Roxiper

Package leaflet: Information for the patient

Roxiper, 10 mg + 4 mg + 1.25 mg, coated tablets
Roxiper, 20 mg + 4 mg + 1.25 mg, coated tablets
Roxiper, 10 mg + 8 mg + 2.5 mg, coated tablets
Roxiper, 20 mg + 8 mg + 2.5 mg, coated tablets
Rosuvastatin + Perindopril tert-butylamine + Indapamide
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Roxiper is and what it is 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 Roxiper is and what it is 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 inhibitor). 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 (hypertension)
and concomitant high cholesterol levels. Patients who are already taking rosuvastatin,
perindopril, and indapamide as separate tablets may instead take a single Roxiper tablet
containing all three components.

2. Important information before using Roxiper

When not to use Roxiper

• If the patient is allergic to rosuvastatin, perindopril, or any other ACE inhibitor, or to indapamide, or any other sulphonamide-containing medicine, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching or severe skin rashes while taking ACE inhibitors, or if such symptoms occurred in the patient or a family member under any other circumstances (a condition known as angioedema);
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• in case of low blood potassium levels;
• in patients with suspected untreated or unbalanced heart failure (symptoms may include fluid retention and difficulty breathing);
• if the patient has severe kidney disease resulting in reduced blood supply to the kidneys (renal artery stenosis);
• if the patient is undergoing dialysis or another form of blood filtration. 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 disorder 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) when using Roxiper 10 mg/8 mg/2.5 mg or 20 mg/8 mg/2.5 mg;
• if the patient has experienced recurrent or unexplained muscle pain;
• if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C);
• if the patient is taking cyclosporine (used, for example, after organ transplantation);
• if the patient is pregnant or breastfeeding. If pregnancy occurs while taking Roxiper, treatment must be stopped immediately and the doctor informed. Women of childbearing potential should use effective contraception during treatment with Roxiper;
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat certain types of chronic heart failure in adults, because this increases the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat). See "Warnings and precautions" and "Roxiper with other medicines".

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

• if the patient has aortic valve stenosis (narrowing of the main artery leaving the heart), hypertrophic cardiomyopathy (a heart muscle disorder), or renal artery stenosis (narrowing of the artery supplying blood to the kidney);
• if the patient has heart failure or any other heart conditions;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient has muscle disorders, including pain, tenderness, weakness, or cramps;
• if the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• if the patient has liver disease;
• if the patient has connective tissue disorders (skin diseases), such as systemic lupus erythematosus or systemic sclerosis;
• if the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after taking Roxiper or similar medicines;
• if the patient has severe respiratory insufficiency;
• if the patient has excessive acid levels in the blood, which may 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 these should be avoided with Roxiper (see "Roxiper with 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 previously had photosensitivity reactions;
• if the patient develops a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema) – swelling may occur at any time during treatment. If such symptoms occur, stop treatment and seek immediate medical attention;
• if the patient has diabetes;
• if the thyroid gland is not functioning properly;
• if the patient has atherosclerosis (hardening of the arterial walls);
• if the patient is of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor should select an appropriate starting dose of perindopril, indapamide, and rosuvastatin for the patient;
• angioedema (swelling of the face, lips, mouth, tongue, or throat, possibly causing difficulty swallowing or breathing) occurs more frequently in black patients, and the medicine may be less effective in lowering blood pressure;
• if the patient is undergoing dialysis with high-flux membranes;
• if the patient has recurrent or unexplained muscle pain, if muscle pain occurred previously in the patient or their family, or if muscle disorders occurred in the past while taking other cholesterol-lowering medicines. If unexplained muscle pain occurs, especially with malaise or fever, contact the doctor immediately. If the patient experiences persistent muscle weakness, they should also contact the doctor;
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen symptoms or trigger 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). Read the leaflet carefully, even if the patient has taken other cholesterol-lowering medicines before;
• if the patient is taking medicines used to treat HIV infection, e.g. ritonavir with lopinavir and/or atazanavir, see section "Roxiper with other medicines";
• if the patient regularly consumes large amounts of alcohol;
• if the patient is taking any of the following medicines for high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan (e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "When not to use Roxiper".

