Romazic

Leaflet attached to the packaging: patient information

Romazic, 5 mg, film-coated tablets

Romazic, 10 mg, film-coated tablets

Romazic, 20 mg, film-coated tablets

Romazic, 40 mg, film-coated tablets

Rosuvastatinum

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 necessary.
• 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.
• 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.

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 been found to have 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 Romazic because diet and increased physical activity have proven insufficient to achieve normal cholesterol levels 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. 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 the blood vessels.

Why it is important to take Romazic

Romazic is used to achieve normal levels of fatty substances in the blood. The most common of these is cholesterol. There are different types of cholesterol in the blood - "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C). Romazic reduces the amount of "bad" cholesterol and increases the amount of "good" cholesterol. Romazic limits the production of "bad" cholesterol in the body and facilitates its removal from the blood. In most people, high cholesterol levels do not cause any symptoms and do not affect well-being. However, if this condition is not treated, fatty deposits accumulate in the walls of blood vessels, causing their narrowing. Sometimes, narrowed blood vessels can become blocked, cutting off blood flow to the heart or brain and leading to myocardial infarction or stroke. If the patient's cholesterol levels are lowered, the risk of myocardial infarction or stroke is reduced. Romazic should be taken even after cholesterol levels have been lowered to normal levels, as it prevents the levels from rising again. However, its use should be discontinued if the doctor so advises or if the patient is pregnant.

2. Important information before taking Romazic

When not to take Romazic

• if the patient is allergicto rosuvastatinor any of the other ingredientsof this medicine (listed in section 6)
• in pregnantor breastfeedingwomen. If the patient becomes pregnant while taking Romazic, she should stop taking it immediately and consult her doctor.
• if the patient has liver disease
• if the patient has severe kidney disease
• if the patient experiences recurring or unexplained muscle pain
• if the patient is taking cyclosporin(e.g., after organ transplantation)
• if the patient has ever had a severe skin rash or peeling, blisters, and (or) ulcers in the mouth after taking Romazic or other similar medicines.

If any of the above points apply to the patient or if the patient has doubts, they should consult their doctor again. Additionally, the 40 mg dose of Romazic (the highest dose) should not be used in the following cases:

• if the patient has moderate kidney impairment(in case of doubt, the patient should ask their doctor)
• if the patient has thyroid dysfunction
• if the patient has experienced recurring or unexplained muscle pain, or if the patient or their family members have had muscle disordersrelated to the use of other cholesterol-lowering medicines
• if the patient regularly consumes large amounts of alcohol
• if the patient is of Asian origin(is Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian)
• if the patient is taking other cholesterol-lowering medicines called fibrates.

If any of the above points apply to the patient (or if the patient is in doubt), they should consult their doctor again.

Warnings and precautions

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

• if the patient has kidney disease
• if the patient has liver disease
• if the patient has experienced recurring or unexplained muscle pain, or if the patient or their family members have had muscle disordersrelated to the use of other cholesterol-lowering medicines. The patient should immediately inform their doctor if they experience unexplained muscle pain, especially if it is accompanied by malaise or fever. The patient should also tell their doctor or pharmacist if they experience persistent muscle weakness.
• if the patient regularly consumes large amounts of alcohol
• if the patient has thyroid dysfunction
• if the patient is taking other cholesterol-lowering medicines called fibrates. 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 (see "Romazic and other medicines").
• if the patient is currently taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). Concurrent administration of rosuvastatin and fusidic acid may lead to severe muscle damage (rhabdomyolysis), see "Romazic and other medicines".
• if the patient is over 70 years old(the doctor should choose an appropriate initial dose of Romazic for them)
• if the patient has severe respiratory failure
• if the patient is of Asian origin(is Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor should choose an appropriate initial dose of Romazic for them.

If any of the above situations apply to the patient (or if the patient is unsure), they should not take the 40 mg dose of Romazic and should consult their doctor or pharmacist before starting any dose of Romazic. Statins can rarely affect liver function. These disorders can be detected by performing a liver enzyme test. For this reason, the doctor usually orders liver function tests 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 who have high blood sugar and fat levels, are overweight, and have high blood pressure may be at risk of developing diabetes. With the use of 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: the 40 mg dose of Romazic should not be used 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, e.g., after organ transplantation)
• warfarin, clopidogrel, or tikagrelor(or other blood thinners)
• fibrates(such as gemfibrozil, fenofibrate) or other cholesterol-lowering medicines (such as ezetimibe)
• antacids(used to treat indigestion)
• erythromycin(an antibiotic), fusidic acid(an antibiotic - see also "Warnings and precautions" and 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 virus, given 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 it is necessary to treat a bacterial infection with fusidic acid orally or by injection, the patient should temporarily stop taking Romazic. The doctor will inform the patient when they can safely resume taking Romazic.

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 taken during pregnancy or breastfeeding. If the patient becomes pregnant while taking Romazic, she should stop taking it immediately and consult her doctor.

Women taking Romazic should avoid becoming pregnant by using effective contraception. Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Most patients can drive and use machines while taking Romazic, as it does not affect their ability to perform these activities. However, some people may experience dizziness while taking Romazic. If the patient experiences dizziness, they should consult their doctor before driving or using machines.

