Romazic Plus

Leaflet accompanying the packaging: patient information

Romazic Plus, 5 mg + 10 mg, film-coated tablets

Romazic Plus, 10 mg + 10 mg, film-coated tablets

Romazic Plus, 20 mg + 10 mg, film-coated tablets

Romazic Plus, 40 mg + 10 mg, film-coated tablets

Rosuvastatine + Ezetimibe

It is essential to carefully read the contents of the leaflet before taking the medication, as it contains important information for the patient.

• The leaflet should be kept to be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Romazic Plus and what is it used for

Romazic Plus contains two different active substances in one tablet. One of the active substances is rosuvastatine, belonging to the group of so-called statins, and the other active substance is ezetimibe. Romazic Plus is a medication used to reduce the level of total cholesterol, so-called "bad" cholesterol (LDL cholesterol) and fatty substances called "triglycerides", and also to increase the level of so-called "good" cholesterol (HDL cholesterol). The medication reduces cholesterol levels by acting in two ways: reducing the amount of cholesterol absorbed in the digestive tract and the amount of cholesterol produced in the body. In most people, high cholesterol levels do not affect well-being, as they do not cause any symptoms. However, if left untreated, it can cause fatty deposits to accumulate in the walls of blood vessels, leading to their narrowing. As a result of narrowing, it is sometimes possible for the blood vessel to close, cutting off blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other similar health problems can be reduced. Romazic Plus is used in patients whose cholesterol levels cannot be controlled by diet alone. During treatment with this medication, the patient should continue to follow a cholesterol-lowering diet. The doctor may prescribe Romazic Plus if the patient is already taking rosuvastatine and ezetimibe in the same doses as in the combination medication. Romazic Plus is used in patients with:

• high blood cholesterol levels (primary hypercholesterolemia)
• heart disease - Romazic Plus reduces the risk of heart attack, stroke, the need for surgical intervention to improve blood flow to the heart, or hospitalization due to chest pain.

Romazic Plus does not help with weight loss.

2. Important information before taking Romazic Plus

When not to take Romazic Plus

• if the patient is allergic to rosuvastatine, ezetimibe, or any of the other ingredients of this medication (listed in section 6);
• if the patient has liver disease;
• if the patient has severe kidney problems;
• if the patient experiences recurring, unexplained muscle pain (myopathy);
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection);
• if the patient is taking a medication containing cyclosporine (used, for example, after organ transplantation);
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Romazic Plus, they should stop taking the medication immediately and inform their doctor. During treatment with Romazic Plus, patients should avoid becoming pregnant by using effective birth control methods.
• if the patient has ever had a severe skin rash or blistering of the skin, peeling, and (or) ulcers in the mouth after taking Romazic Plus or other similar medications.

In addition, Romazic Plus 40 mg + 10 mg (the highest dose) should not be taken:

• if the patient has moderately severe kidney disease (in case of doubt, the patient should consult their doctor);
• if the patient has been diagnosed with abnormal thyroid function (hypothyroidism);
• if the patient experiences recurring or unexplained muscle pain or weakness, or if the patient or their family members have had muscle diseases or have had muscle problems while taking cholesterol-lowering medications;
• 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 other cholesterol-lowering medications, known as fibrates (see "Romazic Plus and other medications").

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

Warnings and precautions

Before starting to take Romazic Plus, the patient should discuss the following with their doctor:

• if the patient has kidney problems;
• if the patient has liver problems;
• if the patient has experienced recurring or unexplained muscle pain or weakness, or if they or their family members have had muscle diseases or have had muscle problems while taking cholesterol-lowering medications. If unexplained muscle pain or weakness occurs, especially if accompanied by malaise or fever, the patient should immediately consult their doctor. The patient should also inform their doctor or pharmacist about persistent muscle weakness.

Additionally:

• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian), the doctor will determine the appropriate dose of Romazic Plus for the patient.
• if the patient is taking antiviral medications, including those used to treat HIV or hepatitis C virus infection, such as lopinavir, ritonavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, and (or) pibrentasvir (see "Romazic Plus and other medications");
• if the patient has severe respiratory failure;
• if the patient is taking other cholesterol-lowering medications, known as fibrates. See "Romazic Plus and other medications".
• if the patient is to undergo surgery. It may be necessary to stop taking Romazic Plus for a short time.
• if the patient regularly consumes large amounts of alcohol;
• if the patient has been diagnosed with abnormal thyroid function (hypothyroidism);
• if the patient is over 70 years old (as the doctor should determine the appropriate dose of Romazic Plus for the patient);
• if the patient is taking or has taken fusidic acid (used to treat bacterial infections) orally or by injection within the last 7 days. Concurrent use of fusidic acid and Romazic Plus may rarely cause serious muscle problems (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• if the patient is taking a medication containing regorafenib (used to treat cancer);
• 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 in the eyes), as statins may sometimes exacerbate 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 if the patient has doubts), they should consult their doctor or pharmacist before starting to take Romazic Plus.

In rare cases, statins may affect liver function. This can be detected by a simple test that checks for increased liver enzyme activity in the blood. Therefore, the doctor will recommend regular testing during treatment with Romazic Plus. It is essential for the patient to attend these tests as scheduled. Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients taking Romazic Plus. If the patient experiences any of the symptoms described in section 4, they should stop taking Romazic Plus and consult their doctor immediately. During treatment with this medication, the doctor will closely monitor patients with diabetes or at risk of developing diabetes. There is a high risk of developing diabetes if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure.

Children and adolescents

Romazic Plus should not be used in children and adolescents under 18 years of age.

Romazic Plus and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. The patient should inform their doctor about taking any of the following medications:

• cyclosporine (a medication used, for example, after organ transplantation to prevent rejection. Cyclosporine increases the effect of rosuvastatine when taken concurrently. Romazic Plus should not be taken while taking cyclosporine.
• anticoagulant medications, such as warfarin, acenocoumarol, or fluindione (concurrent use with Romazic Plus may increase the anticoagulant effect, increasing the risk of bleeding), ticagrelor, or clopidogrel;
• other cholesterol-lowering medications, known as fibrates, which also regulate triglyceride levels in the blood (e.g., gemfibrozil and other medications in this class). Concurrent use with Romazic Plus increases the effect of rosuvastatine.
• colestyramine (a medication used to lower cholesterol levels), as it affects the way ezetimibe works;
• medications used to treat indigestion, containing aluminum and magnesium (used to neutralize stomach acid). These medications may decrease rosuvastatine levels in the blood. This effect can be reduced by taking these medications 2 hours after taking rosuvastatine.
• erythromycin (an antibiotic). Concurrent use with rosuvastatine may decrease its effect.
• fusidic acid. If the patient must take fusidic acid orally to treat a bacterial infection, it may be necessary to temporarily stop taking Romazic Plus. The doctor will inform the patient when it is safe to resume taking the medication. Concurrent use of fusidic acid and Romazic Plus may rarely cause serious muscle problems (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• oral contraceptives (birth control pills). Concurrent use with Romazic Plus may increase hormone levels in the blood.
• hormone replacement therapy (increasing hormone levels in the blood);
• regorafenib (used to treat cancer);
• any of the following medications used to treat viral infections, including HIV or hepatitis C virus infection, alone or in combination (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir, sofosbuvir, voxilaprevir.

If the patient is to be hospitalized or treated for another condition, they should inform the medical staff about taking Romazic Plus.

Romazic Plus and alcohol

Romazic Plus 40 mg + 10 mg (the highest dose) should not be taken if the patient regularly consumes large amounts of alcohol.

Pregnancy and breastfeeding

Romazic Plus should not be taken if the patient is pregnant, trying to become pregnant, or suspects they may be pregnant. If the patient becomes pregnant while taking Romazic Plus, they should stop taking the medication immediately and inform their doctor. During treatment with Romazic Plus, female patients should use effective birth control methods to avoid becoming pregnant. Romazic Plus should not be taken during breastfeeding, as it is not known whether the medication passes into breast milk.

Driving and operating machinery

Romazic Plus is unlikely to affect the patient's ability to drive or operate machinery. However, the patient should be aware that Romazic Plus may cause dizziness. If this occurs, the patient should not drive or operate machinery.

Romazic Plus contains lactose

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

Romazic Plus contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Romazic Plus

This medication should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. During treatment with Romazic Plus, the patient should continue to follow a cholesterol-lowering diet and maintain physical activity. The recommended daily dose for adults is one tablet of the prescribed strength.

Romazic Plus should be taken once a day.

The medication can be taken at any time of day, with or without food. The tablets should be swallowed whole, with a glass of water. The patient should take the medication at the same time every day. Romazic Plus is not suitable for initiating treatment. If treatment is started or the dose needs to be changed, the patient should take each active substance separately and only switch to Romazic Plus once the doses have been established. If the doctor prescribes Romazic Plus in combination with another cholesterol-lowering medication containing colestyramine or any other bile acid sequestrant, Romazic Plus should be taken at least 2 hours before or 4 hours after taking these medications.

Regular cholesterol level checks

It is essential for the patient to attend regular check-ups with their doctor to monitor their cholesterol levels and ensure they have reached and maintained the target value.

Overdose

In case of overdose, the patient should consult their doctor or the emergency department of the nearest hospital, as medical attention may be necessary.

Missed dose

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

Stopping treatment

The patient should inform their doctor if they want to stop taking Romazic Plus. After stopping Romazic Plus, cholesterol levels may increase again. If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Romazic Plus can cause side effects, although not everyone will experience them. It is essential for the patient to know which side effects may occur.

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

• any unexplained muscle pain, tenderness, or weakness that lasts longer than expected. This is because muscle problems, including muscle breakdown that can cause kidney damage, can be serious and potentially life-threatening (rhabdomyolysis). This side effect is rare (occurring in less than 1 in 1000 patients).

Other side effects include:

• severe allergic reactions (angioedema) - symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, and severe itching of the skin (with hives). This side effect is rare (occurring in less than 1 in 1000 patients).
• 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 these severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• muscle rupture
• symptoms of lupus-like syndrome (including rash, joint pain, and effects on blood cells).

Other known side effects:

Common side effects (occurring in less than 1 in 10 patients):

• 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 during treatment with this medication.
• headache
• dizziness
• constipation
• nausea
• abdominal pain
• diarrhea
• bloating (excess gas in the digestive tract)
• muscle pain
• weakness
• fatigue
• increased results of some blood tests that assess liver function (aminotransferase activity)
• increased protein in the urine. This usually resolves on its own and does not require stopping Romazic Plus (only applies to the 40 mg rosuvastatine dose).

Uncommon side effects (occurring in less than 1 in 100 patients):

• decreased appetite
• tingling sensation
• hot flashes
• high blood pressure
• cough
• indigestion
• heartburn
• dry mouth
• gastritis
• rash, itching, hives
• joint pain
• muscle spasms
• neck pain
• back pain
• muscle weakness
• arm and leg pain
• chest pain
• pain
• swelling, especially of the hands and feet
• increased results of some laboratory tests that assess muscle function (creatine kinase test)
• protein in the urine - this usually resolves on its own, without the need to stop taking Romazic Plus (only applies to the 10 mg and 20 mg rosuvastatine doses).

Rare side effects (occurring in less than 1 in 1000 patients):

• bleeding or bruising more easily than usual due to low platelet count
• pancreatitis, which causes severe abdominal pain that may radiate to the back
• symptoms of lupus-like syndrome (including rash, joint pain, and effects on blood cells)
• muscle rupture

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

• nerve damage in the arms and legs (such as numbness)
• memory loss
• jaundice (yellowing of the skin and eyes)
• liver inflammation
• blood in the urine
• breast enlargement in men (gynecomastia)

Side effects with unknown frequency (cannot be estimated from available data):

• depression
• sleep disturbances, including insomnia and nightmares
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• myasthenic syndrome (a disease that causes muscle weakness in the eyes)
• shortness of breath
• gallstones or cholecystitis (which can cause abdominal pain, nausea, vomiting)
• tendon injury
• persistent muscle weakness
• sexual problems
• breathing problems, including persistent cough and (or) shortness of breath or fever
• swelling (edema)
• muscle tenderness
• a bulging red rash, sometimes with oval-shaped patches (erythema multiforme)

The patient should consult their doctor if they experience muscle 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 this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 medication.

5. How to store Romazic Plus

The medication should be stored out of sight and reach of children. It should be stored in its original packaging to protect it from light and moisture. There are no special storage temperature requirements. The medication should not be taken after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. The packaging also includes the batch number (Lot/LOT) and expiration date (EXP). Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications, as this will help protect the environment.

6. Package contents and other information

What Romazic Plus contains

The active substances of Romazic Plus are rosuvastatine (in the form of rosuvastatine calcium) and ezetimibe. Romazic Plus, 5 mg + 10 mg: Each film-coated tablet contains 5 mg of rosuvastatine (in the form of rosuvastatine calcium) and 10 mg of ezetimibe. Romazic Plus, 10 mg + 10 mg: Each film-coated tablet contains 10 mg of rosuvastatine (in the form of rosuvastatine calcium) and 10 mg of ezetimibe. Romazic Plus, 20 mg + 10 mg: Each film-coated tablet contains 20 mg of rosuvastatine (in the form of rosuvastatine calcium) and 10 mg of ezetimibe. Romazic Plus, 40 mg + 10 mg: Each film-coated tablet contains 40 mg of rosuvastatine (in the form of rosuvastatine calcium) and 10 mg of ezetimibe.

Other ingredients

Tablet core (the same for all strengths): microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, povidone K30, sodium croscarmellose, sodium lauryl sulfate, lactose monohydrate, hypromellose. Coating: Romazic Plus, 5 mg + 10 mg: hypromellose, titanium dioxide (E 171), macrogol, yellow iron oxide (E 172), red iron oxide (E 172), talc. Romazic Plus, 10 mg + 10 mg: hypromellose, titanium dioxide (E 171), macrogol, yellow iron oxide (E 172), talc. Romazic Plus, 20 mg + 10 mg: hypromellose, titanium dioxide (E 171), macrogol, yellow iron oxide (E 172), talc. Romazic Plus, 40 mg + 10 mg: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol.

What Romazic Plus looks like and package contents

Romazic Plus, 5 mg + 10 mg: Light yellow, round, biconvex film-coated tablets, approximately 10 mm in diameter, with "EL 5" engraved on one side. Romazic Plus, 10 mg + 10 mg: Beige, round, biconvex film-coated tablets, approximately 10 mm in diameter, with "EL 4" engraved on one side. Romazic Plus, 20 mg + 10 mg: Yellow, round, biconvex film-coated tablets, approximately 10 mm in diameter, with "EL 3" engraved on one side. Romazic Plus, 40 mg + 10 mg: White, round, biconvex film-coated tablets, approximately 10 mm in diameter, with "EL 2" engraved on one side. The packaging contains 28, 30, 56, 60, 84, or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

ELPEN Pharmaceutical Co. Inc., Marathonos Ave. 95, 19009 Pikermi Attiki, Greece, RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A., P.O. BOX 3012 Larissa Industrial Area, 41500 Larissa, Greece

Date of last revision of the leaflet