Zahron

Package Leaflet: Information for the Patient

Zahron, 15 mg, Film-Coated Tablets

Zahron, 30 mg, Film-Coated Tablets

Rosuvastatinum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

What is Zahron and what is it used for
Important information before taking Zahron
How to take Zahron
Possible side effects
How to store Zahron
Contents of the pack and other information

1. What is Zahron and What is it Used For

Zahron belongs to a group of medications called statins.

Zahron Has Been Prescribed to the Patient Because:

• The patient has high cholesterol levels. This means 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 that the patient take a statin because diet and exercise changes were not enough to achieve normal cholesterol levels in the blood. The patient taking Zahron should also follow a cholesterol-lowering diet and exercise.

or

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

Heart attack, stroke, and other problems can be caused by a disease called atherosclerosis.
Atherosclerosis is the result of fat deposits building up in the blood vessels.

Why is it Important to Take Zahron Regularly

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

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

Most people with high cholesterol do not feel unwell, as it does not cause any symptoms. However, if left untreated, it can lead to the buildup of fatty substances in the walls of blood vessels and their narrowing.
Sometimes, a narrowed blood vessel can become blocked, cutting off blood flow to the heart or brain, leading to a heart attack or stroke. Lowering blood cholesterol levels reduces the risk of heart attack, stroke, or similar diseases.
Even if Zahron lowers cholesterol levels to normal, the patient should continue taking it. This prevents cholesterol levels from rising again, which can lead to the buildup of fatty substances. However, the patient should stop taking Zahron if their doctor advises them to or if they 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 medication (listed in section 6).
• If the patient is pregnant or breastfeeding. If a woman taking Zahron becomes pregnant, she should stop taking it immediately and consult her doctor. Women taking Zahron should avoid becoming pregnant using effective birth control methods.
• If the patient has liver disease.
• If the patient has severe kidney disease.
• If the patient has 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 medication used, for example, after organ transplantation). If any of the above situations apply to the patient or they have doubts, they should consult their doctor again.

In Addition, Do Not Take Zahron at a Dose of 30 mg or 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 has ever had frequent or unexplained muscle pain or weakness, or if they or a family member have had muscle diseases, or if they have previously experienced muscle problems while taking cholesterol-lowering medications.
• 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 (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medication. If any of the above situations apply to the patient (or they have doubts), they should consult their doctor again.

Warnings and Precautions

Before starting Zahron, consult a doctor or pharmacist:

• If the patient has kidney disease.
• If the patient has liver disease.
• If the patient has ever had frequent or unexplained muscle pain or weakness, or if they or a family member have had muscle diseases, or if they have previously experienced muscle problems while taking cholesterol-lowering medications. The patient should immediately consult their doctor if they experience unexplained muscle pain or weakness, especially if accompanied by general malaise or fever. They should also inform their doctor or pharmacist if they experience persistent muscle weakness.
• 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 eye muscle weakness), as statins can sometimes exacerbate symptoms or lead to 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 medications.
• If the patient regularly consumes large amounts of alcohol.
• If the patient has thyroid disorders.
• If the patient is taking fibrates to lower cholesterol levels. The patient should read this leaflet carefully, even if they have taken other cholesterol-lowering medications before.
• If the patient is taking medications for HIV infection, such as ritonavir with lopinavir and/or atazanavir, see "Zahron and Other Medications".
• If the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection within the last 7 days. Taking fusidic acid with Zahron can lead to severe muscle damage (rhabdomyolysis); see "Zahron and Other Medications".
• If the patient is over 70 years old (as the doctor needs to choose an appropriate starting dose of Zahron for the patient).
• If the patient has severe respiratory failure.
• If the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). For these patients, the doctor needs to determine the appropriate starting dose of Zahron.

If any of the above situations apply to the patient (or they have doubts):

Do Not Take Zahron at a Dose of 30 mg or 40 mg (the Highest Dose) and Before Taking Zahron at Any Other Dose, Consult a Doctor or Pharmacist.

Rosuvastatin has been associated with severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient experiences any of the symptoms described in section 4, they should stop taking Zahron and consult their doctor immediately.
In a small group of patients, statins may affect liver function. To confirm this effect, a blood test is performed to check liver enzyme activity. Usually, the doctor recommends a liver enzyme test before starting and during Zahron treatment.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medication. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and Adolescents

• If the patient is under 6 years old: Zahron should not be used in children under 6 years old.
• If the patient is under 18 years old: Zahron at a dose of 30 mg or 40 mg is not suitable for use in children and adolescents under 18 years old.

Zahron and Other Medications

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

• Cyclosporine (used, for example, after organ transplantation),
• Warfarin, clopidogrel, or ticagrelor (or any other blood-thinning medication),
• A fibrate (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medication (e.g., ezetimibe),
• Medications for indigestion (used to neutralize stomach acid),
• Erythromycin (an antibiotic), fusidic acid (an antibiotic - see below and "Warnings and Precautions"),
• Oral contraceptives,
• Regorafenib (used to treat cancer),
• Darolutamide (used to treat cancer),
• Cabozantinib (used to treat cancer),
• Hormone replacement therapy,
• Fostamatinib (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 medications used to treat viral infections, including HIV or hepatitis C, alone or in combination with other medications (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 way these medications work, or these medications may affect the way Zahron works.
If the patient is being treated for a bacterial infection and needs to take fusidic acid orally, they should temporarily stop taking Zahron. The doctor will inform the patient when it is safe to restart 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 baby, they should consult their doctor or pharmacist before taking this medication.
Zahron Should Not Be Takenduring pregnancy or breastfeeding. If the patient becomes pregnant while taking Zahron, they should stop taking it immediatelyand consult their doctor. Women taking Zahron should avoid becoming pregnant using effective birth control methods.
Before taking any medication, the patient should consult their doctor or pharmacist.

Driving and Using Machines

Most people can drive and use machines while taking Zahron - it will not affect their ability. However, some patients may experience dizziness while taking Zahron. If the patient experiences dizziness, they should consult their doctor before driving or using machines.
Zahron Contains Lactose.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Zahron.

Zahron Contains Yellow Iron Oxide, Lake (E104).

It may cause allergic reactions.
A full list of excipients is found in section 6 "Contents of the Pack and Other Information".

3. How to Take Zahron

This medication should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

Usual Doses for Adults

Taking Zahron to Lower Cholesterol Levels:

Starting Dose

Zahron treatment should be started with a dose of 5 mg or 10 mg, even if the patient has taken higher doses of another statin before. The starting dose depends on:

• Cholesterol levels.
• The degree of risk of heart attack or stroke.
• The presence of factors that increase the risk of side effects. The patient should ask their doctor or pharmacist which starting dose of Zahron is most suitable for them.

The doctor may decide to use the lowest dose (5 mg) 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 pain or weakness (myopathy).

Increasing the Dose and Maximum Daily Dose

The doctor may decide to increase the dose to suit the patient's needs.
If the patient starts with a dose of 5 mg, the doctor may increase the dose gradually to a maximum of 40 mg once daily if necessary. If the patient starts with a dose of 10 mg, the doctor may increase the dose to 20 mg and then to 40 mg if necessary. There will be an interval of 4 weeks between each dose increase.
The maximum daily dose of Zahron is 40 mg. It is used only in patients with very high cholesterol levels and a high risk of heart attack or stroke, for whom lower doses have not been sufficient 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 6-17 years is 5-20 mg once daily. The usual starting dose is 5 mg. The doctor may increase the dose to suit the patient's needs. The maximum daily dose of Zahron in children aged 6-17 years is 10 mg or 20 mg, depending on the disease being treated. The medication should be taken once daily. Zahron at a dose of 30 mg or 40 mg should not be usedin children.

