Rosamera

Leaflet accompanying the packaging: patient information

Rosamera, 10 mg + 5 mg + 4 mg, film-coated tablets

Rosamera, 10 mg + 5 mg + 8 mg, film-coated tablets

Rosamera, 10 mg + 10 mg + 8 mg, film-coated tablets

Rosamera, 20 mg + 5 mg + 4 mg, film-coated tablets

Rosamera, 20 mg + 5 mg + 8 mg, film-coated tablets

Rosamera, 20 mg + 10 mg + 8 mg, film-coated tablets

Rosuvastatin + Amlodipine + tert-Butylamine perindopril

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

1. What is Rosamera and what is it used for

Rosamera is a combination of three active substances: rosuvastatin, perindopril, and amlodipine. Rosuvastatin belongs to a group of medicines called statins. Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine belongs to a group of medicines called calcium channel blockers.

Rosuvastatin helps control high cholesterol levels:

• if the patient is at risk of heart attack or stroke - rosuvastatin is used to treat high cholesterol.
• if diet and increased physical activity have not been enough to lower cholesterol levels. While taking rosuvastatin, the patient should continue to follow a cholesterol-lowering diet and exercise. Perindopril and amlodipine help control high blood pressure (hypertension).

Rosamera is prescribed for use in adult patients to treat high blood pressure (hypertension) and high cholesterol. Patients who are already taking rosuvastatin, perindopril, and amlodipine may take one Rosamera tablet, which contains all three active substances, instead of separate tablets for each medicine.

2. Important information before taking Rosamera

When not to take Rosamera

• if the patient is allergic to rosuvastatin, perindopril, or any other ACE inhibitor, amlodipine, or any other calcium channel blocker, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe skin rashes or hives while taking ACE inhibitors in the past;
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine that contains aliskiren;
• if the patient has very low blood pressure (severe hypotension);
• if the patient has a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply the body with enough blood);
• if the patient has heart failure after a heart attack;
• if the patient has severe kidney disease;
• if the patient has liver disease;
• if the patient has recurring or unexplained muscle pain;
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C infection);
• if the patient is taking cyclosporine (a medicine used after organ transplantation);
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Rosamera, they should stop taking the medicine and contact their doctor immediately;
• if the patient is undergoing dialysis or blood filtration using a method other than hemodialysis. Depending on the device used, Rosamera may not be suitable for the patient;
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a medicine that contains sacubitril and valsartan, used to treat a certain type of chronic heart failure in adults, as the risk of angioedema (sudden swelling of the tissues under the skin, such as the throat) increases.

Warnings and precautions

Before starting to take Rosamera, the patient should discuss the following with their doctor or pharmacist:

• if the patient has recently had a heart attack;
• if the patient has aortic stenosis (narrowing of the main blood vessel that carries blood from the heart), hypertrophic cardiomyopathy (a disease of the heart muscle), or renal artery stenosis (narrowing of the artery that supplies blood to the kidney);
• if the patient has heart failure or any other heart problems;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient has liver problems;
• if the patient has collagenosis (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• if the patient has severe respiratory failure;
• if the patient has swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema); may occur at any time during treatment - if the patient experiences these symptoms, they should stop taking the medicine and contact their doctor immediately;
• if the patient is taking a low-salt diet or is taking salt substitutes that contain potassium;
• if the patient is taking lithium or is taking potassium-sparing diuretics (such as spironolactone, triamterene) - the patient should avoid taking Rosamera at the same time as these medicines (see "Rosamera and other medicines");
• if the patient is elderly;
• if the patient has an abnormal level of a hormone called aldosterone in the blood (primary aldosteronism);
• if the patient has diabetes;
• if the patient is going to have anesthesia and/or undergo major surgery;
• if the patient is going to undergo LDL apheresis (a procedure to mechanically remove cholesterol from the blood);
• if the patient is going to undergo desensitization treatment to reduce the allergic reaction to bee or wasp stings;
• if the patient has recently had diarrhea or vomiting, or if the patient is dehydrated;
• if the patient has been informed by their doctor that they have an intolerance to some sugars;
• if the patient has thyroid problems;
• if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, and India). The doctor will choose a suitable starting dose of Rosamera for the patient;
• if the patient is black - in this case, there may be a greater risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races;
• if the patient has had recurring or unexplained muscle pain or muscle problems in the past, or if the patient has had similar problems while taking other cholesterol-lowering medicines. If the patient experiences unexplained muscle pain, especially if it is accompanied by a feeling of being unwell or fever, they should contact their doctor immediately. The patient should also inform their doctor if they experience persistent muscle weakness;
• if the patient has 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 the patient is taking other medicines called fibrates, which lower cholesterol. The patient should carefully read the leaflet, especially if they have taken other cholesterol-lowering medicines in the past;
• if the patient is taking medicines used to treat HIV infection, such as ritonavir, lopinavir, and/or atazanavir, see "Rosamera and other medicines" and "When not to take Rosamera";
• if the patient regularly consumes large amounts of alcohol;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren.
• women taking Rosamera should use effective contraception to avoid becoming pregnant;
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, and/or ulcers in the mouth after taking Rosamera or similar medicines.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood.

If the patient is taking or has taken fusidic acid (used to treat bacterial infections) orally or by injection in the last 7 days, they should not take Rosamera. The combination of fusidic acid and rosuvastatin can lead to serious muscle problems (rhabdomyolysis), see section 4.

If the patient is taking any of the following medicines, the risk of angioedema increases:

• racecadotril, a medicine used to treat diarrhea,
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the so-called mTOR inhibitors (medicines used to prevent organ rejection),
• vildagliptin, a medicine used to treat diabetes.

Angioedema

In patients treated with ACE inhibitors, including Rosamera, angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing and breathing) has been reported. Angioedema may occur at any time during treatment. If the patient experiences these symptoms, they should stop taking Rosamera and contact their doctor immediately. See also section 4.

In connection with the use of rosuvastatin, severe skin reactions, including Stevens-Johnson syndrome and drug reaction 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 Rosamera and contact their doctor immediately.

In a small number of patients, taking statins may affect liver function. This can be detected by a simple blood test to check if liver enzyme activity has increased. Therefore, the doctor will usually recommend blood tests (liver enzyme tests) before starting and during treatment with Rosamera.

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.

Children and adolescents

Rosamera should not be used in children and adolescents.

Rosamera 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.

Other medicines may affect the action of Rosamera.

The patient should inform their doctor about taking any of the following medicines, as special caution may be necessary:

• other medicines that lower blood pressure, including angiotensin II receptor antagonists (ARBs), aliskiren (see also "When not to take Rosamera" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing diuretics (such as triamterene, amiloride), potassium supplements (including salt substitutes), and other medicines that increase potassium levels in the blood (such as trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine or tacrolimus, immunosuppressive medicines used to prevent organ rejection, and heparin, a medicine used to thin the blood to prevent blood clots);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at a dose of 12.5 mg to 50 mg per day;
• lithium, used to treat mania or depression;
• non-steroidal anti-inflammatory medicines (such as ibuprofen) or high doses of salicylates, such as acetylsalicylic acid ("aspirin");
• medicines used to treat diabetes (such as insulin or metformin);
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (such as tricyclic antidepressants, antipsychotic medicines);
• trimethoprim (used to treat infections);
• estramustine (used to treat cancer);
• medicines most commonly used to treat diarrhea (racecadotril) or to prevent organ rejection (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See "Warnings and precautions";
• allopurinol (a medicine used to treat gout);
• procainamide (a medicine used to treat irregular heartbeat);
• vasodilators, including nitrates;
• heparin (a medicine used to thin the blood);
• medicines used to treat low blood pressure, shock, or asthma (such as ephedrine, norepinephrine, or adrenaline);
• gold salts, especially when given intravenously (used to treat symptoms of rheumatoid arthritis);
• warfarin, ticagrelor, or clopidogrel (or any other blood-thinning medicine),
• fibrates (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (such as ezetimibe);
• antacids (used to neutralize stomach acid);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• oral contraceptives ("the pill") or hormone replacement therapy;
• regorafenib (used to treat cancer);
• darolutamide (used to treat cancer);
• capmatinib (used to treat cancer);
• fostamatinib (used to treat low platelet count);
• febuxostat (used to treat and prevent high levels of uric acid in the blood);
• teriflunomide (used to treat multiple sclerosis);
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, given alone or in combination with other medicines (see "Warnings and precautions" and "When not to take Rosamera"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• roxadustat (used to treat anemia in patients with chronic kidney disease);
• tafamidis (used to treat a disease called transthyretin amyloidosis);
• Hypericum perforatum(St. John's Wort);
• verapamil, diltiazem (medicines used to treat heart conditions);
• dantrolene (used in infusion to treat severe body temperature disorders);
• simvastatin (a cholesterol-lowering medicine).

If it is necessary to take fusidic acid orally to treat a bacterial infection, the patient should temporarily stop taking Rosamera. The doctor will inform the patient when it is safe to restart taking the medicine. Taking fusidic acid with Rosamera can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

The doctor may need to change the dose and/or take other precautions:

• if the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also "When not to take Rosamera" and "Warnings and precautions").

Rosamera with food and drink

Rosamera should be taken before a meal.

Pregnancy and breastfeeding

Rosamera should not be takenif the patient is pregnant or breastfeeding.

Before taking any medicine, the patient should consult their doctor or pharmacist.

Pregnancy

If the patient is pregnant (or thinks they may be pregnant), they should inform their doctor. If the patient becomes pregnant while taking Rosamera, they should stop taking the medicine and inform their doctor immediately. The doctor will usually recommend stopping Rosamera before planned pregnancy or immediately after becoming pregnant and prescribe a different medicine instead of Rosamera.

While taking Rosamera, women should use effective contraception to avoid becoming pregnant.

Breastfeeding

The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Taking Rosamera is contraindicated during breastfeeding. The doctor may recommend a different medicine if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Rosamera may affect the patient's ability to drive and use machines. The patient should not drive or operate machinery until they are sure how Rosamera affects them.

If the medicine causes nausea, dizziness, fatigue, or headache, the patient should not drive or operate machinery. The patient should immediately inform their doctor about these symptoms.

3. How to take Rosamera

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.

The recommended dose of Rosamera is one tablet per day. The tablet should be taken in the morning, before a meal, and swallowed with a glass of water.

The doctor will determine the dose of Rosamera that is right for the patient. Rosamera is prescribed for patients who are already taking rosuvastatin, perindopril, and amlodipine as separate tablets.

Taking a higher dose of Rosamera than recommended

If the patient has taken too many tablets, they should immediately contact their doctor or go to the emergency department of the nearest hospital. The most likely symptom of overdose is low blood pressure, which can cause symptoms such as dizziness or fainting. If the patient experiences these symptoms, they should lie down and raise their legs.

Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Rosamera

It is important to take the medicine every day, as regular treatment is most effective. If the patient misses a dose of Rosamera, they should take the next dose at the usual time.

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Rosamera

Since treatment for high blood pressure usually lasts for life, the patient should consult their doctor before stopping treatment with Rosamera.

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, Rosamera can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking Rosamera and contact their doctor immediately:

• swelling of the face, lips, mouth, tongue, or throat, with difficulty swallowing (angioedema) (see section 2 "Warnings and precautions") (uncommon - may affect up to 1 in 100 people),
• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people),
• abnormal or irregular heartbeat, chest pain (angina), or heart attack (very rare - may affect up to 1 in 10,000 people),
• weakness or numbness of the arms and legs or problems with speech - these may be symptoms of a stroke (very rare - may affect up to 1 in 10,000 people),
• sudden wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (uncommon - may affect up to 1 in 100 people),
• inflammation of the pancreas, which may cause severe abdominal pain, radiating to the back, and accompanied by a feeling of being very unwell (rare - may affect up to 1 in 1,000 people),
• yellowing of the skin and eyes (jaundice), which may be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people),
• a skin rash, often starting with red, itchy patches on the face, arms, or legs (erythema multiforme) (very rare - may affect up to 1 in 10,000 people),
• red, flat, round patches on the body, sometimes 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 may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare - may affect up to 1 in 10,000 people),
• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (frequency not known - cannot be estimated from the available data).

The patient should also stop taking Rosamera and contact their doctor immediately if they experience any unusual muscle pain or muscle problems

that last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, muscle side effects can occur in a small number of patients and can rarely develop into a potentially life-threatening muscle injury called rhabdomyolysis.

Other side effects are listed below, in order of decreasing frequency:

• Very common (may affect more than 1 in 10 people):
• edema (fluid retention).

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

• diabetes (the risk of developing diabetes is higher in patients with high blood sugar and fat levels, are overweight, and have high blood pressure; the doctor will monitor patients at risk while they are taking this medicine),
• dizziness, headache, dizziness, feeling of numbness and tingling, drowsiness,
• palpitations (feeling of heartbeat),
• low blood pressure, sudden flushing (especially of the face),
• cough, shortness of breath,
• gastrointestinal disorders (taste disturbances, nausea, vomiting, abdominal pain, diarrhea, constipation),
• allergic reactions (such as skin rashes, itching),
• vision disturbances (including double vision),
• tinnitus (a feeling of hearing sounds),
• muscle pain, muscle cramps,
• feeling of fatigue, weakness.

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

• increased eosinophil count (a type of white blood cell),
• mood changes, sleep disturbances, depression, insomnia,
• tingling, numbness, or tingling of the limbs, lack of sensation, fainting,
• arrhythmias, tachycardia,
• vasculitis (inflammation of blood vessels),
• bronchospasm (a feeling of constriction in the chest, wheezing, and shortness of breath), rhinitis (inflammation of the nasal mucosa),
• dry mouth,
• angioedema (symptoms such as wheezing, swelling of the face or tongue),
• kidney problems,
• intense itching or severe skin rashes, blistering of the skin, hair loss, excessive sweating, itching, red spots on the skin, skin discoloration,
• photosensitivity reactions (increased skin sensitivity to sunlight),
• joint pain,
• back pain,
• urinary disorders (urinary frequency, nocturia, increased urination),
• erectile dysfunction, discomfort, or breast enlargement in men,
• chest pain, pain, malaise, peripheral edema, fever,
• changes in laboratory test results: high potassium levels in the blood, transient after stopping treatment, low sodium levels, hypoglycemia (very low blood sugar) in diabetic patients, increased urea levels in the blood, increased creatinine levels in the blood,
• weight gain or loss,
• falls.

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

• changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in serum, decreased platelet count,
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion),
• disorientation,
• severe abdominal pain (pancreatitis),
• severe allergic reaction - symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised bumps). If the patient experiences an allergic reaction, they should stop taking Rosameraand contact their doctor immediately,

if the patient experiences an allergic reaction, they should stop taking Rosameraand contact their doctor immediately,

• lupus-like syndrome (including rash, joint disorders, and effects on blood cells),
• acute kidney failure, decreased or absent urine production,
• muscle damage in adults, muscle rupture - if the patient experiences unusual muscle pain or muscle problemsthat last longer than expected, as a precaution, they should stop taking Rosamera and contact their doctor immediately.

Very rare (may affect up to 1 in 10,000 people):

• changes in blood test results, such as decreased white blood cell count and red blood cell count, decreased hemoglobin levels,
• high blood sugar levels (hyperglycemia),
• nerve damage in the arms and legs (symptoms such as numbness),
• memory loss,
• cardiovascular disorders (angina pectoris, heart attack),
• increased muscle tone,
• eosinophilic pneumonia (a rare type of pneumonia), rhinitis,
• abdominal distension (gastritis),
• gum hypertrophy,
• liver function disorders, liver inflammation, jaundice (yellowing of the skin and eyes),
• erythema multiforme (a skin rash, often starting with red, itchy patches on the face, arms, or legs),
• blood in the urine.

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

• sleep disturbances, including insomnia and nightmares,
• muscle damage, persistent muscle weakness,
• redness and peeling of the skin over a large area of the body,
• angioedema,
• severe skin reactions (toxic epidermal necrolysis),
• discoloration, numbness, and pain in the fingers and toes (Raynaud's phenomenon),
• 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).

The patient should talk to their doctor if they experience weakness or numbness of the arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

There may be blood disorders, kidney, liver, or pancreas problems, and changes in laboratory test results (blood tests). The doctor may order blood tests to monitor the patient's condition.

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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Phone: +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 Rosamera

The medicine should be stored out of sight and reach of children.

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.

Store in the original packaging to protect from light.

There are no special storage temperature requirements.

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 Rosamera contains

• The active substances of Rosamera are rosuvastatin, amlodipine, and perindopril tert-butylamine.

Rosamera, 10 mg + 5 mg + 4 mg, film-coated tablets

• Each film-coated tablet contains 10 mg of rosuvastatin (corresponding to 10.395 mg of rosuvastatin calcium), 5 mg of amlodipine (corresponding to 6.934 mg of amlodipine besylate), and 4 mg of perindopril tert-butylamine (corresponding to 3.338 mg of perindopril).
• Other ingredients are microcrystalline cellulose (type 200), microcrystalline cellulose (type 112), crospovidone (type A), colloidal anhydrous silica, and magnesium stearate in the tablet core, and polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172), and talc in the tablet coating.

Rosamera, 10 mg + 5 mg + 8 mg, film-coated tablets

• Each film-coated tablet contains 10 mg of rosuvastatin (corresponding to 10.395 mg of rosuvastatin calcium), 5 mg of amlodipine (corresponding to 6.934 mg of amlodipine besylate), and 8 mg of perindopril tert-butylamine (corresponding to 6.676 mg of perindopril).
• Other ingredients are microcrystalline cellulose (type 200), microcrystalline cellulose (type 112), crospovidone (type A), colloidal anhydrous silica, and magnesium stearate in the tablet core, and polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and black iron oxide (E 172), and talc in the tablet coating.

Rosamera, 10 mg + 10 mg + 8 mg, film-coated tablets

• Each film-coated tablet contains 10 mg of rosuvastatin (corresponding to 10.395 mg of rosuvastatin calcium), 10 mg of amlodipine (corresponding to 13.870 mg of amlodipine besylate), and 8 mg of perindopril tert-butylamine (corresponding to 6.676 mg of perindopril).
• Other ingredients are microcrystalline cellulose (type 200), microcrystalline cellulose (type 112), crospovidone (type A), colloidal anhydrous silica, and magnesium stearate in the tablet core, and polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), and talc in the tablet coating.

Rosamera, 20 mg + 5 mg + 4 mg, film-coated tablets

• Each film-coated tablet contains 20 mg of rosuvastatin (corresponding to 20.79 mg of rosuvastatin calcium), 5 mg of amlodipine (corresponding to 6.934 mg of amlodipine besylate), and 4 mg of perindopril tert-butylamine (corresponding to 3.338 mg of perindopril).
• Other ingredients are microcrystalline cellulose (type 200), microcrystalline cellulose (type 112), crospovidone (type A), colloidal anhydrous silica, and magnesium stearate in the tablet core, and polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and talc in the tablet coating.

Rosamera, 20 mg + 5 mg + 8 mg, film-coated tablets

• Each film-coated tablet contains 20 mg of rosuvastatin (corresponding to 20.79 mg of rosuvastatin calcium), 5 mg of amlodipine (corresponding to 6.934 mg of amlodipine besylate), and 8 mg of perindopril tert-butylamine (corresponding to 6.676 mg of perindopril).
• Other ingredients are microcrystalline cellulose (type 200), microcrystalline cellulose (type 112), crospovidone (type A), colloidal anhydrous silica, and magnesium stearate in the tablet core, and polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), and talc in the tablet coating.

Rosamera, 20 mg + 10 mg + 8 mg, film-coated tablets

• Each film-coated tablet contains 20 mg of rosuvastatin (corresponding to 20.79 mg of rosuvastatin calcium), 10 mg of amlodipine (corresponding to 13.87 mg of amlodipine besylate), and 8 mg of perindopril tert-butylamine (corresponding to 6.676 mg of perindopril).
• Other ingredients are microcrystalline cellulose (type 200), microcrystalline cellulose (type 112), crospovidone (type A), colloidal anhydrous silica, and magnesium stearate in the tablet core, and polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), and talc in the tablet coating.

What Rosamera looks like and contents of the pack

10 mg + 5 mg + 4 mg, film-coated tablets

Pink, round, slightly convex film-coated tablets with beveled edges and engraved with "PAR1" on one side of the tablet (tablet diameter: approximately 8.5 mm).

10 mg + 5 mg + 8 mg, film-coated tablets

Light pink-brown, round, slightly convex film-coated tablets with beveled edges and engraved with "PAR2" on one side of the tablet (tablet diameter: approximately 8.5 mm).

10 mg + 10 mg + 8 mg, film-coated tablets

Yellow-brown, round, slightly convex film-coated tablets with beveled edges and engraved with "PAR3" on one side of the tablet (tablet diameter: approximately 11 mm).

20 mg + 5 mg + 4 mg, film-coated tablets

Light orange-pink, round, slightly convex film-coated tablets with beveled edges and engraved with "PAR4" on one side of the tablet (tablet diameter: approximately 11 mm).

20 mg + 5 mg + 8 mg, film-coated tablets

Light yellow, round, slightly convex film-coated tablets with beveled edges and engraved with "PAR5" on one side of the tablet (tablet diameter: approximately 11 mm).

20 mg + 10 mg + 8 mg, film-coated tablets

White, round, slightly convex film-coated tablets with beveled edges and engraved with "PAR6" on one side of the tablet (tablet diameter: approximately 11 mm).

Rosamera is available in cartons containing 30, 60, 90, and 100 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

phone: +48 22 573 75 00

Date of last revision of the leaflet:31.12.2024