Rosufi

Leaflet accompanying the packaging: information for the user

Rosufy, 5 mg, film-coated tablets

Rosufy, 10 mg, film-coated tablets

Rosufy, 20 mg, film-coated tablets

Rosufy, 40 mg, film-coated tablets

Rosuvastatin

You should carefully read the contents of the 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.
• You should consult a doctor or pharmacist if you have any further doubts.
• 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 you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Rosufy and what is it used for

Rosufy belongs to a group of medicines called statins.

Rosufy 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. Rosufy is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol levels.
• The doctor has recommended taking a statin because diet changes and increased physical activity have proven insufficient to achieve proper cholesterol levels in the blood. The patient taking Rosufy should also follow a low-cholesterol diet and exercise.

or

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

Heart attack, stroke, and other problems can be caused by atherosclerosis (hardening of the arteries)
Atherosclerosis is the result of the accumulation of atherosclerotic plaques in blood vessels.

Why is it important to constantly take Rosufy?

Rosufy 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).

• Rosufy can cause a decrease in "bad" cholesterol and an increase in "good" cholesterol.
• The action of Rosufy 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 accumulation of fatty deposits in the walls of blood vessels and their narrowing.
Sometimes, it can 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 heart attack, stroke, or similar diseases.

Even if the cholesterol level is normal after taking Rosufy, you should still

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

2. Important information before taking Rosufy

When not to take Rosufy

• if the patient has been found to be hypersensitive (allergic) to rosuvastatinor any of the other ingredients of Rosufy;
• if the patient is pregnantor breastfeeding. If a woman taking Rosufy becomes pregnant, she should stop taking it immediately and inform her doctor. Women taking Rosufy 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 weakness;
• if the patient is taking cyclosporin(a medicine used, for example, after organ transplantation).

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

In addition, do not take Rosufy, 40 mg (the highest dose):

• if the patient has moderately severe kidney disease(in case of doubts, ask your doctor);
• if the patient has thyroid disease;
• if the patient experiences frequent or unexplained muscle pain or weakness, if the patient or their family members have had muscle diseases or have had muscle disorders while taking cholesterol-lowering medicines;
• if the patient regularly consumes large amounts of alcohol;
• if the patient is of Asian origin(Japanese, Chinese, Filipinos, Vietnamese, Koreans, and Indians);
• if the patient is taking fibrates, i.e., other cholesterol-lowering medicines.

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

Warnings and precautions

Before starting to take the medicine Rosufy, you should consult a 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 weakness, or if the patient or their family members have had muscle diseases or have had muscle disorders while taking cholesterol-lowering medicines. The patient should immediately contact their doctor if they experience muscle pain or weakness of unknown origin, especially if it is accompanied by general malaise and fever. You should also inform your doctor if you experience persistent muscle weakness.
• if the patient regularly consumes large amounts of alcohol;
• if the patient has thyroid disease;
• if the patient is taking cholesterol-lowering medicines from the fibrate group. You should read the leaflet carefully, even if you have taken other cholesterol-lowering medicines before. if the patient is taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and (or) atazanavir, you should read the information in the section: Other medicines and Rosufy.
• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid(an antibiotic used in bacterial infections). Taking Rosufy with fusidic acid can lead to severe muscle damage (rhabdomyolysis); see the section Other medicines and Rosufy.
• if the patient is over 70 years old(because the doctor must choose the appropriate initial dose of Rosufy for the patient);
• if the patient has severe respiratory failure
• if the patient is of Asian origin(Japanese, Chinese, Filipinos, Vietnamese, Koreans, and Indians). For these patients, the doctor will determine the appropriate initial dose of Rosufy. If any of the above situations apply to the patient (or the patient has doubts):
• Do not take Rosufy at a dose of 40 mg (the highest dose) and before taking Rosufy at any other dose, consult a doctor or pharmacist.

In a small group of patients, statin medicines may affect liver function. To confirm such action, 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 Rosufy.
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, being overweight, and having high blood pressure may be at risk of developing diabetes.

Children and adolescents

• If the patient is under 6 years old:Rosufy should not be used in children under 6 years old.
• If the patient is under 18 years old:Rosufy 40 mg is not suitable for use in children and adolescents under 18 years old.

Other medicines and Rosufy

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should tell your doctor if you are taking: cyclosporin (used, for example, after organ transplantation), warfarin or clopidogrel (or any other blood-thinning medicine), a fibrate medicine (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (e.g., ezetimibe), medicines used for 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, regorafenib (used to treat cancer), or any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, given alone or in combination with other medicines (see: Warnings and precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. Rosufy may affect the action of these medicines or these medicines may affect the action of Rosufy.

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

muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

Pregnancy and breastfeeding

Rosufy should not be takenduring pregnancy or breastfeeding. If a patient becomes pregnant while taking Rosufy, they should stop taking it immediately and consult their doctor. While taking Rosufy, patients should avoid becoming pregnant and use effective methods of contraception.
Before taking any medicine, patients should consult their doctor or pharmacist.

Driving and using machines

Most people can drive and use machines while taking Rosufy – it will not affect their ability. However, some patients may experience dizziness while taking Rosufy. If this symptom occurs, the patient should consult their doctor before driving or using machines.
Rosufy contains lactose monohydrate.
Each 5 mg Rosufy tablet contains 101.86 mg of lactose monohydrate.
Each 10 mg Rosufy tablet contains 96.786 mg of lactose monohydrate.
Each 20 mg Rosufy tablet contains 193.572 mg of lactose monohydrate.
Each 40 mg Rosufy tablet contains 174.984 mg of lactose monohydrate.
If the patient has been found to have an intolerance to some sugars (lactose, i.e., milk sugar), they should inform their doctor before taking Rosufy.
A full list of excipients is found in the section: Contents of the packaging and other information.

3. How to take Rosufy

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

Adults

Taking Rosufy to lower cholesterol levels:

Initial dose:
Treatment with Rosufy should be started with a dose of 5 mg or 10 mg, even if the patient has taken higher doses of other statins before. 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 adverse reactions.

You should ask your doctor which initial dose of Rosufy is most suitable for you.
The doctor may decide to use a dose of 5 mg as the initial dose if:

• the patient is of Asian origin(Japanese, Chinese, Filipinos, Vietnamese, Koreans, and Indians);
• the patient is over 70 years old;
• the patient has moderately severe kidney disease;
• the patient is at risk of muscle disease (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 starts 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 starts 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 increase is 4 weeks.
The maximum daily dose of Rosufy 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 Rosufy 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.

Taking Rosufy 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.
Usually, the initial dose is 5 mg per day; the doctor may gradually increase the dose to suit the patient. The maximum daily dose of Rosuvastatin NLP Health in children aged 6-17 years is 10 mg or 20 mg, depending on the disease being treated. The medicine should be taken once daily.
Rosuvastatin NLP Health should not be used at a dose of 40 mg in children.

Taking the medicine

The tablet should be swallowed whole, with a glass of water.
Rosufy 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 checks

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

Taking a higher dose of Rosufy than recommended

If you have taken a higher dose of Rosufy than recommended, you should consult a doctor or go to the nearest hospital.
If you are in the hospital or being treated for another illness, you should inform your doctor or other medical staff that you are taking Rosufy.

Missing a dose of Rosufy

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

Stopping treatment with Rosufy

You should tell your doctor if you want to stop taking Rosufy.
Cholesterol levels may increase again if treatment with Rosufy is stopped.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important for the patient to know what side effects may occur. Usually, they are mild and disappear shortly after starting treatment.
You should stop taking Rosufy and seek medical help immediatelyif you experience the following allergic reactions:

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

You should stop taking Rosufy and contact your doctor immediately,

• if you 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 had adverse effects on muscles. Rarely, these patients have had potentially life-threatening muscle damage (rhabdomyolysis).
• If you experience muscle rupture
• If you have a syndrome similar to lupus (including rash, joint disorders, and effects on blood cells).

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 stopping Rosufy (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 attending doctor will monitor patients at risk while they are taking this medicine.

Uncommon side effects (occurring in more than 1 in 1000 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 stopping Rosuvastatin NLP Health (applies to doses of 5 mg, 10 mg, and 20 mg).

Side effects that occur rarely (in more than 1 in 10,000 but less than 1 in 1000 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 you suspect you have had an allergic reaction, you should stop taking Rosufy immediately and seek medical help.
• Muscle damage in adults - you should be cautious, i.e., stop taking Rosufy and contact your doctor immediatelyif you experience muscle pain or other muscle symptoms that last longer than expected.
• Other abdominal pain (pancreatitis);
• Increased liver enzyme activity in the blood.

Side effects that occur very rarely (in less than 1 in 10,000 patients)

• Jaundice (yellowing of the skin and eyes)
• Hepatitis
• Blood in the urine
• Nerve damage to the arms and legs (felt as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynecomastia).

Side effects with unknown frequency:

• Diarrhea (loose stools)
• Stevens-Johnson syndrome (severe blistering of the skin, mouth, eyes, and genital area)
• Cough
• Shortness of breath
• Edema
• Sleep disorders (insomnia and nightmares)
• Sexual dysfunction
• Depression
• Breathing problems (persistent cough and (or) shortness of breath or fever)
• Tendon damage
• Persistent muscle weakness.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your 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:
Jerozolimskie Avenue 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail:
ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rosufy

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the month stated.
Do not store above 30°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rosufy contains

• The active substance is rosuvastatin.
• Each film-coated tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (as calcium salt), respectively. The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, crospovidone, lactose monohydrate, magnesium stearate. Tablet coating: Opadry II Yellow 33K12488(5 mg film-coated tablets): hypromellose, titanium dioxide (E 171), lactose monohydrate, triacetin, iron oxide, yellow (E 172).

Opadry II Pink 33K94423(10 mg and 20 mg film-coated tablets): hypromellose, titanium dioxide (E 171), lactose monohydrate, triacetin, iron oxide, red (E 172).
Opadry II Pink 33K94424(40 mg film-coated tablets): hypromellose, titanium dioxide (E 171), lactose monohydrate, triacetin, iron oxide, red (E 172).
Not all pack sizes may be marketed.

Marketing authorization holder

Centrient Pharmaceuticals Netherlands B.V.
Alexander Fleminglaan 1
2613 AX Delft
Netherlands

Manufacturer

Medochemie Ltd (Central Factory)
1-10 Constantinopoleos Street
3011 Limassol
Cyprus
Medochemie Ltd (Factory AZ)
2 Michael Erakleous Street, Agios Athanassios Industrial Area,
Agios Athanassios,
Limassol, 4101,
Cyprus

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark: Rosufy
Poland: Rosufy
Romania: Rosufy 5 mg, 10 mg, 20 mg, 40 mg film-coated tablets
Hungary: Rosufy 5 mg, 10 mg, 20 mg, 40 mg film-coated tablets

Date of approval of the leaflet: 09/2021