Zaranta: detailed information

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
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.

Contents of the leaflet

What Zaranta is and what it is used for
What you need to know before taking Zaranta
How to take Zaranta
Possible side effects
How to store Zaranta
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.
You have been prescribed Zaranta because:

You have been diagnosed with high cholesterol levels. This increases the risk of heart attack or stroke. Zaranta is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol levels.

You have been prescribed a statin because changes in diet and increased physical activity have not been sufficient to achieve normal cholesterol levels in the blood. You should continue a cholesterol-lowering diet and regular physical exercise while taking Zaranta.
Or

You have other risk factors that increase your chance of heart attack, stroke, or similar conditions.

Heart attack, stroke, and other related problems may be caused by atherosclerosis. Atherosclerosis results from the build-up of fatty deposits (atherosclerotic plaques) in the blood vessels.
Why it is important to take Zaranta regularly
Zaranta is used to achieve normal levels of blood lipids (fats). The most common of these is cholesterol.
There are different types of cholesterol in the blood, commonly known as "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

Zaranta can reduce levels of "bad" cholesterol and increase levels 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 cause any symptoms or affect how you feel. However, if left untreated, fatty deposits build up in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, cutting off blood supply to the heart or brain, resulting in a heart attack or stroke. Achieving normal cholesterol levels reduces the risk of heart attack, stroke, or similar conditions.
Even if your cholesterol levels become normal after starting Zaranta, you must continue taking it. This prevents cholesterol levels from rising again and further accumulation of fatty deposits. You should stop taking Zaranta only if your doctor advises you to do so, or if you become pregnant.

2. Important information before taking Zaranta

When not to take Zaranta:

if the patient is allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
if the patient has ever experienced severe skin rash or skin peeling, blisters and (or) mouth ulcers after taking Zaranta or other medicines containing rosuvastatin,
if the patient is pregnant or breastfeeding. If a woman becomes pregnant while taking Zaranta, she must stop taking it immediately and inform her doctor. Women taking Zaranta should use effective methods of contraception,
if the patient has liver disease,
if the patient has severe kidney disease,
if the patient has recurrent or unexplained muscle symptoms or muscle pain,
if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral hepatitis infection known as hepatitis C),
if the patient is taking medicines containing the substance called cyclosporine (a medicine used, for example, after organ transplantation). If any of the above situations apply to the patient or if the patient has any doubts, they should contact their doctor again.

Do not use the 30 mg or 40 mg dose (the two strongest doses) of Zaranta in the following
cases:

if the patient has moderate kidney disease (if in doubt, ask the doctor),
if the patient has thyroid disease,
if the patient has recurrent or unexplained muscle symptoms or muscle pain, or if the patient or members of their family have previously been diagnosed with muscle disorders or muscle-related problems during prior use of other cholesterol-lowering medicines,
if the patient regularly consumes large amounts of alcohol,
if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea or India),
if the patient is taking other medicines called fibrates to reduce cholesterol levels.

If any of the above situations apply to the patient or if the patient has any doubts,
they should contact their doctor again.
Warnings and precautions
Before starting to take Zaranta, discuss this with your doctor or pharmacist.
When to exercise special caution when taking Zaranta:

if the patient has kidney disease,
if the patient has liver disease,
if the patient has recurrent or unexplained muscle symptoms or muscle pain, or if the patient or members of their family have previously been diagnosed with muscle disorders or muscle-related problems during prior use of other cholesterol-lowering medicines. The patient should contact their doctor immediately if they experience unexplained muscle symptoms or muscle pain, especially if accompanied by general malaise and fever. The patient should also inform their doctor or pharmacist if persistent muscle weakness occurs. Additional tests and additional medicines may be necessary to diagnose and treat these symptoms,
if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4),
if the patient has ever experienced severe rash or skin peeling, blistering and (or) mouth ulcers after taking Zaranta or other medicines with similar action,
if the patient regularly consumes large amounts of alcohol,
if the patient has thyroid disease,
if the patient is taking cholesterol-lowering medicines called fibrates. Read the leaflet carefully, even if the patient has previously taken other cholesterol-lowering medicines,
if the patient is taking medicines used to treat HIV infection or hepatitis C, e.g. ritonavir with lopinavir and (or) atazanavir, refer to the section: Zaranta and other medicines,
if the patient is taking or has taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). Concomitant treatment with fusidic acid and Zaranta may lead to serious muscle-related disorders (rhabdomyolysis).
if the patient is over 70 years of age (because the doctor should determine the appropriate starting dose of Zaranta for the patient),
if the patient has severe respiratory insufficiency,
if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea or India). The doctor should determine the appropriate starting dose of Zaranta for the patient.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of rosuvastatin. If any of the symptoms described in section 4 occur, stop taking Zaranta and contact your doctor immediately.
If the patient has any of the above problems (or has any other doubts), do not take Zaranta at a dose of 30 mg or 40 mg (the two strongest doses), and contact a doctor or pharmacist before taking Zaranta at any other dose.
In a small group of patients, statins may affect liver function. To confirm this effect, a simple blood test checking liver enzyme activity is performed. For this reason, the doctor usually recommends performing this blood test (liver function test) before and during treatment with Zaranta.
If the patient has diabetes or is at risk of developing diabetes, they should be closely monitored by a doctor during treatment with this medicine. The patient is at risk of developing diabetes if they have high levels of blood sugar and fats, 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 at a dose of 30 mg or 40 mg should not be used in children and adolescents under 18 years of age.

