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 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 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 attack, stroke, and other problems can be caused by atherosclerosis (hardening of the arteries). Atherosclerosis is due to the build-up 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. The most common of these lipids is cholesterol.
There are different types of cholesterol in the blood, including "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Zaranta may lower the level of "bad" cholesterol and increase the level of "good" cholesterol.
• Zaranta works by inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the blood.

In most people, high cholesterol does not make them feel ill, as it does not cause any symptoms. However, if left untreated, it can lead to the build-up of fatty deposits in the walls of the blood vessels and narrowing of the blood vessels. Sometimes, this can lead to blockage of the narrowed blood vessel, interruption of blood flow to the heart or brain, and subsequent heart attack or stroke. Lowering the level of cholesterol in the blood reduces the risk of heart attack, stroke, or other diseases.
Even if Zaranta lowers your cholesterol level, you should continue to take it, as it prevents the level of cholesterol from rising again, which can cause the build-up of fatty deposits. You should stop taking Zaranta if your doctor advises you to or if you become pregnant.

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 peeling, blistering, and (or) mouth sores after taking Zaranta or other medicines like it,
• if you are pregnant or breastfeeding. 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, 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 medicines containing cyclosporin (used, for example, 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 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 your family members have had muscle problems during previous treatment with statins or fibrates,
• 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 in doubt, 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 your family members have had muscle problems during previous treatment with statins or fibrates. 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 or pharmacist if you experience persistent muscle weakness,
• if you have had a severe skin rash or skin peeling, blistering, and (or) mouth sores after taking Zaranta or other medicines like it,
• if you regularly drink large amounts of alcohol,
• if you have thyroid disease,
• if you are taking medicines to lower your cholesterol, such as fibrates,
• if you are taking medicines used to treat HIV or hepatitis C, such as ritonavir with lopinavir and (or) atazanavir,
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. Combination of fusidic acid and Zaranta can lead to 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 concerns), 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.

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 if you are taking any of the following medicines:

• cyclosporin (used, for example, after organ transplantation; the level of rosuvastatin in the blood increases),
• warfarin, ticagrelor, or clopidogrel (or any other "blood thinner"; the effect of the "blood thinner" may be increased when taken with rosuvastatin),
• fibrates (such as gemfibrozil, fenofibrate; used to lower cholesterol; the level of rosuvastatin in the blood increases) or any other cholesterol-lowering medicines (such as ezetimibe),
• medicines used to treat indigestion (such as antacids; the level of rosuvastatin in the blood may decrease),
• erythromycin (an antibiotic; the level of rosuvastatin in the blood may decrease),
• baicalin (a herbal medicine),
• oral contraceptives (the "pill"; the level of the hormone released from the pill in the blood may increase),
• hormone replacement therapy (the level of the hormone in the blood may increase),
• regorafenib, darolutamide, capmatinib (used to treat cancer),
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and 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, 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,
• (an antiviral medicine used to treat hepatitis C; the level of rosuvastatin in the blood may increase),
• if you need to take fusidic acid by mouth to treat a bacterial infection, you should temporarily stop taking Zaranta. Your doctor will tell you when you can safely start taking Zaranta again. Taking Zaranta with fusidic acid may rarely lead to muscle damage (rhabdomyolysis). For more information, see section 4.

Zaranta with food, drink, and alcohol

Zaranta can be taken with or without food.
Regular consumption of large amounts of alcohol should be avoided while taking Zaranta.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Zaranta should not be taken during pregnancy or while breastfeeding. If you become pregnant while taking Zaranta, stop taking it immediately and contact your doctor. While taking Zaranta, you should not become pregnant and should use effective birth control methods.

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, contact your doctor before driving or using machines.

Zaranta contains lactose

If you have been told that you have an intolerance to some sugars, such as lactose or milk sugar, 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 be started 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 pain (myopathy).

Increasing the dose and maximum dose
Your doctor may decide to increase your dose. This is so that you are taking the dose of Zaranta that is right for you.
The time between dose increases is at least 4 weeks.
If you started with a dose of 5 mg, your doctor may increase it to 10 mg, then 15 mg or 20 mg, and then to 30 mg or 40 mg if necessary. If you started with a dose of 10 mg, your doctor may increase it to 20 mg, then to 40 mg if necessary.
The maximum daily dose of Zaranta is 40 mg. It is used in patients with 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 levels.
Taking Zaranta to reduce the risk of heart attack, stroke, or other diseases:
The recommended dose is 20 mg once daily.
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 dose that is right for you.
The maximum daily dose of Zaranta is 10 mg or 20 mg for children and adolescents aged 6 to 17 years, depending on the disease being treated.
The dose should be taken once daily.
Zaranta should not be taken at the 30 mg or 40 mg dose in children and adolescents under 18 years of age.
Taking 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 the day, with or without food.
It is recommended that you take Zaranta at the same time every day to help you remember to take it.
Regular check-ups to monitor your cholesterol levels
To make sure that your cholesterol levels have decreased and are under control, you should have regular check-ups and blood tests.
Your doctor may decide to increase your dose of Zaranta to the dose that is right 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 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

Tell your doctor if you want to stop taking Zaranta. Your cholesterol levels may rise again if you stop taking Zaranta.
If you have any further questions on the use of this medicine, 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 them.
Stop taking Zaranta and seek medical help immediately if you experience any of the following allergic reactions:

• difficulty breathing with swelling of the face, lips, tongue, and (or) throat, with or without difficulty swallowing,
• swelling of the face, lips, tongue, and (or) throat, which may cause difficulty swallowing,
• severe skin itching (with raised patches),
• skin rash with redness and blistering of the skin, blistering of the mouth, throat, eyes, and genitals, which may progress to widespread skin peeling and life-threatening complications (Stevens-Johnson syndrome),
• widespread skin rash, high fever, and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS).

Also, stop taking Zaranta and contact your doctor immediately if you experience muscle pain, tenderness, or weakness that persists, as this may be a sign of a rare but serious side effect called rhabdomyolysis. Muscle symptoms are more common in children and adolescents than in adults.

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 directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: 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.
Reporting side effects will help to gather 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.
No special storage instructions are required 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.
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:
Round, biconvex, film-coated tablets, white or almost white. One side is marked with "C33".
Diameter approximately 5.5 mm, thickness from 2.7 to 3.3 mm.
Tablets are packaged in blisters (PA/Aluminum/PVC/Aluminum). One carton contains 28, 30, or 56 film-coated tablets.
Zaranta, 10 mg, film-coated tablets:
Round, biconvex, film-coated tablets, white or almost white. 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, film-coated tablets, white or almost white. 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, film-coated tablets, white or almost white. One side is marked with "C36".
Length approximately 15.5 mm, width 8 mm, thickness from 4.5 to 5.5 mm.
Tablets are packaged in blisters (PA/Aluminum/PVC/Aluminum). One carton contains 28 or 30 film-coated tablets.
Zaranta, 15 mg, film-coated tablets:
Round, biconvex, film-coated tablets, white or almost white. 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, film-coated tablets, white or almost white. One side is marked with "C38".
Diameter approximately 10.0 mm, thickness from 5.5 to 6.2 mm.
Tablets are packaged in blisters (PA/Aluminum/PVC/Aluminum). 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
Poland

Manufacturer:

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
To obtain more detailed information on this medicine and its names in other European Economic Area countries, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the package leaflet: May 2023

(( logo of the marketing authorization holder))