Crosuvo Plus

Leaflet accompanying the packaging: patient information

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

Rosuvastatin + Ezetimibe

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 packaging 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 medicines called statins, and the other active substance is ezetimibe.
Crosuvo Plus is a medicine used to lower the level of cholesterol in the blood, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides. Additionally, the medicine increases the levels of "good" cholesterol (HDL cholesterol).
This medicine lowers cholesterol levels by acting in two ways: it reduces the amount of cholesterol absorbed in the gut 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 medicine, you should follow a cholesterol-lowering diet.
Your doctor may prescribe Crosuvo Plus if you are already taking rosuvastatin and ezetimibe in the same dose.
Crosuvo Plus is used in the case of:

• 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:

Warnings and precautions

Before starting to take Crosuvo Plus, you should discuss it with your doctor or pharmacist:

There have been reports of serious skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), in patients taking Crosuvo Plus. If you experience any of the symptoms described in section 4, you should stop taking Crosuvo Plus and contact your doctor immediately.
If any of the above applies to you (or if you are in doubt), you should consult your doctor or pharmacist before taking Crosuvo Plus.
In rare cases, statins may affect liver function. To confirm this effect, a simple blood test is performed to detect increased liver enzyme activity in the blood. For this reason, your doctor will regularly order this blood test (liver function test) while you are taking Crosuvo Plus. It is essential to visit your doctor, who will order the necessary laboratory tests.
Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. 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 should not be used in children and adolescents under 18 years of age.

Crosuvo Plus and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
You should tell your doctor if you are taking any of the following medicines:

• cyclosporin (used, for example, after organ transplantation to prevent rejection of the transplanted organ. When taken together, the effect of rosuvastatin is increased). 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 medicines called fibrates, which also lower triglyceride levels in the blood (e.g., gemfibrozil and other fibrates). When taken together, the effect of rosuvastatin is increased;
• cholestyramine (a cholesterol-lowering medicine), as it affects the way ezetimibe works;
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, 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 aluminum and magnesium (used to neutralize stomach acid; they lower the level of rosuvastatin in the blood). This effect can be avoided by taking these medicines 2 hours after taking rosuvastatin;
• erythromycin (an antibiotic). When taken together, the effect of rosuvastatin is decreased;
• fusidic acid. If you need to take fusidic acid to treat a bacterial infection, you should temporarily stop taking Crosuvo Plus. Your doctor will advise when it is safe to restart taking Crosuvo Plus. Taking Crosuvo Plus with fusidic acid can rarely cause serious muscle problems (rhabdomyolysis).

Crosuvo Plus with alcohol

You should not take Crosuvo Plus at a dose of 40 mg + 10 mg (the highest dose) if you regularly drink large amounts of alcohol.

Pregnancy and breastfeeding

Crosuvo Plus should not be taken if you are pregnant, plan to become pregnant, or think you may be pregnant. If you become pregnant while taking Crosuvo Plus, you should stop taking the medicine and consult your doctor immediately. While taking Crosuvo Plus, women should use effective methods of contraception.
Crosuvo Plus should not be taken during breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

You should not expect Crosuvo Plus to affect your ability to drive or use machines.
However, you should consider that some people may experience dizziness after taking Crosuvo Plus. If you experience dizziness after taking this medicine, you should contact your doctor before driving or using machines.

Crosuvo Plus contains lactose

Crosuvo Plus tablets contain a sugar called lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Crosuvo Plus

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are in doubt, you should consult your doctor or pharmacist.
While taking Crosuvo Plus, you should follow a cholesterol-lowering diet and engage in physical activity.
The recommended daily dose for adults is one tablet of the given strength.

Crosuvo Plus should be taken once a day.

The medicine can be taken at any time of day, with or without food. You should swallow each tablet whole, with a glass of water.
The medicine should be taken at the same time every day.
Crosuvo Plus is not suitable for starting treatment. Starting treatment or changing the dose, if necessary, should be done by taking the active substances in the form of separate medicines.
Only after determining the appropriate doses 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 very high cholesterol levels and a high risk of heart attack or stroke, in whom a dose of 20 mg was not sufficient to lower cholesterol levels.

Regular cholesterol tests

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

Taking a higher dose of Crosuvo Plus than recommended

You should contact your doctor or go to the emergency room of the nearest hospital, as medical attention may be necessary.

Missing a dose of Crosuvo Plus

You should skip the missed dose and take the next planned dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping treatment with Crosuvo Plus

If you want to stop taking Crosuvo Plus, you should consult your doctor. After stopping treatment with Crosuvo Plus, your cholesterol levels may increase again.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Crosuvo Plus can cause side effects, although not everybody gets them.
It is essential to know what side effects can occur.

You should stop taking Crosuvo Plus and contact your doctor immediately if you 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, patchy, or circular spots on the torso, often with blisters in the center, skin peeling, 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome). If you experience unusual muscle pain that persists longer than expected, you should contact your 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. It is more likely to occur if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor your condition while you are taking this medicine;
• 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:

inflammation of the pancreas, 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 trace amounts 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 disorders, 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 in some cases muscles involved in breathing), ocular myasthenia (a disease that causes muscle weakness in the eyes).
You should talk to your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 medicine.

5. How to store Crosuvo Plus

The medicine should be stored in its original packaging to protect it from moisture and light. There are no special storage temperature requirements.
The medicine should be kept out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 about 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 about 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 about 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 about 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 medicine is authorized in the Member States of the European Economic Area under the following names:

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