ROSUVASTATIN 10 mg + 10 Mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Table of contents of the leaflet:
2. What is Rosuvastatin + Ezetimibe /Rafarm and what is it used for
3. Important information before taking Rosuvastatin + Ezetimibe /Rafarm
4. How to take Rosuvastatin + Ezetimibe /Rafarm
5. Possible side effects
6. How to store Rosuvastatin + Ezetimibe /Rafarm
7. Contents of the packaging and other information
8. Important information before taking Rosuvastatin + Ezetimibe /Rafarm
   1. Warnings and precautions
   2. Medicines taken at the same time as Rosuvastatin + Ezetimibe /Rafarm
   3. Pregnancy and breastfeeding
   4. Driving and operating machines
   5. Tests 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 important for the patient to undergo these tests as directed by the doctor.
   6. Stopping treatment with Rosuvastatin + Ezetimibe /Rafarm
   7. Reporting side effects
9. Contents of Rosuvastatin + Ezetimibe Rafarm
   1. Responsible entity
   2. Manufacturer
   3. Date of last update of the leaflet

Leaflet attached to 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.
• 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.
• 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 lower 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 lowers cholesterol levels in patients with coronary heart disease (a disease caused by narrowing of the coronary arteries).
The medicine is used in patients with high risk of coronary heart disease, in whom the LDL cholesterol level in the blood is high enough, despite a cholesterol-lowering diet.

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 inflammation or liver disease of unknown origin.
• If the patient has ulcers or bleeding from the digestive tract.
• If the patient is taking HIV medications (protease inhibitors).

Rosuvastatin + Ezetimibe /Rafarm should be used with caution:

• Before starting treatment with Rosuvastatin + Ezetimibe /Rafarm, the patient should tell their doctor if they have any liver or kidney problems.
• If the patient abuses alcohol.
• If the patient has diabetes or is at risk of developing it.
• If the patient has thyroid function disorders.
• If the patient is of Asian origin.

Rosuvastatin + Ezetimibe /Rafarm and other medicines:
The patient should inform their doctor or pharmacist if they are taking or have recently taken any other medicines, including those available without a prescription.
It is especially important to inform the doctor about taking the following medicines:

• Cyclosporine (a medicine used after transplants).
• Warfarin (an anticoagulant medicine).
• Fibrates (medicines that lower cholesterol levels).
• Other cholesterol-lowering medicines (e.g. niacin).
• Cholestyramine and colestipol (medicines that lower cholesterol levels).
• Antacids (medicines that neutralize stomach acid) containing aluminum or magnesium.

3. How to take Rosuvastatin + Ezetimibe /Rafarm

Rosuvastatin + Ezetimibe /Rafarm should be taken as directed by the doctor.
Usually, the initial dose 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 check their cholesterol levels in the blood, as directed by the doctor.

4. Possible side effects

Like all medicines, Rosuvastatin + Ezetimibe /Rafarm can cause side effects, although not everybody gets them.
Common side effects (may occur in up to 1 in 10 people):

• Headache
• Muscle pain
• Constipation
• Nausea
• Abdominal pain
• Weakness
• Increased creatine kinase activity in the blood (a muscle enzyme).

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

• Diarrhea
• Rash
• Itching
• Joint pain
• Increased liver enzyme activity in the blood.

Rare side effects (may occur in up to 1 in 1000 people):

• Liver inflammation
• Muscle pain, weakness, pain or tenderness in the muscles (rhabdomyolysis).

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

The packaging contains 30 tablets.
Responsible entity:
Rafarm S.A.
Żniwna 4
02-663 Warsaw
Date of last update of the leaflet: 01.05.2010

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 of the other components 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 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 consult a doctor. During treatment with Rosuvastatin + Ezetimibe /Rafarm, the patient should avoid becoming pregnant, using effective contraceptive methods (see "Pregnancy and breastfeeding").

If any of the above situations apply to the patient (or the patient has doubts), they should consult a 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 had muscle problems related to taking other cholesterol-lowering medicines. If unexplained muscle pain occurs, especially if accompanied by malaise or fever, the patient should immediately consult a doctor. The patient should also tell their doctor or pharmacist about persistent muscle weakness;
• the patient is of Asian origin, as patients of Asian origin who respond to rosuvastatin treatment are at increased risk of myopathy (see "Side effects");
• the patient abuses alcohol;
• the patient has other conditions that may increase the risk of myopathy (e.g. hypothyroidism, kidney disease);
• the patient is taking other cholesterol-lowering medicines (e.g. fibrates, niacin).

Rosuvastatin + Ezetimibe /Rafarm is not recommended for use in children and adolescents under the age of 18.

Medicines taken at the same time as Rosuvastatin + Ezetimibe /Rafarm

The patient should inform their doctor or pharmacist if they are taking, have recently taken, or plan to take medicines such as:

• warfarin (an anticoagulant medicine) - taking it at the same time as rosuvastatin may increase the risk of bleeding.
• colchicine (a medicine used to treat gout) - taking it at the same time as rosuvastatin may increase the risk of myopathy.
• fibrates (e.g. gemfibrozil, fenofibrate) and niacin - taking them at the same time as rosuvastatin may increase the risk of myopathy.
• cyclosporine (an immunosuppressive medicine) - taking it at the same time as ezetimibe may increase the level of cyclosporine in the blood.
• bile acid sequestrants (e.g. cholestyramine, colestipol) - they may reduce the absorption of ezetimibe. The patient should take ezetimibe at least 2 hours before or 4 hours after taking bile acid sequestrants.

Rosuvastatin + Ezetimibe /Rafarm with food and drink
Rosuvastatin + Ezetimibe /Rafarm can be taken with or without food.
The patient should avoid consuming large amounts of grapefruit juice while taking Rosuvastatin + Ezetimibe /Rafarm, as it may increase the level of rosuvastatin in the blood.

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 a doctor.

Driving and operating machines

Rosuvastatin + Ezetimibe /Rafarm usually does not affect the ability to drive and operate machines. However, some patients may experience dizziness. The patient should check how the medicine affects them before driving or operating machines.

Tests 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 important for the patient to undergo these tests as directed by the doctor.

During treatment with this medicine, the doctor will carefully monitor the condition of patients with diabetes or at risk of developing it. There is a high probability of developing diabetes if the patient has high blood sugar and fat levels, 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 the age of 18.
Rosuvastatin + Ezetimibe /Rafarm and other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking, as well as any medicines they plan to take.
The patient should tell their doctor or pharmacist about taking any of the following medicines: cyclosporine (a medicine used, for example, after organ transplantation). Cyclosporine increases the effect of rosuvastatin. 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, such as fibrates, which also regulate triglyceride levels in the blood (e.g. gemfibrozil and other medicines in this group). Taking them at the same time as rosuvastatin increases its effect. cholestyramine (a medicine used to lower cholesterol levels), as it affects the absorption of medicines.

Stopping treatment with Rosuvastatin + Ezetimibe /Rafarm

The patient should tell their doctor if they want to stop taking Rosuvastatin + Ezetimibe /Rafarm. After stopping 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 important for the patient to know what side effects may be associated with taking the medicine.
The patient should stop taking Rosuvastatin + Ezetimibe /Rafarm and seek medical attention immediatelyif they experience any of the following:

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

The patient should seek medical attention immediatelyif 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 was used:

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

Common side effects

• headache
• constipation
• nausea
• muscle pain
• weakness
• dizziness
• diabetes - it is more likely in patients with high blood sugar levels, obesity, and high blood pressure. The doctor will monitor blood sugar levels while taking this medicine.
• increased creatine kinase activity
• heartburn
• bloating
• diarrhea
• abdominal pain
• vomiting
• insomnia
• dizziness

Uncommon side effects

• loss of appetite
• joint pain
• memory loss
• numbness or tingling in the fingers and toes
• taste disorders
• ringing in the ears
• liver inflammation
• hives
• hair loss

Rare side effects

• pancreatitis
• liver inflammation

Very rare side effects

• jaundice
• liver inflammation

Side effects with unknown frequency

• shortness of breath
• edema
• 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 may cause abdominal pain, nausea, vomiting)

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Reporting side effects helps to gather information on the safety of the medicine.

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 in an amount equivalent to 5 mg, 10 mg, or 20 mg of rosuvastatin. Each tablet contains 10 mg of ezetimibe.
The 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 tablet, with the inscription E2 on one side and 2 on the other. The tablet diameter is 10 mm.
Rosuvastatin + Ezetimibe Rafarm, 10 mg + 10 mg tablets: white or almost white, oval, biconvex, uncoated tablet, with the inscription E1 on one side and 1 on the other. The tablet dimensions are 15 mm x 7 mm.
Rosuvastatin + Ezetimibe Rafarm, 20 mg + 10 mg tablets: white or almost white, round, biconvex, uncoated tablet. The tablet diameter is 11 mm.
Packaging containing 30 tablets in a blister pack with PA/Aluminum/PVC/Aluminum foil. Not all pack sizes are available in every country.

Responsible entity

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 update of the leaflet

2023-10