Zahron

Package leaflet: information for the user

Zahron, 15 mg, coated tablets
Zahron, 30 mg, coated tablets
Rosuvastatin
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:
What Zahron is and what it is 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 Zahron is and what it is used for

Zahron belongs to a group of medicines called statins.
Zahron has been prescribed for the patient because:

• The patient has been diagnosed with high cholesterol levels. This means there is a 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.
• The doctor has recommended that the patient take a statin because changes in diet and increased physical activity have not been sufficient to achieve normal cholesterol levels in the blood. The patient taking Zahron should also follow a cholesterol-lowering diet and engage in regular physical exercise.

or

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

Heart attack, stroke, and other problems may be caused by a condition called atherosclerosis.
Atherosclerosis results from the buildup of fatty deposits in blood vessels.
Why it is important to take Zahron regularly
Zahron is used to achieve normal levels of fatty substances in the blood called lipids.
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 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 symptoms and does not affect how a person feels. However, if left untreated, fatty deposits build up in the walls of blood vessels, causing them to narrow.
Sometimes the narrowed blood vessel may become blocked, cutting off blood supply to the heart or brain, leading to a heart attack or stroke. Lowering cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar conditions.
Even if cholesterol levels become normal after taking Zahron, you must continue taking the medicine. This prevents cholesterol levels from rising again, which could lead to further fatty deposits. However, you should stop taking the medicine if your doctor advises you to do so, or if you become pregnant.

2. Important information before using Zahron

When not to use 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 avoid becoming pregnant by using effective contraceptive methods.
• 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 use Zahron at a dose of 30 mg or 40 mg (the highest dose):

• If the patient has moderate kidney disease (if in doubt, consult the doctor).
• If the patient has thyroid disease.
• If the patient has ever experienced frequent or unexplained muscle pain or discomfort, if the patient or a family member has been diagnosed with muscle disorders, or if muscle-related side effects occurred previously during treatment with 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 medicines called fibrates to lower 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 Zahron, consult a doctor or pharmacist:

• If the patient has kidney disease.
• If the patient has liver disease.
• If the patient has ever experienced frequent or unexplained muscle pain or discomfort, if the patient or a family member has been diagnosed with muscle disorders, or if muscle-related side effects occurred previously during treatment with cholesterol-lowering medicines. The patient should contact their doctor immediately if they experience unexplained muscle pain or discomfort, especially if accompanied by general malaise or fever. The doctor or pharmacist should also be informed if persistent muscle weakness occurs.
• 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), as statins may sometimes worsen symptoms or trigger the onset 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 other similar medicines.
• If the patient regularly consumes large amounts of alcohol.
• If the patient has thyroid disorders.
• If the patient is taking medicines called fibrates to lower cholesterol levels. Read this 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; see 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); see section: Zahron and other medicines.
• If the patient is over 70 years old (because the doctor must select an appropriate starting dose of Zahron).
• If the patient has severe respiratory insufficiency.
• If the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In these patients, the doctor must determine the appropriate starting dose of Zahron.

If any of the above situations apply to the patient (or if the patient has any 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, contact a doctor or pharmacist.
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 Zahron and contact a doctor immediately.
In a small number of patients, statins may affect liver function. To confirm this effect, blood tests checking liver enzyme activity are performed. Usually, the doctor will recommend checking liver enzyme activity in blood (liver function tests) before starting and during treatment with Zahron.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. 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 of age: Zahron should not be used in children under 6 years of age.
• If the patient is under 18 years of age: Zahron at a dose of 30 mg or 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 you are currently taking, have recently taken, or plan to take.
Inform your doctor if you are taking:

• cyclosporine (used, for example, after organ transplantation),
• warfarin, clopidogrel, or ticagrelor (or any other blood-thinning medicine),
• a fibrate medicine (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 (an antibiotic - 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 blood uric acid levels),
• teriflunomide (used to treat multiple sclerosis),
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, 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 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 restart Zahron. Taking 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 is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Zahron must not be used during pregnancy or while breastfeeding. If a woman becomes pregnant while taking Zahron, she must stop taking Zahron immediately and contact her doctor. Women taking Zahron should avoid becoming pregnant by using effective contraceptive methods.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Most people can drive and operate machinery while taking Zahron – it will not impair their abilities. However, some patients may experience dizziness while taking Zahron. If the patient experiences dizziness, they should contact their doctor before driving or operating machinery.

Zahron contains lactose.
If the patient has previously been diagnosed with an intolerance to certain sugars, they should contact their doctor before taking Zahron.

Zahron contains quinoline yellow, lac (E104).
It may cause allergic reactions.
A complete 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 directed by your doctor. If in doubt, consult your doctor or pharmacist.

Usual doses for adults

Zahron for lowering cholesterol levels:

Starting dose
Treatment with Zahron should be initiated at a dose of 5 mg or 10 mg, even if the patient has previously taken higher doses of another statin. 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. Ask your doctor or pharmacist which starting dose of Zahron is most appropriate for the patient.

