ROSUVANOR 20 mg. 30 tablets

WHAT ROSUVANOR AND WHAT IT IS USED?
Rosuvanor tablets contain the active substance rosuvastatin / rosuvastatin calcium as /. Rosuvanor tablets belongs 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 - "bad" cholesterol (low-density lipoprotein or LDL-C) and "good" cholesterol (high density lipoprotein or NDL-C). Rosuvanor can reduce levels of "bad" cholesterol and triglycerides and increase levels of "good" cholesterol in the blood.
Rosuvanor action to support the blocking of production in the body of "bad" cholesterol and improves the ability of the body to remove it from the blood.
Rosuvanor is prescribed to you because you have high cholesterol. This means that you are at risk of heart attack or stroke.
Recommended you take Rozuvanor as a change in diet and more exercise were not enough to correct your cholesterol levels.

Why is it important to continue taking Rosuvanor?
You must keep taking Rozuvanor, even if your cholesterol has reached an appropriate value, as it prevents the re-raise cholesterol.
However, you should stop taking it if so advise your doctor or get pregnant.
While taking Rosuvanor must continue to follow cholesterol-lowering diet and do exercise.
For most people, high cholesterol does not feel as it does not cause any symptoms. However, if left untreated, fatty deposits can be thickened blood vessel walls, thus making them more narrow.
Sometimes these narrowed blood vessels are clogged, which stops the flow of blood to the heart or the brain, thereby causing a heart attack or stroke. If you correct your cholesterol levels, you can reduce the risk of heart attack or stroke.

2. BEFORE YOU TAKE ROSUVANOR
Do not take Rozuvanor 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 breast-feeding. If you become pregnant while taking Rozuvanor, stop taking it immediately and tell your doctor. Women need to protect themselves from pregnancy while taking Rosuvanor;
have liver disease;
have severe kidney disease;
You have repeated or unexplained muscle pain;
taking medicine that contains a substance called ciclosporin (used eg after an organ transplant).
If any of the above conditions apply to you, please contact your doctor.

Furthermore, do not take Rosuvanor 40 mg (Tablet with the greatest amount of the active ingredient of this medicine) if you:
you have moderate kidney disease (if in doubt ask your doctor);
your thyroid gland is not functioning properly;
They had any repeated or unexplained muscle pain, personal or family history of muscle disease or pre-existing muscle disease appeared in previous intake of other cholesterol-lowering drug;
regularly drink large amounts of alcohol;
You are of Asian origin (if you are from Japan, China, the Philippines, Vietnam, Korea or India);
taking other drugs called fibrates to lower your cholesterol level.
If any of the above apply to you, please contact your doctor.

Take special care with Rosuvanor
Prior to treatment with Rosuvanor 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 pre-existing muscle disease appeared while taking other medicines to lower cholesterol. If you have unexplained muscle pain, especially if you feel sick or have a fever, immediately tell your doctor;
if you regularly drink large amounts of alcohol;
if your thyroid gland is not functioning properly;
if you take other medicines called fibrates to lower your cholesterol level. Please read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
if you are taking drugs used to combat HIV infection 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) were above average (between 5.6 to 6,9 mmol / L);
If patients are under the age of 10 years: Rozuvanor should not be given to children under the age of 10 years;
If patients are under the age of 18 years: Rozuvanor 40 mg tablets is not suitable for use in children and adolescents under the age of 18 years;
if you are aged over 70 (as your doctor needs to choose the right starting dose of Rosuvanor);
if you are of Asian origin - that is Japanese, Chinese, Filipinos, Vietnamese, Koreans and Indians. Your doctor will need to choose the right starting dose Rozuvanor;
If you go into hospital for treatment of another disease. Inform medical personnel that you are taking rosuvastatin.
If any of the above applies to you (or suspect)
Do not take Rosuvanor 40 mg (tablet with the greatest amount of the active ingredient of this drug), and consult your doctor or pharmacist before actually taking any tablet Rozuvanor.
In a small number of people, rosuvastatin can affect the liver. This is established by a simple study that seeks elevated levels of liver enzymes in the blood. Therefore, your doctor will conduct these blood tests (liver function test) before and during treatment with Rosuvanor.

Taking other medicines:
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 you are taking any of the following:
ciclosporin (used eg after an organ transplant);
warfarin (or any other medication to thin the blood);
fibrates (used to reduce cholesterol levels such as gemfibrozil, fenofibrate) or any other drug used for lowering cholesterol (such as ezetimibe);
medicines for indigestion (used to neutralize acid in the stomach);
erythromycin (antibiotic);
oral contraceptives (pills to prevent pregnancy);
hormone replacement therapy;
lopinavir / ritonavir (used to treat HIV infection).
The effect of the above-mentioned medicines may be changed by Rozuvanor or they could change the effect of Rozuvanor.

Taking Rosuvanor with food and drink:
Rosuvanor can be taken with or without food.

Pregnancy and lactation:
Do not take Rozuvanor tablets if you are pregnant or breast-feeding. 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 Rosuvanor - it will not affect their ability. However, some people feel dizzy during treatment with Rozuvanor. If this happens, before attempting to drive or operate any tools or machines talk to your doctor.

