Roxiper 10 mg/4 mg/1.25mg. 30 tablets

What Roxyper is and what it is used for
Roxiper is a combination of three active ingredients - rosuvastatin, perindopril and indapamide. Rosuvastatin belongs to a group of medicines called statins. Perindopril is an ACE (angiotensin-converting enzyme) inhibitor. Indapamide is a diuretic.

Rosuvastatin helps control high cholesterol. Perindopril and indapamide help control high blood pressure (hypertension).
Roxyper is prescribed to treat high blood pressure (hypertension) and associated high cholesterol. Patients who are already taking rosuvastatin, perindopril and indapamide in separate tablets can instead take one Roxiper tablet that contains all three ingredients.

2. What you need to know before you take Roxyper
Do not take Roxyper
if you are allergic to rosuvastatin, perindopril or other ACE inhibitors, to indapamide or other sulfonamides, or to any of the other ingredients of Roxyper (listed in section 6);
if you have had symptoms such as wheezing, swelling of the face or tongue, severe itching or severe skin rashes during previous treatment with an ACE inhibitor, or if you or a member of your family have had such symptoms in other circumstances (a condition called angioedema);
if you have diabetes or impaired kidney function and are being treated with a blood pressure lowering medicine containing aliskiren;
if you have a low level of potassium in your blood;
if you are suspected of having untreated decompensated heart failure (severe water retention; difficulty breathing);
if you have kidney disease in which the blood supply to the kidneys is reduced (renal artery stenosis);
if you are on dialysis treatment or on another type of blood filtration, Depending on the device used, Roxyper may not be suitable for you;
if you have liver disease or suffer from 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 renal impairment (creatinine clearance 30-60 ml/min), for Roxyper in doses of 10 mg/8 mg/2.5 mg and 20 mg/8 mg/2.5 mg;
if you are taking a fixed-dose medicine with sofosbuvir/velpatasvir/voxilaprevir (used for a viral infection of the liver called hepatitis C);
if you have recurring or unexplained muscle aches or pains;
if you are taking a medicine called cyclosporine (used, for example, after an organ transplant);
if you are pregnant or breastfeeding. If you become pregnant while taking Roxyper, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Roxyper by using appropriate contraception;
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as there is an increased risk of angioedema (rapid swelling under the skin in an area such as the throat) (see Warning and precautions' and 'Other medicines and Roxyper').
Warnings and precautions
Talk to your doctor or pharmacist before taking Roxyper:

if you have aortic valve stenosis (narrowing of the main blood vessel taking blood away from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the arteries supplying blood to the kidneys);
if you have heart failure or other heart problems; if you have kidney problems or are receiving dialysis treatment;
if you have muscle disorders, including muscle pain, tenderness, weakness or cramps;
if you have abnormally high blood levels of a hormone called aldosterone (primary aldosteronism);
if you have liver problems;
if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma;
if you have ever had a severe skin rash or skin peeling, blistering and/or mouth ulcers after taking Roxyper or other related medicines; if you have severe respiratory failure;
if you have too high a concentration of substances of an acidic nature in the blood, which can cause an increased frequency of breathing;
if you are on a salt-restricted diet or use salt substitutes that contain potassium;
if you are taking lithium or potassium-sparing medicines (spironolactone, potassium supplements, as their use with Roxyper should be avoided (see "Other medicines and Roxyper");
if you suffer from hyperparathyroidism (overactive parathyroid gland);
if you suffer from gout;
if you are elderly and your dose needs to be increased;
if you have had photosensitivity reactions (photosensitization);
if you have a severe allergic reaction with swelling of the face, lips, mouth, tongue or throat which may make swallowing or breathing difficult (angioedema). This can happen at any time during treatment. If you develop such symptoms, you should stop treatment and see a doctor immediately.
if you have diabetes;
if your thyroid gland is not working normally;
if you have atherosclerosis (hardening of the arteries);
if you are of Asian descent - ie. Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor should choose the correct starting dose of perindopril, indapamide and rosuvastatin that is right for you.
if you are black you may have a higher incidence of angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing) and less effectiveness in lowering blood pressure;
if you are a hemodialysis patient with high flux membranes;
if you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Tell your doctor right away if you have unexplained muscle aches or pains, especially if you feel sick or have a fever. Also tell your doctor if you have muscle weakness that is persistent.
if you are taking other medicines called fibrates to lower cholesterol or another medicine used to lower cholesterol (such as ezetimibe). Please read this leaflet carefully, even if you have previously taken other medicines for high cholesterol.
if you are taking medicines used to fight HIV infection, for example ritonavir with lopinavir and/or atazanavir, please see 'Other medicines and Roxiper';
if you regularly drink large amounts of alcohol;
if you are taking any of the following medicines used to treat high blood pressure:
an angiotensin II receptor blocker (ARB, also known as sartans - eg valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
aliskiren.
Your doctor may periodically check your kidney function, blood pressure and the amount of electrolytes (eg potassium) in your blood.