If the patient has taken or is currently taking fusidic acid (a medicine used to treat infections), orally or by injection, within the last seven days. Combining fusidic acid with rosuvastatin may 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 diarrhoea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the so-called mTOR inhibitors (used to prevent organ transplant rejection and to treat cancer),
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of drugs called gliptins (medicines used to treat diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat and difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Roxiper. This reaction may occur at any time during treatment. If such symptoms occur, stop taking Roxiper immediately and contact a doctor without delay. See also section 4.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Roxiper. If any of the symptoms described in section 4 occur, stop taking Roxiper and contact a doctor immediately.
Pregnancy must be reported to the doctor, if suspected or planned. Roxiper is not recommended during early pregnancy and must not be taken beyond the third month of pregnancy, as it may seriously harm the unborn child (see "Pregnancy and breastfeeding").
Inform your doctor or healthcare provider if you are taking Roxiper in the following situations:

• if a dry cough develops;
• before planned anaesthesia and/or surgery;
• after recent diarrhoea, vomiting, or dehydration;
• before planned dialysis or LDL cholesterol apheresis (a procedure to remove cholesterol from the blood using a special device);
• before planned desensitisation treatment for bee or wasp venom;
• before a diagnostic procedure involving intravenous administration of iodine-containing contrast agents (a substance used to visualise organs such as kidneys or the stomach on X-ray images);
• if vision disturbances or pain in one or both eyes occur. These may be symptoms of fluid accumulation in the avascular membrane surrounding the eye (excessive fluid accumulation between the choroid and sclera) or glaucoma, increased pressure in one or both eyes – these may occur from a few hours to weeks after taking Roxiper. Untreated, this may lead to permanent vision loss. Patients with a history of allergy to sulphonamides or penicillin may be at higher risk of developing this condition. Roxiper should be discontinued and medical advice sought.

Athletes should be aware that Roxiper contains an active substance (indapamide) that may lead to a positive result in doping tests.
In a small number of people, statins may affect the liver. This can be detected by a simple blood test showing increased liver enzyme activity. Therefore, the doctor usually performs blood tests (liver function tests) before and during treatment with Roxiper.
Patients with diabetes or at risk of developing diabetes will remain under close medical supervision during treatment with this medicine. Individuals with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.
Children and adolescents
Roxiper must not be used in children and adolescents.
Roxiper with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
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 problems;
• potassium-sparing medicines (e.g. spironolactone, triamterene, amiloride), potassium salts, and other medicines that may increase potassium levels in the body (such as trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, used for bacterial infections; and cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection, 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 sections "When not to use Roxiper" and "Warnings and precautions";
• other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists.

Other medicines may affect treatment with Roxiper.
Inform your doctor if you are taking any of the following medicines, as special medical care may be required:

• other medicines used to treat high blood pressure, including diuretics (medicines that increase urine production by the kidneys);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at 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 to prevent organ transplant 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);
• intravenous gold (used in rheumatoid arthritis);
• vinpocetine (used to treat symptomatic cognitive disorders in the elderly, including memory loss);
• bepridil, verapamil, diltiazem (heart medicines);
• sulpiride (used to treat psychosis);
• benzamides (used to treat psychosis);
• cisapride, difenoxin (used to treat gastrointestinal disorders);
• digoxin or other cardiac glycosides (used to treat heart conditions);
• baclofen (used for muscle stiffness in conditions such as multiple sclerosis);
• antidiabetic medicines, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• stimulant laxatives (e.g. senna);
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high-dose salicylates (e.g. acetylsalicylic acid);
• intravenous amphotericin B (used for severe fungal infections);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics);
• anaesthetics;
• iodine-containing contrast agents;
• 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 neutralise stomach acid);
• oral contraceptives (pills) or hormone replacement therapy;
• capmatinib (used to treat cancer);
• fostamatinib (used to treat low platelet count);
• febuxostat (used to treat and prevent high blood uric acid levels);
• teriflunomide (used to treat multiple sclerosis);
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, taken alone or in combination with other medicines: ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir – see: "When not to use Roxiper" and "Warnings and precautions";
• roxadustat (used to treat anaemia in patients with chronic kidney disease);
• tafamidis (used to treat transthyretin amyloidosis);
• a medicine commonly used to treat diarrhoea (racecadotril) or medicines used to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See section "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 oral fusidic acid is required to treat a bacterial infection, Roxiper should be discontinued during this time. The doctor will inform the patient when it is safe to restart Roxiper. Taking Roxiper with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

