ROSUVANOR table. 10 mg

ROSUVANOR table. 10 mg
€ 36.00
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Rozuvanor tablet contains the active ingredient rosuvastatin / as rosuvastatin calcium /. Rozuvanor tablets belong to a group of medicines called statins. They are used to adjust the level of blood fats called lipids, the most common of which is cholesterol.



ROSUVANOR table. 10 mg
 

ROZUVANOR WHAT IS AND WHAT IT IS USED FOR?

Rozuvanor tablet contains the active ingredient rosuvastatin / as rosuvastatin calcium /. Rozuvanor tablets belong to a group of medicines called statins. They are used to adjust the level of blood fats called lipids, the most common of which is cholesterol.
In blood there are different types of cholesterol - the "bad" cholesterol (low density lipoprotein or LDL-C) and "good" cholesterol (high density lipoprotein or NDL-C). Rozuvanor can reduce levels of "bad" cholesterol and triglycerides and increase levels of "good" cholesterol in the blood.
Rozuvanor blocking works by helping the body in the production of "bad" cholesterol and improves the body's ability to remove it from the blood.
Rozuvanor are prescribed because you have high cholesterol. This means that you are at risk of heart attack or stroke.
We recommend that you take Rozuvanor as changes in diet and more exercise were not sufficient to adjust the level of your cholesterol.
Why is it important to continue taking Rozuvanor?
You should continue to take Rozuvanor, even if your cholesterol has reached a good value because it prevents increased cholesterol.
However, you should stop taking it, if you advise your doctor or get pregnant.
While taking Rozuvanor should continue to follow cholesterol-lowering diet and exercise.
For most people, high cholesterol do not feel as it does not cause any symptoms. However, if left untreated, fatty deposits can thickened walls of blood vessels, making them narrower.
Sometimes these narrowed blood vessels are blocked, which restricts blood flow to the heart or brain, thus causing a heart attack or stroke. If correct cholesterol, may reduce the risk of heart attack or stroke.

 BEFORE YOU TAKE ROZUVANOR

Rozuvanor not take if:
 you are allergic (hypersensitive) to rosuvastatin or any of the other ingredients na Rozuvanor. An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat, or tongue;
 if you are pregnant or breastfeeding. If you become pregnant while taking Rozuvanor, stop taking it immediately and contact your doctor. Women need to protect themselves from pregnancy while taking Rozuvanor;
 have liver disease;
 have severe kidney disease;
 have repeated or unexplained muscle pain;
 taking medicine that contains a substance called cyclosporine (used for example after organ transplantation).
If any of the above conditions applies to you, please ask your doctor.
Moreover, do not take Rozuvanor 40 mg (tablet with highest amount of the active ingredient of this drug) if you:
 you have moderate to severe kidney disease (in doubt, ask your doctor);
 your thyroid gland is not functioning properly;
 you had any repeated or unexplained muscle pain, personal or family history of muscle disease or prior muscle disease experienced by previous intake of other cholesterol-lowering drugs;
 regularly drink large amounts of alcohol;
 are of Asian origin (if you are from Japan, China, Philippines, Vietnam, Korea and India);
 taking medicines called fibrates to lower cholesterol.
If any of the above apply to you, please ask your doctor.
Take special care with Rozuvanor
Before treatment Rozuvanor tell your doctor:
 if you have kidney disease;
 if you have liver disease;
 if you have repeated or unexplained muscle pain, personal or family history of muscle disease, or prior muscle disease appeared while taking other drugs to lower cholesterol. If you have unexplained muscle pain, especially if you feel unwell or have a fever, tell your doctor;
 if you regularly drink large amounts of alcohol;
If your thyroid gland is not functioning properly;
 if you are taking other medicines called fibrates to lower cholesterol. Please read this leaflet carefully, even if you have used other medicines for high cholesterol;
 if you are taking drugs used to combat HIV infection, such as lopinavir / ritonavir;
if you have interstitial lung disease;
if you have severe respiratory failure;
 if the blood test values of fasting glucose (blood sugar) are above average (between 5.6 to 6,9 mmol / L);
 If patients are younger than 10 years: Rozuvanor should not be given to children under the age of 10 years;
 If patients are younger than 18 years: Rozuvanor 40 mg tablets are not suitable for use in children and adolescents under the age of 18 years;
 If you are older than 70 years (since your doctor should select the appropriate starting dose of Rozuvanor);
 if you're Asian - they are Japanese, Chinese, Filipinos, Vietnamese, Koreans and Indians. Your doctor will need to select the appropriate starting dose Rozuvanor;
 if you enter the hospital for treatment of other diseases. Inform medical staff that you are taking rosuvastatin.
If any of the above applies to you (or suspect):
 Do not take Rozuvanor 40 mg (tablet with highest amount of the active ingredient of this drug) and check with your doctor or pharmacist before actually taking any tablet Rozuvanor.
A small number of persons, rosuvastatin can affect the liver. This is determined by a simple study that looks for elevated levels of liver enzymes in the blood. Therefore, your doctor will conduct these blood tests (liver function tests) before and during treatment with Rozuvanor.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor if, any of the following:
 cyclosporine (used for example after organ transplantation);
 warfarin (or any other medication to thin the blood);
 fibrates (used to lower cholesterol such as gemfibrozil, fenofibrati) or any other medicine used to lower cholesterol (such as ezetimibe);
 medicines for indigestion (used to neutralize the acid in the stomach);
 erythromycin (an antibiotic);
 oral contraceptives (pills prevent pregnancy);
 hormone replacement therapy;
 lopinavir / ritonavir (used to treat HIV infection).
The effect of the above drugs may change from Rozuvanor or they could alter the effect of Rozuvanor.
Taking Rozuvanor food and drink
Rozuvanor can be taken with or without food.
Pregnancy and lactation:
Do not take Rozuvanor tablets if you are pregnant or breastfeeding. If you become pregnant while taking Rozuvanor, stop taking it immediately and call your doctor. Women need to protect themselves from pregnancy while taking Rozuvanor, using appropriate means of protection.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines:
Most people can not drive or operate machinery while taking Rozuvanor - it will not affect their abilities. However, some people feel dizzy during treatment with Rozuvanor. If this happens, before attempting to drive or operate any tools or machinery, talk to your doctor.
Important information about some of the ingredients of Rozuvanor:
Patients who are intolerant to lactose (milk sugar), you know that Rozuvanor tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
The tablet coating contains 5 mg sunset yellow FCF / E110 / and those of 10 mg, 20 mg, 40 mg contain karmozin / E122 /. These colorants can cause allergic reactions.

  HOW TO TAKE ROZUVANOR?

Always Rozuvanor exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist. The usual dose is taken once daily with or without food. Swallow the tablets recommended dose with a little water.
Starting dose
Your Rozuvanor therapy should begin with 5 mg or 10 mg, even if you are taking higher doses of other cholesterol-lowering drugs. The selection of the starting dose will depend on:
 cholesterol;
 level of risk of having a heart attack or stroke;
 if you have risk factors that make you more sensitive to possible side effects.
Please consult your doctor or pharmacist what is the appropriate starting dose of Rozuvanor for you.
Your doctor will give you the lowest possible dose (5 mg), if:
 you are Asian (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian);
you are older than 70 years;
 you have moderate to severe kidney disease;
There is a risk of muscle pain.
Increasing the dose and maximum daily dose
Your doctor may decide to increase your dose. This is necessary to adopt appropriate amount Rozuvanor for you. If you started with a dose of 5 mg, your doctor may decide to double to 10 mg, then 20 mg and finally to a maximum of 40 mg, if necessary. If you started with an initial dose of 10 mg, your doctor may decide to double to 20 mg, and then to a maximum of 40 mg, if necessary. Between dose adjustments should be an interval of four weeks.
The maximum daily dose of 40 mg Rozuvanor only be prescribed to patients with high cholesterol and a higher risk of heart attack or stroke whose cholesterol levels have dropped enough with 20 mg.
The usual recommended dose in children aged 10 - 17 years
Typically, the recommended starting dose is 5 mg. Your doctor may increase your dose to find the right dose for you Rozuvanor. The maximum daily dose is 20 mg. Take your dose once a day. 
Rozuvanor 40 mg tablets should not be administered to children.
Taking the tablets
Swallow each tablet whole with a drink of water. Do not chew.
Take Rozuvanor daily. You can take it anytime of the day. Try to take your tablets at the same time each day, you may find it easier to remember to take them.
Regular cholesterol testing
It is important to see your doctor for regular testing of cholesterol to make sure that your cholesterol is reached and remained at a good level.
Your doctor may decide that it is necessary to increase the dose in order to take the appropriate amount for you Rozuvanor.
If you take more than the dose Rozuvanor
Call your doctor or the nearest hospital emergency room for advice, do not forget to bring along your medication.
If you forget to take Rozuvanor
If you miss a dose, do not worry and take it as soon as possible. However, if it is almost time for your next dose, skip forward and proceed as usual. Do not take a double dose to make up for a missed dose.
If you stop taking Rozuvanor
This decision should be taken only with the consent of your doctor, because it is likely cholesterol levels to rise again after you stop taking rosuvastatin.