Zaranta and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Tell your doctor if the patient is taking any of the following medicines, because Zaranta may alter the effect of these medicines or these medicines may alter the effect of Zaranta:

cyclosporine (used, for example, after organ transplantation; rosuvastatin blood levels increase),
warfarin, ticagrelor or clopidogrel (or any other blood-thinning medicine; anticoagulant effect may increase when used together with rosuvastatin),
fibrates such as gemfibrozil, fenofibrate (used to reduce cholesterol levels; rosuvastatin blood levels increase) or any other medicine reducing blood cholesterol levels (e.g. ezetimibe),
medicines used for indigestion (for example, medicines used to neutralize stomach hydrochloric acid; rosuvastatin blood levels decrease),
erythromycin (an antibiotic; rosuvastatin blood levels decrease),
baicalin (a herbal medicine),
oral contraceptives (birth control pills; blood levels of hormones released from the pill increase),
hormone replacement therapy (hormone blood levels increase),
regorafenib, darolutamide, capmatinib (used in cancer treatment),
fostamatinib (used to treat low platelet count),
febuxostat (used to treat and prevent high blood uric acid levels),
teriflunomide (used to treat multiple sclerosis),
leflunomide (used to treat rheumatoid arthritis),
any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, administered alone or in combination with other medicines (see: Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, tipranavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir, darunavir,
eltrombopag, used to treat thrombocytopenia (abnormally low platelet count) and severe aplastic anemia,
dronedarone, a medicine used in heart rhythm disorders,
itraconazole, used to treat various fungal infections,
roxadustat (used to treat anaemia in patients with chronic kidney disease),
tafamidis (used to treat a disease called transthyretin amyloidosis),
momelotinib (used to treat myelofibrosis in adults with anaemia),
if the patient needs to take oral fusidic acid to treat bacterial infection, treatment with this medicine should be temporarily interrupted. The doctor will advise when it is safe to resume taking Zaranta. Concomitant use of Zaranta with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Zaranta with food, drink and alcohol
Zaranta can be taken with or without food.
Avoid regular consumption of large amounts of alcohol during treatment with Zaranta.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Zaranta must not be taken during pregnancy or while breastfeeding. If the patient becomes pregnant while taking Zaranta, she must stop taking it immediately and contact her doctor. While taking Zaranta, pregnancy should be avoided by using effective methods of contraception. It has been shown that rosuvastatin passes into human milk.
Driving and using machines
Most people can drive and operate machinery while taking Zaranta – it will not impair their abilities. However, some patients may experience dizziness during treatment with Zaranta. If the patient experiences dizziness, they should contact their doctor before driving or operating machinery.
Zaranta contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars (e.g. lactose or milk sugar), the patient should contact their doctor before taking this medicine.

3. How to take Zaranta

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Recommended doses in adult patients
Treatment with Zaranta for high cholesterol:
Starting dose
Treatment should be initiated with a dose of 5 mg or 10 mg, even if the patient has previously used
higher doses of other cholesterol-lowering medicines (statins). The choice of starting dose depends on:

the patient's cholesterol level,
the patient's risk of having a heart attack or stroke,
the presence of factors increasing the patient's susceptibility to adverse effects.

Ask your doctor which starting dose of Zaranta is most appropriate for you.
Your doctor may decide to use the lowest dose (5 mg) if:

the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India),
the patient is over 70 years of age,
the patient has moderate kidney problems,
the patient is at risk of muscle pain (myopathy).

Increasing the dose and maximum dose
Your doctor may decide to increase the dose to ensure that the dose of Zaranta is appropriate for the
patient.
There should be a four-week interval between dose adjustments.
If treatment was started at 5 mg, your doctor may decide to increase the dose to 10 mg, then to 15 mg
or 20 mg, and later to 30 mg or 40 mg, if necessary. If treatment was started at 10 mg, your doctor
may decide to increase the dose to 20 mg, and then to 40 mg, if necessary.
The maximum daily dose of Zaranta is 40 mg. This dose is used in patients with high cholesterol and
a high risk of heart attack or stroke, in whom a 20 mg dose was insufficient to reduce cholesterol
levels.
Treatment with Zaranta to reduce the risk of heart attack, stroke, or similar conditions:
The recommended dose is 20 mg once daily. However, your doctor may decide to use a lower
dose if the patient has any of the factors described above.
Use in children and adolescents
Recommended doses in children and adolescents aged 6–17 years
The recommended 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 achieve a dose appropriate for the patient.
The maximum daily dose of Zaranta is 10 mg or 20 mg in children and adolescents aged 6 to 17
years, depending on the condition being treated.
The medicine should be taken once daily.
Zaranta tablets of 30 mg or 40 mg strength should not be used in children and adolescents under
18 years of age.
How to take the medicine
Tablets should be swallowed whole with water.
Zaranta should be taken once daily. It can be taken at any time of day, with or without food.
It is recommended to take the medicine at the same time each day to help remember.
Regular cholesterol monitoring
Regular check-ups and blood tests are necessary to ensure that cholesterol levels have decreased
and remain within the normal range.
Your doctor may decide to adjust the dose of Zaranta to ensure it is appropriate for you.
Taking more than the recommended dose of Zaranta
Contact your doctor or go to the nearest hospital immediately.
If you are in hospital or being treated for another condition, inform medical staff that you are taking
Zaranta.
Missing a dose of Zaranta
Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
Stopping Zaranta
Tell your doctor if you wish to stop taking Zaranta. Cholesterol levels may rise again if treatment
with Zaranta is stopped.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
It is important for the patient to be aware of the possible adverse reactions. Usually, they are
mild and resolve within a short period of time.
The use of Zaranta should be discontinued and immediate medical assistance sought if
the following allergic reactions occur:

breathing difficulties with swelling of the face, lips, tongue and (or) throat, with or without,
swelling of the face, lips, tongue and (or) throat, which may cause difficulty in swallowing,
severe skin itching (with hives),
red, flat, disc-shaped or circular patches on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs, and around the eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
extensive rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The use of Zaranta should also be discontinued and immediate contact with a physician established if
muscle pain or other muscle-related symptoms persist longer than expected,
as muscle rupture may occur. Muscle-related symptoms occur more frequently in children and
adolescents than in adult patients. As with other statins, in a very small number of
patients, adverse effects on muscles have been observed. Rarely, in these patients, potentially life-threatening muscle damage called rhabdomyolysis has occurred. The use of Zaranta should be discontinued and immediate contact with a physician established if the patient develops a rash and joint disorders. These may be symptoms of a lupus-like syndrome associated with blood cell abnormalities.

Common adverse reactions: may occur in no more than 1 in 10 patients	Headache Abdominal pain Constipation Nausea Muscle pain Weakness Dizziness Increased protein in urine. This symptom usually resolves spontaneously without the need to discontinue Zaranta tablets. (This adverse reaction is common when the daily dose exceeds 20 mg). Diabetes. This is more likely if the patient has high levels of blood sugar and lipids, overweight, and high blood pressure. Patients should be monitored by a physician during treatment with this medicine.
Uncommon adverse reactions: may occur in no more than 1 in 100 patients	Skin rash, itching, and urticaria Increased protein in urine. This symptom usually resolves spontaneously without the need to discontinue Zaranta tablets. (This adverse reaction occurs uncommonly when the daily dose is 20 mg or less).
Rare adverse reactions: may occur in no more than 1 in 1000 patients	Severe allergic reaction – symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe skin itching (with raised bumps). If an allergic reaction is suspected, Zaranta should be stopped immediately and medical help sought. Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
	Muscle injury in adults – caution should be exercised, Zaranta should be discontinued, and medical advice sought promptly if unexplained muscle pain or discomfort occurs and persists longer than expected. Muscle rupture. Severe abdominal pain (pancreatitis). Increased liver enzyme activity in blood. Reduced platelet count, increasing the risk of bleeding or bruising.
Very rare adverse reactions: may occur in no more than 1 in 10,000 patients	Yellowing of the skin and eyes (jaundice) Hepatitis (liver inflammation) Blood in urine Nerve damage (peripheral neuropathy) Joint pain Memory loss Breast enlargement in men (gynecomastia).
Frequency unknown (frequency cannot be estimated from available data)	Depression Sleep disorders (including insomnia and nightmares) Cough Loose stools (diarrhea) Swelling (edema) Sexual problems Breathing problems (non-productive cough and/or shallow breathing or fever) Numbness, tingling, pain, and/or burning sensation in arms and/or legs (peripheral neuropathy) Tendon disorders, in some cases complicated by tendon rupture. Persistent muscle weakness Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing). Ocular myasthenia (a disease causing weakness of eye muscles). Patients should consult a doctor if they experience weakness in arms or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath. Thickening of supporting tissues between lung air sacs (interstitial lung disease) with symptoms such as breathlessness, cough, fever, fatigue, and weight loss.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in the leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
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.: 22 49-21-301
Fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicinal product can be collected.

5. How to store Zaranta

Keep this medicine out of the sight and reach of children.
Keep this medicine in its original packaging in order to protect it from light.
There are no special requirements regarding the storage temperature of the medicinal product.
Do not use this medicine after the expiry date stated on the carton and on the blisters after
the word "Exp:". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

6. Contents of the Packaging and Other Information

What Zaranta contains

The active substance is rosuvastatin.
Zaranta 5 mg, film-coated tablets: 5 mg of rosuvastatin (as rosuvastatin calcium) per tablet
Zaranta 10 mg, film-coated tablets: 10 mg of rosuvastatin (as rosuvastatin calcium) per tablet
Zaranta 15 mg, film-coated tablets: 15 mg of rosuvastatin (as rosuvastatin calcium) per tablet
Zaranta 20 mg, film-coated tablets: 20 mg of rosuvastatin (as rosuvastatin calcium) per tablet
Zaranta 30 mg, film-coated tablets: 30 mg of rosuvastatin (as rosuvastatin calcium) per tablet
Zaranta 40 mg, film-coated tablets: 40 mg of rosuvastatin (as rosuvastatin calcium) per tablet
Other ingredients are:
monohydrate lactose, microcrystalline cellulose type 12, magnesium hydroxide, magnesium stearate, crospovidone type A
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. Marked with the code "C33" on one side.
Approximate diameter: 5.5 mm, thickness: 2.7 – 3.3 mm.
Tablets are packed in blisters (PA/Aluminium/PVC/Aluminium). Each cardboard box contains 28, 30 or 56 film-coated tablets.

Zaranta 10 mg, film-coated tablets:
Round, biconvex, film-coated tablets, white or almost white. Marked with the code "C34" on one side.
Approximate diameter: 7.0 mm, thickness: 3.3 – 4.2 mm.

Zaranta 20 mg, film-coated tablets:
Round, biconvex, film-coated tablets, white or almost white. Marked with the code "C35" on one side.
Approximate diameter: 9.0 mm, thickness: 4.2 – 4.9 mm.

Zaranta 40 mg, film-coated tablets:
Oblong, film-coated tablets, white or almost white. Marked with the code "C36" on one side.
Approximate length: 15.5 mm, width: 8 mm, thickness: 4.5 – 5.5 mm.
Tablets are packed in blisters (PA/Aluminium/PVC/Aluminium). Each cardboard box contains 28 or 30 film-coated tablets.

Zaranta 15 mg, film-coated tablets:
Round, biconvex, film-coated tablets, white or almost white. Marked with the code "C37" on one side.
Approximate diameter: 8.0 mm, thickness: 4.1 – 4.6 mm.

Zaranta 30 mg, film-coated tablets:
Round, biconvex, film-coated tablets, white or almost white. Marked with the code "C38" on one side.
Approximate diameter: 10.0 mm, thickness: 5.5 – 6.2 mm.
Tablets are packed in blisters (PA/Aluminium/PVC/Aluminium). Each cardboard box 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

For further information about this medicinal product and its trade names in other European Economic Area countries, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]
(( logo of the marketing authorisation holder ))