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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should 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 signs of illness 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 pack and other information

• 1. What Zaranta is and what it is used for
• 2. What you need to know before you take 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 Zaranta is and what it is 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 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 your physical activity were not 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 a disease called atherosclerosis. Atherosclerosis is due to the buildup of fatty deposits in your arteries.

Why is it important to keep taking Zaranta?

Zaranta is used to lower the levels of fatty substances such as cholesterol in your blood.

• Zaranta may also help to increase the levels of 'good' cholesterol in your blood.
• Zaranta works by inhibiting an enzyme in the liver (HMG-CoA reductase) that produces cholesterol.

High levels of cholesterol do not usually cause any symptoms. However, if left untreated, it can lead to the buildup of fatty deposits in your arteries. This can lead to a heart attack or stroke.

2. What you need to know before you take Zaranta

Do not take Zaranta:

• if you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver disease,
• if you have severe kidney disease,
• if you have repeated or unexplained muscle pain,
• 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 to suppress the immune system after organ transplantation). If any of the above applies to you, or if you are in doubt, please consult your doctor.

Do not take 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 muscle pain or have ever had muscle problems,
• you regularly drink large amounts of alcohol,
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• 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, please consult your doctor.

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 pain,
• you have a history of muscle disease or have had muscle problems in the past,
• you have had a previous stroke with bleeding,
• you have had a recent history of alcohol abuse,
• you have thyroid disease,
• you are taking other medicines called fibrates to lower your cholesterol,
• you are taking medicines used to treat HIV or hepatitis C virus infection, such as lopinavir/ritonavir, atazanavir, sofosbuvir/velpatasvir/voxilaprevir, or elbasvir/grazoprevir,
• you are taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Zaranta can lead to serious muscle damage (rhabdomyolysis),
• you are over 70 years old (as your doctor needs to choose the right starting dose of Zaranta),
• you have severe respiratory failure,
• you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the right starting dose of Zaranta.

Rosuvastatin has been associated with severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If you get any of the symptoms listed in section 4, stop taking Zaranta and contact your doctor immediately.

If you think any of the above applies to you, or if you are in doubt, do not take 30 mg or 40 mg (the two highest doses) of Zaranta, and consult your doctor or pharmacist before taking any dose of Zaranta.

Statins can cause liver enzyme abnormalities in blood tests. This is usually mild and does not cause any symptoms. Your doctor will do a blood test to check your liver before and during treatment with Zaranta.

If you have diabetes or are at risk of developing diabetes, you should be carefully monitored while taking Zaranta. You are at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight, or 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 30 mg or 40 mg should not be used in children and adolescents under 18 years of age.

Zaranta with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• ciclosporin (used to prevent rejection after organ transplantation; rosuvastatin levels may increase),
• warfarin, ticagrelor, or clopidogrel (or any other 'blood thinning' medicine; the effect of these medicines may be increased when used with rosuvastatin),
• fibrates (such as gemfibrozil, fenofibrate; used to lower cholesterol; rosuvastatin levels may increase) or any other medicine used to lower cholesterol,
• antacids (used to neutralize stomach acid; rosuvastatin levels may decrease),
• erythromycin (an antibiotic; rosuvastatin levels may decrease),
• bacillus subtilis (a probiotic),
• oral contraceptives (the 'pill'; levels of the hormone released from the pill may increase),
• hormone replacement therapy (levels of the hormone may increase),
• regorafenib, darolutamide, capmatinib (used to treat cancer),
• fostamatinib (used to treat low platelet count and severe aplastic anemia),
• 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 virus infection, alone or in combination with other medicines (see 'Warnings and precautions'): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, elbasvir, grazoprevir, ombitasvir, paritaprevir, dasabuvir, glecaprevir, pibrentasvir, darunavir,
• eltrombopag (used to treat low platelet count and severe aplastic anemia),
• dronedarone (used to treat irregular heartbeat),
• itraconazole (used to treat fungal infections),
• boceprevir (an antiviral medicine used to treat hepatitis C virus infection; rosuvastatin levels may increase),
• if you need to take fusidic acid by mouth to treat a bacterial infection, treatment with Zaranta should be temporarily stopped. Your doctor will tell you when you can start taking Zaranta again. Taking Zaranta with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (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 breastfeeding

Do not take Zaranta if you are pregnant or breastfeeding. If you become pregnant while taking Zaranta, stop taking it immediately and consult your doctor.

Women of childbearing age must use reliable contraceptive measures while taking Zaranta.

Driving and using machines

Zaranta is unlikely to affect your ability to drive or use machines. 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 dose

• The recommended dose is 5-40 mg per day.

Starting dose

Treatment should start with 5 mg or 10 mg per day.

Increasing the dose and maximum dose

Your doctor may decide to increase the dose. This will depend on how you respond to the treatment.

The dose should be adjusted at intervals of not less than 4 weeks.

Use in children and adolescents

The recommended dose in children and adolescents aged 6-17 years is 5-20 mg per day.

Administration

Swallow the tablet whole with water.

Zaranta can be taken at any time of day, with or without food.

Try to take your tablet at the same time every day to help you remember it.

If you take more Zaranta than you should

Contact your doctor or pharmacist immediately. If you are in a hospital or being treated for another condition, tell the medical staff that you are taking Zaranta.

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.

If you stop taking Zaranta

Consult your doctor before stopping treatment. Your cholesterol levels might increase again if you stop taking Zaranta.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people) include:

• headache
• abdominal pain
• constipation
• nausea
• muscle pain
• weakness
• dizziness
• increased protein in the urine (which usually disappears after stopping treatment with Zaranta)
• diabetes (more likely if you have high levels of sugars and fats in your blood, are overweight, or have high blood pressure)

Uncommon side effects (may affect up to 1 in 100 people) include:

• rash
• itching
• hives
• increased protein in the urine (which usually disappears after stopping treatment with Zaranta)

Rare side effects (may affect up to 1 in 1,000 people) include:

• severe allergic reactions, including anaphylaxis
• lupus-like disease (including rash, joint pain, and changes in blood tests)
• muscle damage (rhabdomyolysis)
• severe liver disease
• inflammation of the pancreas (pancreatitis)
• increased liver enzymes in the blood
• decreased platelet count, which may increase the risk of bleeding or bruising

Very rare side effects (may affect up to 1 in 10,000 people) include:

• jaundice (yellowing of the skin and eyes)
• hepatitis (inflammation of the liver)
• blood in the urine
• nerve damage (peripheral neuropathy)
• joint pain
• memory loss
• breast enlargement in men (gynecomastia)

Frequency not known (cannot be estimated from the available data):

• depression
• sleep disorders (including insomnia and nightmares)
• cough
• diarrhea
• edema (swelling)
• sexual problems
• breathing difficulties (including non-productive cough and shortness of breath or fever)
• numbness, tingling, pain, or burning sensation in the arms and legs (peripheral neuropathy)
• tendon disorders, sometimes complicated by tendon rupture
• permanent muscle weakness
• myasthenia gravis (a disease characterized by muscle weakness, including muscles used for breathing)
• myasthenic syndrome (a disease characterized by muscle weakness, including eye muscles)
• interstitial lung disease (a disease characterized by inflammation of the lungs)

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.

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'. 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.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium hydroxide, magnesium stearate, and crospovidone.

What Zaranta looks like and contents of the pack

Zaranta 5 mg film-coated tablets are white or almost white, round, and biconvex. They are marked with 'C33' on one side.

Zaranta 10 mg film-coated tablets are white or almost white, round, and biconvex. They are marked with 'C34' on one side.

Zaranta 20 mg film-coated tablets are white or almost white, round, and biconvex. They are marked with 'C35' on one side.

Zaranta 40 mg film-coated tablets are white or almost white, oval, and biconvex. They are marked with 'C36' on one side.

Zaranta 15 mg and 30 mg film-coated tablets are also available.

The tablets are packaged in blisters (PA/Aluminum/PVC/Aluminum). Each carton contains 28, 30, or 56 tablets.

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

For more information about this medicine, 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

Email: [email protected]

Date of last revision of the leaflet: May 2023