Rosutrox

Leaflet accompanying the packaging: patient information

Rosutrox, 5 mg, film-coated tablets

Rosutrox, 10 mg, film-coated tablets

Rosutrox, 20 mg, film-coated tablets

Rosutrox, 40 mg, film-coated tablets

Rosuvastatin

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you.Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

“Medicine absolutely contraindicated in pregnancy”.

Table of contents of the leaflet

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

1. What is Rosutrox and what is it used for

Rosutrox belongs to a group of medicines called statins.

Rosutrox is recommended for use because:

• The patient has been found to have high cholesterol levels. This means a risk of heart attack (myocardial infarction) or stroke. Rosutrox is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol levels.
• The doctor has prescribed a statin because diet changes and increased physical activity have proven insufficient to achieve proper cholesterol levels in the blood. The patient taking Rosutrox should also follow a low-cholesterol diet and exercise.

or

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

Myocardial infarction, stroke, and other problems can be caused by atherosclerosis of the arteries.
Atherosclerosis of the arteries is the result of the deposition of atherosclerotic plaques in blood vessels.

Why is it important to take Rosutrox regularly

Rosutrox is used to achieve proper 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).

• Rosutrox may cause a decrease in "bad" cholesterol and an increase in "good" cholesterol.
• The action of Rosutrox 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 change their well-being, as they do not cause any symptoms. However, if the patient does not receive treatment, it leads to the deposition of fatty substance deposits in the walls of blood vessels and their narrowing.
Sometimes, it may lead to the blockage of a narrowed blood vessel, disruption of blood flow to the heart or brain, and consequently to a heart attack or stroke. Achieving proper cholesterol levels in the blood reduces the risk of a heart attack, stroke, or similar diseases.

Even if the cholesterol level in the blood is normal after taking Rosutrox,

you should still take it. This prevents the cholesterol level from increasing again, which causes the deposition of fatty substances in the blood vessels. You should stop taking the medicine if your doctor advises you to do so or if you become pregnant.

2. Important information before taking Rosutrox

When not to take Rosutrox

• or any of the other ingredients of this medicine (listed in section 6),
• or breastfeeding. If a woman taking Rosutrox becomes pregnant, she should immediately stop taking the medicine and inform her doctor. Women taking Rosutrox should use effective methods of contraception.
• ,
• ,
• ,
• (a medicine used, for example, after organ transplantation),
• or peeling and blistering of the skin and mucous membranes after taking Rosutrox or other similar medicines.

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

In addition, Rosutrox 40 mg (the highest dose) should NOT be taken:

• (in case of doubt, the patient should ask their doctor),
• ,
• , if the patient or their family members have had muscle diseases or previously experienced muscle disorders while taking cholesterol-lowering medicines,
• ,
• (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• , i.e., other cholesterol-lowering medicines.

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

Warnings and precautions

Before starting to take Rosutrox, the patient should consult their doctor or pharmacist:

• ,
• ,
• , or if the patient or their family members have had muscle diseases or previously experienced muscle disorders while taking cholesterol-lowering medicines. The patient should immediately consult their doctor if they experience muscle pain or weakness of unknown origin, especially if it is accompanied by general malaise and fever. The patient should also inform their doctor if they experience persistent muscle weakness.
• ,
• ,
• . The patient should read the leaflet carefully, even if they have previously taken other cholesterol-lowering medicines.
• , e.g., ritonavir with lopinavir and/or atazanavir, the patient should refer to the information in the section “Other medicines and Rosutrox”.
• (an antibiotic - see also the section “Warnings and precautions”). Taking fusidic acid at the same time as Rosutrox may lead to severe muscle damage (rhabdomyolysis); see the section “Other medicines and Rosutrox”.
• (because the doctor must choose the appropriate initial dose of Rosutrox for the patient),
• ,
• (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). For these patients, the doctor will determine the appropriate initial dose of Rosutrox.
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness of the eyes), because statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).

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

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

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

Children and adolescents

• : Rosutrox should not be taken by children under 6 years old,
• : Rosutrox 40 mg should not be taken by children and adolescents under 18 years old.

Other medicines and Rosutrox

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 tell their doctor if they are taking:

• cyclosporin(used, for example, after organ transplantation),
• regorafenib(used to treat cancer),
• blood thinners, e.g., warfarin, acenocoumarol, or fluindione(their blood-thinning effect and risk of bleeding may be increased when taken with this medicine), tikagreloror clopidogrel,
• a fibrate medicine(such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (e.g., ezetimibe),
• medicines used to treat indigestion(used to neutralize stomach acid),
• erythromycin(an antibiotic),
• fusidic acid(an antibiotic - see also the section “Warnings and precautions”),
• oral contraceptives,
• hormone replacement therapy,
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, taken alone or in combination with other medicines (see: “Warnings and precautions”): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Rosutrox may affect the action of these medicines or these medicines may affect the action of Rosutrox.

If the patient needs to take fusidic acid orally for the treatment of a bacterial infection, they should temporarily stop taking Rosutrox. The doctor will inform the patient when they can safely start taking Rosutrox again. Taking Rosutrox with

fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

Rosutrox with food and drink

Rosutrox can be taken with or without food.

Pregnancy and breastfeeding

Rosutrox should not be takenduring pregnancy or breastfeeding. If the patient becomes pregnant while taking Rosutrox, they should immediately stop taking the medicineand consult their doctor. While taking Rosutrox, the patient should avoid pregnancy 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 Rosutrox - it will not affect their ability. However, some patients may experience dizziness while taking Rosutrox. If the patient experiences this symptom, they should consult their doctor before driving or using machines.
Rosutrox contains lactose.
If the patient has been found to be intolerant to some sugars (lactose, a sugar found in milk), they should inform their doctor before taking Rosutrox.

Rosutrox 5 mg contains colorants - orange yellow FCF, lake (E110) and tartrazine, lake (E102).

Rosutrox 10 mg, 20 mg, and 40 mg contain colorants - orange yellow FCF, lake (E110); tartrazine, lake (E102), and Allura Red AC, lake (E129).

Due to the presence of these colorants, this medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose, i.e., the medicine is considered "sodium-free".
A full list of excipients can be found in the section “Contents of the packaging and other information”.

3. How to take Rosutrox

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Adults

Taking Rosutrox to lower cholesterol levels

Initial dose

Treatment should be started with a dose of 5 mg or 10 mg, even if the patient has previously taken higher doses of other statins. 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 patient should ask their doctor which initial dose of Rosutrox is most suitable for them.
The doctor may decide to use a dose of 5 mgas 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 diseases (myopathy).

Increasing the dose and maximum daily dose

The doctor may decide to increase the dose so that it is suitable for the patient. If the patient started treatment with a dose of 5 mg, the doctor may decide to increase it to 10 mg, and 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, and then to 40 mg if necessary. The treatment period with the established dose, between each dose increase, is 4 weeks.
The maximum daily dose of Rosutrox 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 Rosutrox 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 described above.

Children and adolescents

Taking Rosutrox 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 so that it is suitable for the patient. The maximum daily dose of Rosutrox in children aged 6 to 17 years is 10 mgor 20 mg, depending on the disease being treated.
The medicine should be taken once daily. Rosutrox 40 mg should not be taken by children.

Taking the medicine

The tablet should be swallowed with water.
Rosutrox 20 mg and 40 mg tablets can be divided into two equal doses.
Rosutrox should be taken once a dayat 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 control tests

To ensure that cholesterol levels have decreased and are normal, the patient should regularly have check-ups and blood tests.
The doctor may decide to increase the dose of Rosutrox so that it is suitable for the patient.

Taking a higher dose of Rosutrox than recommended

If the patient has taken a higher dose of Rosutrox than recommended, they should consult their doctor or go to the nearest hospital. The patient should take the medicine with them.
If the patient is in the hospital or is being treated for another disease, they should inform their doctor or other medical staff that they are taking Rosutrox.

Missing a dose of Rosutrox

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

Stopping Rosutrox treatment

The patient should tell their doctor if they want to stop taking Rosutrox. Cholesterol levels may increase again if Rosutrox treatment 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, Rosutrox can cause side effects, although not everybody gets them.
It is essential for the patient to know what side effects can occur. They are usually mild and disappear shortly after starting treatment.
The patient should stop taking Rosutrox and seek medical help immediatelyif they experience the following allergic reactions:

• difficulty breathing with swelling of the face, lips, tongue, and/or throat, with or without it;
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing;
• severe itching of the skin (with hives).

The patient should stop taking Rosutrox 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 adult patients. As with other statins, a 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(including rash, joint disorders, and effects on blood cells)
• 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 syndrome or drug hypersensitivity syndrome)

The frequency of side effects is defined as follows:
Common:
occurring in 1 to 10 out of 100 treated patients
Uncommon:
occurring in 1 to 10 out of 1,000 treated patients
Rare:
occurring in 1 to 10 out of 10,000 treated patients
Very rare:
occurring in less than 1 out of 10,000 treated patients
Frequency not known: cannot be estimated from the available data

Common side effects (occurring 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 symptom usually resolves on its own and does not require treatment to be discontinued (only applies 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 medicine.

Uncommon side effects (occurring 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 symptom usually resolves on its own and does not require treatment to be discontinued (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 patients):

• severe allergic reactions - symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and severe itching of the skin (with hives). If the patient suspects they have had an allergic reaction, they should stop taking Rosutrox and seek medical help immediately.
• muscle damage in adults, the patient should stop taking Rosutrox and consult their doctor immediatelyif they experience muscle pain or other muscle symptoms that last longer than expected;

The patient should stop taking Rosutrox and consult their doctor immediately if they experience
muscle pain or other muscle symptomsthat last longer than expected;

• severe abdominal pain (pancreatitis);
• increased liver enzyme levels in the blood;
• a greater than usual tendency to bleed or bruise due to a low platelet count.
• symptoms of lupus-like syndrome (including rash, joint disorders, and effects on blood cells);
• muscle rupture.

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

• jaundice (yellowing of the skin and eyes);
• hepatitis;
• 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 (edema);
• sleep disorders (including 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 that causes general muscle weakness, including in some cases muscles involved in breathing);
• myasthenic syndrome (a disease that causes muscle weakness of the eyes);

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 side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Rosutrox

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the medicine.
The patient should not take this medicine after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the specified month.
The patient should not take this medicine if they notice visible signs of packaging damage.
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. Contents of the packaging and other information

What Rosutrox contains

The active substance of Rosutrox is rosuvastatin (in the form of rosuvastatin calcium).
Rosutrox film-coated tablets contain the calcium salt of rosuvastatin in a dose equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
Other ingredients of the medicine are:
tablet core:
calcium citrate, microcrystalline cellulose, lactose, hydroxypropyl cellulose, mannitol, crospovidone, magnesium stearate.
tablet coating:
Rosutrox 5 mg film-coated tablets:
Opadry II Yellow [polyvinyl alcohol; titanium dioxide (E171); macrogol 3350; talc; tartrazine, lake (E102); orange yellow FCF, lake (E110), and indigo carmine, lake (E132)].
Rosutrox 10 mg, 20 mg, and 40 mg film-coated tablets:
Opadry II Pink [polyvinyl alcohol; titanium dioxide (E171); macrogol 3350; talc; tartrazine, lake (E102); Allura Red AC, lake (E129); orange yellow FCF, lake (E110), and indigo carmine, lake (E132)].

What Rosutrox looks like and contents of the pack

Rosutrox 5 mg film-coated tablets:
round, yellow, biconvex film-coated tablets.
Rosutrox 10 mg film-coated tablets:
round, pink, biconvex film-coated tablets.
Rosutrox 20 mg film-coated tablets:
oval, pink, biconvex film-coated tablets with a score line on one side.
The tablet can be divided into two equal doses.
Rosutrox 40 mg film-coated tablets:
oblong, pink, biconvex film-coated tablets with a score line on one side.
The tablet can be divided into two equal doses.
Rosutrox film-coated tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters, together with the patient information leaflet, in a cardboard box.
Pack sizes:
7, 10, 28, 30, 56, or 60 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]
Date of last revision of the leaflet:05.04.2023