 POSSIBLE SIDE EFFECTS

Like all medicines, Rozuvanor can cause side effects, although not everybody gets them. It is important you are aware what may have these side effects.
Stop taking Rozuvanor and seek immediate medical attention if you experience any of the following allergic reactions:
 difficulty breathing with or without swelling of the face, lips, tongue and / or throat;
 swelling of face, lips, tongue and / or throat that may cause difficulty in swallowing;
 severe itching of the skin (with raised lumps formation).
Moreover, you should stop taking Rozuvanor and consult urgently with your doctor if you have any unusual muscle pain that lasts longer than expected. As with other drugs to lower cholesterol, very few people have experienced unpleasant muscle effects and rarely have they continued to potentially life-threatening muscle damage known as rhabdomyolysis.
Common (affects 1 to 10 users in 100):
 headache;
dizziness;
 constipation;
 nausea;
 abdominal pain;
 muscle pain;
 high amounts of protein in the urine - this condition is usually transient and restored to normal without having to stop your tablets Rozuvanor (only Rozuvanor 40 mg);
 diabetes patients with elevated blood sugar;
feeling faint.
Uncommon (affects 1 to 10 users in 1,000):
rash, itching and urticaria (hives). 
Rare (affects 1 to 10 users in 10,000):
severe stomach pain (caused by inflammation of the pancreas);
 muscle damage - as a precaution, stop taking Rozuvanor and consult your doctor immediately if you experience unusual muscle pain that lasts longer than expected;
 severe allergic reaction - signs include swelling of the face, lips, tongue and / or throat, difficulty swallowing and breathing, severe itching of the skin with raised lumps forming. If you think you have an allergic reaction, stop taking Rozuvanor and seek medical advice without delay;
 elevation of liver enzymes in the blood.
Very rare (affects less than 1 user in 10,000):
 damage to the nerves in the hands and feet (such as numbness);
loss of memory;
 traces of blood in the urine, pain in the joints;
 yellowing of the skin and whites of the eyes;
 inflammation of the liver (hepatitis). 
Unknown (estimates of frequency can not be made from the available data):
 Liquid loose stools (diarrhea);
 serious condition with blistering and peeling of the skin, mouth, eyes and genitals known as syndrome Stevens-Johnson;
sleep disorders, including insomnia and nightmares;
 sexual offenses;
 depression;
 breathing problems including persistent cough and / or shortness of breath or fever;
 Edema (swelling);
 Violation of tendons;
 Indigestion.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

 HOW TO STORE ROZUVANOR

Keep out of reach of children.
Rozuvanor 5 mg tablets.
Do not store above 25 ° C.
Rozuvanor 10 mg, 20 mg and 40 mg tablets.
Do not store above 30 ° C.
Keep the blister in the outer carton in order to protect from moisture and light.
Rozuvanor Do not use after the expiry date stated on the blister and carton after "EXP" date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 ADDITIONAL INFORMATION

What Rozuvanor?
Active ingredient is rosuvastatin (as rosuvastatin calcium). Each tablet contains Rozuvanor 5 mg, 10 mg, 20 mg or 40 mg rosuvastatin (as rosuvastatin calcium).
The other ingredients are:
Core:
microcrystalline cellulose (Avicel PH-112);
 crospovidone (Kollidon CL);
lactose anhydrous;
povidone (PVP K-30);
sodium stearyl (PRUV).
Film coating:
Rozuvanor 5 mg film-coated tablets:
 Opadry II 85F23426;
 Orange (polyvinyl alcohol) - partially hydrolyzed;
 Titanium dioxide (E171);
 Macrogol 3350 (polyethylene glycol);
 Talc (E553b);
 Yellow iron oxide (E 172);
 Black iron oxide (E172);
 Sunset yellow (E110, FD & C Yellow # 6)
Rozuvanor 10 mg, 20 mg and 40 mg film-coated tablets:
Opadry II 85F23426;
 Pink (polyvinyl alcohol) - partially hydrolyzed;
 Titanium dioxide (E171);
 Macrogol 3350 (polyethylene glycol);
 Talc (E553b);
 Yellow iron oxide (E 172);
 Black iron oxide (E172);
 Karmuzin (E 122 aluminum lake);
 Indigotine (E132, indigo carmine aluminum lake FD & C blue # 2);
Rozuvanor looks like and contents of pack
Rozuvanor 5 mg tablets: orange, round, standard biconvex film-coated tablets marked "N 'on one side of the tablet and" 5 "on the other side of the tablet.
Rozuvanor 10 mg tablets: light pink to pink, round, standard biconvex film-coated tablets marked "N" on one side of the tablet her "10" on the other side of the tablet.
Rozuvanor 20 mg tablets: light pink to pink, round, standard biconvex film-coated tablets marked "N" on one side of the tablet and "20" on the other side of the tablet.
Rozuvanor 40 mg tablets: light pink to pink, oblong shaped tablets, marked "N" on one side of the tablet and "40" on the other side of the tablet.
€ 36.00
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