Romazic Plus

Leaflet attached to 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

Rosuvastatin + Ezetimibe

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 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 rosuvastatin, which belongs to a group of medicines called statins, and the other active substance is ezetimibe. Romazic Plus is used to lower the level of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood, and to increase the level of "good" cholesterol (HDL cholesterol). The medicine works by reducing the amount of cholesterol absorbed in the gut and the amount of cholesterol produced in the body. In most people, high cholesterol does not affect their well-being, as it does not cause any symptoms. However, if left untreated, it can cause fatty deposits to build up in the walls of blood vessels, leading to their narrowing. As a result of the narrowing, it is sometimes possible for the blood vessel to become blocked, 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 level cannot be controlled by diet alone. While taking this medicine, you should continue to follow a cholesterol-lowering diet. Your doctor may prescribe Romazic Plus if you are already taking rosuvastatin and ezetimibe in the same doses as in the combination medicine. Romazic Plus is used in patients with:

• high cholesterol levels in the blood (primary hypercholesterolemia)
• heart disease - Romazic Plus reduces the risk of heart attack, stroke, the need for surgical procedures 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 rosuvastatin, ezetimibe, or any of the other ingredients of this medicine (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 medicine containing cyclosporin (e.g., after organ transplantation);
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Romazic Plus, they should stop taking the medicine immediately and inform their doctor. While taking Romazic Plus, women should use effective methods of contraception to avoid becoming pregnant.
• if the patient has ever had a severe skin rash or skin peeling, blisters, and (or) ulcers in the mouth, throat, nose, genitals, and eyes after taking Romazic Plus or other similar medicines.

In addition, do not take Romazic Plus, 40 mg + 10 mg (the highest dose):

• if the patient has moderately severe kidney disease (if in doubt, consult a doctor);
• if the patient has 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 medicines;
• if the patient regularly consumes large amounts of alcohol;
• 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 other cholesterol-lowering medicines called fibrates (see "Romazic Plus and other medicines").

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 medicines. If unexplained muscle pain or weakness occurs, especially if accompanied by malaise or fever, the patient should consult their doctor immediately. The patient should also inform their doctor or pharmacist about persistent muscle weakness.

and

• 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 medicines, 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 medicines");
• if the patient has severe respiratory failure;
• if the patient is taking other cholesterol-lowering medicines called fibrates. See "Romazic Plus and other medicines".
• 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 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 (an antibiotic used to treat bacterial infections) orally or by injection in the last 7 days. The 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 medicine 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 ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate the symptoms of the disease or cause 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 blood test that checks for increased liver enzyme activity. Therefore, the doctor will recommend regular blood tests while taking 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 with 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. While taking this medicine, 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 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. The patient should inform their doctor about taking any of the following medicines:

• cyclosporin (a medicine used, e.g., after organ transplantation to prevent rejection. Cyclosporin increases the effect of rosuvastatin when taken together). Do not take Romazic Plus if you are taking cyclosporin.
• anticoagulants, such as warfarin, acenocoumarol, or fluindione (concomitant use with Romazic Plus may increase the anticoagulant effect, increasing the risk of bleeding), ticagrelor, or clopidogrel;
• other cholesterol-lowering medicines called fibrates, which also regulate triglyceride levels in the blood (e.g., gemfibrozil and other medicines in this class). Concomitant use increases the effect of rosuvastatin.
• colestyramine (a medicine used to lower cholesterol levels), as it affects the way ezetimibe works;
• medicines used to treat indigestion, containing aluminum and magnesium (used to neutralize stomach acid). These medicines may decrease rosuvastatin levels in the blood. This effect can be reduced by taking these medicines 2 hours after taking rosuvastatin.
• erythromycin (an antibiotic). Concomitant use decreases the effect of rosuvastatin.
• fusidic acid. If the patient needs to take fusidic acid orally to treat a bacterial infection, they should stop taking Romazic Plus temporarily. The doctor will inform them when it is safe to restart taking Romazic Plus. Concomitant use of Romazic Plus and fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• oral contraceptives (birth control pills). Concomitant use increases the level of sex hormones released by the pill.
• hormone replacement therapy (increases hormone levels in the blood);
• regorafenib (used to treat cancer);
• any of the following medicines 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 that they are taking Romazic Plus.

Romazic Plus with alcohol

Do not take Romazic Plus, 40 mg + 10 mg (the highest dose), if you regularly consume large amounts of alcohol.

Pregnancy and breastfeeding

Romazic Plus should not be used if the patient is pregnant, trying to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Romazic Plus, they should stop taking the medicine immediately and inform their doctor. While taking Romazic Plus, women should use effective methods of contraception to avoid becoming pregnant. Romazic Plus should not be used during breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

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

Romazic Plus contains lactose

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

Romazic Plus contains sodium

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 Plus

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. While taking 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 medicine 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 medicine 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 medicine containing colestyramine or any other bile acid sequestrant, the patient should take Romazic Plus at least 2 hours before or 4 hours after taking these medicines.

Regular cholesterol level checks

It is essential for the patient to attend regular check-ups with their doctor to ensure that their cholesterol levels are under control.

Taking a higher dose of Romazic Plus than recommended

If the patient takes more Romazic Plus than they should, they should consult their doctor or the emergency department of the nearest hospital, as medical attention may be necessary.

Missing a dose of Romazic Plus

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 Romazic Plus 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 medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Romazic Plus can cause side effects, although not everybody gets them. It is essential for the patient to know what side effects can occur.

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

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

This side effect is rare (affects less than 1 in 1000 people).

• a severe allergic reaction (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 (affects less than 1 in 1000 people).
• red, flat, round, or oval patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash 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).
• muscle rupture
• symptoms of lupus-like syndrome (including rash, joint pain, and effects on blood cells).

Other known side effects Common side effects (affect less than 1 in 10 people):

• 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.
• 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 rosuvastatin dose).

Uncommon side effects (affect less than 1 in 100 people):

• 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 blood tests for muscle function (creatine kinase test)
• may experience increased protein in the urine - usually resolves on its own without needing to stop Romazic Plus (only applies to the 10 mg and 20 mg rosuvastatin doses).

Rare side effects (affect less than 1 in 1000 people):

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

Very rare side effects (affect less than 1 in 10,000 people):

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

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

• depression
• sleep disorders, including insomnia and nightmares
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (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 talk to 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 tell 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 gathered on the safety of the medicine.

5. How to store Romazic Plus

The medicine should be stored out of sight and reach of children. Store in the original packaging to protect from light and moisture. There are no special storage temperature requirements. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates 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. Package contents and other information

What Romazic Plus contains

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

Other ingredients are:

Tablet core (the same for all strengths): microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, povidone K30, croscarmellose sodium, 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 contents of the pack

Romazic Plus, 5 mg + 10 mg: Light yellow, round, biconvex film-coated tablets, approximately 10 mm in diameter, with the inscription "EL 5" on one side. Romazic Plus, 10 mg + 10 mg: Beige, round, biconvex film-coated tablets, approximately 10 mm in diameter, with the inscription "EL 4" on one side. Romazic Plus, 20 mg + 10 mg: Yellow, round, biconvex film-coated tablets, approximately 10 mm in diameter, with the inscription "EL 3" on one side. Romazic Plus, 40 mg + 10 mg: White, round, biconvex film-coated tablets, approximately 10 mm in diameter, with the inscription "EL 2" on one side. The pack 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

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: