Rosutrox

Package leaflet: information for the patient

Rosutrox, 5 mg, film-coated tablets
Rosutrox, 10 mg, film-coated tablets
Rosutrox, 20 mg, film-coated tablets
Rosutrox, 40 mg, film-coated tablets
Rosuvastatinum
Please read this leaflet carefully before using the medicine, as it contains important
information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

“Medicine absolutely contraindicated during pregnancy.”
Contents of the leaflet

1. What Rosutrox is and what it is 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 pack 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:

• You have been diagnosed with high cholesterol levels. This indicates 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.
• Your doctor has recommended taking a statin because dietary changes and increased physical activity have not been sufficient to achieve normal blood cholesterol levels. While taking Rosutrox, you should also follow a cholesterol-lowering diet and engage in regular physical exercise.

or

• Rosutrox is also recommended if you have other risk factors that increase the likelihood of heart attack (myocardial infarction), stroke, or similar conditions.

Heart attack, stroke, and other problems may be caused by atherosclerosis of the arteries.
Atherosclerosis results from the buildup of atherosclerotic plaques in blood vessels.
Why it is important to take Rosutrox regularly
Rosutrox is used to achieve normal levels of blood lipids. The most common of these is cholesterol.
There are different types of cholesterol in the blood, known as “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).

• Rosutrox may reduce levels of “bad” cholesterol and increase levels of “good” cholesterol.
• Rosutrox 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 they feel. However, if left untreated, fatty deposits build up in the walls of blood vessels, causing them to narrow.
Sometimes, a narrowed blood vessel may become blocked, interrupting blood flow to the heart or brain, leading to a heart attack or stroke. Achieving normal cholesterol levels reduces the risk of heart attack, stroke, or similar conditions.
Even if your blood cholesterol levels become normal after taking Rosutrox,
you should continue taking it. This prevents cholesterol levels from rising again,
which could lead to further fatty deposits in the blood vessels. You should stop taking the medicine only if your doctor advises you to do so or if you become pregnant.

2. Important information before taking Rosutrox

When not to take Rosutrox

• if you are allergic (hypersensitive) to rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant or breastfeeding. If you become pregnant while taking Rosutrox, you must stop taking it immediately and inform your doctor. Women taking Rosutrox should use effective contraception.
• if you have liver disease,
• if you have severe kidney disease,
• if you experience frequent or unexplained muscle pain or discomfort,
• if you are taking cyclosporine (a medicine used, for example, after organ transplantation),
• if you have ever had a severe skin rash or skin peeling, blisters, and/or mouth ulcers after taking Rosutrox or similar medicines.

If any of the above situations apply to you or if you have any doubts,
please consult your doctor again.
Additionally, DO NOT take Rosutrox 40 mg (the highest dose):

• if you have moderately severe kidney disease (if in doubt, consult your doctor),
• if you have thyroid disease,
• if you experience frequent or unexplained muscle pain or discomfort, if you or your family members have a history of muscle disorders, or if you previously experienced muscle-related problems while taking lipid-lowering medicines,
• if you regularly consume large amounts of alcohol,
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• if you are taking fibrates, i.e., other cholesterol-lowering medicines.

If any of the above situations apply to you (or if you have any doubts),
please consult your doctor again.
Warnings and precautions
Before starting Rosutrox, consult your doctor or pharmacist:

• if you have kidney disease,
• if you have liver disease,
• if you experience frequent or unexplained muscle pain or discomfort, or if you or your family members have a history of muscle disorders, or if you previously experienced muscle-related problems while taking lipid-lowering medicines. You should contact your doctor immediately if you develop unexplained muscle pain or discomfort, especially if accompanied by malaise or fever. You should also inform your doctor if you experience persistent muscle weakness.
• if you regularly consume large amounts of alcohol,
• if you have thyroid disease,
• if you are taking fibrates, other cholesterol-lowering medicines. Read the leaflet carefully, even if you have previously taken other cholesterol-lowering medicines.
• if you are taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and/or atazanavir; please refer to the section: “Other medicines and Rosutrox”.
• if you are taking or have 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 Rosutrox may lead to severe muscle damage (rhabdomyolysis); see section: “Other medicines and Rosutrox”.
• if you are over 70 years of age (because your doctor must determine the appropriate starting dose of Rosutrox),
• if you have severe respiratory insufficiency,
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will determine the appropriate starting dose of Rosutrox for you,
• if you have or have had myasthenia (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 any of the above situations apply to you (or if you have any doubts):

