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

Rosuvastatin + Ezetimibe

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.
• 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 as yours.
• 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. Contents of the pack 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 known as statins, and the other active substance is ezetimibe. Romazic Plus is used to reduce the level of total cholesterol, so-called "bad" cholesterol (LDL cholesterol) and a type of fat in the blood called triglycerides, and to increase the level of so-called "good" cholesterol (HDL cholesterol). The medicine works by reducing the amount of cholesterol absorbed in the gut and the amount of cholesterol produced by 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 lead to the accumulation of fatty deposits in the walls of blood vessels, causing them to narrow. As a result of the narrowing, it is sometimes possible for the blood vessel to become blocked, cutting off the blood supply 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 levels of cholesterol 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 in 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 viral hepatitis C infection);
• if the patient is taking a medicine containing cyclosporin (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 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 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 previously experienced 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);
• if the patient is taking other cholesterol-lowering medicines, known as 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 it with their doctor if:

• the patient has kidney problems;
• the patient has liver problems;
• the patient has experienced recurring or unexplained muscle pain or weakness, or if they or their family members have had muscle diseases or previously experienced muscle problems while taking cholesterol-lowering medicines. If unexplained muscle pain or weakness occurs, especially if it is accompanied by a feeling of illness or fever, the patient should consult their doctor immediately. The patient should also tell their doctor or pharmacist about persistent muscle weakness.

Statins can affect the liver in a small number of people. 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. Severe 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 levels of sugar and fat in the blood, is overweight, and has high blood pressure.

Children and adolescents

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

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 tell their doctor about taking any of the following medicines:

• cyclosporin (a medicine used, for example, after organ transplantation, which increases the effect of rosuvastatin taken at the same time. Do not take Romazic Plus while taking cyclosporin).
• anticoagulant medicines, such as warfarin, acenocoumarol, or fluindione (taking Romazic Plus at the same time may increase the anticoagulant effect, with an increased risk of bleeding), ticagrelor, or clopidogrel;
• other cholesterol-lowering medicines, known as fibrates, which also regulate triglyceride levels in the blood (e.g., gemfibrozil and other medicines in this group). Taking Romazic Plus at the same time increases the effect of rosuvastatin.
• colestyramine (a medicine used to lower cholesterol levels, which affects the way ezetimibe works);
• medicines used to treat indigestion, containing aluminum and magnesium (used to neutralize stomach acid). These medicines can reduce the level of rosuvastatin in the blood. This effect can be reduced by taking these medicines 2 hours after taking rosuvastatin.
• erythromycin (an antibiotic). Taking Romazic Plus at the same time reduces the effect of rosuvastatin.
• fusidic acid. If the patient needs to take fusidic acid orally to treat a bacterial infection, they will need to stop taking Romazic Plus temporarily. The doctor will inform them when it is safe to restart taking the medicine. Taking Romazic Plus and fusidic acid at the same time can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• oral contraceptives (birth control pills). Taking Romazic Plus at the same time increases the level of sex hormones released by the pill.
• hormone replacement therapy (increasing 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, and (or) 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

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 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 taken 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 patient's ability to drive or use machines. However, the patient should be aware that Romazic Plus can cause dizziness. If this happens, 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 the medicine.

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 low-cholesterol 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 starting 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 has prescribed Romazic Plus in combination with another cholesterol-lowering medicine containing colestyramine or any other medicine containing bile acid sequestrants, Romazic Plus should be taken 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 monitor their cholesterol levels and ensure they have reached and maintained the correct levels.

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 tell their doctor if they want to stop taking Romazic Plus. After stopping Romazic Plus, 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 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 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 severe and potentially life-threatening (rhabdomyolysis). This side effect is rare (it occurs in less than 1 in 1000 people).

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 levels of sugar and fat in the blood, 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 system)
• muscle pain
• weakness
• fatigue
• increased results of some blood tests that check 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 rosuvastatin 40 mg dose).

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

• decreased appetite
• tingling sensation
• hot flushes
• 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 that check muscle function (creatine kinase test)
• protein in the urine may increase - this usually resolves on its own, without the need to stop Romazic Plus (only applies to rosuvastatin 10 mg and 20 mg 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 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 (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 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 gallbladder inflammation (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 raised, red rash, sometimes with circular 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. It should be stored in its original packaging to protect it from light and moisture. There are no special storage temperature requirements. The medicine should not be taken after the expiry date stated on the carton and blister pack 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. Contents of the pack 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, 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 contents of the pack

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