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 a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 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
(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 may take one tablet
of Roxiper, which contains all three ingredients.

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, or to any of the other ingredients 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 rash during previous treatment with ACE inhibitors, or if these symptoms have occurred in the patient or their family in any other circumstances (a condition called angioedema);
• 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 by other means. 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 (a brain disease caused by liver disease);
• if the patient has 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 repeated or unexplained muscle pain;
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C infection);
• if the patient is taking a medicine called cyclosporine (used, for example, 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 methods of contraception;
• if the patient has taken or is currently taking, orally or by injection, a medicine called fusidic acid (an antibiotic used to treat infections) within the last 7 days. The combination of fusidic acid and rosuvastatin may lead to severe muscle damage (rhabdomyolysis).

Warnings and precautions

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

• if the patient has a narrowing of the aortic valve (narrowing of the main artery valve) or hypertrophic cardiomyopathy (a 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 an abnormally high level 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 sclerosis;
• if the patient has ever experienced a 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 too high a level 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 sunlight;
• 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's thyroid is not functioning properly;
• 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 repeated or unexplained muscle pain, or if muscle pain has occurred in the patient or their family in the past, 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 or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes 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). The combination of fusidic acid and rosuvastatin may lead to severe muscle damage (rhabdomyolysis).
If the patient is taking any of the following medicines, the risk of angioedema may increase

• 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 (a 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, 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 association with 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 planning to become pregnant. Roxiper is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the fetus (see "Pregnancy and breastfeeding").
The patient should also inform their doctor or healthcare professional 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 treatment 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 eye pain. 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 used in 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),
• vinpocetine (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, 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);
• febuxostat (used to treat and prevent high levels of uric acid in the blood);
• teriflunomide (used to treat multiple sclerosis);
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, 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";
• roxadustat (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 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.

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

Roxiper should not be takenduring pregnancy or breastfeeding.
Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planning to become pregnant. 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 methods of contraception 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 planning to breastfeed. 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. It is recommended that the patient does not drive or operate machinery until they know how Roxiper affects them.

3. How to take Roxiper

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose 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 immediately consult their doctor or go to the emergency department of the nearest hospital. 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.

Missing a dose of Roxiper

It is important to take the medicine every day, as the effectiveness of the treatment of hypertension depends on regular medication. 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 treatment with Roxiper

Since the treatment of hypertension usually lasts for the rest of the patient's life, the patient should consult their doctor before stopping 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 affect up to 1 in 10 people);
• bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath; uncommon - may affect up to 1 in 100 people);
• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema, see "Warnings and precautions"; uncommon - may affect up to 1 in 100 people);
• severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS); (very rare - may affect up to 1 in 10,000 people);

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.
As with other statins, unpleasant muscle symptoms have been reported in a very small number of people, which can rarely worsen and lead to a potentially life-threatening muscle damage called rhabdomyolysis.
The following side effects may occur (in decreasing order of frequency):
Common (may affect up to 1 in 10 people):

• 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 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 affect up to 1 in 100 people):

• increased eosinophil count (a type of white blood cell);
• changes in laboratory test results: high potassium levels in the blood that are temporary and resolve 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 heartbeats), tachycardia (fast heartbeat);
• vasculitis (inflammation of blood vessels);
• bronchospasm (constriction of the airways, wheezing, and shortness of breath);
• dry mouth;
• angioedema (symptoms such as wheezing, facial or tongue swelling), urticaria, purpura (red spots on the skin), blistering;
• kidney problems;
• impotence (inability to achieve or maintain an erection);
• excessive sweating;
• reactions to sunlight (increased skin sensitivity to the sun);
• joint pain, muscle pain;
• chest pain, peripheral edema, fever;
• increased urea levels in the blood, increased creatinine levels in the blood;
• falls.

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

• 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, including muscle rupture - as a precaution, the patient should stop taking Roxiper and consult their doctor immediately if they experience any unusual muscle painthat lasts longer than expected;
• reduced or absent urine production;
• acute kidney failure;
• fatigue.

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

• decreased white blood cell count, anemia (decreased red blood cell count);
• decreased hemoglobin levels, decreased 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, and heart attack);
• eosinophilic pneumonia (a rare lung inflammation), vasculitis (inflammation of blood vessels);
• abnormal liver function, hepatitis, jaundice (yellowing of the skin and eyes);
• Stevens-Johnson syndrome (a life-threatening skin and mucous membrane reaction), severe skin reactions, including blistering and peeling of the skin, and ulcers in the mouth, throat, eyes, and genital area;
• joint pain;
• gynecomastia (breast enlargement in men).

Unknown frequency (frequency cannot be estimated from the available data):

• hepatic encephalopathy (a brain disease caused by liver disease);
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing);
• myasthenic syndrome (a disease that causes muscle weakness in the eyes); The patient should consult their doctor if they experience muscle weakness in their arms or legs, worsening over time, 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);
• severe skin reactions, including Stevens-Johnson syndrome and DRESS;
• permanent muscle weakness, tendon damage;
• abnormal ECG results, irregular heartbeat, potentially life-threatening (a heart rhythm disorder called torsades de pointes);
• cyanosis, numbness, and pain in the fingers and 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.

There may be blood, kidney, liver, or pancreas disorders, as well as changes in laboratory parameters (blood tests). The doctor may order blood tests to monitor the patient's condition.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Roxiper

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging after the abbreviation EXP. The expiration 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 requirements for the 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 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).
• Other ingredients are: Tablet core: Microcrystalline cellulose (type 200), microcrystalline cellulose (type 112), crospovidone (type A), colloidal silica anhydrous, 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 mark PIR1 embossed 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 mark PIR2 embossed 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 mark PIR3 embossed 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 mark PIR4 embossed 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.
ul. 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 the last update of the leaflet:07.03.2025