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

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, your doctor will recommend checking liver enzyme activity in the blood before 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 with high blood sugar and lipid levels, overweight, and high blood pressure may be at increased risk of developing diabetes.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Rosutrox. If any of the symptoms described in section 4 occur, stop taking Rosutrox and contact your doctor immediately.
Children and adolescents

• if you are under 6 years of age: Rosutrox should not be used in children under 6 years of age,
• if you are under 18 years of age: Rosutrox 40 mg is not suitable for use in children and adolescents under 18 years of age.

Other medicines and Rosutrox
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),
• regorafenib (used to treat cancer),
• blood-thinning medicines such as warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken together with this medicine), tikagrelor, or clopidogrel,
• a medicine from the fibrate group (such as gemfibrozil, fenofibrate) or any other medicine that lowers blood cholesterol (e.g., ezetimibe),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see below and section “Warnings and precautions”),
• oral contraceptives,
• hormone replacement therapy,
• 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, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

Rosutrox may alter the effects of these medicines or these medicines may alter the effects of Rosutrox.
If you need to take oral fusidic acid for a bacterial infection,
temporarily discontinue Rosutrox. Your doctor will inform you when you can safely restart
Rosutrox. Taking Rosutrox with fusidic acid may 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 used during pregnancy or while breastfeeding. If you become pregnant while taking Rosutrox, you must stop taking Rosutrox immediately and contact your doctor. While taking Rosutrox, avoid pregnancy and use effective contraception.
Before taking any medicine, consult your doctor or pharmacist.
Driving and using machines
Most people can drive and operate machinery while taking Rosutrox – it will not impair their abilities. However, some patients may experience dizziness while taking Rosutrox. If you experience this symptom, consult your doctor before driving or operating machinery.
Rosutrox contains lactose.
If you have been diagnosed with intolerance to certain sugars [lactose (milk sugar)], you should inform your doctor before taking Rosutrox.
Rosutrox 5 mg contains colourants – Orange Yellow FCF, lac (E110) and tartrazine, lac (E102).
Rosutrox 10 mg, 20 mg and 40 mg contain colourants – Orange Yellow FCF, lac (E110); tartrazine, lac (E102) and Allura Red AC, lac (E129).
Due to the presence of these colourants, this medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, meaning the medicine is considered “sodium-free”.
A full list of excipients is provided in section “Contents of the pack and other information”.
3. How to take Rosutrox
Always take this medicine exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
Adults
Taking Rosutrox to lower cholesterol levels
Starting dose
Treatment should begin with a 5 mg or 10 mg dose, even if you have previously taken higher doses of other statins. The starting dose depends on:

• cholesterol levels,
• the risk of heart attack or stroke,
• the presence of factors increasing your susceptibility to adverse effects.

Ask your doctor which starting dose of Rosutrox is most appropriate for you.
Your doctor may decide to start treatment with a 5 mg dose if:

• you are of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India),
• you are over 70 years of age,
• you have moderately severe kidney disease,
• you are at risk of developing muscle disorders and muscle pain (myopathy).

Increasing the dose and maximum daily dose
Your doctor may decide to increase the dose to suit your needs. If you started treatment with 5 mg, your doctor may increase it to 10 mg, then to 20 mg or 40 mg, if necessary. If you started with 10 mg, your doctor may increase it to 20 mg, then to 40 mg, if necessary. The treatment period at each dose level, between dose increases, 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, when a 20 mg dose has been insufficient to reduce cholesterol levels.
Taking Rosutrox to reduce the risk of heart attack, stroke, or similar
health problems
The recommended daily dose is 20 mg, but your doctor may decide to reduce it if you have any of the factors described above.
Children and adolescents
Use 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 starting dose is 5 mg once daily, and your doctor may gradually increase the dose as appropriate. The maximum daily dose of Rosutrox in children aged 6 to 17 years is 10 mg or 20 mg, depending on the condition being treated.
The medicine should be taken once daily. Rosutrox 40 mg should not be used in children.
Taking the medicine
Swallow the tablet with water.
Rosutrox 20 mg and 40 mg tablets may be divided into two equal doses.
Rosutrox 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 you remember.
Cholesterol monitoring tests
To ensure cholesterol levels have decreased and are within normal range, regular check-ups and blood tests are necessary.
Your doctor may decide to increase the dose of Rosutrox as appropriate.
Taking more than the recommended dose of Rosutrox
If you take more than the recommended dose of Rosutrox, contact your doctor or go to the nearest hospital. Take the medicine with you.
If you are in hospital or being treated for another condition, inform your doctor or medical staff that you are taking Rosutrox.
Missing a dose of Rosutrox
Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Rosutrox
Inform your doctor if you wish to stop taking Rosutrox. Cholesterol levels may rise again if you stop taking Rosutrox.
If you have any further questions about using 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 which adverse reactions may occur. Usually, they are
mild and resolve shortly after starting treatment.
Immediately discontinue use of Rosutrox and seek medical help if the following allergic reactions occur:

• difficulty breathing, with or without 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).

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

• muscle pain or other muscle 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, this has led to potentially life-threatening muscle damage (rhabdomyolysis).
• muscle rupture
• symptoms of lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
• flat, red, disc-shaped or round spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital or eye lesions. These serious skin rashes 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)

Below is a description of the frequency of adverse reactions:
Common: occurs in 1 to 10 out of 100 treated patients
Uncommon: occurs in 1 to 10 out of 1,000 treated patients
Rare: occurs in 1 to 10 out of 10,000 treated patients
Very rare: occurs in fewer than 1 out of 10,000 treated patients
Frequency not known: cannot be estimated from available data

Adverse reactions occurring commonly (in more than 1 out of 100 but less than 1 out of 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 treatment (occurs only with 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.

Adverse reactions occurring uncommonly (in more than 1 out of 1,000 but less than 1 out of 100 patients):

• rash, itching, or other skin reactions;
• increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of treatment (occurs only with 5 mg, 10 mg, and 20 mg doses).

Adverse reactions occurring rarely (in more than 1 out of 10,000 but less than 1 out of 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 an allergic reaction is suspected, immediately stop taking Rosutrox and seek medical help.
• muscle damage in adults – caution is required, i.e. discontinue use of Rosutrox and contact your doctor immediately if muscle pain or other muscle symptoms occur that 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 (including rash, joint disorders, and effects on blood cells);
  • muscle rupture.

Adverse reactions occurring very rarely (in fewer than 1 out of 10,000 patients):

• jaundice (yellowing of the skin and eyes);
• hepatitis;
• presence of blood in urine;
• damage to nerves of 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 (edema);
• sleep disturbances (including 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 eye muscles).

Patients should speak with their doctor if they 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 those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Rosutrox
Keep the medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
Do not use this medicine if visible signs of package damage are present.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Rosutrox contains
The active substance is rosuvastatin (in the form of rosuvastatin calcium).
Rosutrox film-coated tablets contain rosuvastatin calcium in strengths corresponding to
5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
Other ingredients are:
tablet core:
calcium citrate, microcrystalline cellulose, lactose, hydroxypropylcellulose, 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); sunset 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); sunset 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 packed in blisters made of OPA/Aluminium/PVC/Aluminium foil,
together with the patient 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 Authorisation 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]