See also the information under the heading "Do not take Roxyper".

If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for a bacterial infection), by mouth or by injection. The combination of fusidic acid and rosuvastatin can cause serious muscle problems (rhabdomyolysis).

If you take any of the following medicines, the risk of angioedema increases:

racecadotril (used to treat diarrhoea);
sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTor inhibitors (used to avoid rejection of transplanted organs and to treat certain types of cancer),
linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines belonging to the class of so-called gliptins (used to treat diabetes).
Angioedema
Angioedema (severe allergic reaction manifested by swelling of the face, lips, tongue or throat with difficulty swallowing or breathing) has been reported in patients treated with AC E inhibitors, including Roxyper. This can happen at any time during treatment. If you develop such symptoms, you should stop taking Roxyper and see your doctor immediately. See also point 4.

Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with Roxyper. Stop using Roxyper and seek medical help immediately if you notice any of the symptoms described in section 4.

You should tell your doctor if you think you are (or may become) pregnant. It is not recommended in early pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby if used during this period (see Pregnancy and breast-feeding).

When taking Roxyper, you should also inform your doctor or medical staff:

if you have a dry cough;
if you are about to undergo general anesthesia and/or major surgery; if you have recently had diarrhea or vomiting, or are dehydrated; if you are about to have dialysis or low-density lipoprotein apheresis (which is removing cholesterol from the blood with a machine);
if you are about to undergo desensitizing treatment to reduce the effects of an allergy to a bee or wasp sting;
if you are about to have a medical examination that requires an injection of iodine-containing contrast agent (a substance that makes organs such as the kidneys or stomach visible on X-rays);
if you have a change in vision or pain in one or both eyes while taking Roxyper. This can e
procainamide (to treat irregular heartbeat);
quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium (medicines used for heart rhythm problems);
allopurinol (to treat gout);
antihistamines used to treat allergic reactions such as hay fever (eg mizolastine, terfenadine or astemizole;
corticosteroids used to treat various conditions, including severe asthma and rheumatoid arthritis,
tetracosactide (to treat Crohn's disease);
immunosuppressants used to treat autoimmune diseases or after transplant surgery (eg cyclosporine);
fluconazole, ketoconazole (antifungal drugs);
moxifloxacin, sparfloxacin, rifampicin, erythromycin, clarithromycin (antibiotics - medicines to treat infections);
methadone (used to treat addiction);
halofantrine (used to treat certain types of malaria);
pentamidine (used to treat pneumonia);
injectable gold (used to treat rheumatoid arthritis);
vincamine (used to treat symptomatic cognitive impairment in elderly patients, including memory loss);
bepridil, verapamil, diltiazem (heart medicines);
sultopride (for the treatment of psychosis);
benzamides (for the treatment of psychosis);
cisapride, diphemanil (used to treat stomach and digestive problems);
digoxin or other cardiac glycosides (to treat heart problems);
baclofen (to treat muscle stiffness caused by diseases such as multiple sclerosis);
medicines to treat diabetes, such as insulin, metformin or gliptins;
calcium, including calcium supplements;
stimulant laxatives (eg senna);
non-steroidal anti-inflammatory drugs (eg ibuprofen) or high doses of salicylates (eg aspirin);
amphotericin B by injection (to treat severe fungal disease);
medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia (eg tricyclic antidepressants, neuroleptics);
anesthetics;
iodine contrast agent;
warfarin, ticagrelor or clopidogrel (or any other medicine used to thin the blood);
fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
indigestion medicines (used to neutralize stomach acid);
oral contraceptives (birth control) or hormone replacement therapy;
any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (please see section "Warnings and precautions"): ritonavir, lopnnavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir - please see sections "Do not take Roxyper" and "Warnings and precautions";
medicines most often used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolinmus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTor inhibitors). See section "Warnings and precautions",
regorafenib or darolutamide (used to treat cancer);
trimethoprim (used to treat infections);
vasodilators, including nitrates (medicines that cause blood vessels to dilate);
medicines used to treat low blood pressure, shock or asthma (for example, ephedrine, norepinephrine or adrenaline);
if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to start it again. Taking fusidic acid may rarely cause muscle weakness, soreness or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.
Your doctor may need to change your dose and/or take other precautions:

