Rosuvastatin/ezetimibe teva

Internal Use Only

Package leaflet: Information for the patient

Rosuvastatin/Ezetimibe Teva, 5 mg + 10 mg, tablets
Rosuvastatin/Ezetimibe Teva, 10 mg + 10 mg, tablets
Rosuvastatin/Ezetimibe Teva, 20 mg + 10 mg, tablets
rosuvastatinum/ezetimibum
Please read this leaflet carefully before using this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Rosuvastatin/Ezetimibe Teva is and what it is used for
2. Important information before taking Rosuvastatin/Ezetimibe Teva
3. How to take Rosuvastatin/Ezetimibe Teva
4. Possible side effects
5. How to store Rosuvastatin/Ezetimibe Teva
6. Contents of the pack and other information

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

Rosuvastatin/Ezetimibe Teva contains two different active substances in one tablet. One of the active substances is rosuvastatin, belonging to a group of medicines called statins, and the other active substance is ezetimibe.
Rosuvastatin/Ezetimibe Teva is a medicine used to lower blood levels of total cholesterol, so-called "bad" cholesterol (LDL cholesterol), and fatty substances called "triglycerides," while also increasing levels of so-called "good" cholesterol (HDL cholesterol).
This medicine reduces cholesterol levels by acting in two ways: by decreasing the amount of cholesterol absorbed in the gastrointestinal tract and by reducing the amount of cholesterol produced in the body.
In most people, high cholesterol levels do not affect well-being, as they cause no symptoms. However, if left untreated, fatty deposits may accumulate in the walls of blood vessels, causing them to narrow. This narrowing may lead to complete blockage of a blood vessel, cutting off blood supply to the heart or brain, resulting in a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other related health problems can be reduced.
Rosuvastatin/Ezetimibe Teva is used in patients in whom diet alone is not sufficient to maintain normal cholesterol levels. While taking this medicine, you must continue to follow a cholesterol-lowering diet.
Your doctor may prescribe Rosuvastatin/Ezetimibe Teva if you are already taking rosuvastatin and ezetimibe separately at the same doses as contained in this combination medicine.
This medicine is used in patients:

• with elevated blood cholesterol levels (primary hypercholesterolemia)
• with heart disease – Rosuvastatin/Ezetimibe Teva reduces the risk of heart attack, stroke, need for a surgical procedure 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 in reducing body weight.

2. Important information before using Rosuvastatin/Ezetimibe Teva

When not to use 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 function impairment
• if the patient experiences recurrent, unexplained muscle pain (myopathy)
• if the patient has ever had severe skin rash, skin peeling, blisters, and/or oral ulcers after taking Rosuvastatin/Ezetimibe Teva or similar medicines
• if the patient is taking a medicine containing cyclosporine (e.g. used after organ transplantation)
• if the patient is pregnant or breastfeeding. If pregnancy occurs during treatment with Rosuvastatin/Ezetimibe Teva, the patient must stop taking the medicine immediately and inform her doctor. Effective contraception must be used during treatment with Rosuvastatin/Ezetimibe Teva to avoid pregnancy (see section "Pregnancy and breastfeeding").

If any of the above situations apply to the patient (or if the patient has any doubts),
the patient should consult a doctor.
Warnings and precautions
Before using Rosuvastatin/Ezetimibe Teva, discuss with your doctor or pharmacist if
the patient has kidney function impairment;
the patient has liver function impairment;
the patient has experienced recurrent or unexplained muscle pain, or if there was a history of muscle disorders in the patient or family members, or previous muscle problems related to taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially if associated with malaise or fever, the patient should contact a doctor immediately. The patient should also inform the doctor or pharmacist about persistent muscle weakness;
the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4);
the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine the appropriate dose of Rosuvastatin/Ezetimibe Teva for the patient;
the patient is taking antiviral medicines, including those used to treat HIV infection or hepatitis C virus, such as ritonavir with lopinavir and/or atazanavir or simeprevir (see section "Rosuvastatin/Ezetimibe Teva and other medicines");
the patient has severe respiratory insufficiency;
the patient is taking other medicines (so-called fibrates) to reduce cholesterol levels (see section "Rosuvastatin/Ezetimibe Teva and other medicines");
the patient regularly consumes large amounts of alcohol;
the patient has been diagnosed with thyroid dysfunction (hypothyroidism);
the patient is over 70 years of age (as the doctor will need to select an appropriate dose of Rosuvastatin/Ezetimibe Teva);
the patient is receiving or has received within the last 7 days oral or injectable fusidic acid (used to treat bacterial infections). Concomitant use of fusidic acid and Rosuvastatin/Ezetimibe Teva may lead to serious muscle disorders (rhabdomyolysis).
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If any of the above situations apply to the patient (or if there is any doubt whether such a situation exists), the patient should consult again with a doctor or pharmacist before starting treatment with Rosuvastatin/Ezetimibe Teva.
When to exercise special caution during treatment with Rosuvastatin/Ezetimibe Teva
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Rosuvastatin/Ezetimibe Teva. If any of the symptoms described in section 4 occur, treatment with Rosuvastatin/Ezetimibe Teva must be discontinued and the patient should contact a doctor immediately.
In a small number of people, statins may affect liver function. This is detected by a simple blood test measuring increased liver enzyme activity. Therefore, the doctor will recommend regular monitoring of these parameters during treatment with Rosuvastatin/Ezetimibe Teva. It is important that the patient attends scheduled medical appointments for these tests.
During treatment with this medicine, the doctor will closely monitor patients with diabetes or risk factors for developing diabetes. There is a high probability of developing diabetes if the patient has high blood sugar and lipid levels, overweight, and high blood pressure.
If the patient is admitted to hospital or is being treated for another condition, he or she should inform the medical staff about taking Rosuvastatin/Ezetimibe Teva.
Children and adolescents
Rosuvastatin/Ezetimibe Teva is not recommended for use in children and adolescents under 18 years of age.
Rosuvastatin/Ezetimibe Teva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:

• cyclosporine (a medicine used, for example, after organ transplantation to prevent transplant rejection. Cyclosporine increases the effect of concomitantly administered rosuvastatin). Rosuvastatin/Ezetimibe Teva must not be taken during treatment with cyclosporine.
• anticoagulants, e.g. warfarin, acenocoumarol, or fluindione (concomitant use with Rosuvastatin/Ezetimibe Teva may enhance anticoagulant effect, increasing the risk of bleeding) or clopidogrel.
• other cholesterol-lowering medicines, so-called fibrates, which also regulate blood triglyceride levels (e.g. gemfibrozil and other medicines in this class). Concomitant use increases the effect of rosuvastatin.
• colestyramine (a medicine used to reduce cholesterol levels), as it affects the way ezetimibe works.
• regorafenib (a medicine used to treat cancer)
• any of the following antiviral medicines used to treat viral infections, including HIV or hepatitis C virus infection, used 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 aluminium and magnesium (used to neutralize gastric hydrochloric acid). These medicines may reduce rosuvastatin plasma concentration. This interaction can be minimized by taking these medicines 2 hours after rosuvastatin.

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• erythromycin (an antibiotic). Concomitant use reduces the effect of rosuvastatin.
• fusidic acid. If the patient needs to take oral fusidic acid to treat a bacterial infection, temporary discontinuation of Rosuvastatin/Ezetimibe Teva will be necessary. The doctor will advise when it is safe to resume treatment. Concomitant use of Rosuvastatin/Ezetimibe Teva and fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis is provided in section 4.
• ticagrelor (a medicine preventing platelet aggregation and arterial blockage)
• oral contraceptives (birth control pill). Concomitant use increases the concentration of sex hormones released from the pill.
• medicines used in hormone replacement therapy (increased hormone levels in blood).

If the patient is to be admitted to hospital or is being treated for another illness, he or she should inform the medical staff about taking Rosuvastatin/Ezetimibe Teva.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Rosuvastatin/Ezetimibe Teva must not be used if the patient is pregnant, trying to become pregnant, or suspects she may be pregnant. If pregnancy occurs during treatment with Rosuvastatin/Ezetimibe Teva, the patient must stop taking the medicine immediately and inform her doctor. Female patients should use effective contraception methods during treatment with Rosuvastatin/Ezetimibe Teva.
Breastfeeding
Rosuvastatin/Ezetimibe Teva must not be used during breastfeeding, as it is unknown whether the medicine passes into breast milk.
Driving and operating machinery
Rosuvastatin/Ezetimibe Teva is not expected to affect the ability to drive or operate machinery. However, it should be noted that Rosuvastatin/Ezetimibe Teva may cause dizziness in some patients. In such a case, the patient should consult a doctor before driving or operating machinery.
Rosuvastatin/Ezetimibe Teva contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
Rosuvastatin/Ezetimibe Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning that the medicine is considered "sodium-free".

3. How to use Rosuvastatin/Ezetimibe Teva

This medicine should always be taken as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
While taking Rosuvastatin/Ezetimibe Teva, patients should continue a cholesterol-lowering diet and maintain physical activity.
The recommended daily dose for adults is one tablet of a given strength.
Rosuvastatin/Ezetimibe Teva should be taken once daily.
The medicine may be taken at any time of day, with or without food. Tablets should be swallowed whole with water.
The medicine should be taken at the same time each day.
Rosuvastatin/Ezetimibe Teva is not intended for initiating treatment. If starting therapy or if a dose adjustment is required, each active substance should be administered separately in individual medicinal products. Only after determining the appropriate doses should treatment be switched to Rosuvastatin/Ezetimibe Teva tablets of a specified strength.
Regular monitoring of cholesterol levels
It is important to visit the doctor regularly to monitor cholesterol levels, to ensure that target values have been achieved and are being maintained.
Taking more Rosuvastatin/Ezetimibe Teva than prescribed
In case of overdose, contact a doctor or go to the emergency department of the nearest hospital immediately, as medical intervention may be necessary.
Missing a dose of Rosuvastatin/Ezetimibe Teva
If a dose is missed, take the next tablet at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Rosuvastatin/Ezetimibe Teva
Inform the doctor if the patient wishes to discontinue treatment with Rosuvastatin/Ezetimibe Teva. After stopping Rosuvastatin/Ezetimibe Teva, cholesterol levels may rise again.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
It is important for the patient to be aware of the adverse reactions that may be associated with the use of this medicine.
If any of the following allergic reactions occur, the patient must STOP taking
Rosuvastatin/Ezetimibe Teva and seek immediate medical help:

• swelling of the face, lips, tongue and (or) throat, which may cause difficulty in breathing or swallowing
• ulcers or blisters on the skin, mouth, eyes and genital organs. 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 immediately contact a doctor if:

• the patient experiences any unusual, persistent muscle pain. This condition may rarely progress to life-threatening muscle damage (known as rhabdomyolysis), causing malaise, fever and kidney dysfunction
• the patient develops a lupus-like syndrome (including rash, joint disorders and effects on blood cells)
• muscle rupture occurs.

The patient must stop taking Rosuvastatin/Ezetimibe Teva and immediately seek medical help if any of the following symptoms occur:

• red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, skin peeling, oral, throat, nasal, genital or ocular ulcers. These severe skin rashes 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 fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

To describe the frequency of adverse reactions, 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 adverse reactions
headache
constipation
nausea
muscle pain
feeling of weakness
dizziness
diabetes – more likely in patients with high levels of sugar and fats in the blood, overweight and high blood pressure. The doctor will monitor the patient’s condition during treatment with this medicine.
stomach pain
diarrhea
flatulence (excess gas in the intestines)
feeling of fatigue
increased results of certain blood tests assessing liver function (aminotransferase activity)

Uncommon adverse reactions
rash, itching, urticaria
increased protein in the urine, which usually resolves spontaneously without the need to discontinue Rosuvastatin/Ezetimibe Teva tablets
increased results of certain tests assessing muscle status (creatine kinase, CK activity)
cough
indigestion
heartburn
joint pain
muscle cramps
neck pain
decreased appetite
pain
chest pain
hot flushes
high blood pressure
tingling
dry mouth
gastritis (inflammation of the stomach mucosa)
back pain
muscle weakness
pain in arms and legs
swelling, especially in hands and feet

Rare adverse reactions
pancreatitis causing severe abdominal pain, which may radiate to the back
decreased platelet count, lupus-like syndrome, muscle rupture

Very rare adverse reactions
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jaundice (yellowing of the skin and eyes)
hepatitis (liver inflammation)
trace amounts of blood in the urine
nerve damage in arms and legs (e.g. numbness)
memory loss
breast enlargement in men (gynecomastia)

Adverse reactions with unknown frequency may include:
shortness of breath
swelling
sleep disorders, including insomnia and nightmares
sexual dysfunction
depression
breathing disorders, including persistent cough and (or) shortness of breath or fever
tendon injury
persistent muscle weakness
gallstones or cholecystitis (which may cause abdominal pain, nausea, vomiting)
myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing), ocular myasthenia (a disease causing weakness of eye muscles).
The patient should talk to their doctor if they experience weakness in the arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to collect further information on the safety of this medicine.

5. How to store Rosuvastatin/Ezetimibe Teva

Keep this medicine out of the sight and reach of children.
Do not use 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures help protect the environment.
Keep the medicine in its original packaging to protect it from light.
No special storage temperature requirements apply.

6. Contents of the pack and other information

What Rosuvastatin/Ezetimibe Teva contains
The active substances 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: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
crospovidone type A, povidone K-30, sodium lauryl sulfate and magnesium stearate.
Rosuvastatin/Ezetimibe Teva contains lactose and sodium – for further 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.
Packs containing 10, 28, 30, 84, 90, 98 or 100 tablets in blisters (PA/Aluminium/PVC//Aluminium), in a cardboard box with patient information leaflet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands
Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland
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