Rosuvastatin/ezetimibe zentiva

Package leaflet: Information for the patient

Rosuvastatin/Ezetimib Zentiva, 5 mg + 10 mg, tablets
Rosuvastatin/Ezetimib Zentiva, 10 mg + 10 mg, tablets
Rosuvastatin/Ezetimib Zentiva, 20 mg + 10 mg, tablets
Rosuvastatinum + Ezetimibum
Please read this leaflet carefully before taking 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 you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

List of contents of the leaflet:

1. What Rosuvastatin/Ezetimib Zentiva is and what it is used for
2. What you need to know before taking Rosuvastatin/Ezetimib Zentiva
3. How to take Rosuvastatin/Ezetimib Zentiva
4. Possible side effects
5. How to store Rosuvastatin/Ezetimib Zentiva
6. Contents of the pack and other information

1. What Rosuvastatin/Ezetimib Zentiva is and what it is used for

Rosuvastatin/Ezetimib Zentiva 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/Ezetimib Zentiva 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).
The medicine lowers cholesterol by acting in two ways: it reduces the amount of cholesterol absorbed in the gastrointestinal tract and the amount of cholesterol produced in the body.
In most people, high cholesterol does not affect well-being, as it causes 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 blockage of the 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/Ezetimib Zentiva is used in patients in whom diet alone is not sufficient to maintain normal cholesterol levels. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Your doctor may prescribe Rosuvastatin/Ezetimib Zentiva if you are already taking rosuvastatin and ezetimibe at the same doses as in this combination medicine.
This medicine is used in patients:

• with increased blood cholesterol levels (primary hypercholesterolaemia)
• with heart disease – Rosuvastatin/Ezetimib Zentiva reduces the risk of heart attack, stroke, need for a surgical procedure to improve blood flow to the heart, or need for hospitalisation due to chest pain.

Rosuvastatin/Ezetimib Zentiva does not help reduce body weight.

2. Information before using Rosuvastatin/Ezetimib Zentiva

When not to use Rosuvastatin/Ezetimib Zentiva

• 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 impairment
• if the patient experiences recurrent, unexplained muscle pain (myopathy)
• if the patient is taking a medicine containing cyclosporine (used, for example, after organ transplantation)
• if the patient is pregnant or breastfeeding. If a patient becomes pregnant while taking Rosuvastatin/Ezetimib Zentiva, she must stop taking the medicine immediately and inform her doctor. Effective contraception must be used during treatment with Rosuvastatin/Ezetimib Zentiva to avoid pregnancy (see section “Pregnancy and breastfeeding”)
• if the patient is taking the combination sofosbuvir/velpatasvir/voxilaprevir (used in the treatment of viral hepatitis C).

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 taking Rosuvastatin/Ezetimib Zentiva, discuss it with your doctor or
pharmacist if:
the patient has kidney impairment;
the patient has liver impairment;
the patient has previously experienced recurrent or unexplained muscle pain, or if there has been a history of muscle disorders in the patient or in their family, 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 seek medical advice immediately. The patient should also inform the doctor or pharmacist about persistent muscle weakness;
the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine the appropriate dose of Rosuvastatin/Ezetimib Zentiva for the patient;
the patient is taking antiviral medicines, including those used to treat HIV or hepatitis C virus infection, e.g. ritonavir with lopinavir and (or) atazanavir (see section “Rosuvastatin/Ezetimib Zentiva and other medicines”);
the patient has severe respiratory insufficiency;
the patient is taking other lipid-lowering medicines (so-called fibrates) to reduce cholesterol levels (see section “Rosuvastatin/Ezetimib Zentiva 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/Ezetimib Zentiva);
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/Ezetimib Zentiva may lead to serious muscle disorders (rhabdomyolysis);
if the patient has ever experienced severe skin rash, skin peeling, blisters and (or) oral ulcers after taking Rosuvastatin/Ezetimib Zentiva or similar medicines;
if the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen symptoms or trigger myasthenia (see section 4).
Exercise particular caution when using Rosuvastatin/Ezetimib Zentiva
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Rosuvastatin/Ezetimib Zentiva. If any of the symptoms described in section 4 occur, the patient should discontinue Rosuvastatin/Ezetimib Zentiva.
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/Ezetimib Zentiva.
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 blood tests during treatment with Rosuvastatin/Ezetimib Zentiva. It is important that the patient attends 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 an increased risk of developing diabetes if the patient has high blood sugar and fat levels, overweight, and high blood pressure.
If the patient is admitted to hospital or is being treated for another condition, they should inform medical staff about taking Rosuvastatin/Ezetimib Zentiva.
Children and adolescents
Rosuvastatin/Ezetimib Zentiva is not recommended for use in children and adolescents under 18 years of age.
Rosuvastatin/Ezetimib Zentiva and other medicines
The patient should inform their doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines they plan to take.
The patient should inform their doctor if they are 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/Ezetimib Zentiva must not be taken during treatment with cyclosporine.
• Anticoagulants, e.g. warfarin, acenocoumarol or fluindione (concomitant use with Rosuvastatin/Ezetimib Zentiva may enhance anticoagulant effect, increasing the risk of bleeding), ticagrelor or clopidogrel.
• Other cholesterol-lowering medicines, so-called fibrates, which also regulate blood triglyceride levels (e.g. gemfibrozil and other medicines in this group). Concomitant use increases the effect of rosuvastatin.
• Colestyramine (a medicine used to reduce cholesterol levels), as it affects the way ezetimibe works.
• Medicines used to treat indigestion, containing aluminium and magnesium (used to neutralize stomach acid). These medicines may reduce plasma concentrations of rosuvastatin. This effect can be minimized by taking these medicines 2 hours after taking rosuvastatin.
• 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/Ezetimib Zentiva will be necessary. The doctor will advise when it is safe to resume treatment. Concomitant use of Rosuvastatin/Ezetimib Zentiva and fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• Oral contraceptives (birth control pills). Concomitant use
  increases blood levels of sex hormones released from the pill.
• Medicines used in hormone replacement therapy (increased hormone levels in blood).
• Regorafenib (used in cancer treatment).
• Any of the following antiviral medicines, used alone or in combination with other medicines (see: Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If the patient is admitted to hospital or is being treated for another condition, they should
inform medical staff about taking Rosuvastatin/Ezetimib Zentiva.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Rosuvastatin/Ezetimib Zentiva must not be used if the patient is pregnant, trying to become pregnant, or suspects she may be pregnant. If the patient becomes pregnant during treatment with Rosuvastatin/Ezetimib Zentiva, she must stop taking the medicine immediately and inform her doctor. Effective contraception must be used during treatment with Rosuvastatin/Ezetimib Zentiva.
Breastfeeding
Rosuvastatin/Ezetimib Zentiva must not be used during breastfeeding, as it is unknown whether the medicine passes into breast milk.
Driving and using machines
Rosuvastatin/Ezetimib Zentiva is not expected to affect the ability to drive or operate machinery. However, it should be noted that Rosuvastatin/Ezetimib Zentiva may cause dizziness in some patients. In such a case, the patient should consult a doctor before driving or operating machinery.
Rosuvastatin/Ezetimib Zentiva tablets contain lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Rosuvastatin/Ezetimib Zentiva

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
While taking Rosuvastatin/Ezetimib Zentiva, you should continue a cholesterol-lowering diet and maintain physical activity.
The recommended daily dose for adults is one tablet of a given strength.
Rosuvastatin/Ezetimib Zentiva should be taken once daily.
The medicine can 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/Ezetimib Zentiva is not intended for initiating treatment. If starting therapy or if a dose adjustment is required, each active substance should be taken separately as individual medicines. Only after determining the appropriate doses should treatment be switched to Rosuvastatin/Ezetimib Zentiva of a specified strength.
Regular monitoring of cholesterol levels
It is important to visit your doctor regularly to monitor your cholesterol levels, to ensure that the desired target level has been achieved and maintained.
Taking more Rosuvastatin/Ezetimib Zentiva than recommended
In case of overdose, contact your doctor or go to the emergency department of the nearest hospital, as medical assistance may be required.
If you miss a dose of Rosuvastatin/Ezetimib Zentiva
If you miss a dose, take the next tablet at your usual time. Do not take a double dose to make up for the missed dose.
Stopping Rosuvastatin/Ezetimib Zentiva
Tell your doctor if you wish to stop taking Rosuvastatin/Ezetimib Zentiva. After discontinuing Rosuvastatin/Ezetimib Zentiva, cholesterol levels may rise again.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important for the patient to be aware of the side effects that may be associated with taking this medicine.
Stop taking Rosuvastatin/Ezetimib Zentiva and seek immediate medical help

• if the patient experiences any of the following allergic reactions:
• swelling of the face, lips, tongue and (or) throat, which may make breathing or swallowing difficult;
• lupus-like syndrome (including rash, joint problems and effects on blood cells);
• muscle rupture;
• red, flat, circular or target-shaped patches on the trunk, often with blisters in the centre, peeling skin, mouth ulcers, ulcers in the throat, nose, genitals and around the eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• extensive rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Contact a doctor immediately 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 problems.
To describe the frequency of side effects, the following classification is used:

• very common (may affect more than 1 in 10 people)
• common (may affect less than 1 in 10 people)
• uncommon (may affect less than 1 in 100 people)
• rare (may affect less than 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
feeling of weakness
dizziness
diabetes – more likely in patients with high levels of sugar and fats in the blood, overweight and high blood pressure. Your doctor will monitor your condition during treatment with this medicine.
stomach pain
diarrhoea
flatulence (excess gas in the intestines)
feeling of tiredness
increased results of certain blood tests assessing liver function (aminotransferase activity)

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

Rare side effects
pancreatitis causing severe abdominal pain, which may radiate 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 arms and legs (e.g. numbness)
memory loss
breast enlargement in men (gynaecomastia)

Side effects with unknown frequency
shortness of breath
swelling
sleep disorders, including insomnia and nightmares
sexual disorders
depression
breathing problems, including persistent cough and (or) shortness of breath or fever
tendon damage
persistent muscle weakness
red raised rash, sometimes with lesions in the shape of a target (erythema multiforme)
gallstones or inflammation of the gallbladder (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 the eye muscles)

Talk to your doctor if the patient experiences weakness in arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathing.

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Rosuvastatin/Ezetimib Zentiva

Keep the medicine in its original packaging to protect it from light.
There are no special storage temperature requirements.
Keep the 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Rosuvastatin/Ezetimib Zentiva contains
The active substances 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 and 10 mg of ezetimibe.
Other ingredients: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
crospovidone type A, povidone K-30, sodium lauryl sulfate and magnesium stearate.

What Rosuvastatin/Ezetimib Zentiva looks like and contents of the pack
Rosuvastatin/Ezetimib Zentiva, 5 mg + 10 mg
White or almost white, round, flat, uncoated tablets marked with "E2" on one side and "2" on the other, 10 mm in diameter.

Rosuvastatin/Ezetimib Zentiva, 10 mg + 10 mg
White or almost white, oval, biconvex, uncoated tablets marked with "E1" on one side and "1" on the other, 15 mm x 7 mm in size.

Rosuvastatin/Ezetimib Zentiva, 20 mg + 10 mg
White or almost white, round, biconvex, uncoated tablets, 11 mm in diameter.

Aluminium/PA/PVC/Aluminium foil blisters in cardboard packs containing 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, k.s.,
U kabelovny 130,
Dolní Měcholupy,
102 37 Prague 10,
Czech Republic

Manufacturer
Adamed Pharma S.A.
ul. Marsz. Józefa Piłsudskiego 5
95-200 Pabianice
Poland

This medicinal product is authorised in the European Economic Area under the following names:
Italy: Quiloga
Poland: Rosuvastatin/Ezetimib Zentiva

For further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00