Taking the Medication

Each tablet should be swallowed whole with water.
Zahron should be taken once daily. The medication can be taken at any time of day, with or without food.
The patient should try to take the tablet at the same time every day to help them remember.

Regular Cholesterol Checks

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

Taking More Than the Recommended Dose of Zahron

The patient should consult their doctor or go to the nearest hospital.
If the patient is in the hospital or being treated for another illness, they should inform the medical staff that they are taking Zahron.

Missing a Dose of Zahron

The patient should take the next dose at the usual time without worrying. They should not take a double dose to make up for the missed dose.

Stopping Zahron Treatment

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

4. Possible Side Effects

Like all medications, Zahron can cause side effects, although not everybody gets them.
It is essential for the patient to know which side effects can occur. They are usually mild and disappear shortly after starting treatment.
The patient should stop taking Zahron immediately and seek medical helpif they experience the following allergic reactions:

• Difficulty breathing, which may be accompanied by swelling of the face, lips, tongue, and/or throat,
• Swelling of the face, lips, tongue, and/or throat, which may 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 may 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 last longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adults. As with other statins, rare cases of muscle damage have been reported in patients. In very rare cases, this has led to potentially life-threatening muscle damage (rhabdomyolysis);
• Muscle rupture;
• Symptoms of a lupus-like syndrome(such as rash, joint diseases, and hematological changes).

Common Side Effects (May Occur in More Than 1 in 100 but Less Than 1 in 10 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 Zahron (applies only to a dose of 40 mg).
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The treating doctor will monitor patients at risk while they are taking this medication.

The patient's doctor will monitor them for diabetes while they are taking this medication.

Uncommon Side Effects (May Occur in More Than 1 in 1,000 but Less Than 1 in 100 Patients):

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

Rare Side Effects (May Occur in More Than 1 in 10,000 but Less Than 1 in 1,000 Patients):

• 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 the patient suspects an allergic reaction, they should stop taking Zahron immediately and seek medical help.
• Muscle damage in adults, the patient should stop taking Zahron and consult their doctor immediately if they experience muscle pain or other muscle symptoms that last longer than expected.
• Severe abdominal pain (pancreatitis).
• Bleeding or bruising more easily than usual due to a low platelet count.
• Increased liver enzymes in the blood.
• Symptoms of a lupus-like syndrome (such as rash, joint diseases, and hematological changes).

Very Rare Side Effects (May Occur in Less Than 1 in 10,000 Patients):

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

Side Effects with Unknown Frequency:

• Diarrhea (loose stools), cough, shortness of breath, swelling, sleep disturbances (insomnia and nightmares), sexual dysfunction, depression, breathing problems (persistent cough and/or shortness of breath 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 eye muscle weakness). The patient should talk to 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 not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration 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 this medication.

5. How to Store Zahron

The medication should be stored out of sight and reach of children.
Store in the original packaging to protect from light. Do not use this medication after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.
Do not use this medication if visible signs of deterioration are observed.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Zahron Contains

• The active substance of Zahron is rosuvastatin. Zahron film-coated tablets contain calcium rosuvastatin equivalent to 15 mg or 30 mg of rosuvastatin.
• Other ingredients of the medication are:

Tablet core
o Microcrystalline cellulose, type 102
o Lactose monohydrate
o Crospovidone, type A
o Magnesium stearate
Tablet coating
o Lactose monohydrate
o Hypromellose
o Titanium dioxide (E 171)
o Triacetin
o Yellow iron oxide, lake (E 104)

What Zahron Looks Like and Contents of the Pack

Zahron is available in blisters containing 7, 10, 14, 28, 30, 56, 60, 84, 90, 98, or 100 tablets.
Not all pack sizes may be marketed.
Zahron 15 mg film-coated tablets: round, biconvex, pale yellow tablets, 8 mm in diameter, with the symbol "15" embossed on one side and "^ 15" on the other side.
Zahron 30 mg film-coated tablets: round, biconvex, pale yellow tablets, 10 mm in diameter, with the symbol "30" embossed 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:January 2025