if you are taking angiotensin II receptor blockers (ARBs) or aliskiren (see also the information under the headings "Do not take Roxyper" and "Warnings and precautions").
Roxyper with food and drinks
It is preferable to take Roxyper before meals.

Pregnancy and breastfeeding
Do not take Roxyper if you are pregnant or breastfeeding.

Pregnancy
You should tell your doctor if you think you are (or may become) pregnant. If you become pregnant while taking Roxyper, stop taking it immediately and tell your doctor. Your doctor will usually advise you to stop taking Roxyper before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Roxyper.
Women should avoid becoming pregnant while taking Roxyper by using appropriate contraception.

Ask your doctor or pharmacist before using any medicine.

Breastfeeding
Tell your doctor if you are breast-feeding or about to start
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicinal product and see a doctor immediately if you experience any of the following side effects, which may be serious:
severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people),
bronchospasm (chest tightness, 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 section 2 "Warnings and precautions") (uncommon - may affect up to 1 in 100 people),
severe skin reactions, including erythema multiforme (a skin rash that often starts with red, itchy patches on the face, hands or feet) or red, non-raised, target-like or round patches on the body, often centrally located blisters, peeling of the skin, ulcers in mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or other allergic reactions (very rare - may affect up to 1 in 10,000 people),
extensive rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (frequency not known - frequency cannot be determined from the available data),
cardiovascular disorders (irregular heartbeat, angina pectoris (angina) (pain in the chest, jaw and back caused by physical exertion), heart attack) (very rare - may affect up to 1 in 10,000 people),
weakness of the arms or legs, or problems which may be a sign of a possible stroke (very rare - may affect up to 1 in 10,000 people),
inflammation of the pancreas, which can cause severe abdominal and back pain,
accompanied by severe illness (very rare - may affect up to 1 in 10,000 people),
yellowing of the skin or eyes (jaundice) which may be a sign of hepatitis (very rare - may affect up to 1 in 10,000 people),
life-threatening irregular heart rhythm (of unknown frequency - the frequency cannot be determined from the available data),
brain disease caused by liver disease (hepatic encephalopathy) (frequency not known - frequency cannot be estimated from the available data),
muscle weakness, cramps, tenderness or pain and especially if you feel unwell or have a fever at the same time, this may be due to abnormal muscle breakdown (of unknown frequency).
Also, stop taking Roxyper and talk to your doctor right away if you have unusual muscle soreness or pain that lasts longer than you expect. Muscular symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have had unpleasant muscle effects, and in rare cases these have progressed to a potentially life-threatening muscle damage known as rhabdomyolysis.

In descending order of frequency, side effects may include:

Common (may affect up to 1 in 10 people):
skin reactions in patients who are prone to allergic or asthmatic reactions;
low levels of potassium in the blood;
diabetes (this is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure; your doctor will monitor you while you are taking this medicine);
dizziness, headache, vertigo, tingling and numbness;
visual disturbances (including double vision);
tinnitus (ringing in the ears)
dizziness due to low blood pressure;
shortness of breath (dyspnea), cough;
gastrointestinal disorders (dry mouth, taste disturbances, pain in the epigastrium, dyspepsia or indigestion, anorexia, vomiting, abdominal pain, nausea, diarrhea, constipation);
allergic reactions (such as skin rashes, itching); muscle pain, cramps; feeling tired.
Uncommon (may affect up to 1 in 100 people):
an excess of eosinophils (a type of white blood cell);
changes in parameters from laboratory tests: high level of potassium in the blood,
reversible on discontinuation, low sodium levels in the blood, which can lead to dehydration and low blood pressure;
hypoglycaemia (very low blood sugar levels) in patients with diabetes;
mood changes, sleep disorders;
depression;
drowsiness, fainting;
palpitations (feeling your heart beat), tachycardia (fast heart rate);
vasculitis (inflammation of blood vessels);
bronchospasm (tightness in the chest, wheezing and shortness of breath);
dry mouth
angioedema (symptoms such as wheezing, swelling of the face or tongue), urticaria (hives), purpura (red spots on the skin), clusters of blisters. If you suffer from systemic lupus erythematosus (a type of collagen disease), it may get worse.
kidney problems;
impotence (inability to achieve or maintain an erection);
sweating, photosensitivity reactions (increased sensitivity of co
5. How to store Roxyper
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date corresponds to the last day of the specified month.

Store in the original package in order to protect from light.
This medicine does not require special temperature storage conditions.

Do not dispose of medicines down the drain or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Roxyper contains
The active substances are rosuvastatin, perindopril tert-butylamine and indapamide.
Roxyper 10 me/4 mg/1.25 mg film-coated tablets
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium), 4 mg tert-butylamine perindopril and 1.25 mg indapamide,
Roxyper 20 mg/4 me/1.25 mg film-coated tablets
Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium), 4 mg tert-butylamine perindopril and 1.25 mg indapamide.
Roxyper 10 mg/8 mg/2.5 mg film-coated tablets
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium), 8 mg tert-butylamine perindopril and 2.5 mg indapamide.
Roxyper 20 mg/8 mg/2.5 mg film-coated tablets
Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium), 8 mg tert-butylamine perindopril and 2.5 mg indapamide.

The other ingredients (excipients) are:
Tablet core: microcrystalline cellulose (type 200 LM), microcrystalline cellulose (type 112), crospovidone (type A), colloidal anhydrous silica and magnesium stearate (E470b).
Film coating:
Roxyper 10 me/4 mg/1.25 me film-coated tablets.
Roxyper 20 mg/4 mg/1.25 me film-coated tablets.
Roxyper 20 me/8 mg/2.5 mg film-coated tablets: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172), black iron oxide (E 172) and yellow iron oxide (E172)
Roxyper 10 me/8 mg/2.5 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc and red iron oxide (E 172)

What Roxyper looks like and contents of the pack
Roxyper 10 mg/4 mg/1.25 mg film-coated tablets: reddish-brown, round, slightly biconvex film-coated tablets with bevelled edges, debossed with PIR1 on one side of the tablet. Diameter: approximately 7.5mm (outlined by punching).

Roxyper 20 mg/4 mg/1.25 mg film-coated tablets: almost pink, round, slightly biconvex film-coated tablets with beveled edges, debossed with PIR2 on one side of the tablet. Diameter: approximately 10 mm (outlined by punching).

Roxyper 10 mg/8 mg/2.5 mg film-coated tablets: light pink, round, slightly biconvex film-coated tablets with beveled edges, debossed with PIR3 on one side of the tablet. Diameter: approximately 10 mm (outlined by punching).

Not all types of packaging can be marketed.

 

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