Rosuvastatin/ezetimibe Teva

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

Rosuvastatin/Ezetimibe Teva 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 Teva is a medicine used to lower the level of cholesterol in the blood, so-called "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides, and also to increase the level of "good" cholesterol (HDL cholesterol).
The medicine works 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 does not affect their well-being, as it does not cause any symptoms. However, if left untreated, it can cause fatty deposits to build up in the walls of blood vessels, leading to their narrowing. As a result of the narrowing, it is possible for the blood vessel to become blocked, cutting off blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other similar health problems can be reduced.
Rosuvastatin/Ezetimibe Teva is used in patients for whom diet alone is not enough to maintain a healthy cholesterol level. While taking this medicine, you should continue to follow a low-cholesterol diet and maintain physical activity.
Your doctor may prescribe Rosuvastatin/Ezetimibe Teva if you are already taking rosuvastatin and ezetimibe in the same doses as in the combination medicine.
The medicine is used in patients:

• with high cholesterol levels in the blood (primary hypercholesterolemia)
• with heart disease - Rosuvastatin/Ezetimibe Teva reduces the risk of heart attack, stroke, the need for surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain. PL/H/0500/001-003/IB/009

Internal Use Only
Rosuvastatin/Ezetimibe Teva does not help reduce body weight.

2. Important information before taking Rosuvastatin/Ezetimibe Teva

When not to take Rosuvastatin/Ezetimibe Teva

• if the patient is allergic to rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has liver disease
• if the patient has severe kidney problems
• if the patient experiences recurring, unexplained muscle pain (myopathy)
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, or ulcers in the mouth after taking Rosuvastatin/Ezetimibe Teva or other similar medicines
• if the patient is taking a medicine containing cyclosporin (used, for example, after organ transplantation to prevent rejection of the transplanted organ)
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Rosuvastatin/Ezetimibe Teva, they should stop taking the medicine immediately and inform their doctor. While taking Rosuvastatin/Ezetimibe Teva, the patient should avoid becoming pregnant, using effective methods of contraception (see subsection "Pregnancy and breastfeeding").

If any of the above situations apply to the patient (or if the patient is in doubt), they should consult a doctor.

Warnings and precautions

Before taking Rosuvastatin/Ezetimibe Teva, the patient should discuss it with their doctor or pharmacist if they:
have kidney problems;
have liver problems;
have experienced recurring or unexplained muscle pain, or have had muscle problems in the past or have a family history of muscle problems, or have had previous muscle problems related to taking other cholesterol-lowering medicines. If the patient experiences unexplained muscle pain, especially if accompanied by a feeling of illness or fever, they should contact their doctor immediately. The patient should also inform their doctor or pharmacist about persistent muscle weakness;
have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenia gravis (a disease that causes muscle weakness, including eye muscles), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
are of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine the appropriate dose of Rosuvastatin/Ezetimibe Teva for the patient;
are taking antiviral medicines, including those used to treat HIV or hepatitis C, such as ritonavir with lopinavir and/or atazanavir or simeprevir (see "Rosuvastatin/Ezetimibe Teva and other medicines");
have severe respiratory failure;
are taking other cholesterol-lowering medicines (so-called fibrates) (see "Rosuvastatin/Ezetimibe Teva and other medicines");
regularly consume large amounts of alcohol;
have been diagnosed with abnormal thyroid function (hypothyroidism);
are over 70 years old (as the doctor will need to choose an appropriate dose of Rosuvastatin/Ezetimibe Teva for the patient);
are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). Taking fusidic acid and Rosuvastatin/Ezetimibe Teva at the same time may lead to serious muscle problems (rhabdomyolysis).
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If any of the above situations apply to the patient (or if the patient is in doubt), they should consult their doctor or pharmacist again before starting to take Rosuvastatin/Ezetimibe Teva.
When to exercise special caution when taking Rosuvastatin/Ezetimibe Teva
There have been reports of severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), in patients taking Rosuvastatin/Ezetimibe Teva. If the patient experiences any of the symptoms described in section 4, they should stop taking Rosuvastatin/Ezetimibe Teva and contact their doctor immediately.
A small number of people taking statins may experience liver problems. This can be detected by a simple blood test that checks for increased liver enzyme activity. Therefore, the doctor will recommend regular blood tests while taking Rosuvastatin/Ezetimibe Teva. It is essential for the patient to attend these tests as scheduled.
While taking this medicine, the doctor will closely monitor the condition of patients with diabetes or at risk of developing diabetes. There is a high risk of developing diabetes if the patient has high levels of sugar and fat in the blood, is overweight, and has high blood pressure.
If the patient is hospitalized or treated for another condition, they should inform the medical staff that they are taking Rosuvastatin/Ezetimibe Teva.

Children and adolescents

Rosuvastatin/Ezetimibe Teva should not be used in children and adolescents under 18 years of age.

Rosuvastatin/Ezetimibe Teva 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 inform their doctor about taking any of the following medicines:

• cyclosporin (a medicine used, for example, after organ transplantation to prevent rejection of the transplanted organ. Cyclosporin increases the effect of rosuvastatin). While taking cyclosporin, the patient should not take Rosuvastatin/Ezetimibe Teva.
• anticoagulant medicines, such as warfarin, acenocoumarol, or fluindione (taking Rosuvastatin/Ezetimibe Teva at the same time may increase the anticoagulant effect, increasing the 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 class). When taken together, the effect of rosuvastatin is increased.
• colestyramine (a medicine used to lower cholesterol levels), as it affects the way ezetimibe works.
• regorafenib (a medicine used to treat cancer)
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• medicines used to treat indigestion, containing aluminum and magnesium (used to neutralize stomach acid). These medicines may reduce the level of rosuvastatin in the blood. This effect can be reduced by taking these medicines 2 hours after taking rosuvastatin.

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• erythromycin (an antibiotic). When taken together, the effect of rosuvastatin is reduced.
• fusidic acid. If the patient needs to take fusidic acid orally to treat a bacterial infection, they will need to stop taking Rosuvastatin/Ezetimibe Teva temporarily. The doctor will inform the patient when it is safe to restart taking the medicine. Taking Rosuvastatin/Ezetimibe Teva and fusidic acid at the same time may rarely cause muscle weakness, muscle tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
• tikagrelor (a medicine that prevents blood clots from forming and blocking blood vessels)
• oral contraceptives (birth control pills). When taken together, the level of sex hormones released by the pill may increase.
• hormone replacement therapy (which increases hormone levels in the blood).

If the patient is to be hospitalized or treated for another condition, they should inform the medical staff that they are taking Rosuvastatin/Ezetimibe Teva.

Pregnancy and breastfeeding

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

Pregnancy

Rosuvastatin/Ezetimibe Teva should not be takenif the patient is pregnant, trying to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Rosuvastatin/Ezetimibe Teva, they should stop taking the medicine immediatelyand inform their doctor. While taking Rosuvastatin/Ezetimibe Teva, female patients should use effective methods of contraception (see subsection "Pregnancy and breastfeeding").

Breastfeeding

Rosuvastatin/Ezetimibe Teva should not be takenduring breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Rosuvastatin/Ezetimibe Teva is unlikely to affect the patient's ability to drive or use machines. However, the patient should be aware that Rosuvastatin/Ezetimibe Teva may cause dizziness. If this happens, the patient should contact their doctor before driving or using machines.

Rosuvastatin/Ezetimibe Teva contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking this medicine.

Rosuvastatin/Ezetimibe Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that it is essentially "sodium-free".

3. How to take Rosuvastatin/Ezetimibe Teva

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is in doubt, they should consult their doctor or pharmacist.
While taking Rosuvastatin/Ezetimibe Teva, 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 Teva 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.
The patient should take the medicine at the same time every day.
Rosuvastatin/Ezetimibe Teva is not suitable for starting treatment. If treatment is started or the dose needs to be changed, the patient should take each active substance separately and only switch to Rosuvastatin/Ezetimibe Teva tablets of the prescribed strength after the doses have been established.

Regular cholesterol level checks

It is essential for the patient to attend regular check-ups with their doctor to ensure that they have achieved and maintained a healthy cholesterol level.

Taking a higher dose of Rosuvastatin/Ezetimibe Teva than recommended

In case of overdose, the patient should contact their doctor or the emergency department of the nearest hospital, as medical attention may be necessary.

Missing a dose of Rosuvastatin/Ezetimibe Teva

If the patient misses a dose, they should take the next tablet at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Rosuvastatin/Ezetimibe Teva

The patient should inform their doctor if they want to stop taking Rosuvastatin/Ezetimibe Teva. After stopping Rosuvastatin/Ezetimibe Teva, the patient's cholesterol level may increase again.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rosuvastatin/Ezetimibe Teva can cause side effects, although not everybody gets them.
It is essential for the patient to know what side effects may be associated with taking Rosuvastatin/Ezetimibe Teva.
If the patient experiences any of the following allergic reactions, they should stop taking Rosuvastatin/Ezetimibe Teva and seek medical attention immediately:

• swelling of the face, lips, tongue, and/or throat, which may make breathing and swallowing difficult
• ulcers or blisters on the skin, mouth, eyes, and genitals. These may be symptoms of Stevens-Johnson syndrome (a life-threatening allergic reaction affecting the skin and mucous membranes).

The patient should also stop taking Rosuvastatin/Ezetimibe Teva and contact their doctor immediately:

• if they experience any unusual, persistent muscle pain. This condition can rarely progress to a life-threatening muscle injury (known as rhabdomyolysis), causing illness, fever, and kidney problems
• if they experience a lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
• if they experience muscle rupture.

The patient should stop taking Rosuvastatin/Ezetimibe Teva and seek medical attention immediately if they experience any of the following symptoms:

• 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). PL/H/0500/001-003/IB/009

Internal Use Only

• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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 up to 1 in 10,000 people), including isolated cases.

Common side effects

headache
constipation
nausea
muscle pain
feeling of weakness
dizziness
diabetes - this is more likely in patients with high levels of sugar and fat in the blood, who are overweight, and have high blood pressure. The doctor will monitor the patient's condition while taking this medicine.
stomach pain
diarrhea
bloating (excess gas in the intestines)
feeling of fatigue
increased results of some blood tests that assess liver function (aminotransferase activity)

Uncommon side effects

rash, itching, hives
increased protein in the urine, which usually resolves on its own without the need to stop taking Rosuvastatin/Ezetimibe Teva tablets
increased results of some tests that assess muscle condition (creatine kinase activity, CK)
cough
indigestion
heartburn
joint pain
muscle spasms
neck pain
decreased appetite
pain
chest pain
hot flashes
high blood pressure
tingling
dry mouth
stomach inflammation
back pain
muscle weakness
pain in the arms and legs
swelling, especially in the hands and feet

Rare side effects

pancreatitis causing severe stomach pain, which may radiate to the back
decreased platelet count, lupus-like syndrome, muscle rupture.

Very rare side effects

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jaundice (yellowing of the skin and eyes)
liver inflammation
trace amounts of blood in the urine
nerve damage in the hands and feet (e.g., numbness)
memory loss
breast enlargement in men (gynecomastia)

Side effects with unknown frequency may include

shortness of breath
swelling
sleep disorders, including insomnia and nightmares
sexual disorders
depression
breathing difficulties, including persistent cough and/or shortness of breath or fever
tendon damage
persistent muscle weakness
gallstones or gallbladder inflammation (which may cause stomach pain, nausea, vomiting)
myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing), myasthenia gravis (a disease that causes muscle weakness, including 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 any side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Rosuvastatin/Ezetimibe Teva

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

6. Contents of the packaging and other information

What Rosuvastatin/Ezetimibe Teva contains

The active substances of the medicine are rosuvastatin (in the form of rosuvastatin calcium) and ezetimibe.
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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 type A, povidone K-30, sodium lauryl sulfate, and magnesium stearate.
Rosuvastatin/Ezetimibe Teva contains lactose and sodium - for more information, see section 2.

What Rosuvastatin/Ezetimibe Teva looks like and contents of the pack

Rosuvastatin/Ezetimibe Teva, 5 mg + 10 mg: white to almost white, round, flat, uncoated tablets, with the symbol "E2" embossed on one side and the number "2" on the other side. The tablet diameter is 10 mm.
Rosuvastatin/Ezetimibe Teva, 10 mg + 10 mg: white to almost white, oval, biconvex, uncoated tablets, with the symbol "E1" embossed on one side and the number "1" on the other side. The tablet dimensions are 15 mm x 7 mm.
Rosuvastatin/Ezetimibe Teva, 20 mg + 10 mg: white to almost white, round, biconvex, uncoated tablets. The tablet diameter is 11 mm.
Packaging containing 10, 28, 30, 84, 90, 98, or 100 tablets in a blister pack (PA/Aluminum/PVC//Aluminum), in a cardboard box with a patient information leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Manufacturer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland
Date of last revision of the leaflet:April 2023
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