Your doctor may decide to start with 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 to severe kidney disease.
• The patient is at risk of developing muscle pain or muscle disorders (myopathy).

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose as appropriate for the patient's needs.
If treatment is initiated at 5 mg, your doctor may decide to gradually increase the dose up to a maximum of 40 mg once daily, if necessary. If treatment is initiated at 10 mg, your doctor may decide to increase the dose to 20 mg, and subsequently to 40 mg, if necessary. An interval of 4 weeks should be maintained between each dose increase.
The maximum daily dose of Zahron is 40 mg. This dose is used only in patients with high cholesterol levels and a high risk of heart attack or stroke, in whom lower doses have been insufficient to reduce cholesterol levels.

Zahron for reducing the risk of heart attack, stroke, or similar health problems:
The recommended daily dose is 20 mg. However, your doctor may decide to reduce this dose 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 mg to 20 mg once daily. The usual starting dose is 5 mg. Your doctor may increase the dose as appropriate for the patient. The maximum daily dose of Zahron in children and adolescents aged 6 to 17 years is 10 mg or 20 mg, depending on the condition being treated. The medicine should be taken once daily. Zahron at doses of 30 mg or 40 mg must not be used in children.

How to take the medicine
Each tablet should be swallowed whole with water.
Zahron should be taken once daily. It can be taken at any time of day, with or without food.
Try to take the tablet at the same time each day to help you remember.

Regular cholesterol monitoring
To ensure that cholesterol levels have decreased and remain within the normal range, regular check-ups and blood tests are necessary.
Your doctor may decide to increase the dose of Zahron as appropriate for the patient.

If you take more Zahron than prescribed
Contact your doctor or go to the nearest hospital immediately.
If you are in hospital or being treated for another condition, inform the medical staff that you are taking Zahron.

If you miss a dose of Zahron
Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

Stopping Zahron
Tell your doctor if you wish to stop taking Zahron. Cholesterol levels may rise again if you stop taking Zahron.

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 will experience them.
It is important for the patient to be aware of the possible adverse reactions. Usually, they are
mild and resolve shortly after starting treatment.
You must stop taking Zahron immediately and seek medical help if the following allergic
reactions occur:

• Difficulty breathing, possibly 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 skin itching (with hives),
• Red, flat, disc-shaped or circular rashes on the trunk, often with blisters in the center, peeling of the skin, ulcers 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).

You should stop taking Zahron and contact your doctor immediately if:

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

Common adverse reactions (may occur in more than 1 in 100 but not more than 1 in 10 patients):

• Headache, abdominal pain, constipation, nausea, muscle pain, fatigue, dizziness.
• Increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of Zahron (applies only to the 40 mg dose).
• Diabetes. The likelihood of developing diabetes is higher if the patient has high blood sugar and lipid levels, overweight and high blood pressure. The treating physician
  will monitor patients at risk during treatment with this
  medicine.

Uncommon adverse reactions (may occur in more than 1 in 1,000 but not more than 1 in 100 patients):

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

Rare adverse reactions (may occur in more than 1 in 10,000 but not more 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 skin itching (with hives). If a patient suspects an allergic reaction, they should stop taking Zahron immediately and seek medical help.
• Muscle damage in adults – exercise caution: discontinue Zahron and contact your doctor immediately if muscle pain or other muscle symptoms persist longer than expected.
• Severe abdominal pain (pancreatitis).
• Increased tendency to bleeding or bruising due to low platelet count.
• Increased blood levels of liver enzymes.
• Symptoms of a lupus-like syndrome (such as rash, joint disorders and hematological changes).

Very rare adverse reactions (may occur in not more than 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes), hepatitis, presence of blood in urine, damage to nerves in the upper and lower limbs (felt as numbness), joint pain, memory loss, breast enlargement in men (gynecomastia).

Adverse reactions with unknown frequency include:

• Diarrhea (loose stools), cough, shallow breathing, swelling, sleep disturbances (insomnia and nightmares), sexual dysfunction, breathing problems (persistent 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 the eye muscles). You should talk to your doctor if you experience weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 to provide more information on the safety of the medicine.

5. How to store Zahron

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light. Do not use this medicine
after the expiry date stated on the blister and carton following EXP. The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 salt at a dose equivalent to 15 mg or 30 mg of rosuvastatin.
• Other components of the medicine 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 Quinoline yellow lake (E 104)

What Zahron looks like and contents of the pack
Zahron is supplied in blister packs containing 7, 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.

Zahron 15 mg coated tablets: round, biconvex, pale yellow tablets, 8 mm in diameter, with the imprint "15" on one side and ^ "15" on the other side.

Zahron 30 mg coated tablets: round, biconvex, pale yellow tablets, 10 mm in diameter, with the imprint "30" on one side.

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