Rosuvastatin + Ezetimibe Rafarm

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
Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
In case of any doubts, 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 not listed in this leaflet, they should inform 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 medicines 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 reduces the risk of complications of heart disease, such as heart attack and stroke.
Rosuvastatin + Ezetimibe /Rafarm is used in patients with high cholesterol who do not achieve sufficient reduction in cholesterol levels with a statin alone.
In patients with high cholesterol and a high risk of heart disease (confirmed by the presence of cardiovascular disease or other risk factors), Rosuvastatin + Ezetimibe /Rafarm may be used from the start of treatment.

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 ingredient of this medicine.
• If the patient is pregnant or breastfeeding (see "Pregnancy and breastfeeding").
• If the patient has active liver inflammation or liver disease of unknown cause.
• If the patient has abnormal liver function test results of unknown cause.

When to exercise caution when taking Rosuvastatin + Ezetimibe /Rafarm

Before starting treatment with Rosuvastatin + Ezetimibe /Rafarm, the patient should inform their doctor if they:

• have kidney disease
• have liver disease
• have impaired liver function
• consume large amounts of alcohol
• have a history of muscle diseases or unexplained muscle pain
• have thyroid function disorders
• are taking other medicines (see "Rosuvastatin + Ezetimibe /Rafarm with other medicines")

The doctor may order liver function tests before and during treatment with Rosuvastatin + Ezetimibe /Rafarm.
Statins, including rosuvastatin, can cause muscle disorders, including rare cases of muscle disease (myopathy) and rhabdomyolysis (severe muscle damage). If symptoms such as muscle pain, weakness, tenderness, or muscle cramps occur, the patient should contact their doctor immediately. The risk of these symptoms is higher in older adults, people with kidney disease, people with liver disease, people with hypothyroidism, people who abuse alcohol, and people who take other medicines that increase the risk of muscle disorders.
If the patient plans to become pregnant, they should inform their doctor. The medicine should be discontinued if the patient becomes pregnant.

Rosuvastatin + Ezetimibe /Rafarm with other medicines

The patient should inform their doctor or pharmacist if they are taking or have recently taken other medicines, including those available without a prescription.
The following medicines may interact with Rosuvastatin + Ezetimibe /Rafarm:

• cyclosporin (an immunosuppressive medicine)
• warfarin (an anticoagulant medicine)
• fibrates (e.g. gemfibrozil, fenofibrate - medicines that lower cholesterol levels)
• other statins (e.g. simvastatin, atorvastatin - medicines that lower cholesterol levels)
• cholestyramine (a medicine that lowers cholesterol levels)
• antiviral medicines used to treat HIV (ritonavir, lopinavir)

The patient should avoid taking Rosuvastatin + Ezetimibe /Rafarm with colestipol, as colestipol may reduce the absorption of ezetimibe.

3. How to take Rosuvastatin + Ezetimibe /Rafarm

The medicine should be taken as directed by the doctor.
Usually, the initial dose of Rosuvastatin + Ezetimibe /Rafarm is 1 tablet once a day.
The doctor may adjust the dose based on the individual response to treatment and cholesterol levels.
The tablets should be taken once a day at a fixed time, regardless of meals.
The patient should not stop taking the medicine without consulting their doctor.
If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they 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.
In case of doubts, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rosuvastatin + Ezetimibe /Rafarm can cause side effects, although not everybody gets them.
If the patient experiences any side effects, they should inform their doctor or pharmacist.
Common side effects (may affect up to 1 in 10 people):

• headache
• muscle pain
• weakness
• constipation
• nausea
• abdominal pain
• increased blood creatine kinase (a muscle enzyme)

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

• diarrhea
• indigestion
• fatigue
• dizziness
• insomnia
• skin rash
• hives
• itching
• increased liver enzyme activity in the blood

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

• liver inflammation
• joint pain
• numbness or tingling in the limbs
• memory disorders
• drowsiness
• lung disease (including pneumonia)

Very rare side effects (may affect up to 1 in 10,000 people):

• severe allergic reactions (e.g. facial swelling, tongue or throat swelling, difficulty breathing)
• rhabdomyolysis (severe muscle damage)

5. How to store Rosuvastatin + Ezetimibe /Rafarm

Keep out of the reach and sight of 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 are rosuvastatin and ezetimibe.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, and magnesium stearate.

What Rosuvastatin + Ezetimibe /Rafarm looks like and contents of the pack
The tablets are film-coated, oval, and white or almost white.
Packaging: 30 tablets, 60 tablets, 90 tablets.
Marketing Authorisation Holder: Rafarm S.A., ul. Gryfińska 25, 71-403 Szczecin.
Manufacturer: Rafarm S.A., ul. Gryfińska 25, 71-403 Szczecin.
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 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 disease;
• the patient has liver disease;
• the patient has experienced recurring or unexplained muscle pain, or has a history of muscle diseases, or has had previous muscle problems related to taking other cholesterol-lowering medicines. If unexplained muscle pain occurs, especially with a feeling of illness or fever, the patient should immediately consult their doctor. The patient should also inform their doctor or pharmacist about any difficulties in urinating;
• the patient is of East Asian, Chinese, Filipino, Vietnamese, Korean, or Japanese origin, as the risk of myopathy (muscle disease) is increased in patients responding to rosuvastatin treatment.
• the patient regularly consumes large amounts of alcohol;
• the patient has other diseases that may increase the risk of myopathy (e.g. hypothyroidism, kidney disease, alcohol abuse, liver disease, diabetes, age over 65, female sex);
• the patient is taking other medicines (see "Rosuvastatin + Ezetimibe /Rafarm with other medicines").

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

Medicines taken with Rosuvastatin + Ezetimibe /Rafarm

The patient should inform their doctor or pharmacist if they are taking or have recently taken:

• anticoagulant medicines (e.g. warfarin)
• colchicine (a medicine used to treat gout)
• other cholesterol-lowering medicines (e.g. fibrates, niacin)
• immunosuppressive medicines (e.g. cyclosporin)
• macrolide antibiotics (e.g. erythromycin, clarithromycin)
• azole antifungal medicines (e.g. ketoconazole, itraconazole)
• antiviral medicines (e.g. ritonavir, lopinavir)
• the antidepressant nefazodone

The patient should always inform their doctor or pharmacist about all medicines they are taking, including those available without a prescription.

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 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 dizziness may occur.

Dosage

This medicine should always be taken as directed by the doctor. The doctor will determine the appropriate dose.
Usually, the initial dose is 10 mg of rosuvastatin and 10 mg of ezetimibe, taken once a day. The doctor may adjust the dose based on the result of the cholesterol test and the patient's individual response to treatment. The maximum dose of the medicine is 40 mg of rosuvastatin and 10 mg of ezetimibe, taken once a day.
The patient should regularly have their blood cholesterol levels checked, as directed by their doctor.
If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they 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.
In case of doubts, the patient should consult their doctor or pharmacist.

Side effects

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

• headache
• muscle pain
• weakness
• nasal congestion
• upper respiratory tract infection
• increased liver enzyme activity in the blood (detected in laboratory tests)

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

• drowsiness
• dizziness
• numbness or tingling
• liver inflammation
• hives
• joint pain
• muscle weakness
• fatigue

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

• muscle disease (myopathy)
• liver inflammation

Very rare side effects (may affect up to 1 in 10,000 people):

• severe muscle damage (rhabdomyolysis)
• allergic reactions, such as facial swelling, tongue or throat swelling, difficulty breathing or swallowing

Other possible side effects reported during treatment with rosuvastatin and ezetimibe:

• pancreatitis (inflammation of the pancreas)
• liver disorders
• skin inflammation
• feeling of weakness, pain, or illness
• sleep disorders
• loss of appetite
• diarrhea
• nausea
• heartburn
• bloating
• abdominal pain
• skin rash
• itching
• chest pain
• swelling of the lower limbs
• fever
• flu-like symptoms

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist.

Storage

Keep out of the reach and sight of 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.

