Romazic

Package Leaflet: Information for the Patient

Romazic, 15 mg, Film-Coated Tablets

Romazic, 30 mg, Film-Coated Tablets

Rosuvastatinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Romazic and what is it used for

Romazic belongs to a group of medicines called statins.

Romazic is recommended for use because:

• The patient has high cholesterol levels. This means a risk of heart attack (myocardial infarction) or stroke. Romazic 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 and increased physical activity have not been enough to achieve the correct cholesterol level in the blood. The patient taking Romazic should also follow a low-cholesterol diet and exercise regularly. or

• Romazic 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 of the arteries. Atherosclerosis of the arteries is the result of the deposition of atherosclerotic plaques in the blood vessels.

Why is it important to take Romazic regularly

Romazic is used to achieve the correct levels of fat 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).

• Romazic may reduce the level of "bad" cholesterol and increase the level of "good" cholesterol.
• The action of Romazic involves inhibiting the production of "bad" cholesterol in the body. It also helps to 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 substances 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 the correct cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar diseases.

Even if the cholesterol level is correct after taking Romazic, the medicine should still be taken.

It prevents the cholesterol level from increasing again, which causes the deposition of fatty substances. The treatment should be stopped if the doctor so advises or if the patient becomes pregnant.

2. Important information before taking Romazic

When not to take Romazic

• if the patient is allergic to rosuvastatinor any of the other ingredientsof this medicine (listed in section 6),
• if the patient is pregnantor breastfeeding. If a woman taking Romazic becomes pregnant, she should stop taking the medicine immediately and inform her doctor. Women taking Romazic should use effective methods of contraception,
• 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 cyclosporin(a medicine used, for example, after organ transplantation),
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, or ulcers in the mouth, after taking Romazic or other similar medicines.

If any of the above situations apply to the patient or the patient has any doubts, they should contact their doctor again. In addition, rosuvastatin should not be taken at a dose of 30 mg or 40 mgin the following cases:

• if the patient has moderately severe kidney disease(in case of doubt, ask your doctor),
• if the patient has thyroid disease,
• if the patient has frequent or unexplained muscle pain or weakness, if the patient or their family members have had muscle diseases or if muscle disorders have occurred previously while taking 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 fibrates, i.e., other cholesterol-lowering medicines.

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

Warnings and precautions

Before starting treatment with Romazic, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney disease,
• if the patient has liver disease,
• if the patient has frequent or unexplained muscle pain or weakness, or if the patient or their family members have had muscle diseases or if muscle disorders have occurred previously while taking cholesterol-lowering medicines. The patient should contact their doctor immediately 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.
• 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. The patient should read this leaflet carefully, even if they 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, the patient should read the information in the section "Romazic and other medicines",
• if the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid(a medicine used to treat bacterial infections). Taking fusidic acid with Romazic can lead to severe muscle damage (rhabdomyolysis); see the section "Romazic and other medicines",
• if the patient is over 70 years old(because the doctor must choose the appropriate initial dose of Romazic 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 will determine the appropriate initial dose of Romazic.

If any of the above situations apply to the patient (or the patient is unsure), they should not take rosuvastatin at doses of 30 mg or 40 mg (the highest doses) and should consult their doctor or pharmacist before starting treatment with any dose of Romazic. A small group of patients taking statins may experience liver problems. To confirm this effect, a blood test is performed to check liver enzyme activity. Usually, the doctor recommends a liver enzyme test before and during treatment with Romazic. Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes. With rosuvastatin, severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported. If the patient experiences any of the symptoms described in section 4, they should stop taking Romazic and contact their doctor immediately.

Children and adolescents

• if the patient is under 6 years old: Romazic should not be used in children under 6 years old.
• if the patient is under 18 years old: Romazic should not be used at doses of 30 mg or 40 mg in children and adolescents under 18 years old.

Romazic and other medicines

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, especially:

• cyclosporin(used, for example, after organ transplantation)
• warfarin, clopidogrel, or ticagrelor(or other blood thinners)
• fibrates(such as gemfibrozil, fenofibrate) or other cholesterol-lowering medicines (such as ezetimibe)
• antacids(used to neutralize stomach acid)
• erythromycin(an antibiotic), fusidic acid(an antibiotic - see also "Warnings and precautions" and the section "Romazic and other medicines")
• oral contraceptives
• regorafenib(used to treat cancer)
• hormone replacement therapy
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. Romazic may affect the action of these medicines, and these medicines may affect the action of Romazic.

If the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Romazic.

The doctor will inform the patient when they can safely start taking Romazic again. Taking Romazic with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Romazic with food and drink

Romazic can be taken with or without food.

Pregnancy and breastfeeding

Romazic should not be takenduring pregnancy or breastfeeding. If the patient becomes pregnant while taking Romazic, they should stop taking the medicine immediately and contact their doctor. While taking Romazic, the patient should avoid becoming pregnant 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 Romazic - it will not affect their ability. However, some patients may experience dizziness while taking Romazic. If this symptom occurs, the patient should contact their doctor before driving or operating machinery.

Romazic contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Romazic

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

Adults

Taking Romazic to lower cholesterol levels

Initial dose

Treatment 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 side effects.

The patient should ask their doctor which initial dose of Romazic is most suitable for them. The doctor may decide to use a dose of 5 mg as 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 of Romazic to choose the right dose for the patient. If the initial dose is 5 mg, the doctor may increase it to 10 mg, then to 15 mg or 20 mg, and finally to 30 mg or 40 mg. If the initial dose is 10 mg, the doctor may double it to 20 mg and then increase it to 40 mg. The dose of Romazic should not be increasedmore often than every 4 weeks. The maximum daily dose of rosuvastatin is 40 mg. It is used in patients with very high cholesterol levels and a high risk of heart attack or stroke, for whom a dose of 20 mg was not enough to lower cholesterol levels.

Taking Romazic 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 Romazic 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 initial dose is 5 mg, and the doctor may gradually increase the dose of rosuvastatin to suit the patient. The maximum daily dose of rosuvastatin is 10 mg or 20 mg in children aged 6-17 years, depending on the disease being treated. The medicine should be taken once daily. Doses of 30 mg and 40 mg should not be used in children and adolescents under 18 years old.

Taking the medicine

The tablet should be swallowed whole with water. Romazic should be taken once a dayat any time. It is recommended to take the medicine at the same time every day to make it easier to remember.

Cholesterol checks

To ensure that the cholesterol level has decreased and is correct, the patient should have regular check-ups and blood tests. The doctor may decide to increase the dose of Romazic to suit the patient.

Taking a higher dose of Romazic than recommended

If the patient has taken a higher dose of Romazic than recommended, they should contact their doctor or go to the nearest hospital. If the patient is in the hospital or being treated for another illness, they should inform their doctor or other medical staff that they are taking Romazic.

Missing a dose of Romazic

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

Stopping treatment with Romazic

The patient should tell their doctor if they want to stop taking Romazic. The cholesterol level may increase again if treatment with Romazic 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, Romazic 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 Romazic immediately and contact their doctorif they experience:

• Difficulty breathing, with (or without) swelling of the face, lips, tongue, and (or) throat
• Swelling of the face, lips, tongue, and (or) throat, which can cause difficulty swallowing
• Severe itching of the skin (with lumps)

The patient should stop taking Romazic and contact their doctor immediately if they experience

unexplained muscle pain or weaknessthat lasts longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adult patients. Like other statins, Romazic can cause troublesome muscle symptoms, which in rare cases can lead to potentially life-threatening muscle damage, called rhabdomyolysis.

• muscle rupture
• symptoms of lupus-like syndrome(including rash, joint pain, 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 can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome)
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

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 Romazic (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 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 stopping Romazic (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 lumps). If the patient suspects an allergic reaction, they should stop taking Romazic immediately and seek medical help.
• Muscle damage in adults - the patient should exercise caution, i.e., stop taking Romazic and contact their doctor immediately if they experience muscle pain or weakness.
• Severe abdominal pain (pancreatitis)
• Increased liver enzyme levels in the blood
• Increased tendency to bleed or bruise due to low platelet count
• Symptoms of lupus-like syndrome (including rash, joint pain, and effects on blood cells).

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 (frequency cannot be estimated from available data)

• Diarrhea (loose stools)
• Cough
• Shortness of breath
• Swelling
• 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 the patient experiences any side effects, including those not listed in this 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Romazic

The medicine should be stored out of sight and reach of children. There are no special storage instructions for the medicine. Do not take this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT, it means the batch number. 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 pack and other information

What Romazic contains

• The active substance of Romazic is rosuvastatin. Each tablet contains 15 mg or 30 mg of rosuvastatin (in the form of calcium salt).
• Other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, sodium citrate, crospovidone (Type B), colloidal anhydrous silica, magnesium stearate. tablet coating: hypromellose 2910 (6cP), lactose monohydrate, macrogol 3350, triacetin, titanium dioxide (E171).

What Romazic looks like and contents of the pack

Romazic, 15 mg, are white or almost white, elongated, and biconvex film-coated tablets with the inscription "15" on one side. Romazic, 30 mg, are white or almost white, elongated, and biconvex film-coated tablets with the inscription "30" on one side and a dividing line on the other side. The tablet can be divided into equal doses. Pack sizes: 30, 60, 90 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Date of last revision of the leaflet: