Roxiper

Leaflet accompanying the packaging: patient information

Roxiper, 10 mg + 4 mg + 1.25 mg, film-coated tablets

Roxiper, 20 mg + 4 mg + 1.25 mg, film-coated tablets

Roxiper, 10 mg + 8 mg + 2.5 mg, film-coated tablets

Roxiper, 20 mg + 8 mg + 2.5 mg, film-coated tablets

Rosuvastatin + Tert-butylamine perindopril + Indapamide

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

1. What is Roxiper and what is it used for

Roxiper is a combination of three active substances, rosuvastatin, perindopril, and indapamide.
Rosuvastatin belongs to a group of medicines called statins. Perindopril is an ACE inhibitor
(ang. angiotensin converting enzyme). Indapamide is a diuretic.
Rosuvastatin helps control high cholesterol levels. Perindopril and indapamide help
control high blood pressure (hypertension).
Roxiper is prescribed for the treatment of high blood pressure (arterial hypertension)
and high cholesterol levels. Patients who are already taking rosuvastatin, perindopril, and indapamide in separate tablets can take one tablet
of Roxiper, which contains all three components.

2. Important information before taking Roxiper

When not to take Roxiper

• If the patient is allergic to rosuvastatin, perindopril, or any other ACE inhibitor, or to indapamide, or to any other sulfonamide drug, or to any of the other components of this medicine (listed in section 6);
• if the patient has experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes while taking ACE inhibitors in the past;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• in case of low potassium levels in the blood;
• in patients with suspected untreated, uncontrolled heart failure (symptoms may include fluid retention and breathing difficulties);
• if the patient has severe kidney disease that reduces blood flow to the kidneys (renal artery stenosis);
• if the patient is undergoing dialysis or blood filtration using a different method. Depending on the device used, Roxiper may not be suitable for the patient.
• if the patient has liver disease or a condition called hepatic encephalopathy (brain disease caused by liver disease);
• if the patient has experienced severe kidney impairment (creatinine clearance below 30 ml/min);
• if the patient has moderate kidney impairment (creatinine clearance 30-60 ml/min) for Roxiper in doses of 10 mg/8 mg/2.5 mg and 20 mg/8 mg/2.5 mg;
• if the patient has experienced recurring or unexplained muscle pain;
• 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 called cyclosporine (used after organ transplants);
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Roxiper, they should stop taking the medicine immediately and inform their doctor. Women of childbearing age taking Roxiper should use effective birth control methods;
• if the patient has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of chronic heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases. See "Warnings and precautions" and "Roxiper and other medicines".

Warnings and precautions

Before starting Roxiper, the patient should discuss the following with their doctor or pharmacist:

• if the patient has aortic stenosis (narrowing of the main artery valve) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney);
• if the patient has heart failure or any other heart disease;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps;
• if the patient has high levels of a hormone called aldosterone in the blood (primary aldosteronism);
• if the patient has liver disease;
• if the patient has connective tissue diseases (skin diseases), such as systemic lupus erythematosus or systemic scleroderma;
• if the patient has ever experienced severe skin rash or peeling of the skin, blisters, or ulcers in the mouth after taking Roxiper or other similar medicines;
• if the patient has severe respiratory failure;
• if the patient has high levels of acid in the blood, which can cause rapid breathing;
• if the patient is on a low-salt diet or uses salt substitutes containing potassium;
• if the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene) or potassium supplements, as they should be avoided when taking Roxiper (see "Roxiper and other medicines");
• if the patient has hyperparathyroidism;
• if the patient has gout;
• if the patient is elderly and the dose needs to be increased;
• if the patient has experienced allergic reactions to light;
• if the patient experiences a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema) - swelling can occur at any time during treatment. If such symptoms occur, the patient should stop taking Roxiper and consult their doctor immediately;
• if the patient has diabetes;
• if the patient has thyroid problems;
• if the patient has atherosclerosis (hardening of the arteries);
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor should choose an appropriate initial dose of perindopril, indapamide, and rosuvastatin for the patient;
• in black patients, angioedema (swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing) may occur more frequently, and the medicine may be less effective in lowering blood pressure;
• if the patient is undergoing dialysis using high-flux membranes;
• if the patient experiences recurring or unexplained muscle pain, or if muscle pain has occurred in the past or in the patient's family, or if muscle disorders have occurred while taking other cholesterol-lowering medicines. If unexplained muscle pain occurs, especially if the patient feels unwell or has a fever, they should consult their doctor immediately. If the patient experiences persistent muscle weakness, they should also consult their doctor;
• if the patient has myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes worsen the symptoms of the disease or cause myasthenia (see section 4);
• if the patient is taking other medicines called fibrates to lower cholesterol or any other cholesterol-lowering medicines (such as ezetimibe). The patient should carefully read the leaflet, even 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 atazanavir, see "Roxiper and 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:
• angiotensin II receptor antagonist (AIIRA) (also called a sartan - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals. See also "When not to take Roxiper" and "Warnings and precautions".

If the patient is taking or has taken within the last 7 days, orally or by injection, a medicine called fusidic acid (an antibiotic used to treat infections), they should not take Roxiper. The combination of fusidic acid and rosuvastatin can lead to severe muscle damage (rhabdomyolysis).
If the patient is taking any of the following medicines, the risk of angioedema increases

• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the so-called mTOR inhibitors (used to prevent organ rejection and treat cancer),
• linagliptin, saxagliptin, sitagliptin, wildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes).

Angioedema
Patient's treated with ACE inhibitors, including Roxiper, have reported angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing). This reaction can occur at any time during treatment. If such symptoms occur, the patient should stop taking Roxiper and consult their doctor immediately. See also section 4.
Severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported in patients taking Roxiper. If any of the symptoms described in section 4 occur, the patient should stop taking Roxiper and consult their doctor immediately.
The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Roxiper is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may harm the fetus (see "Pregnancy and breastfeeding").
The patient should also inform their doctor or medical staff about taking Roxiper in the following situations:

• if they experience a dry cough;
• if they are scheduled for anesthesia and/or surgery;
• if they have recently had diarrhea, vomiting, or dehydration;
• if they are scheduled for dialysis or LDL apheresis (a procedure to remove cholesterol from the blood using a special device);
• if they are scheduled for desensitization therapy for wasp or bee stings;
• if they are scheduled for a diagnostic test involving the injection of contrast agents containing iodine (a substance that allows organs such as the kidneys or stomach to be visible on X-rays);
• if they experience vision disturbances or pain in one or both eyes. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or glaucoma, increased pressure in one or both eyes - they can occur within a few hours to weeks after taking Roxiper. If left untreated, it can lead to permanent vision loss. Patients with a history of sulfonamide or penicillin allergy may be more prone to developing this condition. The patient should stop taking Roxiper and consult their doctor.

Athletes should be aware that Roxiper contains an active substance (indapamide) that may give a positive result in doping tests.
In a small number of people, statins may affect the liver. This can be determined by a simple test that shows increased liver enzyme activity in the blood. For this reason, the doctor usually performs a blood test (liver function tests) before and during treatment with Roxiper.
Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. People with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

Roxiper should not be taken by children and adolescents.

Roxiper 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 avoid taking Roxiper with:

• lithium (used to treat depression);
• aliskiren (a medicine used to treat high blood pressure) in patients who do not have diabetes or kidney disease;
• potassium-sparing medicines (e.g., spironolactone, triamterene), potassium salts, and other medicines that may increase potassium levels in the body (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; and cyclosporine, an immunosuppressive medicine used to prevent organ rejection and treat cancer, and heparin, a medicine used to thin the blood and prevent clots);
• estramustine (used to treat cancer);
• sacubitril/valsartan (used to treat chronic heart failure). See sections "When not to take Roxiper" and "Warnings and precautions";
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Other medicines may affect treatment with Roxiper.
The patient should inform their doctor if they are taking any of the following medicines, as special medical attention may be necessary:

• other medicines used to treat high blood pressure, including diuretics (medicines that increase urine production in the kidneys);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• procainamide (used to treat heart rhythm disorders);
• quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium (medicines used to treat heart rhythm disorders);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, terfenadine, or astemizole);
• corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
• tetracosactide (used to treat Crohn's disease);
• immunosuppressive medicines used to treat autoimmune diseases or prevent organ rejection (e.g., cyclosporine);
• fluconazole, ketoconazole (antifungal medicines);
• moxifloxacin, sparfloxacin, rifampicin, erythromycin, clarithromycin (antibiotics used to treat infections);
• methadone (used to treat addiction);
• halofantrine (used to treat certain types of malaria);
• pentamidine (used to treat pneumonia);
• gold given intravenously (used to treat rheumatoid arthritis),
• vinkamine (used to treat cognitive disorders in the elderly, including memory loss);
• bepridil, verapamil, diltiazem (heart medicines);
• sultopride (used to treat psychosis);
• benzamides (used to treat psychosis);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• digoxin or other cardiac glycosides (used to treat heart diseases);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• antidiabetic medicines, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• laxatives that stimulate peristalsis (e.g., senna);
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) or salicylates in high doses (e.g., acetylsalicylic acid);
• amphotericin B given intravenously (used to treat severe fungal infections);
• medicines used to treat mental disorders, such as depression, anxiety, or schizophrenia (e.g., tricyclic antidepressants, neuroleptics);
• anesthetics;
• contrast agents containing iodine;
• warfarin, ticagrelor, or clopidogrel (or any other medicine used to thin the blood);
• fibrates (e.g., gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol levels (e.g., ezetimibe);
• antacids (used to neutralize stomach acid);
• oral contraceptives (birth control pills) or hormone replacement therapy;
• capmatinib (used to treat cancer);
• fostamatinib (used to treat low platelet count);
• febuksostat (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: ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir - see "When not to take Roxiper" and "Warnings and precautions";
• roksadustat (used to treat anemia in patients with chronic kidney disease);
• tafamidis (used to treat transthyretin amyloidosis);
• a medicine commonly used to treat diarrhea (racecadotril) or medicines used to prevent organ rejection (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See "Warnings and precautions".
• regorafenib or darolutamide (used to treat cancer);
• trimethoprim (used to treat infections);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline);
• if it is necessary to take fusidic acid orally to treat a bacterial infection, the patient should stop taking Roxiper during this time. The doctor will inform the patient when it is safe to restart Roxiper. Taking Roxiper with fusidic acid can rarely lead to weakness, sensitivity, or muscle pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

The doctor may recommend a dose change and/or take other precautions:

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

Roxiper with food and drink

Roxiper should be taken before a meal.

Pregnancy and breastfeeding

Do not takeRoxiper during pregnancy or breastfeeding.
Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. If the patient becomes pregnant while taking Roxiper, they should stop takingthe medicine immediately and consult their doctor. The doctor will usually recommend stopping Roxiper before planned pregnancy or as soon as possible after pregnancy is confirmed, and prescribe a different medicine instead of Roxiper. Women of childbearing age should use effective birth control methods while taking Roxiper.
Before taking any medicine, the patient should consult their doctor or pharmacist.
Breastfeeding
The patient should inform their doctor about breastfeeding or planned breastfeeding. Roxiper is contraindicated during breastfeeding.
The patient should consult their doctor immediately.

Driving and using machines

Roxiper does not affect alertness, but the patient may experience dizziness or weakness due to low blood pressure, which can affect their ability to drive or operate machinery. The patient should not drive or operate machinery until they know how Roxiper affects them.

3. How to take Roxiper

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose is one tablet per day. It is recommended to take the tablet in the morning, before a meal.
The tablet should be swallowed with a glass of water.
The doctor will determine the correct dose of Roxiper. Roxiper is intended for patients who are already taking rosuvastatin, perindopril, and indapamide in separate tablets.

Overdose of Roxiper

If the patient has taken too many tablets, they should consult their doctor or go to the emergency department of the nearest hospital immediately. The most likely symptom of overdose is low blood pressure. If the patient experiences significant lowering of blood pressure (symptoms such as dizziness or fainting), they should lie down with their legs elevated above the level of their torso.

Missed dose of Roxiper

It is essential to take the medicine every day, as the effectiveness of the treatment of hypertension depends on regular medication intake. However, if the patient misses a dose of Roxiper, they should take the next dose at the usual time.
The patient should not take a double dose to make up for the missed dose.

Stopping Roxiper treatment

Since the treatment of hypertension usually lasts for the rest of the patient's life, the patient should consult their doctor before stopping the treatment.
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, Roxiper can cause side effects, although not everybody gets them.

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

• severe dizziness or fainting due to low blood pressure (common - may occur in less than 1 in 10 patients);
• bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath; uncommon - may occur in less than 1 in 100 patients);
• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema, see "Warnings and precautions"; uncommon - may occur in less than 1 in 100 patients);
• severe skin reactions, including erythema multiforme (a skin rash that often starts with red, itchy patches on the face, arms, or legs) or

red, flat, or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, or eyes. The occurrence of this type of serious skin rash can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or other allergic reactions (very rare - may occur in less than 1 in 10,000 patients);

• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome; frequency not known - frequency cannot be estimated from available data);
• cardiovascular disorders (arrhythmias, angina pectoris, myocardial infarction; very rare - may occur in less than 1 in 10,000 patients);
• weakness or numbness in the arms or legs, or speech disorders, which may be symptoms of a stroke (very rare - may occur in less than 1 in 10,000 patients);
• pancreatitis, which can cause severe abdominal pain and a very bad feeling (very rare - may occur in less than 1 in 10,000 patients);
• jaundice (yellowing of the skin and eyes), which can be a symptom of liver inflammation (very rare - may occur in less than 1 in 10,000 patients);
• life-threatening arrhythmias (frequency not known - frequency cannot be estimated from available data);
• hepatic encephalopathy (brain disease caused by liver disease; frequency not known - frequency cannot be estimated from available data);
• muscle weakness, cramps, tenderness, or pain, especially if the patient feels unwell or has a fever, which can be a sign of abnormal muscle breakdown (frequency not known).

In addition, the patient should stop taking Roxiper and consult their doctor immediately,

if they experience any unusual muscle painthat lasts longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adults.
Similar to other statins, unpleasant muscle symptoms have been reported in a very small number of people, which can rarely worsen and lead to potentially life-threatening muscle damage called rhabdomyolysis.
The following side effects may occur (in decreasing order of frequency):
Common (may occur in less than 1 in 10 patients):

• skin reactions in patients with a history of allergic reactions and asthma;
• low potassium levels in the blood;
• diabetes (the risk of developing diabetes is higher if the patient has high blood sugar and fat levels; the doctor will monitor the patient's condition while taking this medicine);
• dizziness, headache, vertigo, tingling, and numbness;
• vision disturbances (including double vision);
• tinnitus;
• a feeling of "emptiness" in the head due to low blood pressure;
• shortness of breath, cough;
• gastrointestinal disorders (dry mouth, taste disturbances, abdominal pain, indigestion or digestive problems, loss of appetite, vomiting, abdominal pain, nausea, diarrhea, constipation);
• allergic reactions (such as skin rashes, itching);
• muscle pain, cramps;
• fatigue.

Uncommon (may occur in less than 1 in 100 patients):

• increased eosinophil count (a type of white blood cell);
• changes in laboratory test results: high potassium levels in the blood that return to normal after treatment is stopped, low sodium levels in the blood, which can cause dehydration and low blood pressure;
• hypoglycemia (very low blood sugar) in patients with diabetes;
• mood changes, sleep disturbances;
• depression;
• drowsiness, fainting;
• palpitations (feeling of heartbeat), tachycardia (rapid heartbeat);
• vasculitis (inflammation of blood vessels);
• bronchospasm (constriction of the airways);
• dry mouth;
• angioedema (swelling of the face, lips, mouth, tongue, or throat), urticaria, erythema (redness of the skin), purpura (purple spots on the skin);
• kidney function disorders;
• impotence (inability to achieve or maintain an erection);
• excessive sweating;
• photosensitivity reactions (increased skin sensitivity to sunlight);
• joint pain, muscle pain;
• chest pain, peripheral edema, fever;
• increased urea levels in the blood, increased creatinine levels in the blood;
• falls.

Rare (may occur in less than 1 in 1,000 patients):

• worsening of psoriasis;
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion);
• low chloride levels in the blood;
• low magnesium levels in the blood;
• sudden flushing of the face and neck;
• severe abdominal pain (pancreatitis);
• changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood;
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells) - the patient should stop taking Roxiper and consult their doctor immediately;
• muscle damage with muscle rupture - as a precaution, the patient should stop taking Roxiper and consult their doctor immediately if they experience any unusual muscle pain;
• reduced or absent urine production;
• acute kidney failure;
• fatigue.

Very rare (may occur in less than 1 in 10,000 patients):

• reduced white blood cell count, anemia (reduced red blood cell count);
• reduced hemoglobin levels, reduced platelet count;
• high calcium levels in the blood;
• nerve damage in the arms and legs (e.g., numbness), memory loss;
• cardiovascular disorders (irregular heartbeat, angina pectoris, myocardial infarction);
• eosinophilic pneumonia (a rare lung inflammation), nasal congestion;
• abnormal liver function, liver inflammation, jaundice (yellowing of the skin and eyes);
• erythema multiforme (a skin rash that often starts with red, itchy patches on the face, arms, or legs), severe skin ulcers or blisters, or peeling of the skin, ulcers in the mouth, throat, eyes, or genitals (Stevens-Johnson syndrome - life-threatening allergic reactions affecting the skin and mucous membranes);
• joint pain;
• gynecomastia (breast enlargement in men).

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

• hepatic encephalopathy (brain disease caused by liver disease);
• myasthenia (a disease that causes general muscle weakness, including 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 muscle weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
• myopia, blurred vision, decreased vision, or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or acute glaucoma);
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• persistent muscle weakness, tendon damage;
• abnormal ECG results, irregular heartbeat, potentially life-threatening (arrhythmias called torsade de pointes);
• cyanosis, numbness, and pain in the fingers or toes (Raynaud's phenomenon); changes in laboratory test results: high uric acid levels in the blood;
• if the patient has systemic lupus erythematosus (a type of collagen disease), the symptoms of the disease may worsen.

Blood, kidney, liver, or pancreas disorders, as well as changes in laboratory test results (blood tests), may occur. 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:
Jerozolimskie Avenue 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Roxiper

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
The medicine should be stored in its original packaging to protect it from light.
There are no special storage temperature recommendations for this medicine.
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 Roxiper contains

• The active substances of Roxiper are rosuvastatin, perindopril tert-butylamine, and indapamide. Roxiper, 10 mg + 4 mg + 1.25 mg, film-coated tablets Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium), 4 mg perindopril tert-butylamine (tert-Butylamini perindoprilum), and 1.25 mg indapamide (Indapamidum). Roxiper, 20 mg + 4 mg + 1.25 mg, film-coated tablets Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium), 4 mg perindopril tert-butylamine (tert-Butylamini perindoprilum), and 1.25 mg indapamide (Indapamidum). Roxiper, 10 mg + 8 mg + 2.5 mg, film-coated tablets Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium), 8 mg perindopril tert-butylamine (tert-Butylamini perindoprilum), and 2.5 mg indapamide (Indapamidum). Roxiper, 20 mg + 8 mg + 2.5 mg, film-coated tablets Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium), 8 mg perindopril tert-butylamine (tert-Butylamini perindoprilum), and 2.5 mg indapamide (Indapamidum).
• Other ingredients are: Tablet core: Microcrystalline cellulose (type 200), microcrystalline cellulose (type 112), crospovidone (type A), colloidal anhydrous silica, and magnesium stearate Tablet coating:
• Roxiper, 10 mg + 4 mg + 1.25 mg, film-coated tablets
• Roxiper, 20 mg + 4 mg + 1.25 mg, film-coated tablets
• Roxiper, 20 mg + 8 mg + 2.5 mg, film-coated tablets: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172)
• Roxiper, 10 mg + 8 mg + 2.5 mg, film-coated tablets: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, iron oxide red (E 172)

What Roxiper looks like and contents of the pack

Roxiper, 10 mg + 4 mg + 1.25 mg, film-coated tablets
Brown-red, round, slightly convex film-coated tablets with beveled edges, with the imprint PIR1 on one side.
Diameter: approximately 7.5 mm (defined by the stamp).
Roxiper, 20 mg + 4 mg + 1.25 mg, film-coated tablets
Pink, round, slightly convex film-coated tablets with beveled edges, with the imprint PIR2 on one side.
Diameter: approximately 10 mm (defined by the stamp).
Roxiper, 10 mg + 8 mg + 2.5 mg, film-coated tablets
Light pink, round, slightly convex film-coated tablets with beveled edges, with the imprint PIR3 on one side.
Diameter: approximately 10 mm (defined by the stamp).
Roxiper, 20 mg + 8 mg + 2.5 mg, film-coated tablets
Light pink-brown, round, slightly convex film-coated tablets with beveled edges, with the imprint PIR4 on one side.
Diameter: approximately 10 mm (defined by the stamp).
Packaging: 10, 20, 30, 60, 90, or 100 film-coated tablets in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto,
Šmarješka cesta 6, 8501
Novo mesto, Slovenia
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

This medicine is authorized in the Member States of the European Economic Area

Economically under the following names:

Date of last update of the leaflet:07.03.2025