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

Rosuvastatinum

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

• Keep this package 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 experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of 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 has not been enough to bring your cholesterol level down to a normal level. You should continue with a low-cholesterol diet and regular exercise while taking Zaranta.
Or

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

Heart attack, stroke, and other problems can be caused by atherosclerosis (hardening of the arteries). Atherosclerosis is due to the accumulation of fatty deposits (plaques) in the blood vessels.
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 to increase the levels of high-density lipoprotein cholesterol (HDL-C), known as "good" cholesterol.

• Zaranta may lower the level of "bad" cholesterol and increase the level of "good" cholesterol.
• Zaranta works by inhibiting an enzyme in the liver (HMG-CoA reductase) that is necessary for the production of cholesterol. It also increases the uptake of "bad" cholesterol from the blood by the liver.

High levels of cholesterol do not usually cause any symptoms. However, if left untreated, it can lead to the buildup of fatty deposits in the walls of the blood vessels and narrowing of the blood vessels. Sometimes this can lead to blockage of the blood vessels, which can cause a heart attack or stroke. Lowering the level of cholesterol can help reduce the risk of heart attacks, strokes, and other diseases.

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 pains or strains,
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection),
• if you are taking ciclosporin (a medicine used, for example, after organ transplantation). If any of the above applies to you, or if you are not sure, consult your doctor.

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

• if you have moderate kidney disease (if in doubt, ask your doctor),
• if you have thyroid disease,
• if you have repeated or unexplained muscle pains or strains, or if you or a close family member have had muscle problems or muscle damage when taking other cholesterol-lowering medicines,
• if you regularly drink large amounts of alcohol,
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• if you are taking other medicines called fibrates to lower your cholesterol.

If any of the above applies to you, or if you are not sure, consult your doctor.

Warnings and precautions

Before taking Zaranta, discuss it with your doctor or pharmacist.
When to be extra careful while taking Zaranta:

• if you have kidney disease,
• if you have liver disease,
• if you have repeated or unexplained muscle pains or strains, or if you or a close family member have had muscle problems or muscle damage when taking other cholesterol-lowering medicines. You should contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if you also have a fever. You should also tell your doctor if you experience persistent muscle weakness,
• 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 have myasthenia gravis (a disease that causes muscle weakness) or myasthenic syndrome (a disease that causes muscle weakness, especially in the muscles used for breathing), as statins can sometimes worsen the symptoms of these diseases or cause myasthenia (see section 4),
• if you regularly drink large amounts of alcohol,
• if you have thyroid disease,
• if you are taking fibrates (medicines used to lower cholesterol) or any other medicine used to lower cholesterol (e.g., ezetimibe). Read the package leaflet carefully, even if you have taken other cholesterol-lowering medicines before,
• if you are taking medicines used to treat HIV or hepatitis C, such as ritonavir with lopinavir and/or atazanavir, see the information in the section: Zaranta with other medicines,
• if 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. The combination of fusidic acid and Zaranta can cause serious muscle damage (rhabdomyolysis).
• if you are over 70 years old (as your doctor will need to choose the right starting dose of Zaranta for you),
• if you have severe respiratory failure,
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right starting dose of Zaranta for you.

Rosuvastatin has been associated with severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any of the symptoms described in section 4, stop taking Zaranta and contact your doctor immediately.
If you think you have any of the above problems (or have any other questions), do not take the 30 mg or 40 mg (the two highest doses) of Zaranta, and consult your doctor or pharmacist before taking Zaranta at any other dose.

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 with other medicines

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

• ciclosporin (used, for example, after organ transplantation; rosuvastatin levels in the blood increase),
• warfarin, ticagrelor, or clopidogrel (or any other blood thinner; the blood-thinning effect may increase when taken with rosuvastatin),
• fibrates (such as gemfibrozil, fenofibrate; used to lower cholesterol; rosuvastatin levels in the blood increase) or any other cholesterol-lowering medicine (e.g., ezetimibe),
• medicines used to treat indigestion (e.g., antacids; rosuvastatin levels in the blood decrease),
• erythromycin (an antibiotic; rosuvastatin levels in the blood decrease),
• baicalin (a herbal medicine),
• oral contraceptives (the pill; hormone levels in the blood increase),
• hormone replacement therapy (hormone levels in the blood increase),
• regorafenib, darolutamide, capmatinib (used to treat cancer),
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat or prevent 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, taken alone or in combination with other medicines (see: Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, tipranavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir, darunavir,
• eltrombopag, used to treat low platelet count and severe aplastic anemia,
• dronedarone, a medicine used to treat irregular heartbeat,
• itraconazole, used to treat various fungal infections,
• (an antiviral medicine used to treat hepatitis C; rosuvastatin levels in the blood may increase),
• if you need to take fusidic acid by mouth to treat a bacterial infection, you may need to stop taking Zaranta temporarily. Your doctor will tell you when it is safe to restart Zaranta. Taking Zaranta with fusidic acid can rarely cause serious muscle damage (rhabdomyolysis). For more information, see section 4.

Zaranta with food, drink, and alcohol

Zaranta can be taken with or without food.
Avoid drinking large amounts of alcohol while taking Zaranta.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Zaranta if you are pregnant or breast-feeding. If you become pregnant while taking Zaranta, stop taking it immediately and contact your doctor. While taking Zaranta, use effective birth control methods to prevent pregnancy.

Driving and using machines

Most people can drive and use machines while taking Zaranta - it will not affect their ability. However, some people may experience dizziness while taking Zaranta. If you experience dizziness, 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 medicine.

3. How to take Zaranta

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Recommended doses for adults

Taking Zaranta to treat high cholesterol:
Starting dose
Treatment should start with a dose of 5 mg or 10 mg, even if you have taken higher doses of other cholesterol-lowering medicines (statins) before. The starting dose depends on:

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

Ask your doctor which starting dose of Zaranta is best for you.
Your doctor may decide to start you on the lowest dose (5 mg) 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 damage (myopathy).

Increasing the dose and maximum dose
Your doctor may decide to increase your dose. This is to make sure you are taking the right dose of Zaranta for you.
The time between dose increases is at least 4 weeks.
If you start with a dose of 5 mg, your doctor may increase it to 10 mg, then to 15 mg or 20 mg, and then to 30 mg or 40 mg if necessary. If you start with a dose of 10 mg, your doctor may increase it to 20 mg, then to 40 mg if necessary.
The maximum dose of Zaranta is 40 mg per day. It is used in patients with very high cholesterol and a high risk of heart attack or stroke, for whom a dose of 20 mg is not enough to lower their cholesterol level.

Taking Zaranta to reduce the risk of heart attack, stroke, or other diseases:

The recommended dose is 20 mg per day. However, your doctor may decide to start you on a lower dose if you have any of the factors mentioned above.

Taking Zaranta in children and adolescents

Recommended doses for children and adolescents aged 6-17 years
The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily.
The usual starting dose is 5 mg once daily. Your doctor may gradually increase the dose of Zaranta to the maximum dose of 10 mg or 20 mg for children and adolescents aged 6 to 17 years, depending on the disease being treated.
Take the medicine once daily.
Do not take the 30 mg or 40 mg tablet of Zaranta in children and adolescents under 18 years of age.
How to take the medicine

Swallow the tablets whole with a glass of water.
Zaranta should be taken once daily. You can take it at any time of day, with or without food.
It is recommended to take the medicine at the same time every day to help you remember to take it.

Regular cholesterol checks

To make sure your cholesterol level has gone down and is well controlled, you will need to have regular check-ups and blood tests.
Your doctor may decide to increase your dose of Zaranta to make sure you are taking the right dose for you.

What to do if you take more Zaranta than you should

Contact your doctor or go to the nearest hospital.
If you are in hospital or are being treated for another condition, tell the medical staff that you are taking Zaranta.

What to do if you forget to take Zaranta

Take the 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

Tell your doctor if you want to stop taking Zaranta. Your cholesterol level may go up again if you stop taking Zaranta.
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 that you know what these side effects are, so that you can tell your doctor if you get any of them.
Stop taking Zaranta and seek medical help immediately if you experience any of the following allergic reactions:

• difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat,
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing,
• severe skin rash, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS),
• severe blistering of the skin, mouth, eyes, and genitals (toxic epidermal necrolysis),
• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome).

Also, stop taking Zaranta and contact your doctor immediately if you experience muscle pain or other muscle symptoms that last longer than expected, as this could be a sign of rhabdomyolysis, a rare but serious muscle condition. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have had muscle damage while taking Zaranta. In rare cases, this has led to a life-threatening condition called rhabdomyolysis.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported to the national reporting system via:

Department for the Monitoring of Adverse Reactions to Medicinal Products Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Al. Jerozolimskie 181C 02-222 Warszawa Tel.: 22 49-21-301 Fax: 22 49-21-309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder.

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.
No special storage instructions are needed for this medicine.
Do not use this medicine after the expiry date which is stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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:
Round, biconvex, white or almost white film-coated tablets. One side is marked with "C33".
Diameter approximately 5.5 mm, thickness from 2.7 to 3.3 mm.
Tablets are packed in blisters (PA/Aluminium/PVC/Aluminium). One carton contains 28, 30, or 56 film-coated tablets.
Zaranta 10 mg film-coated tablets:
Round, biconvex, white or almost white film-coated tablets. One side is marked with "C34".
Diameter approximately 7.0 mm, thickness from 3.3 to 4.2 mm.
Zaranta 20 mg film-coated tablets:
Round, biconvex, white or almost white film-coated tablets. One side is marked with "C35".
Diameter approximately 9.0 mm, thickness from 4.2 to 4.9 mm.
Zaranta 40 mg film-coated tablets:
Oval, white or almost white film-coated tablets. One side is marked with "C36".
Length approximately 15.5 mm, width 8 mm, thickness from 4.5 to 5.5 mm.
Tablets are packed in blisters (PA/Aluminium/PVC/Aluminium). One carton contains 28 or 30 film-coated tablets.
Zaranta 15 mg film-coated tablets:
Round, biconvex, white or almost white film-coated tablets. One side is marked with "C37".
Diameter approximately 8.0 mm, thickness from 4.1 to 4.6 mm.
Zaranta 30 mg film-coated tablets:
Round, biconvex, white or almost white film-coated tablets. One side is marked with "C38".
Diameter approximately 10.0 mm, thickness from 5.5 to 6.2 mm.
Tablets are packed 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 authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer:

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
For more information on this medicine, including its other names, please contact:

GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the package leaflet: May 2023

(( marketing authorization holder's logo))