mg of rosuvastatin calcium (equivalent to 5 mg of rosuvastatin) and 10 mg of ezetimibe. Crosuvo Plus 10 mg + 10 mg: Each tablet contains 10.40 mg of rosuvastatin calcium (equivalent to 10 mg of rosuvastatin) and 10 mg of ezetimibe. Crosuvo Plus 20 mg + 10 mg: Each tablet contains 20.80 mg of rosuvastatin calcium (equivalent to 20 mg of rosuvastatin) and 10 mg of ezetimibe. Crosuvo Plus 40 mg + 10 mg: Each tablet contains 41.60 mg of rosuvastatin calcium (equivalent to 40 mg of rosuvastatin) and 10 mg of ezetimibe.
• Other ingredients are: Tablet core (the same for all strengths): microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572), povidone K30 (E1201), sodium croscarmellose (E468), sodium lauryl sulfate (E487), lactose monohydrate, hypromellose 2910 (E464), Coating: Crosuvo Plus 5 mg + 10 mg: Opadry Yellow, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521), yellow iron oxide (E172), talc (E553b), red iron oxide (E171), Crosuvo Plus 10 mg + 10 mg: Opadry Beige, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521), yellow iron oxide (E172), talc (E553b), Crosuvo Plus 20 mg + 10 mg: Vivacoat Yellow, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521), yellow iron oxide (E172), talc (E553b), Crosuvo Plus 40 mg + 10 mg: Opadry white, lactose monohydrate, hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521).

What Crosuvo Plus looks like and contents of the pack

Crosuvo Plus 5 mg + 10 mg: These are light yellow, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, with the inscription "EL5" on one side.
Crosuvo Plus 10 mg + 10 mg: These are beige, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, with the inscription "EL4" on one side.
Crosuvo Plus 20 mg + 10 mg: These are yellow, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, with the inscription "EL3" on one side.
Crosuvo Plus 40 mg + 10 mg: These are white, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, with the inscription "EL2" on one side.
Crosuvo Plus is available in packs containing 30, 60, and 90 film-coated tablets in OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

ELPEN Pharmaceutical Co. Inc.
95, Marathonos Ave., Pikermi 19009
Attica, Greece

This medication is authorized in the European Economic Area member states under the following names:

Slovakia/Czech Republic: Horime
Netherlands: Rosuvastatine/ezetimibe Bausch Health Ireland Limited
Date of last revision of the leaflet:June 2023