Rosamera: detailed information

Patient Information Leaflet

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
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Rosamera is and what it is used for
Important information before taking Rosamera
How to take Rosamera
Possible side effects
How to store Rosamera
Contents of the pack and other information

1. What Rosamera is and what it is 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 known as calcium antagonists.

Rosuvastatin helps control high cholesterol levels:

in patients at risk of heart attack or stroke – rosuvastatin is used to treat high cholesterol levels;
when changes in diet and increased physical activity have not been sufficient to lower cholesterol levels. While taking rosuvastatin, you should continue a cholesterol-lowering diet and maintain physical activity.

Perindopril and amlodipine help control high blood pressure (hypertension).

Rosamera is prescribed for adult patients to treat elevated blood pressure (hypertension) and high cholesterol occurring simultaneously. Patients already taking rosuvastatin, perindopril, and amlodipine may instead of separate tablets of each individual medicine take one tablet of Rosamera containing all three active substances.

2. Important information before using Rosamera

When not to use Rosamera

if the patient is allergic to rosuvastatin, perindopril or another ACE inhibitor, amlodipine or another calcium antagonist, or to any of the other ingredients of this medicine (listed in section 6);
if the patient has previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching or severe skin rash while taking ACE inhibitors, or if such symptoms occurred in the patient or a family member under any other circumstances (a condition known as angioedema);
if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
if the patient has very low blood pressure (severe hypotension);
if the patient has narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body);
if the patient has heart failure following a heart attack;
if the patient has severe kidney disease;
if the patient has liver disease;
if the patient has recurrent or unexplained muscle pain;
if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C);
if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation);
if the patient is pregnant or breastfeeding. If pregnancy occurs during treatment with Rosamera, the medicine must be stopped immediately and a doctor contacted;
if the patient is undergoing dialysis or another form of blood filtration. Depending on the device used, Rosamera may not be suitable for the patient;
if the patient has kidney disorders causing reduced blood supply to the kidneys (renal artery stenosis);
if the patient has previously taken or is currently taking a medicine containing sacubitril and valsartan, used to treat certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) is increased.

Warnings and precautions
Before starting Rosamera, discuss the following with your doctor or pharmacist:

if the patient recently suffered a heart attack;
if the patient has aortic stenopenia (narrowing of the main blood vessel carrying blood from the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the artery supplying 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 function disorders;
if the patient has a collagen disease (connective tissue disease), such as systemic lupus erythematosus or scleroderma;
if the patient has severe respiratory insufficiency;
if the patient develops swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema); this may occur at any time during treatment – if such symptoms occur, treatment with Rosamera must be stopped immediately and a doctor contacted;
if the patient is on a low-salt diet or taking salt substitutes containing potassium;
if the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene) – simultaneous use of Rosamera with these medicines should be avoided (see section "Rosamera with other medicines");
if the patient is elderly;
if the patient has abnormally increased blood levels of a hormone called aldosterone (primary hyperaldosteronism);
if the patient has diabetes;
if the patient is to undergo anesthesia and/or a major surgical procedure;
if the patient is to undergo LDL apheresis (a mechanical procedure to remove cholesterol from the blood);
if the patient is to undergo desensitization therapy to reduce reactions after bee or wasp stings;
if the patient has recently had diarrhea or vomiting, or is dehydrated;
if the patient has been informed by a doctor about intolerance to certain sugars;
if the patient has thyroid function disorders;
if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, and India). The doctor will determine the appropriate starting dose of Rosamera for the patient;
if the patient is of Black race – in such cases, there may be an increased risk of angioedema, and the medicine may be less effective in lowering blood pressure compared to patients of other races;
if the patient has previously experienced recurrent or unexplained muscle pain or muscle problems, or if family members have had similar problems, or if the patient experienced muscle problems while taking other cholesterol-lowering medicines in the past. In case of unexplained muscle pain, especially if accompanied by malaise or fever, contact a doctor immediately. Inform the doctor if the patient experiences persistent muscle weakness;
if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen symptoms or trigger myasthenia (see section 4);
if the patient is taking other cholesterol-lowering medicines called fibrates. Read the leaflet carefully, even if the patient previously took other cholesterol-lowering medicines;
if the patient is taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir – see section "Rosamera with other medicines";
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:
an angiotensin II receptor antagonist (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
aliskiren.
during treatment with Rosamera, female patients should use effective contraception to avoid pregnancy;
if the patient has ever developed severe skin rash, skin peeling, blisters and/or mouth ulcers after taking Rosamera or similar medicines.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Rosamera".
If the patient is taking or has taken fusidic acid (used for bacterial infections) orally or by injection within the last 7 days. Combining fusidic acid with rosuvastatin may lead to serious muscle problems (rhabdomyolysis) – see section "Rosamera with other medicines".
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 transplant rejection),
vildagliptin, a medicine used to treat diabetes.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing and breathing) has been reported in patients treated with ACE inhibitors, including Rosamera. Angioedema may occur at any time during treatment. If the patient experiences the above symptoms, treatment with Rosamera must be stopped immediately and medical advice sought. See also section 4.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of rosuvastatin. If any of the symptoms described in section 4 occur, stop taking Rosamera immediately and contact a doctor without delay.
In a small number of patients, statins may affect liver function. This can be detected by a simple blood test measuring liver enzyme activity. Therefore, the doctor will usually recommend blood tests (liver enzyme activity) before starting and during treatment with Rosamera.
Patients with diabetes or at risk of developing diabetes will be closely monitored while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at increased risk of developing diabetes.

Children and adolescents
Rosamera must not be used in children and adolescents.

Rosamera with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Other medicines may affect the action of Rosamera.
Inform the doctor if the patient is taking any of the following medicines, as special precautions may be necessary:

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

If oral fusidic acid is required for the treatment of a bacterial infection, temporary discontinuation of Rosamera is necessary. The doctor will advise when it is safe to restart treatment. Concomitant use of Rosamera with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
The doctor may need to adjust the dose and/or take additional precautions:

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

Rosamera with food and drink
Rosamera should be taken before a meal.

Pregnancy and breastfeeding
Do not use Rosamera if the patient is pregnant or breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.

Pregnancy
If the patient is pregnant (or suspects she may be pregnant), she must inform her doctor. If pregnancy occurs during treatment with Rosamera, treatment must be stopped immediately and the doctor informed. Usually, the doctor will recommend discontinuing Rosamera before a planned pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine instead of Rosamera.
While taking Rosamera, female patients should use effective contraception to avoid pregnancy.

Breastfeeding
Inform the doctor if the patient is breastfeeding or intends to breastfeed. Rosamera is contraindicated during breastfeeding. The doctor may recommend an alternative medicine if the patient wishes to breastfeed, especially if the baby is a newborn or premature infant.

Driving and operating machinery
Rosamera may affect the ability to drive and operate machinery. Driving and operating machinery are not recommended until the patient knows how Rosamera affects them.
If the medicine causes nausea, dizziness, fatigue or headache, do not drive or operate machinery. Inform the doctor immediately about these symptoms.

3. How to use Rosamera

This medicine should always be taken exactly as recommended by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The recommended dose is one tablet once daily. The tablet should preferably be taken in the morning, before a meal, and swallowed with a glass of water.
Your doctor will determine the dose appropriate for you. Rosamera is prescribed for patients who are already taking rosuvastatin, perindopril, and amlodipine as separate tablets.

Taking more Rosamera than recommended
If you take too many tablets, you should immediately contact your doctor or go to the emergency department of your nearest hospital.
The most likely symptom of overdose is low blood pressure, which may cause symptoms such as dizziness or fainting. If such symptoms occur, you should lie down and raise your legs.
Breathing difficulties caused by excess fluid accumulating in the lungs (pulmonary edema) may occur up to 24–48 hours after taking the medicine.

Missing a dose of Rosamera
It is important to take the medicine every day, as regular treatment is most effective. If you miss a dose of Rosamera, take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.

Stopping Rosamera
Since treatment for high blood pressure usually lasts a lifetime, you should consult your doctor before stopping the medicine.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur, which may be serious, stop taking the medicine immediately and contact your doctor:

swelling of the face, lips, mouth, tongue or throat, with difficulty swallowing (angioedema) (see section 2 "Warnings and precautions") (Uncommon – may occur in up to 1 in 100 patients),
severe dizziness or fainting caused by low blood pressure (Common – may occur in up to 1 in 10 patients),
abnormally fast or irregular heartbeat, chest pain (angina) or heart attack (Very rare – may occur in up to 1 in 10,000 patients),
weakness of arms and legs or difficulty speaking – these may be signs of stroke (Very rare – may occur in up to 1 in 10,000 patients),
sudden wheezing, chest pain, breathlessness or difficulty breathing (bronchospasm) (Uncommon – may occur in up to 1 in 100 patients),
pancreatitis, which may cause severe pain in the upper abdomen spreading to the back, accompanied by severe malaise (Rare – may occur in up to 1 in 1,000 patients),
yellowing of the skin and eyes (jaundice), which may be a sign of liver inflammation (Very rare – may occur in up to 1 in 10,000 patients),
skin rash, often starting with red, itchy spots on the face, arms or legs (erythema multiforme) (Very rare – may occur in up to 1 in 10,000 patients),
red, flat, disc-shaped or circular spots on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, sores in the throat, nose, genital area and around the eyes. These potentially life-threatening skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (Very rare – may occur in up to 1 in 10,000 patients),
widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (Not known – frequency cannot be estimated from available data).

You should also stop taking Rosamera and contact your doctor immediately if you experience any unusual muscle pain or muscle problems lasting longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adults. As with other statins, muscle-related side effects occur in a small number of patients and rarely may develop into a potentially life-threatening muscle damage called rhabdomyolysis.
Other side effects are listed below, in decreasing order of frequency:
Very common (may occur in more than 1 in 10 patients):

swelling (fluid retention).

Common (may occur in up to 1 in 10 patients):

diabetes (the likelihood of developing diabetes is higher in patients with high blood sugar and fat levels, overweight and high blood pressure; your doctor will monitor patients at risk while taking this medicine),
central dizziness, headache, labyrinthine dizziness, tingling or numbness, drowsiness,
palpitations (awareness of heartbeat),
low blood pressure, sudden flushing (especially of the face),
cough, breathlessness,
gastrointestinal disorders (taste disturbances, indigestion or digestive discomfort, vomiting, abdominal pain, nausea, diarrhoea, constipation),
allergic reactions (such as skin rash, itching),
visual disturbances (including double vision),
tinnitus (sensation of hearing sounds),
muscle pain, muscle cramps,
feeling of fatigue, weakness.

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

increased number of eosinophils (a type of white blood cell),
mood swings, sleep disturbances, depression, insomnia,
sensation of trembling, numbness or tingling in limbs, lack of pain sensation, fainting,
heart rhythm disorders, tachycardia,
vasculitis (inflammation of blood vessels),
bronchospasm (feeling of tightness in the chest, wheezing and breathlessness), sneezing/runny nose due to inflammation of the nasal mucosa,
dryness of the oral mucosa,
angioedema (symptoms such as wheezing, swelling of the face or tongue),
kidney function disorders,
intense itching or severe skin rashes, formation of blister clusters on the skin, hair loss, excessive sweating, pruritus, red spots on the skin, skin discoloration,
photosensitivity reactions (increased skin sensitivity to sunlight),
joint pain,
back pain,
urinary disorders, nocturia (urinary urgency at night), increased frequency of urination,
inability to achieve erection, discomfort or enlargement of the breasts in men,
chest pain, pain, malaise, peripheral oedema, fever,
changes in laboratory test results: high potassium levels in blood, transient after discontinuation of treatment, low sodium levels, hypoglycaemia (very low blood sugar levels) in patients with diabetes, increased blood urea levels, increased blood creatinine levels,
weight gain or weight loss,
falls.

Rare (may occur in up to 1 in 1,000 patients):

changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in serum, decreased platelet count,
dark-coloured urine, nausea or vomiting, muscle cramps, disorientation and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion),
disorientation,
severe upper abdominal pain (pancreatitis),
severe allergic reaction – symptoms include swelling of the face, lips, tongue and (or) throat, difficulty swallowing and breathing, severe skin itching (with raised bumps). If

an allergic reaction occurs, stop taking Rosamera and contact your doctor immediately,

lupus-like syndrome (including rash, joint disorders and effects on blood cells),
acute kidney failure, reduced or absent urine output,
muscle damage in adults, muscle rupture – if unusual muscle pain or muscle problems lasting longer than expected occur, as a precautionary measure, stop taking Rosamera and contact your doctor immediately.

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

changes in blood parameters such as decreased number of white and red blood cells, decreased haemoglobin concentration,
increased blood glucose levels (hyperglycaemia),
damage to nerves of upper and lower limbs (symptoms such as numbness),
memory loss,
cardiovascular disorders (angina, myocardial infarction),
increased muscle tone,
eosinophilic pneumonia (a rare type of lung inflammation), inflammation of the nasal mucosa,
abdominal distension (gastritis),
gum swelling,
liver function disorders, hepatitis, jaundice (yellowing of the skin and eyes),
erythema multiforme (skin rash, often starting with red, itchy spots on the face, arms or legs),
blood in urine.

Not known (frequency cannot be estimated from available data):

sleep disorders including insomnia and nightmares,
tendon damage, persistent muscle weakness,
redness and peeling of the skin over large areas of the body,
angioedema,
severe skin reactions (toxic epidermal necrolysis),
discoloration, numbness and pain in fingers and toes (Raynaud's phenomenon),
myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing),
ocular myasthenia (a disease causing weakness of eye muscles).

Talk to your doctor if the patient experiences weakness of arms or legs worsening with activity, double vision or drooping eyelids, difficulty swallowing or breathlessness.
Blood disorders, kidney, liver or pancreas function disturbances, and changes in laboratory parameters (blood tests) may occur. Your doctor may order blood tests to monitor the patient's condition.
Reporting of side effects
If any side effects occur, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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, you help provide more information on the safety of this medicine.

5. How to store the medicine Rosamera

Keep the medicine out of the 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 stated month.
Store in the original packaging in order to protect from light.
No special temperature storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Rosamera contains

The active substances in Rosamera are rosuvastatin, amlodipine, and perindopril with tert-butylamine.

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

Each film-coated tablet contains 10 mg rosuvastatin (equivalent to 10.395 mg rosuvastatin calcium), 5 mg amlodipine (equivalent to 6.934 mg amlodipine besilate), and 4 mg perindopril with tert-butylamine (equivalent to 3.338 mg 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; polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), 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 rosuvastatin (equivalent to 10.395 mg rosuvastatin calcium), 5 mg amlodipine (equivalent to 6.934 mg amlodipine besilate), and 8 mg perindopril with tert-butylamine (equivalent to 6.676 mg 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; polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), 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 rosuvastatin (equivalent to 10.395 mg rosuvastatin calcium), 10 mg amlodipine (equivalent to 13.870 mg amlodipine besilate), and 8 mg perindopril with tert-butylamine (equivalent to 6.676 mg 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; 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 rosuvastatin (equivalent to 20.79 mg rosuvastatin calcium), 5 mg amlodipine (equivalent to 6.934 mg amlodipine besilate), and 4 mg perindopril with tert-butylamine (equivalent to 3.338 mg 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; 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 rosuvastatin (equivalent to 20.79 mg rosuvastatin calcium), 5 mg amlodipine (equivalent to 6.934 mg amlodipine besilate), and 8 mg perindopril with tert-butylamine (equivalent to 6.676 mg 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; 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 rosuvastatin (equivalent to 20.79 mg rosuvastatin calcium), 10 mg amlodipine (equivalent to 13.87 mg amlodipine besilate), and 8 mg perindopril with tert-butylamine (equivalent to 6.676 mg 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; 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
Pinkish, round, slightly biconvex film-coated tablets with bevelled edges and engraved "PAR1" on one side (tablet diameter: approximately 8.5 mm).
10 mg + 5 mg + 8 mg, film-coated tablets
Light pinkish-brown, round, slightly biconvex film-coated tablets with bevelled edges and engraved "PAR2" on one side (tablet diameter: approximately 8.5 mm).
10 mg + 10 mg + 8 mg, film-coated tablets
Yellowish-brown, round, slightly biconvex film-coated tablets with bevelled edges and engraved "PAR3" on one side (tablet diameter: approximately 11 mm).
20 mg + 5 mg + 4 mg, film-coated tablets
Light orange-pink, round, slightly biconvex film-coated tablets with bevelled edges and engraved "PAR4" on one side (tablet diameter: approximately 11 mm).
20 mg + 5 mg + 8 mg, film-coated tablets
Light yellow, round, slightly biconvex film-coated tablets with bevelled edges and engraved "PAR5" on one side (tablet diameter: approximately 11 mm).
20 mg + 10 mg + 8 mg, film-coated tablets
White, round, slightly biconvex film-coated tablets with bevelled edges and engraved "PAR6" on one side (tablet diameter: approximately 11 mm).
Rosamera is available in cardboard boxes containing 30, 60, 90, and 100 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

For further information, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
telephone: +48 22 573 75 00