Romazic contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Romazic. 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.

Usual doses for adults

If Romazic is used to treat high cholesterol:

Initial dose Treatment starts with a dose of 5 mg or 10 mg, even if higher doses of other statins have been used before. The choice of initial dose depends on:

• Cholesterol levels in the blood
• Risk of heart attack or stroke
• Presence of factors that increase the risk of side effects.

The patient should consult their doctor or pharmacist about the size of the initial dose. The doctor may recommend the lowest dose (5 mg) if:

• the patient is of Asian origin(is Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian)
• the patient is over 70 years old
• the patient has moderate kidney impairment
• the patient is at risk of muscle disorders(myopathy).

Dose increase 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 20 mg, up to a maximum dose of 40 mg. If the initial dose is 10 mg, the doctor may double it to 20 mg, then increase it to the maximum dose of 40 mg. The dose of Romazic should not be increased more often than every 4 weeks. The maximum daily dose of Romazic is 40 mg and is used only in patients with high cholesterol levels and a high risk of heart attack or stroke, who have not achieved the desired reduction in cholesterol levels with the 20 mg dose.

If Romazic is used to reduce the risk of heart attack, stroke, or related problems

The recommended daily dose is 20 mg. However, the doctor may decide to use a lower dose if there are other risk factors.

Use 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 to suit the patient. The maximum daily dose of Romazic 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. The 40 mg dose of Romazic should not be used in children.

Taking the tablets

• They should be swallowed whole, with a drink.
• They should be taken once a day, regardless of the time of day.
• They should be taken at the same time every day.

Regular cholesterol level tests

It is essential to have regular check-ups with the doctor to monitor cholesterol levels and ensure that the desired cholesterol levels have been achieved and are maintained during treatment. The doctor may decide to increase the dose of Romazic to choose the right dose for the patient.

Using a higher than recommended dose of Romazic

The patient should consult their doctor or the nearest hospital. If the patient is in the hospital or is being treated for another illness, they should inform their doctor or other medical staff that they are taking Romazic.

Missing a dose of Romazic

If a dose is missed, the patient should take the next dose at the scheduled time the next day. The patient should not take a double dose to make up for the missed dose.

Stopping Romazic

The patient should talk to their doctor if they want to stop taking Romazic. After stopping Romazic, cholesterol levels may rise again. 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 what side effects can occur. They are usually mild and disappear shortly after starting treatment. If the patient experiences the following allergic reactions, they should stop taking Romazic and contact their doctor immediately:

• 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 lumpy rash)

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

• unexplained muscle pain or other muscle symptomsthat persist longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adult patients. Like other statins, Romazic can rarely cause troublesome muscle symptoms, which in rare cases can lead to a 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Common side effects (may affect up to 1 in 10 people):

• headache
• abdominal pain
• constipation
• nausea
• muscle pain
• weakness
• dizziness
• increased protein in the urine, which usually disappears without the need to stop treatment with Romazic (only for the 40 mg dose)
• diabetes. The risk of developing diabetes is higher in people who have high blood sugar and fat levels, are overweight, and have high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

Uncommon side effects (may affect up to 1 in 100 people):

• rash, itching, or other skin reactions
• increased protein in the urine, which usually disappears without the need to stop treatment with Romazic (only for the 5 mg, 10 mg, and 20 mg doses).

Rare side effects (may affect up to 1 in 1,000 people):

• severe allergic reaction - symptoms include: swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe itching of the skin (with lumpy rash). If the patient suspects an allergic reaction, they should stop taking Romazic and contact their doctor immediately
• muscle damage in adults - if the patient experiences unexplained muscle pain, they should stop taking Romazic and inform their doctor
• severe abdominal pain (pancreatitis)
• increased liver enzyme activity 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 (may affect up to 1 in 10,000 people):

• jaundice (yellowing of the skin and whites of the eyes)
• hepatitis
• trace amounts of blood in the urine
• numbness or tingling in the hands and feet (nerve damage)
• joint pain
• memory loss
• breast enlargement in men (gynecomastia).

Frequency not known (frequency cannot be estimated from the available data):

• diarrhea (loose stools)
• cough
• shortness of breath
• swelling
• sleep disorders, including insomnia and nightmares
• sexual disorders
• depression
• breathing difficulties, including 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 gathered 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. The patient should not use 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 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 that are no longer needed. 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 5 mg or 10 mg or 20 mg or 40 mg of rosuvastatin (as calcium salt).
• The other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, sodium citrate, crospovidone (Type B), colloidal anhydrous silica, magnesium stearate. tablet coating: hypromellose 6 cP, lactose monohydrate, macrogol 3 350, triacetin, titanium dioxide (E 171).

What Romazic looks like and contents of the pack

Romazic, 5 mg are white or almost white, round, biconvex, film-coated tablets with a groove on one side. Romazic, 10 mg are white or almost white, round, biconvex, film-coated tablets with a groove on one side. Romazic, 20 mg are white or almost white, round, biconvex, film-coated tablets with a groove on one side. Romazic, 40 mg are white or almost white, oval, biconvex, film-coated tablets. Pack size: 30 tablets.

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: