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

Rosuvastatinum + Tert-butylamini perindoprilum + Indapamidum

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 your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 packaging 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
(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 may take one tablet of Roxiper, which contains all three components.

2. Important information before taking Roxiper

When not to take Roxiper

• If you are allergic to rosuvastatin, perindopril, or any other ACE inhibitor, or to indapamide, or to any other sulfonamide, or to any of the other components of this medicine (listed in section 6);
• if you have experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rash when taking ACE inhibitors in the past;
• if you have diabetes or kidney problems and are 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 you have severe kidney disease that reduces blood flow to the kidneys (renal artery stenosis);
• if you are undergoing dialysis or blood filtration by other means. Depending on the device used, Roxiper may not be suitable for you.
• if you have liver disease or a condition called hepatic encephalopathy (brain disease caused by liver disease);
• if you have severe kidney impairment (creatinine clearance below 30 ml/min);
• if you have 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 you have experienced recurring or unexplained muscle pain;
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplants);
• if you are pregnant or breastfeeding. If you become pregnant while taking Roxiper, you should stop taking the medicine immediately and inform your doctor. Women of childbearing age taking Roxiper should use effective methods of contraception;
• if you have taken or are currently taking, orally or by injection, a medicine called fusidic acid (used to treat infections). The combination of fusidic acid and rosuvastatin can lead to severe muscle damage (rhabdomyolysis).
  If you are taking any of the following medicines, the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases

Warnings and precautions

Before starting treatment with Roxiper, you should discuss it with your doctor or pharmacist:

• if you have a narrowing of the aortic valve (narrowing of the main artery valve) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood);
• if you have heart failure or any other heart disease;
• if you have kidney disease or are undergoing dialysis;
• if you have muscle disorders, including pain, tenderness, weakness, or muscle cramps;
• if you have high levels of a hormone called aldosterone in your blood (primary aldosteronism);
• if you have liver disease;
• if you have connective tissue diseases (skin diseases), such as systemic lupus erythematosus or systemic sclerosis;
• if you have ever had a severe skin rash or scaling, blisters, and (or) ulcers in the mouth after taking Roxiper or other similar medicines;
• if you have severe respiratory failure;
• if you have high levels of acid in your blood, which can cause rapid breathing;
• if you are on a low-salt diet or using salt substitutes that contain potassium;
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene) or potassium supplements, as you should avoid taking them with Roxiper (see "Roxiper and other medicines");
• if you have hyperparathyroidism;
• if you have gout;
• if you are elderly and the dose needs to be increased;
• if you have had allergic reactions to light;
• if you have had 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, you should stop taking the medicine and consult your doctor immediately;
• if you have diabetes;
• if your thyroid does not function properly;
• if you have atherosclerosis (hardening of the arteries);
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should choose an appropriate initial dose of perindopril, indapamide, and rosuvastatin for you;
• 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 you are undergoing dialysis using high-flux membranes;
• if you have recurring or unexplained muscle pain, if muscle pain has occurred in the past in you or your family, or if muscle disorders have occurred while taking other cholesterol-lowering medicines. If unexplained muscle pain occurs, especially if you feel unwell or have a fever, you should inform your doctor immediately. If you experience persistent muscle weakness, you should also contact your doctor;
• if you have 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 can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4);
• if you are taking other medicines called fibrates to lower cholesterol or any other cholesterol-lowering medicines (such as ezetimibe). You should carefully read the leaflet, even if you have taken other cholesterol-lowering medicines in the past;
• if you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and (or) atazanavir, see "Roxiper and other medicines";
• if you regularly drink large amounts of alcohol;
• if you are 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 you have diabetic kidney disease,
• aliskiren. Your 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 you are taking or have taken in the last seven days, orally or by injection, a medicine called fusidic acid (used to treat infections). The combination of fusidic acid and rosuvastatin can lead to severe muscle damage (rhabdomyolysis).
If you are 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
In patients treated with ACE inhibitors, including Roxiper, angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing) has been reported. This reaction can occur at any time during treatment. If such symptoms occur, you should stop taking Roxiper and consult your 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 association with Roxiper. If you experience any of the symptoms described in section 4, you should stop taking Roxiper and consult your doctor immediately.
You must inform your 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").
You should also inform your doctor or medical staff about taking Roxiper in the following situations:

• if you experience a dry cough;
• if you are planning anesthesia and (or) surgery;
• if you have recently had diarrhea, vomiting, or dehydration;
• if you are planning dialysis or LDL apheresis (a procedure to remove cholesterol from the blood using a special device);
• if you are planning desensitization therapy for wasp or bee stings;
• if you are planning a diagnostic test involving intravenous administration of contrast agents containing iodine (a substance that allows organs such as the kidneys or stomach to be visualized on X-rays);
• if you experience vision disturbances or pain in one or both eyes while taking Roxiper. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid 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 disease. You should stop taking Roxiper and consult your doctor.

Athletes should be aware that Roxiper contains an active substance (indapamide) that can give a positive result in doping tests.
In a small number of people, statins can affect the liver. This can be determined by a simple test that shows increased liver enzyme activity in the blood. For this reason, your doctor will usually perform a blood test (liver function tests) before and during treatment with Roxiper.
Patients with diabetes or 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 used in children and adolescents.

Roxiper and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should avoid taking Roxiper with:

• lithium (used to treat depression);
• aliskiren (used to treat hypertension) in patients who do not have diabetes or kidney disease;
• potassium-sparing medicines (e.g., spironolactone, triamterene, amiloride), potassium salts, and other medicines that can 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 to prevent clots);
• estramustine (used to treat cancer);
• sacubitril/valsartan (used to treat chronic heart failure). See "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.
You should inform your doctor if you are taking any of the following medicines, as special medical attention may be required:

• 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 after transplants (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 impairment 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, 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 (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, velpatasvir, 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, norepinephrine, or adrenaline);
• if it is necessary to take fusidic acid orally to treat a bacterial infection, you should stop taking Roxiper during this time. Your doctor will inform you when it is safe to restart taking Roxiper. Taking Roxiper with fusidic acid can rarely lead to muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Your doctor may recommend a dose change and (or) take other precautions:

• if you are 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
You should inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. If you become pregnant while taking Roxiper, you should stop takingthe medicine immediately and consult your doctor. Your doctor will usually recommend stopping Roxiper before planned pregnancy or as soon as possible after pregnancy is confirmed, and will recommend taking a different medicine instead of Roxiper. Women of childbearing age should use effective methods of contraception while taking Roxiper.
Before taking any medicine, you should consult your doctor or pharmacist.
Breastfeeding
You should inform your doctor about breastfeeding or planned breastfeeding. Roxiper is contraindicated during breastfeeding.
You should consult your doctor immediately.

Driving and using machines

Roxiper does not affect alertness, but you may experience dizziness or weakness due to low blood pressure, which can affect your ability to drive and use machines. You should not drive a car or operate machines until you know how Roxiper affects you.

3. How to take Roxiper

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
The recommended dose is one tablet once a day. It is recommended to take the tablet in the morning, before a meal.
The tablet should be swallowed with a glass of water.
Your doctor will determine the correct dose of Roxiper for you. Roxiper is intended for patients who are already taking rosuvastatin, perindopril, and indapamide in separate tablets.

What to do if you take more Roxiper than you should

If you have taken too many tablets, you should contact your doctor or go to the emergency department of the nearest hospital immediately. The most likely symptom of overdose is low blood pressure. If your blood pressure drops significantly (symptoms such as dizziness or fainting), you should lie down with your legs raised above the level of your torso.

What to do if you forget to take Roxiper

It is important to take the medicine every day, as the effectiveness of the treatment of hypertension depends on regular intake of the medicine. However, if you miss a dose of Roxiper, you should take the next dose at the usual time.
You should not take a double dose to make up for a missed dose.

What to do if you stop taking Roxiper

Since the treatment of hypertension usually lasts for the rest of your life, you should consult your doctor before stopping treatment.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Roxiper can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Roxiper and contact your doctor immediately:

• severe dizziness or fainting due to low blood pressure (common - may occur in less than 1 in 10 patients);
• bronchospasm (feeling of compression 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" in section 2); (uncommon - may occur in less than 1 in 100 patients);
• severe skin reactions, including erythema multiforme (skin rash often starting 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, 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 paralysis of 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 heart rhythm disorders (frequency not known - frequency cannot be estimated from available data);
• liver disease caused by liver disease (encephalopathy; frequency not known - frequency cannot be estimated from available data);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a fever, which may be due to abnormal muscle breakdown (frequency not known).

In addition, you should stop taking Roxiper and contact your doctor immediately

if you experience any unusual muscle painthat lasts longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adults.
As with other statins, unpleasant muscle symptoms have rarely occurred in a very small number of people, which can rarely worsen and lead to a potentially life-threatening muscle injury called rhabdomyolysis.
The following side effects may occur (in decreasing order of frequency):

• skin reactions in patients with a tendency to allergic and asthmatic reactions;
• low potassium levels in the blood;
• diabetes (the risk of developing diabetes is higher if your blood sugar and fat levels are high; your doctor will monitor your condition while taking this medicine);
• dizziness, headache, dizziness of inner ear origin, feeling of pins and needles;
• vision disturbances (including double vision);
• tinnitus;
• 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 rash, itching);
• muscle pain, cramps;
• feeling of 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: transient high potassium levels in the blood, 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 (fast heartbeat);
• vasculitis (inflammation of blood vessels);
• bronchospasm (feeling of compression in the chest, wheezing, and shortness of breath);
• dryness of the mucous membranes of the mouth;
• angioedema (swelling of the face, lips, mouth, tongue, or throat), hives, purpura (red spots on the skin), blistering;
• kidney function disorders;
• impotence (inability to achieve or maintain an erection);
• excessive sweating;
• reactions of hypersensitivity to light;
• 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):

• exacerbation of psoriasis;
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone);
• low chloride levels in the blood;
• low magnesium levels in the blood;
• sudden reddening of the face and neck;
• severe abdominal pain (pancreatitis);
• changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in serum;
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells) - you should stop taking Roxiper and contact your doctor immediately;
• muscle injuries, including muscle rupture - as a precaution, you should stop taking Roxiper and contact your doctor immediately if you experience any unusual muscle pain;
• reduced urine output or absence of urine output;
• 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 mucositis (nasal congestion or runny nose);
• abnormal liver function, liver inflammation, jaundice (yellowing of the skin and eyes);
• erythema multiforme (skin rash, which often starts with red, itchy patches on the face, arms, or legs), severe skin ulcers or blisters, 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, or eyes (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 in some cases muscles involved in breathing);
• ocular myasthenia (a disease that causes muscle weakness in the eyes); You should talk to your doctor if you experience muscle weakness in your 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 - excessive accumulation of fluid between the choroid and sclera - or acute glaucoma);
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• persistent muscle weakness, tendon injury;
• abnormal ECG results, irregular heartbeat, potentially life-threatening (heart rhythm disorders called torsades de pointes);
• cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon); changes in laboratory test results: high uric acid levels in the blood;
• if you have systemic lupus erythematosus (a type of collagenosis), the symptoms of the disease may worsen.

There may be blood, kidney, liver, or pancreas disorders, as well as changes in laboratory parameters (blood tests). Your doctor may order blood tests to monitor your condition.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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.
By reporting side effects, you can help provide 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.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
Store in the original packaging to protect from light.
There are no special storage temperature requirements for the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 of rosuvastatin (as rosuvastatin calcium), 4 mg of perindopril tert-butylamine (tert-Butylamini perindoprilum), and 1.25 mg of indapamide (Indapamidum). Roxiper, 20 mg + 4 mg + 1.25 mg, film-coated tablets Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium), 4 mg of perindopril tert-butylamine (tert-Butylamini perindoprilum), and 1.25 mg of indapamide (Indapamidum). Roxiper, 10 mg + 8 mg + 2.5 mg, film-coated tablets Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium), 8 mg of perindopril tert-butylamine (tert-Butylamini perindoprilum), and 2.5 mg of indapamide (Indapamidum). Roxiper, 20 mg + 8 mg + 2.5 mg, film-coated tablets Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium), 8 mg of perindopril tert-butylamine (tert-Butylamini perindoprilum), and 2.5 mg of indapamide (Indapamidum).
• The 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 Reddish-brown, 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, you 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