Rosuvastatin + Ezetimibe Rafarm

Leaflet accompanying the packaging: patient information

Rosuvastatin + Ezetimibe Rafarm, 5 mg + 10 mg, tablets
Rosuvastatin + Ezetimibe Rafarm, 10 mg + 10 mg, tablets
Rosuvastatin + Ezetimibe Rafarm, 20 mg + 10 mg, tablets
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 necessary.
• In case of 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 the symptoms of their illness are the same.
• 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 Rosuvastatin + Ezetimibe /Rafarm and what is it used for
2. Important information before taking Rosuvastatin + Ezetimibe /Rafarm
3. How to take Rosuvastatin + Ezetimibe /Rafarm
4. Possible side effects
5. How to store Rosuvastatin + Ezetimibe /Rafarm
6. Contents of the packaging and other information

1. What is Rosuvastatin + Ezetimibe /Rafarm and what is it used for

Rosuvastatin + Ezetimibe /Rafarm contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to a group of so-called statins, and the other active substance is ezetimibe.
Rosuvastatin + Ezetimibe /Rafarm is a medicine used to reduce the level of total cholesterol, so-called "bad" cholesterol (LDL), and triglycerides in the blood, and to increase the level of "good" cholesterol (HDL).
The medicine reduces cholesterol levels in patients with angina pectoris or coronary heart disease (a disease caused by narrowing of the coronary arteries).
Rosuvastatin + Ezetimibe /Rafarm is used in patients who cannot take high doses of statins, or in patients in whom statins alone are not sufficient to achieve the target cholesterol level.

2. Important information before taking Rosuvastatin + Ezetimibe /Rafarm

Rosuvastatin + Ezetimibe /Rafarm should not be taken in the following cases:

• If the patient is allergic to rosuvastatin, ezetimibe, or any other component of this medicine.
• If the patient is pregnant or breastfeeding.
• If the patient has active liver disease.
• If the patient has stomach or duodenal ulcers or a history of gastrointestinal bleeding.

Special caution should be exercised when taking Rosuvastatin + Ezetimibe /Rafarm:

• If the patient has kidney function disorders.
• If the patient has liver function disorders.
• If the patient abuses alcohol.
• If the patient has diabetes or is at risk of developing diabetes.
• If the patient has severe respiratory disorders (lung disease).
• If the patient is taking other medicines that may increase the risk of rhabdomyolysis (see section 6).

Side effects:
During treatment with statins, including rosuvastatin, cases of rhabdomyolysis (muscle tissue breakdown) have been reported, which can lead to kidney failure. The patient should immediately contact their doctor if they experience symptoms such as:muscle pain, weakness, muscle tenderness, or muscle cramps. The risk of rhabdomyolysis increases when rosuvastatin is taken in high doses, especially in combination with certain other medicines (see section 6).
Before starting treatment with Rosuvastatin + Ezetimibe /Rafarm, liver function tests should be performed.
During treatment, liver enzyme levels should be regularly monitored.
The patient should inform their doctor if they experience any symptoms suggesting liver function disorders, such as fatigue, weakness, loss of appetite, nausea, vomiting, abdominal pain in the right upper quadrant, dark urine, or jaundice.
Ezetimibe may increase the risk of gallstones.

3. How to take Rosuvastatin + Ezetimibe /Rafarm

Rosuvastatin + Ezetimibe /Rafarm should be taken as directed by the doctor.
Typically, the initial dose of Rosuvastatin + Ezetimibe /Rafarm is one tablet once a day.
The medicine should be taken once a day, at a fixed time, regardless of meals.
Treatment is usually long-term.
The patient should regularly monitor their cholesterol and triglyceride levels, as directed by the doctor.
If the patient forgets to take a dose of the medicine:
The patient should take the missed dose as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.
If the patient stops taking the medicine:
Stopping treatment with Rosuvastatin + Ezetimibe /Rafarm without consulting a doctor may cause an increase in blood cholesterol levels.

4. Possible side effects

Like all medicines, Rosuvastatin + Ezetimibe /Rafarm can cause side effects, although not everybody gets them.

• Headache
• Muscle pain
• Weakness
• Nausea
• Constipation
• Diarrhea
• Abdominal pain
• Increased liver enzyme activity in the blood (detected in laboratory tests)

Uncommon side effects (may affect up to 1 in 100 people):

• Lack of appetite
• Joint pain
• Hepatitis
• Itching of the skin
• Rash
• Chest pain
• Fatigue
• Dizziness
• Insomnia
• Nightmares
• Numbness or tingling in the limbs
• Taste disorders
• Increased blood glucose levels
• Increased creatinine levels in the blood (detected in laboratory tests)

Rare side effects (may affect up to 1 in 1,000 people):

• Rhabdomyolysis (muscle tissue breakdown)
• Pancreatitis
• Hepatitis
• Jaundice
• Allergic reactions, including facial, lip, tongue, and/or throat swelling, which can make breathing and swallowing difficult

Very rare side effects (may affect less than 1 in 10,000 people):

• Liver failure

Other possible side effects reported during treatment with statins:

• Memory disorders
• Depression
• Pneumonia
• Skin inflammation
• Hearing impairment
• Gynecomastia (breast enlargement in men)

Reporting side effects:
If side effects occur, the patient should inform their doctor or pharmacist. This includes side effects not listed in the leaflet.

5. How to store Rosuvastatin + Ezetimibe /Rafarm

Store in a place inaccessible and invisible to children.
Do not use the medicine after the expiry date stated on the packaging.
Store in the original packaging to protect from light and moisture.

6. Contents of the packaging and other information

What Rosuvastatin + Ezetimibe /Rafarm contains:
The active substances of the medicine are rosuvastatin and ezetimibe.
A full list of excipients is included in section 6.1.
What Rosuvastatin + Ezetimibe /Rafarm looks like and what the packaging contains:
Rosuvastatin + Ezetimibe /Rafarm tablets are available in packs of 30, 60, 90, or 180 tablets.
Marketing authorization holder:
Rafarm S.A.
ul. Żniwna 40
05-092 Natolin
Manufacturer:
Rafarm S.A.
ul. Żniwna 40
05-092 Natolin
Date of last revision of the leaflet: 01.04.2023

2. Important information before taking Rosuvastatin + Ezetimibe /Rafarm

When not to take Rosuvastatin + Ezetimibe /Rafarm

• if the patient is allergic to rosuvastatin, ezetimibe, or any other component of this medicine (listed in section 6)
• if the patient has severe kidney function disorders
• if the patient has severe, unexplained muscle pain (myopathy)
• if the patient is taking medicines containing cyclosporine (used, for example, after organ transplantation)
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Rosuvastatin + Ezetimibe /Rafarm, they should stop taking the medicine immediately and inform their doctor. During treatment with Rosuvastatin + Ezetimibe /Rafarm, patients should avoid becoming pregnant, using effective contraception methods (see subsection "Pregnancy and breastfeeding").

If any of the above situations apply to the patient (or the patient has doubts), they should consult their doctor.

Warnings and precautions

Before taking Rosuvastatin + Ezetimibe /Rafarm, the patient should discuss it with their doctor or pharmacist if:

• the patient has kidney function disorders;
• the patient has liver function disorders;
• the patient experiences recurring or unexplained muscle pain, has a history of muscle disorders, or has previously experienced muscle problems related to taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially accompanied by malaise or fever, the patient should immediately consult their doctor. The patient should also inform their doctor or pharmacist about difficulties in urinating;
• the patient is of Asian origin, from China, the Philippines, Vietnam, Korea, or Japan (see subsection "Side effects"). Patients from these countries are more likely to develop myopathy (muscle disease);
• the patient regularly consumes large amounts of alcohol;
• the patient has other conditions that may increase the risk of myopathy (e.g., hypothyroidism, kidney disease, alcohol abuse, liver disease, diabetes, people over 65 years old, female sex);
• the patient is taking other medicines (see section "Medicines taken at the same time as Rosuvastatin + Ezetimibe /Rafarm").

Rosuvastatin + Ezetimibe /Rafarm is not recommended for use in children and adolescents.

Pregnancy and breastfeeding

Rosuvastatin + Ezetimibe /Rafarm should not be taken during pregnancy and breastfeeding. If the patient becomes pregnant while taking Rosuvastatin + Ezetimibe /Rafarm, they should stop taking the medicine immediately and consult their doctor.

Driving and using machines

Rosuvastatin + Ezetimibe /Rafarm usually does not affect the ability to drive and use machines. However, the patient should be cautious, especially at the beginning of treatment, as some patients may experience dizziness.
The patient should inform their doctor about all medicines they are taking, including those available without a prescription.
The patient should regularly monitor their cholesterol and liver function during treatment with Rosuvastatin + Ezetimibe /Rafarm.
If the patient experiences muscle pain, weakness, or muscle cramps, they should stop taking the medicine immediately and consult their doctor.

Test to check for increased liver enzyme activity in the blood. Therefore, the doctor will recommend regular tests during treatment with Rosuvastatin + Ezetimibe /Rafarm. It is essential for the patient to attend these tests as scheduled.

During treatment with this medicine, the doctor will closely monitor the condition of patients with diabetes or at risk of developing diabetes. There is a high probability of developing diabetes if the patient has high sugar and fat levels in the blood, is overweight, and has high blood pressure.
If the patient is hospitalized or treated for another reason, they should inform the medical staff about taking Rosuvastatin + Ezetimibe /Rafarm.
Children and adolescents
Rosuvastatin + Ezetimibe /Rafarm is not recommended for use in children and adolescents under 18 years old.
Rosuvastatin + Ezetimibe /Rafarm and other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should tell their doctor or pharmacist if they are taking any of the following medicines: cyclosporine (a medicine used, for example, after organ transplantation). Cyclosporine increases the effect of rosuvastatin taken at the same time. The patient should not take Rosuvastatin + Ezetimibe /Rafarm while taking cyclosporine. anticoagulant medicines, such as warfarin, acenocoumarol, or fluindion (taking Rosuvastatin + Ezetimibe /Rafarm at the same time may increase the anticoagulant effect, with an increased risk of bleeding) or clopidogrel. other cholesterol-lowering medicines, so-called fibrates, which also regulate triglyceride levels in the blood (e.g., gemfibrozil and other medicines from this group). Taking these medicines at the same time increases the effect of rosuvastatin. cholestyramine (a medicine used to lower cholesterol levels), as it affects the absorption of medicines. regorafenib (used to treat cancer), which may increase the level of rosuvastatin in the blood and increase the risk of side effects. any of the following medicines used to treat viral infections: antiviral medicines, such as protease inhibitors, non-nucleoside reverse transcriptase inhibitors, and HIV integrase inhibitors. taking these medicines at the same time may increase the level of rosuvastatin in the blood and increase the risk of side effects. antifungal medicines, such as ketoconazole, itraconazole, or voriconazole. taking these medicines at the same time may increase the level of rosuvastatin in the blood and increase the risk of side effects. colchicine (a medicine used to treat gout). taking this medicine at the same time may increase the risk of myopathy (muscle disease).

• Rosuvastatin + Ezetimibe /Rafarm may enhance the effect of medicines that lower blood sugar levels (e.g., metformin, sulfonylureas).
• If necessary, the doctor may adjust the doses of antidiabetic medicines.

Rosuvastatin + Ezetimibe /Rafarm with food and drink

The medicine can be taken regardless of meals.

Pregnancy and breastfeeding

Rosuvastatin + Ezetimibe /Rafarm should not be taken during pregnancy and breastfeeding. If the patient is pregnant or breastfeeding, they should inform their doctor.

Driving and using machines

Rosuvastatin + Ezetimibe /Rafarm usually does not affect the ability to drive and use machines. However, the patient should be cautious, especially at the beginning of treatment, as some patients may experience dizziness.

Rosuvastatin + Ezetimibe /Rafarm and alcohol

The patient should avoid consuming large amounts of alcohol while taking Rosuvastatin + Ezetimibe /Rafarm, as it may cause liver damage.

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Pregnancy

Rosuvastatin + Ezetimibe /Rafarm should not be taken if the patient is pregnant, trying to become pregnant, or suspects they may be pregnant. If the patient becomes pregnant while taking Rosuvastatin + Ezetimibe /Rafarm, they should stop taking the medicine immediately and inform their doctor. During treatment with Rosuvastatin + Ezetimibe /Rafarm, patients should use effective contraception methods to avoid becoming pregnant.
Breastfeeding
Rosuvastatin + Ezetimibe /Rafarm should not be taken during breastfeeding, as it is not known whether the medicine passes into breast milk.
Driving and using machines
Rosuvastatin + Ezetimibe /Rafarm should not affect the ability to drive and use machines. However, the patient should be aware that some patients may experience dizziness while taking this medicine. In such cases, the patient should consult their doctor before driving or using machines.
Tablets of Rosuvastatin + Ezetimibe /Rafarm contain lactose monohydrate
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

1. How to take Rosuvastatin + Ezetimibe /Rafarm

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
During treatment with Rosuvastatin + Ezetimibe /Rafarm, the patient should continue to follow a low-cholesterol diet and maintain physical activity.
The recommended daily dose for adults is one tablet of the prescribed strength.
Rosuvastatin + Ezetimibe /Rafarm should be taken once a day.
The medicine can be taken at any time of day, with or without food. The tablets should be swallowed whole, with a glass of water.
If the patient forgets to take a dose of the medicine, they should take it as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.
The patient should not take a double dose to make up for the missed dose.
If the patient has doubts about whether they should stop taking the medicine, they should consult their doctor or pharmacist.
If the patient experiences any undesirable effects, they should stop taking the medicine and consult their doctor.
The patient should inform their doctor or pharmacist if they are taking other medicines, including those available without a prescription.
The patient should inform their doctor or pharmacist if they have any other diseases, especially:

• liver diseases
• kidney diseases
• hypothyroidism (underactive thyroid)
• muscle disorders

The patient should inform their doctor or pharmacist if they are pregnant or breastfeeding.
The patient should inform their doctor or pharmacist if they plan to become pregnant.
The patient should inform their doctor or pharmacist if they are allergic to any component of the medicine.

Stopping treatment with Rosuvastatin + Ezetimibe /Rafarm

The patient should tell their doctor if they want to stop taking Rosuvastatin + Ezetimibe /Rafarm. After stopping treatment with Rosuvastatin + Ezetimibe /Rafarm, cholesterol levels may increase again.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

1. Possible side effects

Like all medicines, Rosuvastatin + Ezetimibe /Rafarm can cause side effects, although not everybody gets them.
It is essential for the patient to know which side effects may be associated with taking this medicine.
The patient should stop taking the medicine and seek immediate medical attentionif they experience any of the following:

• allergic reaction: swelling of the face, lips, tongue, and/or throat, which can make breathing and swallowing difficult
• systemic lupus erythematosus (including rash, joint disorders, and effects on blood cells)
• muscle rupture.

The patient should immediately consult their doctorif they experience any unusual, persistent muscle pain. This condition can rarely progress to life-threatening muscle damage (known as rhabdomyolysis), causing malaise, fever, and kidney function disorders.
To determine the frequency of side effects, the following classification has been used:

• very common (may affect more than 1 in 10 people)
• common (may affect up to 1 in 10 people)
• uncommon (may affect up to 1 in 100 people)
• rare (may affect up to 1 in 1,000 people)
• very rare (may affect less than 1 in 10,000 people), including isolated cases

Common side effects

• headache
• constipation
• nausea
• muscle pain
• weakness
• dizziness
• diabetes - this is more likely in patients with high blood sugar levels, obesity, and high blood pressure. The doctor will monitor blood sugar levels during treatment with this medicine.
• increased creatine kinase activity (a muscle enzyme)
• increased cholesterol levels in the blood
• abdominal pain
• bloating
• diarrhea
• insomnia
• dizziness

Uncommon side effects

• hepatitis
• joint pain
• loss of appetite
• skin rash
• hives
• facial, lip, tongue, and/or throat swelling
• liver function disorders

Rare side effects

• pancreatitis, which can cause severe abdominal pain radiating to the back
• decreased platelet count

Very rare side effects

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

Side effects with unknown frequency

• shortness of breath
• swelling
• sleep disorders, including insomnia and nightmares
• sexual disorders
• depression
• respiratory disorders, including persistent cough and/or shortness of breath or fever
• tendon damage
• persistent muscle weakness
• gallstones or cholecystitis (which can cause abdominal pain, nausea, vomiting)

Reporting side effects

If side effects occur, the patient should report them to their doctor or pharmacist. This includes side effects not listed in the leaflet. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych:
Al. Jerozolimskie 181C, 02-222 Warszawa
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Reporting side effects helps to gather information on the safety of the medicine.
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6. Contents of Rosuvastatin + Ezetimibe Rafarm

The active substances of the medicine are rosuvastatin (in the form of rosuvastatin calcium) and ezetimibe. The tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, or 20 mg of rosuvastatin. Each tablet contains 10 mg of ezetimibe.
Other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, crospovidone type A, povidone K-30, sodium lauryl sulfate, and magnesium stearate
What Rosuvastatin + Ezetimibe Rafarm looks like and what the packaging contains
Rosuvastatin + Ezetimibe Rafarm, 5 mg + 10 mg tablets: white or almost white, round, flat, uncoated tablets with the inscription E2 on one side and 2 on the other. The diameter of the tablet is 10 mm.
Rosuvastatin + Ezetimibe Rafarm, 10 mg + 10 mg tablets: white or almost white, oval, biconvex, uncoated tablets with the inscription E1 on one side and 1 on the other. The tablet measures 15 mm x 7 mm.
Rosuvastatin + Ezetimibe Rafarm, 20 mg + 10 mg tablets: white or almost white, round, biconvex, uncoated tablets. The diameter of the tablet is 11 mm.
Packaging containing 30 tablets in a blister pack of PA/Aluminum/PVC/Aluminum foil. Not all pack sizes are available in every country.

Marketing authorization holder

RAFARM S.A.
12 Korotina str.
14561 Ν. Πεύκη, Αθήνα
Greece

Manufacturer

Zad Parma Pharmaceuticals S.A.
6 Thermopylae Street
12131 Athens, Greece

Date of last revision of the leaflet

2023-10