Roxiper 20 mg / 4 mg / 1.25 mg. 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
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. These may be symptoms of a build-up of fluid in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may occur within hours to weeks of taking Roxyper. If left untreated, it can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may be at a higher risk of developing this event. You should stop treatment with Roxyper and seek medical advice.
Athletes should be aware that Roxyper contains an active ingredient (indapamide) that may result in a positive doping test.

In a small number of people, statins can affect the liver. This is determined by a test that looks for elevated levels of liver enzymes in the blood. For this reason, your doctor will usually carry out this blood test (liver function test) before and during treatment with Roxyper.

While you are being treated with this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. If you have high levels of sugars and fats in your blood, are overweight and have high blood pressure, you are probably at risk of developing diabetes.

Children and adolescents
Roxyper should not be used in children and adolescents.

Other medicines and Roxyper
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should avoid taking Roxyper with:

lithium (used to treat depression);
aliskiren (a medicine used to treat high blood pressure) if you do not have diabetes or kidney problems;
potassium-sparing diuretics (eg spironolactone, triamterene, miloride), potassium salts and other medicines that can increase the potassium levels in your body (eg trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, to treat of infections caused by bacteria; cyclosporine, an immune-suppressing drug used to prevent organ transplant rejection; and heparin, a drug used to thin the blood and prevent blood clots from forming); estramustine (used in the treatment of
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 breast-feeding. Roxyper is not recommended during pregnancy.
See your doctor immediately.

Driving and using machines
Roxyper does not affect alertness, but you may feel dizzy or weak due to low blood pressure, which may affect your ability to drive or operate machinery. It is recommended that you do not drive or operate machinery until you know how Roxyper affects you.

3. How to take Roxyper
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is one tablet, once a day. It is preferable to take the tablet in the morning and before meals. Swallow the tablet with a glass of water.
Your doctor will determine the right dose for you. Roxyper is prescribed to patients who are already taking rosuvastatin, perindopril and indapamide as separate tablets.

If you have taken more Roxyper than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. The most likely effect in case of overdose is a lowering of blood pressure. If a sudden drop in blood pressure occurs (symptoms such as dizziness or lightheadedness), lying down with the legs elevated may help.

If you forget to take Roxyper
It is important to take your medicine every day, as regular treatment works better. However, if you forget to take a dose of Roxyper, take the next dose at the usual time.

Do not take a double dose to make up for a missed tablet.

If you have stopped taking Roxyper
As treatment for high blood pressure is usually lifelong, you should discuss this with your doctor before stopping this medicine.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

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), palpitations
sweating, photosensitivity reactions (increased sensitivity of the skin to the sun);
arthralgia (joint pain), myalgia (muscle pain);
chest pain, malaise, peripheral edema, high fever;
increased levels of urea in the blood;
increased levels of creatinine in the blood;
fall.
Rare (may affect up to 1 in 1,000 people):
worsening of psoriasis;
dark urine, nausea or vomiting, muscle cramps, confusion and seizures. These may be symptoms of a condition called SNADH (syndrome of inadequate secretion of antidiuretic hormone);
low blood chloride;
low blood magnesium;
redness;
severe stomach pain (inflamed pancreas);
changes in parameters from laboratory tests: increased level of liver enzymes, high levels of serum bilirubin;
lupus-like syndrome (including rash, joint disorders, and effects on blood cells) - Stop taking Roxyper and see your doctor right away if you get any of these symptoms.
muscle damage, including a muscle tear - as a precaution, stop taking Roxyper and talk to your doctor immediately if you have unusual muscle soreness and pain that lasts longer than expected, decreased or absent urine output;
acute renal failure;
fatigue.
Very rare (may affect up to 1 in 10,000 people)
reduced number of white blood cells, anemia (reduced number of red blood cells);
decreased hemoglobin, decreased platelet count;
high level of calcium in the blood;
nerve damage in the legs and arms (such as numbness), memory loss;
cardiovascular disorders (irregular heartbeat, angina and heart attack);
eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose);
impaired liver function, inflammation of the liver (hepatitis), jaundice (yellowing of the skin and the whites of the eyes);
erythema multiforme (a skin rash that often starts with red itchy patches on the face, hands or feet), severe ulcers or blisters on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome - life-threatening allergic reactions affecting the skin and mucous membranes), photosensitivity reactions (change in skin appearance) after exposure to sunlight or artificial ultraviolet (UVA) light;
joint pain;
gynecomastia (breast enlargement in men).
Not known (frequency cannot be estimated from the available data):
hepatic encephalopathy (brain disease caused by liver disease);
nearsightedness (myopathy), blurred vision, decreased vision or pain in the eye due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
widespread rash, increased body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
muscle weakness that is permanent, tendon damage;
abnormal ECG heart results, life-threatening irregular heartbeat (torsades de pointes);
discoloration, numbness and pain in the fingers or toes (Raynaud's phenomenon), changes in laboratory parameters: high levels of uric acid in the blood;
if you suffer from systemic lupus erythematosus (a type of collagen damage), your condition may get worse.
Disorders of the blood, kidneys, liver or pancreas and changes in laboratory parameters (blood tests) may occur. Your doctor may need to do blood tests to monitor your condition.
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

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