Zaranta

Package Leaflet: Information for the User

Zaranta, 5 mg, film-coated tablets

Zaranta, 10 mg, film-coated tablets

Zaranta, 15 mg, film-coated tablets

Zaranta, 20 mg, film-coated tablets

Zaranta, 30 mg, film-coated tablets

Zaranta, 40 mg, film-coated tablets

Rosuvastatin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Zaranta and what is it used for

Zaranta belongs to a group of medicines called statins.
Your doctor has prescribed Zaranta because:

• you have a high level of cholesterol. This means you are at risk of having a heart attack or stroke. Zaranta is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

Your doctor has prescribed statins because changing your diet and increasing the amount of exercise you do have not been enough to lower your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while taking Zaranta.
Or

• if you have other factors that increase your risk of having a heart attack, stroke, or other diseases.

Heart attacks, strokes, and other problems can be caused by atherosclerosis, which is the build-up of fatty deposits in your arteries. Atherosclerosis is due to the build-up of fatty deposits (plaques) in your arteries.
Why it is important to keep taking Zaranta
Zaranta is used to lower the levels of fatty substances (lipids) in the blood, mainly low-density lipoprotein cholesterol (LDL-C), known as "bad" cholesterol, and also to increase the levels of high-density lipoprotein cholesterol (HDL-C), known as "good" cholesterol.

• Zaranta may also reduce the risk of heart attack, stroke, or other diseases by lowering the level of "bad" cholesterol and increasing the level of "good" cholesterol.
• Zaranta works by inhibiting an enzyme in the liver (HMG-CoA reductase) that produces cholesterol, thereby reducing the amount of cholesterol produced in the liver and increasing the uptake of cholesterol from the bloodstream.

In most people, there are no symptoms of high cholesterol. However, if left untreated, it can lead to the build-up of fatty deposits in your arteries, which can cause problems.

2. Important information before taking Zaranta

When not to take Zaranta:

• if you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had a severe skin rash or skin blistering after taking Zaranta or other medicines in the same class (statins),
• if you are pregnant or breast-feeding. If you become pregnant while taking Zaranta, stop taking it immediately and tell your doctor. Women taking Zaranta should use effective birth control methods,
• if you have liver disease,
• if you have severe kidney disease,
• if you have repeated or unexplained muscle aches or pains, or if you have a history of muscle problems during previous treatment with statins or fibrates,
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection),
• if you are taking cyclosporin (a medicine used after organ transplantation). If any of the above applies to you, or if you are in doubt, consult your doctor.

Do not take the 30 mg or 40 mg (the two highest doses) of Zaranta if:

• you have moderate kidney disease (if in doubt, consult your doctor),
• you have thyroid disease,
• you have repeated or unexplained muscle aches or pains, or if you or your family members have had muscle problems during previous treatment with statins or fibrates,
• you regularly drink large amounts of alcohol,
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• you are taking other medicines to lower cholesterol, such as fibrates.

If any of the above applies to you, or if you are in doubt, consult your doctor.

Special warnings and precautions

Before taking Zaranta, tell your doctor or pharmacist if:

• you have kidney disease,
• you have liver disease,
• you have repeated or unexplained muscle aches or pains, or if you or your family members have had muscle problems during previous treatment with statins or fibrates. If you experience muscle pain, tenderness, or weakness, consult your doctor immediately. You may need to stop taking Zaranta and have some tests to check for muscle problems,
• you have had a severe skin rash or skin blistering after taking Zaranta or other medicines in the same class (statins),
• you regularly drink large amounts of alcohol,
• you have thyroid disease,
• you are taking medicines to lower cholesterol, such as fibrates. Read the leaflet carefully, even if you have taken other statins before,
• you are taking medicines to treat HIV or hepatitis C, such as ritonavir with lopinavir and/or atazanavir, or other medicines that may increase the risk of muscle problems,
• you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) orally or by injection. Taking fusidic acid and Zaranta together may cause muscle problems (rhabdomyolysis),
• you are over 70 years old (your doctor may need to choose a lower starting dose of Zaranta),
• you have severe respiratory disease,
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor may need to choose a lower starting dose of Zaranta.

Rarely, statins may cause serious side effects such as Stevens-Johnson syndrome (a severe skin and mucous membrane disorder) and DRESS syndrome (a severe allergic reaction). If you experience any of the symptoms listed in section 4, stop taking Zaranta and contact your doctor immediately.
If you think you may have any of the above problems, do not take the 30 mg or 40 mg (the two highest doses) of Zaranta, and consult your doctor or pharmacist before taking any dose of Zaranta.
As with other statins, a small number of people may experience liver problems. To check for this, your doctor will need to do a simple blood test to check your liver function before and during treatment with Zaranta.
If you have diabetes or are at risk of developing diabetes, you will need to be closely monitored by your doctor while taking Zaranta. You are at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Children and adolescents

• Patients under 6 years of age: Zaranta should not be used in children under 6 years of age.
• Patients under 18 years of age: Zaranta should not be used in children and adolescents under 18 years of age at the 30 mg or 40 mg dose.

Zaranta and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• cyclosporin (used after organ transplantation; the level of rosuvastatin in your blood may increase),
• warfarin, ticagrelor, or clopidogrel (or any other "blood thinning" medicine; the effect of these medicines may be increased when taken with rosuvastatin),
• fibrates (such as gemfibrozil or fenofibrate; used to lower cholesterol; the level of rosuvastatin in your blood may increase) or any other medicine used to lower cholesterol,
• medicines used to treat indigestion (such as antacids; the level of rosuvastatin in your blood may decrease),
• erythromycin (an antibiotic; the level of rosuvastatin in your blood may decrease),
• baicalin (a herbal medicine),
• oral contraceptives (the "pill"; the level of the hormone in your blood may increase),
• hormone replacement therapy (the level of the hormone in your blood may increase),
• regorafenib, darolutamide, capmatinib (used to treat cancer),
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat high levels of uric acid in the blood),
• teriflunomide (used to treat multiple sclerosis),
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination with other medicines (see "Special warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, elbasvir, grazoprevir, pibrentasvir, glecaprevir,
• eltrombopag (used to treat low platelet count and severe aplastic anemia),
• dronedarone (used to treat irregular heartbeat),
• itraconazole (used to treat fungal infections),
• other medicines that may increase the risk of muscle problems (myopathy),
• fusidic acid (used to treat bacterial infections; if you need to take this medicine, your doctor may ask you to stop taking Zaranta temporarily).

Zaranta with food, drink, and alcohol

Zaranta can be taken with or without food.
Do not drink large amounts of alcohol while taking Zaranta.

Pregnancy and breast-feeding

Do not take Zaranta if you are pregnant or breast-feeding. If you become pregnant while taking Zaranta, stop taking it immediately and tell your doctor. If you are planning to become pregnant, consult your doctor or pharmacist before taking Zaranta.

Driving and using machines

Most people can drive and use machines while taking Zaranta - it is unlikely to affect their ability. However, some people may feel dizzy while taking Zaranta. If you feel dizzy, consult your doctor before driving or using machines.

Zaranta contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Zaranta

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Recommended doses for adults

Treatment of high cholesterol:
Starting dose:
Treatment should start with 5 mg or 10 mg daily. The dose depends on:

• your cholesterol level,
• your risk of heart attack or stroke,
• whether you have any other factors that may increase the risk of side effects.

Ask your doctor which starting dose of Zaranta is best for you.
Your doctor may start you on a dose of 5 mg daily if:

• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• you are over 70 years old,
• you have moderate kidney disease,
• you are at risk of muscle problems (myopathy).

Increasing the dose and maximum dose:
Your doctor may decide to increase your dose. This will depend on your cholesterol level and how you respond to the treatment.
The time between dose increases is at least 4 weeks.
If you start with 5 mg daily, your doctor may increase the dose to 10 mg daily, then to 15 mg daily or 20 mg daily, and then to 30 mg daily or 40 mg daily if necessary. If you start with 10 mg daily, your doctor may increase the dose to 20 mg daily, then to 40 mg daily if necessary.
The maximum dose of Zaranta is 40 mg daily. This dose is only for patients with very high cholesterol levels and a high risk of heart attack or stroke, for whom the 20 mg dose is not enough to lower their cholesterol levels.

Use in children and adolescents

Recommended doses for children and adolescents aged 6-17 years

The dose range for children and adolescents is 5-20 mg once daily.
The usual starting dose is 5 mg once daily. Your doctor may adjust the dose as needed.

The maximum dose is 10 mg or 20 mg once daily for children and adolescents aged 6-17 years, depending on the disease being treated.
Take one dose once a day.
Do not take the 30 mg or 40 mg tablet if you are under 18 years old.
How to take Zaranta

Swallow the tablet whole with water.
Zaranta can be taken at any time of day, with or without food.
Try to take your dose at the same time each day to help you remember it.

Regular cholesterol checks

To check that your cholesterol levels are reducing and are well controlled, you will need to have regular blood tests.

What to do if you take more Zaranta than you should

Contact your doctor or go to the nearest hospital immediately.

What to do if you forget to take Zaranta

Take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

What to do if you want to stop taking Zaranta

Consult your doctor before stopping treatment with Zaranta. If you stop taking Zaranta, your cholesterol levels may rise again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zaranta can cause side effects, although not everybody gets them.
It is important to know what these side effects are, so that you can identify them if they happen.
Stop taking Zaranta and seek medical help immediately if you have any of the following allergic reactions:

• difficulty breathing with swelling of the face, lips, tongue, and/or throat,
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing,
• severe itching of the skin (with raised lumps),
• skin rash, which may be itchy, red, and/or blistered, with peeling of the skin, and possibly swelling of the eyes, face, lips, and/or tongue, and/or mouth sores,
• severe skin rash with blisters, and possibly mouth sores, eye inflammation, and/or low blood pressure (Stevens-Johnson syndrome),
• severe skin rash with fever, and possibly blistering of the skin, mouth sores, and/or swollen lymph nodes (DRESS syndrome).

Also, stop taking Zaranta and contact your doctor immediately if you experience:

• unexplained muscle pain, tenderness, or weakness. These may be signs of a rare but serious side effect called rhabdomyolysis (a condition where muscle tissue breaks down),
• a specific type of blood cancer (multiple myeloma),
• severe lung disease (interstitial lung disease),
• diabetes. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in the "Contact details" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zaranta

Keep this medicine out of the sight and reach of children.
Store in the original package to protect from light.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP".
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Zaranta contains

• The active substance is rosuvastatin. Zaranta 5 mg film-coated tablets: 5 mg rosuvastatin (as rosuvastatin calcium) per tablet Zaranta 10 mg film-coated tablets: 10 mg rosuvastatin (as rosuvastatin calcium) per tablet Zaranta 15 mg film-coated tablets: 15 mg rosuvastatin (as rosuvastatin calcium) per tablet Zaranta 20 mg film-coated tablets: 20 mg rosuvastatin (as rosuvastatin calcium) per tablet Zaranta 30 mg film-coated tablets: 30 mg rosuvastatin (as rosuvastatin calcium) per tablet Zaranta 40 mg film-coated tablets: 40 mg rosuvastatin (as rosuvastatin calcium) per tablet
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium hydroxide, magnesium stearate, crospovidone tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc

What Zaranta looks like and contents of the pack

Zaranta 5 mg film-coated tablets:
White or almost white, round, biconvex film-coated tablets with "C33" on one side.
Diameter: approximately 5.5 mm, thickness: 2.7-3.3 mm.
Tablets are packaged in blisters (PA/Aluminium/PVC/Aluminium). One carton contains 28, 30, or 56 film-coated tablets.
Zaranta 10 mg film-coated tablets:
White or almost white, round, biconvex film-coated tablets with "C34" on one side.
Diameter: approximately 7.0 mm, thickness: 3.3-4.2 mm.
Zaranta 20 mg film-coated tablets:
White or almost white, round, biconvex film-coated tablets with "C35" on one side.
Diameter: approximately 9.0 mm, thickness: 4.2-4.9 mm.
Zaranta 40 mg film-coated tablets:
White or almost white, oval film-coated tablets with "C36" on one side.
Length: approximately 15.5 mm, width: 8 mm, thickness: 4.5-5.5 mm.
Tablets are packaged in blisters (PA/Aluminium/PVC/Aluminium). One carton contains 28 or 30 film-coated tablets.
Zaranta 15 mg film-coated tablets:
White or almost white, round, biconvex film-coated tablets with "C37" on one side.
Diameter: approximately 8.0 mm, thickness: 4.1-4.6 mm.
Zaranta 30 mg film-coated tablets:
White or almost white, round, biconvex film-coated tablets with "C38" on one side.
Diameter: approximately 10.0 mm, thickness: 5.5-6.2 mm.
Tablets are packaged in blisters (PA/Aluminium/PVC/Aluminium). One carton contains 28, 30, 56, or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5,
05-825 Grodzisk Mazowiecki
Poland

Manufacturer

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary