Zahron

Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking this medicine, as 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 adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Zahron is and what it is used for
2. Important information before taking Zahron
3. How to take Zahron
4. Possible side effects
5. How to store Zahron
6. Contents of the pack and other information

1. What Zahron is and what it is used for

Zahron belongs to a group of medicines known as statins.
Why Zahron has been prescribed for you

• Zahron has been prescribed due to elevated cholesterol levels. This means there is an increased risk of heart attack or stroke. Zahron is used in adults, adolescents, and children aged 6 years and older for the treatment of high cholesterol levels.
• Your doctor has prescribed Zahron because diet and increased physical activity have not been sufficient to achieve normal blood cholesterol levels. Patients taking Zahron should continue to follow a cholesterol-lowering diet and maintain regular physical activity.

or

• Zahron may also be prescribed if you have other risk factors that increase the likelihood of a heart attack (myocardial infarction), stroke, or similar conditions.

Heart attack, stroke, and other related problems may be caused by atherosclerosis.
Atherosclerosis results from the buildup of fatty plaques in the blood vessels.
Why it is important to take Zahron regularly
Zahron 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: so-called "bad" cholesterol (LDL-C) and "good"
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cholesterol (HDL-C).

• Zahron may reduce levels of "bad" cholesterol and increase levels of "good" cholesterol.
• Zahron 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 noticeable symptoms or changes in how you feel.
However, if left untreated, fatty deposits may accumulate in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, interrupting blood flow 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 cholesterol levels return to normal after starting Zahron, you should continue taking the medicine. This helps prevent cholesterol levels from rising again and further accumulation of fatty deposits.
You should stop taking Zahron if your doctor advises you to do so, or if you become 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 inform her 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 discomfort,
• if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C 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 any doubts, they should contact their doctor again.

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

• if the patient has moderately severe kidney disease (if in doubt, consult a doctor),
• if the patient has thyroid disease,
• if the patient experiences frequent or unexplained muscle pain or discomfort, if the patient or their family members have had muscle disorders, or if muscle-related problems occurred previously during treatment with lipid-lowering medicines,
• if the patient regularly drinks large amounts of alcohol,
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• if the patient is taking fibrates, i.e. other medicines that lower cholesterol levels.

If any of the above situations apply to the patient or if the patient has any doubts,
the patient should contact their doctor again.
Warnings and precautions
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Before starting Zahron, discuss it with your 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 discomfort, patients with a personal or family history of muscle disorders, or muscle-related problems that occurred previously during treatment with lipid-lowering medicines. The patient should contact their doctor immediately if unexplained muscle pain or discomfort occurs, especially if accompanied by general malaise and fever. The doctor should also be informed if persistent muscle weakness develops,
• if the patient has or has had myasthenia gravis (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 or lead to the development of myasthenia (see section 4),
• if the patient has ever experienced severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Zahron or similar medicines,
• if the patient regularly drinks large amounts of alcohol,
• if the patient has thyroid disease,
• if the patient is taking cholesterol-lowering 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, e.g. ritonavir with lopinavir and (or) atazanavir, refer to the section: Zahron and other medicines,
• if the patient is taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (used to treat bacterial infections). Taking fusidic acid together with Zahron may lead to severe muscle damage (rhabdomyolysis),
• if the patient is over 70 years old (because the doctor must determine the appropriate starting dose),
• if the patient has severe respiratory insufficiency,
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor will determine the appropriate starting dose of Zahron for these patients.

If any of the above situations apply to the patient or if the patient has any doubts:
Do not take Zahron 40 mg (the highest dose), and before taking Zahron at any other dose,
consult your doctor or pharmacist.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Zahron. If any of the symptoms described in section 4 occur, stop taking Zahron and contact your doctor immediately.
In a small number of patients, statins may affect liver function. To monitor this effect, blood tests to check liver enzyme activity are performed. Usually, the doctor will recommend checking liver enzyme activity in the blood before starting and during treatment with Zahron.
While taking this medicine, the doctor will closely monitor whether the patient develops symptoms of diabetes or is at risk of developing diabetes. Patients at risk of developing diabetes are those who have elevated levels of glucose and lipids in the blood, are overweight, and have high blood pressure.
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Children and adolescents

• if the patient is under 6 years of age: Zahron should not be used in children under 6 years of age.
• if the patient is under 18 years of age: Zahron 40 mg is not suitable for use in children and adolescents under 18 years of age.

Zahron 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.
Inform your doctor if the patient is taking:

• cyclosporine (used, for example, after organ transplantation),
• anticoagulant medicines, e.g. warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken together with this medicine), ticagrelor, or clopidogrel,
• a fibrate (such as gemfibrozil, fenofibrate), or any other medicine that lowers blood cholesterol (e.g. ezetimibe),
• medicines used for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (see below and section Warnings and precautions),
• oral contraceptives,
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• hormone replacement therapy,
• 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 virus, administered 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 anaemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis).

Zahron may alter the effect of these medicines, or these medicines may alter the effect of Zahron.
If the patient needs to take fusidic acid orally to treat a bacterial infection, Zahron should be temporarily discontinued. The doctor will inform the patient when it is safe to resume taking Zahron. Concurrent use of Zahron with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
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.
Zahron should not be taken during pregnancy or while breastfeeding. If a woman becomes pregnant while taking Zahron, she should stop taking the medicine immediately and contact her doctor.
While taking Zahron, pregnancy should be avoided and effective methods of contraception should be used.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Most people can drive and operate machinery while taking Zahron. However, some patients may experience dizziness while taking this medicine. If the patient experiences such symptoms, they should contact their doctor before deciding to drive or operate machinery.
Zahron contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking Zahron.
Zahron 5 mg contains quinoline yellow, lac (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 sunset yellow (E 110) and cochineal red (E 124).
The medicine may cause allergic reactions.
A full list of excipients is provided in section 6 "Contents of the pack and other information".

3. How to take Zahron

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
consult your doctor or pharmacist.
Adults
Use of Zahron for lowering cholesterol levels
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 statins. The choice of starting dose depends on:

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

Your doctor will determine which starting dose is most appropriate for you.
Your doctor may decide to use a starting dose of 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 to severe kidney disease,
• the patient is at risk of muscle disorders (myopathy).

Dose escalation and maximum dose
Your doctor may decide to increase the dose as appropriate for the patient's needs. If treatment was initiated at 5 mg, your doctor may decide to increase it to 10 mg, then to 20 mg or 40 mg, if necessary. If treatment was initiated at 10 mg, your doctor may decide to increase it to 20 mg, then to 40 mg, if necessary. The treatment period with a stable dose between each increase is 4 weeks.
The maximum daily dose of Zahron is 40 mg. This dose is used in patients with high cholesterol levels and high risk of heart attack or stroke, in whom a 20 mg dose was insufficient to reduce cholesterol levels.
Use of Zahron to reduce the risk of heart attack, stroke, or similar health problems
The recommended daily dose is 20 mg; however, your doctor may decide to reduce it if the patient has any of the risk factors described above.
Use 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, and your doctor may gradually increase the dose as appropriate for the patient. The maximum daily dose of Zahron in children aged 6 to 17 years is 10 mg or 20 mg, depending on the condition being treated.
Zahron should be taken once daily. Zahron 40 mg should not be used in children.
How to take the medicine
The tablet should be swallowed whole with water.
Zahron should be taken once daily, at any time, with or without food.
It is recommended to take the medicine at the same time each day to help remember.
Cholesterol monitoring tests
To ensure cholesterol levels have decreased and remain within the target range, regular check-ups and blood tests are necessary.
Your doctor may decide to adjust the dose as appropriate for the patient.
If you take more Zahron than you should
If you take more Zahron than prescribed, contact your doctor or go to the nearest hospital immediately.
If you are admitted to hospital or are being treated for another condition, you should inform your doctor or medical staff that you are taking Zahron.
If you forget to take Zahron
Take the next dose at your usual time. Do not take a double dose to make up for a missed tablet.
Stopping Zahron
Tell your doctor if you wish to stop taking Zahron. Cholesterol levels may rise again if Zahron is discontinued.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
It is important for the patient to know which adverse reactions may occur. Usually, they are mild and resolve shortly after starting treatment.
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Immediately discontinue use of Zahron and seek medical help if the following allergic reactions occur:

• difficulty breathing with swelling of the face, lips, tongue and (or) throat, or without;
• swelling of the face, lips, tongue and (or) throat, which may cause difficulty in swallowing;
• severe itching of the skin (with hives);
• red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, peeling of the skin, ulceration in the mouth, throat, nose, genital organs and around the eyes. These potentially life-threatening skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Discontinue use of Zahron and contact your doctor immediately if the following occur:

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

Adverse reactions occurring frequently (in more than 1 in 100 but less than 1 in 10
patients treated)

• headache, abdominal pain, constipation, nausea, muscle pain, fatigue, dizziness;
• increased protein in urine. This symptom usually resolves spontaneously and treatment does not need to be discontinued (applies only to the 40 mg dose);
• diabetes. There is a high probability of developing diabetes in patients with elevated blood sugar and fat levels, overweight, and increased blood pressure. Your doctor will monitor your condition during treatment with this medicine.

Adverse reactions occurring not frequently (in more than 1 in 1,000 but less than 1 in 100
patients treated)

• rash, itching or other skin reactions;
• increased protein in urine. This symptom usually resolves spontaneously and treatment does not need to be discontinued (applies only to the 5 mg, 10 mg and 20 mg doses).

Adverse reactions occurring rarely (in more than 1 in 10,000 but less than 1 in 1,000
patients treated)

• severe allergic reactions – symptoms include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with hives); If a patient suspects an allergic reaction, they should immediately stop taking Zahron and seek medical help;
• muscle damage in adults – exercise caution, i.e. discontinue use of Zahron and contact your doctor immediately if muscle pain or other muscle-related symptoms persist longer than expected;
• severe abdominal pain (pancreatitis);
• increased levels of liver enzymes in blood;
• increased tendency to bleeding or bruising due to low platelet count;
• symptoms of lupus-like syndrome (such as rash, joint disorders and hematological changes).

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Adverse reactions occurring very rarely (in less than 1 in 10,000 patients treated)

• jaundice (yellowing of the skin and eyes), hepatitis, presence of blood in urine, nerve damage in upper and lower limbs (sensation of limb stiffness), joint pain, memory loss, breast enlargement in men (gynecomastia).

Adverse reactions with unknown frequency include:

• diarrhoea (loose stools), cough, shallow breathing, swelling (with itching), sleep disorders (insomnia and nightmares), sexual problems, breathing difficulties (non-productive cough and/or shallow breathing or fever), tendon damage, 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). Talk to your doctor if you experience weakness in hands or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Zahron

Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the specified month.
Do not use this medicine if you notice any visible signs of package damage.
Medicines must 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 Zahron contains

• The active substance is rosuvastatin. Zahron coated tablets contain rosuvastatin calcium in an amount corresponding to 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
• The other ingredients are:

Tablet core:
microcrystalline cellulose
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lactose monohydrate
crospovidone, type A
magnesium stearate

Coating composition for Zahron 5 mg:
lactose monohydrate
hypromellose
titanium dioxide (E 171)
triacetin
quinoline yellow lake (E 104)

Coating composition for Zahron 10 mg:
lactose monohydrate
hypromellose
titanium dioxide (E 171)
triacetin
allura red AC (E 129)

Coating composition for Zahron 20 mg:
lactose monohydrate
hypromellose
titanium dioxide (E 171)
triacetin
carmine (E 120)

Coating composition for Zahron 40 mg:
lactose monohydrate
hypromellose
titanium dioxide (E 171)
triacetin
orange-yellow FCF (E 110)
carmoisine A (E 124)

What Zahron looks like and contents of the pack
Zahron is packed in blisters and cardboard boxes containing 28, 30, 56, or 98 tablets.
Not all pack sizes may be marketed.

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

Marketing Authorisation Holder and Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
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