The doctor may recommend a dose adjustment and/or additional precautions:

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

Roxiper with food and drink
Roxiper should be taken before a meal.
Pregnancy and breastfeeding
Do not take Roxiper during pregnancy or while breastfeeding.
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. If pregnancy occurs while taking Roxiper, stop taking the medicine immediately and contact your doctor. The doctor will usually recommend discontinuing Roxiper before planned pregnancy or as soon as possible after pregnancy is confirmed, and will advise taking an alternative medicine instead. Women of childbearing potential should use effective contraception during treatment with Roxiper.
Before taking any medicine, consult your doctor or pharmacist.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Roxiper is contraindicated during breastfeeding.
Contact your doctor immediately.
Driving and operating machinery
Roxiper does not affect alertness, but the patient may experience dizziness or weakness due to low blood pressure, which may affect the ability to drive or operate machinery. It is recommended not to drive or operate machinery until the effect of Roxiper on the patient is known.

3. How to use Roxiper

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
The recommended dose is one tablet once daily. 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. Roxiper is intended for patients
who are already taking rosuvastatin, perindopril and indapamide in separate tablets.
Taking more Roxiper than recommended
If you have taken too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.
The most likely symptom of overdose is low blood pressure. In the event of a significant drop in blood pressure
(symptoms such as dizziness or fainting), lie down on your back with your legs
elevated above the level of your torso.
Missing a dose of Roxiper
It is important to take the medicine every day, because the effectiveness of hypertension treatment depends on
regular medication use. However, if you miss a dose of Roxiper, take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.
Stopping Roxiper
As treatment for high blood pressure usually lasts for life, you should consult your doctor before stopping treatment.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following adverse reactions, which may be
severe, stop taking this medicine and contact a doctor immediately:

• severe dizziness or fainting due to low blood pressure (common – may occur in less than 1 in 10 patients);

• bronchospasm (feeling of tightness 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 section “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 spots on the face, arms or legs) or
  red, flat, disc-shaped or circular patches on the trunk, often with blisters
  in the center, peeling of the skin, mouth ulcers, ulcers in the throat, nose, genital organs and around the eyes. The occurrence of such serious skin rashes may
  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 unknown – frequency cannot be determined from available data);

• cardiovascular disorders (heart rhythm disturbances, angina pectoris (chest pain radiating to the jaw and back, caused by physical exertion), myocardial infarction; very rare – may occur in less than 1 in 10,000 patients);

• weakness of the arms or legs, or speech disturbances, which may indicate stroke (very rare – may occur in less than 1 in 10,000 patients);

• pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (very rare – may occur in less than 1 in 10,000 patients);

• yellowing of the skin or eyes (jaundice), which may indicate liver inflammation (very rare – may occur in less than 1 in 10,000 patients);

• life-threatening heart rhythm disturbances (frequency unknown – frequency cannot be determined from available data);

• brain disease caused by liver disease (hepatic encephalopathy; frequency unknown – frequency cannot be determined from available data);

• muscle weakness, cramps, tenderness or pain, especially if the patient also feels unwell or has a high fever, which may be due to abnormal muscle breakdown (frequency unknown).

In addition, stop using Roxiper and contact a doctor immediately
if the patient experiences any unusual muscle pain that lasts longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adults.
As with other statins, a very small number of people have experienced unpleasant muscle symptoms, which rarely worsened, progressing to potentially life-threatening muscle damage called rhabdomyolysis.
The following adverse reactions may occur (listed in decreasing order of frequency):
Common (may occur in less than 1 in 10 patients):

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

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

• increased number of eosinophils (a type of white blood cell);
• changes in laboratory test results: high blood potassium levels, which resolve after discontinuation of treatment, low blood sodium levels, which may cause dehydration and low blood pressure;
• hypoglycemia (very low blood sugar levels) in diabetic patients;
• mood changes, sleep disturbances;
• depression;
• drowsiness, fainting;
• palpitations (awareness of heartbeat), tachycardia (rapid heartbeat);
• vasculitis (inflammation of blood vessels);
• bronchospasm (tightness in the chest, wheezing and shortness of breath);
• dryness of the oral mucosa;
• angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria, purpura (red spots on the skin), clusters of blisters;
• 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 blood urea levels, increased blood creatinine levels;
• falls.

Rare (may occur in no more 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 (syndrome of inappropriate antidiuretic hormone secretion);
• low blood chloride levels;
• low blood magnesium levels;
• sudden flushing of the face and neck;
• severe abdominal pain (pancreatitis);
• changes in laboratory test results: increased liver enzyme activity, high serum bilirubin levels;
• lupus-like syndrome (including rash, joint disorders and effects on blood cells) – stop using Roxiper and contact a doctor immediately if this syndrome occurs;
• muscle damage including muscle rupture – as a precaution, stop using Roxiper and contact a doctor immediately if the patient experiences any unusual muscle pain that lasts longer than expected;
• reduced or absent urine output;
• acute kidney failure;
• fatigue.

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

• decreased number of white blood cells, anaemia (reduced number of red blood cells);
• decreased haemoglobin concentration, decreased platelet count;
• high blood calcium levels;
• nerve damage in legs and arms (e.g. numbness), memory loss;
• cardiovascular disorders (irregular heartbeat, angina pectoris and myocardial infarction);
• eosinophilic pneumonia (rare lung inflammation), rhinitis (nasal congestion or runny nose);
• abnormal liver function, hepatitis, jaundice (yellowing of the skin and eyes);
• erythema multiforme (skin rash often starting with red spots on the face, hands or legs), severe ulcers or blisters on the skin, in the mouth, around the eyes and genital organs (Stevens-Johnson syndrome – life-threatening allergic reactions affecting the skin and mucous membranes);
• joint pain;
• gynaecomastia (enlargement of the breasts in men).

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

• hepatic encephalopathy (brain disease caused by liver disease);
• myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing);
• ocular myasthenia (a disease causing weakness of the eye muscles); Talk to a doctor if the patient experiences weakness of the arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
• myopia, blurred vision, visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid accumulation between the choroid and sclera – or acute closed-angle glaucoma);
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• persistent muscle weakness, tendon damage;
• abnormal ECG results, irregular heart rhythm, potentially life-threatening (heart rhythm disturbances known as torsade de pointes);
• cyanosis, numbness and pain in the fingers or toes (Raynaud's phenomenon); changes in laboratory test results: high blood uric acid levels;
• if the patient has systemic lupus erythematosus (a type of collagenosis), symptoms of the disease may worsen.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur.
The doctor may order blood tests to monitor the patient's condition.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of using the medicine.

5. How to store Roxiper

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
EXP. The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from light.
There are no special requirements regarding the storage temperature of this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the
environment.

6. Contents of the packaging and other information

What Roxiper contains

• The active substances in this medicine are rosuvastatin, perindopril with 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 with 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 with 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 with 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 with 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), anhydrous colloidal 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
Brownish-red, round, slightly biconvex film-coated tablets with bevelled edges,
with the imprint "PIR1" on one side. Diameter: approximately 7.5 mm (defined by punches).
Roxiper, 20 mg + 4 mg + 1.25 mg, film-coated tablets
Pink, round, slightly biconvex film-coated tablets with bevelled edges,
with the imprint "PIR2" on one side. Diameter: approximately 10 mm (defined by punches).
Roxiper, 10 mg + 8 mg + 2.5 mg, film-coated tablets
Light pink, round, slightly biconvex film-coated tablets with bevelled edges,
with the imprint "PIR3" on one side. Diameter: approximately 10 mm (defined by punches).
Roxiper, 20 mg + 8 mg + 2.5 mg, film-coated tablets
Light brownish-pink, round, slightly biconvex film-coated tablets with bevelled edges,
with the imprint "PIR4" on one side. Diameter: approximately 10 mm (defined by punches).

Pack sizes: 10, 20, 30, 60, 90 or 100 film-coated tablets in blisters packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: 22 57 37 500
This medicinal product is authorised for sale in the European Economic Area Member States under the following names: