Zahron

Leaflet accompanying the packaging: patient information

Zahron, 5 mg, film-coated tablets

Zahron, 10 mg, film-coated tablets

Zahron, 20 mg film-coated tablets

Zahron, 40 mg, film-coated tablets

Rosuvastatinum

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Zahron and what is it used for
• 2. Important information before taking Zahron
• 3. How to take Zahron
• 4. Possible side effects
• 5. How to store Zahron
• 6. Package contents and other information

1. What is Zahron and what is it used for

Zahron belongs to a group of medicines called statins.

Why is Zahron recommended for the patient

• Zahron is recommended due to high cholesterol levels. This means that there is a risk of heart attack or stroke. Zahron is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol levels.
• The doctor has recommended taking Zahron because diet and increased physical activity have proven insufficient to achieve normal cholesterol levels in the blood. Patients taking Zahron should also follow a low-cholesterol diet and exercise regularly.

or

• Zahron is also recommended if the patient has other factors that increase the risk of heart attack (myocardial infarction), stroke, or similar diseases.

Heart attack, stroke, and other problems can be caused by atherosclerosis of the arteries.
Atherosclerosis of the arteries is the result of the accumulation of atherosclerotic plaques in the blood vessels.

Why is it essential to take Zahron continuously

Zahron is used to achieve normal levels of fatty substances in the blood. The most common of these is cholesterol.
There are different types of cholesterol in the blood, so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Zahron may cause a decrease in "bad" cholesterol and an increase in "good" cholesterol.
• The action of Zahron involves inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the blood.

In most people, high cholesterol levels do not affect their well-being, as they do not cause any symptoms. However, if left untreated, it can lead to the accumulation of fatty deposits in the walls of blood vessels and their narrowing.
Sometimes, this can lead to the blockage of a narrowed blood vessel, disruption of blood flow to the heart or brain, and consequently, a heart attack or stroke. Achieving normal cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar diseases.
Even if the cholesterol level is normal after taking Zahron, the patient should continue taking it. This prevents the cholesterol level from increasing again, which can lead to the accumulation of fatty deposits.
The patient should stop taking Zahron if the doctor advises it or if the patient becomes pregnant.

2. Important information before taking Zahron

When not to take Zahron:

• if the patient is allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
• if the patient is pregnant or breastfeeding. If a woman taking Zahron becomes pregnant, she should stop taking the medicine immediately and consult a doctor. Women taking Zahron should use effective methods of contraception.
• if the patient has liver disease.
• if the patient has severe kidney disease.
• if the patient experiences frequent or unexplained muscle pain or weakness.
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection).
• if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation). If any of the above situations apply to the patient or if the patient has doubts, they should consult their doctor again.

In addition, do not take Zahron 40 mg (the highest dose):

• if the patient has moderately severe kidney disease (in case of doubt, consult a doctor).
• if the patient has thyroid disease.
• if the patient experiences frequent or unexplained muscle pain or weakness, or if the patient or their family members have had muscle diseases, or if muscle disorders have occurred previously while taking cholesterol-lowering medicines.
• if the patient regularly consumes large amounts of alcohol.
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• if the patient is taking fibrates (another type of cholesterol-lowering medicine).

If any of the above situations apply to the patient or if the patient has doubts, they should consult their doctor again.

Warnings and precautions

Before starting to take Zahron, the patient should discuss it with their doctor or pharmacist.

• if the patient has kidney disease.
• if the patient has liver disease.
• if the patient experiences frequent or unexplained muscle pain or weakness, or if the patient or their family members have had muscle diseases, or if muscle disorders have occurred previously while taking cholesterol-lowering medicines. The patient should contact their doctor immediately if they experience muscle pain or weakness of unknown origin, especially if accompanied by general malaise and fever. The patient should also inform their doctor if they experience persistent muscle weakness.
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, or ulcers in the mouth after taking Zahron or similar medicines.
• if the patient regularly consumes large amounts of alcohol.
• if the patient has thyroid disease.
• if the patient is taking fibrates (another type of cholesterol-lowering medicine). The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medicines before.
• if the patient is taking medicines used to treat HIV, such as ritonavir with lopinavir and/or atazanavir, they should consult the information in the section: Zahron and other medicines.
• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (a medicine used to treat bacterial infections). Taking fusidic acid at the same time as Zahron can lead to severe muscle damage (rhabdomyolysis).
• if the patient is over 70 years old (as the doctor will need to choose an appropriate initial dose for the patient).
• if the patient has severe respiratory failure.
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In these patients, the doctor will determine the appropriate initial dose of Zahron.

If any of the above situations apply to the patient or if the patient has doubts:

Do not take Zahron 40 mg (the highest dose), and before taking Zahron in any other dose, consult a doctor or pharmacist

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Zahron. If the patient experiences any of the symptoms described in section 4, they should stop taking Zahron and seek medical attention immediately.
A small number of patients taking statins may experience liver damage. To confirm this, a blood test is performed to check liver enzyme activity. Usually, the doctor recommends performing a liver enzyme activity test in the blood before and during treatment with Zahron.
During treatment with this medicine, the doctor will closely monitor the patient for signs of diabetes or an increased risk of developing diabetes. Patients at risk of developing diabetes are those with high blood sugar and fat levels, overweight, and high blood pressure.

Children and adolescents

• if the patient is under 6 years old: Zahron should not be taken by children under 6 years old.
• if the patient is under 18 years old: Zahron 40 mg is not suitable for children and adolescents under 18 years old.

Zahron and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor if they are taking:

• cyclosporine (used, for example, after organ transplantation).
• blood thinners, such as warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken with this medicine), ticagrelor, or clopidogrel.
• fibrates (such as gemfibrozil or fenofibrate) or any other cholesterol-lowering medicine (such as ezetimibe).
• medicines used to treat indigestion (used to neutralize stomach acid).
• erythromycin (an antibiotic), fusidic acid (see above and the Warnings and precautions section).
• oral contraceptives.
• regorafenib (used to treat cancer).
• darolutamide (used to treat cancer).
• camptothecin (used to treat cancer).
• hormone replacement therapy.
• fosfomycin (used to treat low platelet count).
• febuxostat (used to treat and prevent high uric acid levels 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, taken alone or in combination with other medicines (see Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• roxadustat (used to treat anemia in patients with chronic kidney disease).
• tafamidis (used to treat transthyretin amyloidosis).

Zahron may affect the action of these medicines, or these medicines may affect the action of Zahron.
If the patient needs to take fusidic acid orally for a bacterial infection, they should temporarily stop taking Zahron. The doctor will inform the patient when it is safe to resume taking Zahron. Taking Zahron with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Zahron should not be taken during pregnancy or breastfeeding. If the patient becomes pregnant while taking Zahron, they should stop taking the medicine immediately and consult their doctor. While taking Zahron, the patient should avoid becoming pregnant and use effective methods of contraception.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Most people can drive and use machines while taking Zahron. However, some patients may experience dizziness while taking this medicine. If the patient experiences such symptoms, they should consult their doctor before deciding to drive or operate machinery.

Zahron contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking Zahron.

Zahron 5 mg contains quinoline yellow, lake (E 104).

The medicine may cause allergic reactions.

Zahron 10 mg contains allura red AC (E 129).

The medicine may cause allergic reactions.

Zahron 40 mg contains orange yellow (E 110) and cochineal red (E 124).

The medicine may cause allergic reactions.
A full list of excipients is included in section 6 "Package contents and other information".

3. How to take Zahron

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Adults

Taking Zahron to lower cholesterol levels

Initial dose

Treatment should be started with a dose of 5 mg or 10 mg, even if the patient has taken higher doses of other statins before. The size of the initial dose depends on:

• cholesterol levels.
• the degree of risk of heart attack or stroke in the patient.
• the presence of factors that increase the patient's susceptibility to side effects.

The doctor will determine the most suitable initial dose for the patient.
The doctor may decide to use a dose of 5 mg as the initial dose if:

• the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• the patient is over 70 years old.
• the patient has moderately severe kidney disease.
• the patient is at risk of muscle disease (myopathy).

Increasing the dose and maximum dose

The doctor may decide to increase the dose to suit the patient's needs. If the patient started treatment with a dose of 5 mg, the doctor may decide to increase it to 10 mg, then to 20 mg or 40 mg if necessary. If the patient started treatment with a dose of 10 mg, the doctor may decide to increase it to 20 mg, then to 40 mg if necessary. The treatment period with the established dose between each increase is 4 weeks.
The maximum daily dose of Zahron is 40 mg. It is used in patients with high cholesterol levels and a high risk of heart attack or stroke, in whom a dose of 20 mg was insufficient to lower cholesterol levels.

Taking Zahron to reduce the risk of heart attack or stroke or similar health problems

The recommended daily dose is 20 mg, but the doctor may decide to reduce it if the patient has the factors mentioned above.

Taking Zahron in 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 initial dose is 5 mg once daily, and the doctor may gradually increase the dose to suit the patient's needs. The maximum daily dose of Zahron in children aged 6 to 17 years is 10 mg or 20 mg, depending on the disease being treated.
The medicine should be taken once daily. Zahron 40 mg should not be taken by children.

Taking the medicine

The tablet should be swallowed whole with water.
Zahron should be taken once dailyat any time, with or without food.
It is recommended to take the medicine at the same time every day to make it easier to remember.

Cholesterol checks

To ensure that cholesterol levels have decreased and are normal, regular check-ups and blood tests should be performed.
The doctor may decide to increase the dose to suit the patient's needs.

Taking a higher dose of Zahron than recommended

In case of taking a higher dose of Zahron than recommended, the patient should consult their doctor or go to the nearest hospital.
If the patient is hospitalized or being treated for another illness, they should inform their doctor or other medical staff that they are taking Zahron.

Missing a dose of Zahron

The patient should take the next dose at the usual time. They should not take a double dose to make up for the missed tablet.

Stopping Zahron

The patient should tell their doctor if they want to stop taking Zahron. Cholesterol levels may increase again if Zahron is stopped.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Zahron can cause side effects, although not everybody gets them.
It is essential for the patient to know what side effects can occur. Usually, they are mild and disappear shortly after starting treatment.
The patient should stop taking Zahron and seek medical attention immediatelyif they experience the following allergic reactions:

• difficulty breathing with swelling of the face, lips, tongue, and/or throat, or without.
• swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing.
• severe itching of the skin (with hives).
• red, flat, round, or oval patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

The patient should stop taking Zahron and consult their doctor immediately if they experience:

• muscle pain or other muscle symptomsthat persist longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, a very small number of patients have experienced adverse effects on muscles. Rarely, these patients have developed potentially life-threatening muscle damage (rhabdomyolysis).
• muscle rupture.
• symptoms of lupus-like syndrome(such as rash, joint disease, and hematological changes).

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 treated patients)

• headache, abdominal pain, constipation, nausea, muscle pain, weakness, dizziness.
• increased protein in the urine. This usually resolves on its own and does not require stopping treatment (only applies to a dose of 40 mg).
• diabetes. There is a high likelihood of developing diabetes in patients with high blood sugar and fat levels, overweight, and high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

Uncommon side effects (occurring in more than 1 in 1,000 but less than 1 in 100 treated patients)

• rash, itching, or other skin reactions.
• increased protein in the urine. This usually resolves on its own and does not require stopping treatment (only applies to doses of 5 mg, 10 mg, and 20 mg).

Rare side effects (occurring in more than 1 in 10,000 but less than 1 in 1,000 treated patients)

• severe allergic reactions - including swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe itching of the skin (with hives).

If the patient suspects they have had an allergic reaction, they should stop taking Zahron and seek medical attention immediately.

• muscle damage in adults - the patient should exercise caution, i.e., stop taking Zahron and consult their doctor immediately if they experience muscle pain or weakness of unknown origin.
• severe abdominal pain (pancreatitis).
• increased liver enzyme levels in the blood.
• increased tendency to bleed or bruise due to low platelet count.
• symptoms of lupus-like syndrome (such as rash, joint disease, and hematological changes).

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Very rare side effects (occurring in less than 1 in 10,000 treated patients)

• jaundice (yellowing of the skin and eyes), liver inflammation, blood in the urine, nerve damage in the arms and legs (felt as stiffness), joint pain, memory loss, breast enlargement in men (gynecomastia).

Side effects with unknown frequency:

• diarrhea (loose stools), cough, shortness of breath, swelling (with itching), sleep disturbances (insomnia and nightmares), sexual problems, depression, breathing problems (non-productive cough and/or shortness of breath or fever), tendon damage, persistent muscle weakness.
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing), ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient should discuss with their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 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 gather more information on the safety of the medicine.

5. How to store Zahron

The medicine should be stored out of sight and reach of children.
It should be stored in its original packaging to protect it from light and moisture.
The medicine should not be taken after the expiration date stated on the carton and blister pack after EXP. The expiration date refers to the last day of the given month.
The medicine should not be taken if visible signs of package damage are observed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Zahron contains

• The active substance of Zahron is rosuvastatin. Zahron film-coated tablets contain calcium rosuvastatin equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
• Other ingredients of the medicine are:

tablet core:
microcrystalline cellulose
lactose monohydrate
crospon, type A
magnesium stearate
coating Zahron 5 mg:
lactose monohydrate
hypromellose
titanium dioxide (E 171)
triacetin
quinoline yellow, lake (E 104)
coating Zahron 10 mg:
lactose monohydrate
hypromellose
titanium dioxide (E 171)
triacetin
allura red AC (E 129)
coating Zahron 20 mg:
lactose monohydrate
hypromellose
titanium dioxide (E 171)
triacetin
carmine (E 120)
coating Zahron 40 mg:
lactose monohydrate
hypromellose
titanium dioxide (E 171)
triacetin
orange yellow FCF (E 110)
cochineal red A (E 124)

What Zahron looks like and contents of the pack

Zahron is packaged in blisters and cardboard boxes containing 28, 30, 56, or 98 tablets.
Not all pack sizes may be marketed.

• Zahron, 5 mg, film-coated tablets: light yellow, round, biconvex tablets with "5" engraved on one side.
• Zahron, 10 mg, film-coated tablets: light pink, round, biconvex tablets with "10" engraved on one side.
• Zahron, 20 mg, film-coated tablets: dark pink, round, biconvex tablets with "20" engraved on one side.
• Zahron, 40 mg, film-coated tablets: red, round, biconvex tablets with "40" engraved on one side.

Marketing authorization holder and manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Date of last revision of the leaflet:February 2025
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