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 during pregnancy. If the patient becomes pregnant while taking Rosuvastatin + Ezetimibe /Rafarm, they should stop taking the medicine and consult their doctor. During treatment with Rosuvastatin + Ezetimibe /Rafarm, women should use effective contraceptive methods (see "Pregnancy and breastfeeding").

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 dizziness may occur.

Dosage

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient 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 water.
If the patient forgets to take a dose, they should take it the next day at the usual time. The patient should not take a double dose to make up for the missed dose.
If the patient has doubts about whether to stop taking Rosuvastatin + Ezetimibe /Rafarm, they should consult their doctor or pharmacist.
How long to take Rosuvastatin + Ezetimibe /Rafarm
Rosuvastatin + Ezetimibe /Rafarm should be taken for as long as the doctor recommends. The patient should not stop taking the medicine without consulting their doctor, even if they feel well.
Regular blood tests are necessary to monitor the effectiveness of treatment and potential side effects.
If the patient has any questions about taking this medicine, they should consult their doctor or pharmacist.
What Rosuvastatin + Ezetimibe /Rafarm contains
The active substances are rosuvastatin and ezetimibe.
One tablet contains 10 mg of rosuvastatin and 10 mg of ezetimibe.
One tablet contains 20 mg of rosuvastatin and 10 mg of ezetimibe.
One tablet contains 40 mg of rosuvastatin and 10 mg of ezetimibe.
The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, and magnesium stearate.
What Rosuvastatin + Ezetimibe /Rafarm looks like and contents of the pack
The tablets are film-coated. The packaging contains 14, 28, 30, 56, 60, 84, 90, or 180 tablets.

Stopping Rosuvastatin + Ezetimibe /Rafarm

The patient should inform their doctor if they want to stop taking Rosuvastatin + Ezetimibe /Rafarm. After stopping Rosuvastatin + Ezetimibe /Rafarm, cholesterol levels may increase again.
In case of any further doubts about taking this medicine, the patient 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 immediate medical attentionif they experience any of the following:

• allergic reaction: facial swelling, lip, tongue, or throat swelling, which may cause difficulty breathing or swallowing
• systemic lupus erythematosus-like syndrome (including rash, joint disorders, and effects on blood cells)
• muscle rupture.

The patient should seek immediate medical attentionif they experience any unusual, persistent muscle pain. This condition can progress to a life-threatening muscle injury (rhabdomyolysis), causing illness, fever, and kidney damage.
To determine the frequency of side effects, the following classification is 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 up to 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, 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

Uncommon side effects

• insomnia
• dizziness
• numbness or tingling
• liver inflammation
• hives
• joint pain
• muscle weakness
• fatigue

Rare side effects

• pancreatitis (inflammation of the pancreas) causing severe abdominal pain that may radiate to the back
• decreased platelet count

Very rare side effects

• jaundice (yellowing of the skin and eyes)
• liver inflammation
• 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
• breathing 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 the patient experiences any side effects, including those not listed in the leaflet, they should inform 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, 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, e-mail: [email protected]
Reporting side effects helps to gather information on the safety of the medicine.

Cough

• indigestion
• heartburn
• joint pain
• muscle cramps
• neck pain
• pain
• hot flashes
• dry mouth
• gastritis
• back pain
• muscle weakness
• pain in the arms and legs
• swelling, especially of the hands and feet

Rare side effects

• pancreatitis (inflammation of the pancreas) causing severe abdominal pain that may radiate to the back
• decreased platelet count

Very rare side effects

• jaundice (yellowing of the skin and eyes)
• liver inflammation
• 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
• breathing 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 the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

6. What Rosuvastatin + Ezetimibe Rafarm contains

The active substances are rosuvastatin (as 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.
The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, crospovidone, povidone K-30, sodium lauryl sulfate, and magnesium stearate.
What Rosuvastatin + Ezetimibe Rafarm looks like and contents of the pack
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 of PA/Aluminum/PVC/Aluminum foil. Not all pack sizes are available in every country.

Marketing Authorisation 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