Important information about some of the ingredients of Rosuvanor:
Patients who are intolerant to lactose (milk sugar), they should 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 him before taking this medicine.
The tablet coating of 5 mg contains Sunset Yellow FCF / E110 / and those of 10 mg, 20 mg, 40 mg contains karmozin / E122 /. These dyes can cause allergic reactions.

3. HOW TO TAKE ROSUVANOR?
Always take Rosuvanor just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist. The usual dose is taken once daily with or without food. Swallow recommended dose tablets with some water.

initial dose
Your treatment with Rozuvanor should start with a dose of 5 mg or 10 mg, even if you have been taking higher doses of other cholesterol-lowering drugs. The choice of initial dosage will depend on:
cholesterol;
the degree 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 the appropriate starting dose of Rozuvanor for you.
Your doctor will give you the lowest possible dose (5 mg), if:
are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian);
you are over 70 years;
you have moderate 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 take the appropriate amount for you Rozuvanor. If you started with a dose of 5 mg, your doctor may decide to double this to 10 mg, then 20 mg and eventually to a maximum of 40 mg, if necessary. If you started with a starting dose of 10 mg, your doctor may decide to double this to 20 mg, or then to a maximum of 40 mg, if necessary. Between each dose adjustment 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 attacks or stroke whose cholesterol levels were not lowered enough with 20 mg.
The usual recommended doses in children aged 10 - 17 years
Usually, 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.
Rosuvanor 40 mg tablets should not be administered to children.

Taking tablets
Swallow each tablet whole with a drink of water. Do not chew.
Take Rozuvanor once a day. You can take it at any time of day. Try to take your tablets at the same time each day may find it easier to remember to take them.

Regular testing of cholesterol
It is important to see your doctor for regular testing of cholesterol to make sure your cholesterol has reached and remained at a good level.
Your doctor may decide that it is necessary to increase the dose so you take the appropriate amount for you Rosuvanor.

If you take more than the amount Rosuvanor
Call your doctor or nearest hospital casualty department for advice, and remember to bring along your medication.

If you forget to take Rosuvanor
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 continue as usual. Do not take a double dose to make up the missed dose.

If you stop taking Rosuvanor
This decision should be taken only with the consent of your doctor as likely cholesterol levels to rise again after you stop taking rosuvastatin.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Rosuvanor can cause side effects, although not everybody gets them. It is important to be informed 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 the face, lips, tongue and / or throat that may cause difficulty in swallowing;
severe itching of the skin (with the formation of raised lumps).
Moreover, you should stop taking Rosuvanor and consult without delay with your doctor if you have any unusual muscle pain, which last longer than expected. As with other drugs to lower cholesterol, very few people have received unpleasant muscle effects and rarely these have continued to potentially life-threatening damage to the muscle known as rhabdomyolysis.

Common (affects 1 to 10 users in 100):
headache;
dizziness;
constipation;
nausea;
stomach ache;
muscle pain;
increased amount of protein in the urine - this condition is usually transient and restored to normal without stopping your tablets Rosuvanor (only Rozuvanor 40 mg);
diabetes in patients with elevated values of blood sugar;
feeling faint.
Uncommon (affects 1 to 10 users in 1000):
rash, pruritus and urticaria (hives).
Rare (affects 1 to 10 users in 10,000):
severe abdominal 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 aches that last longer than expected;
severe allergic reaction - the signs include swelling of the face, lips, tongue and / or throat, difficulty swallowing and breathing, severe itching of the skin with formation of raised lumps. If you think you have an allergic reaction, stop taking Rozuvanor and seek medical advice without delay;
increase in liver enzymes in the blood.
Very rare (affects less than 1 user in 10 000):
damage to the nerves in the arms and legs (such as numbness);
memory loss;
traces of blood in the urine; joint pain;
yellowing of the skin and whites of the eyes;
inflammation of the liver (hepatitis).
Unknown (estimates of frequency can not be made from available data):
liquid loose stools (diarrhea);
serious condition with blistering and peeling of the skin, mouth, eyes and genitals known as syndrome Stevens-Johns
Film Coating:
Rosuvanor 5 mg film-coated tablets:
Opadry II 85F23426;
Orange (polyvinyl alcohol) - partially hydrolyzed;
Titanium dioxide (E171);
Macrogol 3350 (polyethylene glycol);
Talc (E553b);
Iron oxide, yellow (E 172);
Black iron oxide (E 172);
Sunset Yellow (E110, FD & C Yellow # 6)
Rozuvanor 10 mg, 20 mg and 40 mg tablets:
Opadry II 85F23426;
Pink (polyvinyl alcohol) - partially hydrolyzed;
Titanium dioxide (E171);
Macrogol 3350 (polyethylene glycol);
Talc (E553b);
Iron oxide, yellow (E 172);
Black iron oxide (E 172);
Karmuzin (E 122 aluminum lake);
Indigotine (E 132 indigo carmine aluminum lake FD & C blue # 2);
Rozuvanor looks like and contents of the pack
Rozuvanor 5 mg tablet: orange, round, standard, film-coated tablets marked "N 'on one side of the tablet and" 5 "on the other side of the tablet.
Rozuvanor 10 mg tablets: pale pink to pink, round, standard, 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, film-coated tablets, labeled "N" from one side of the tablet and "20" on the other side of the tablet.
Rozuvanor 40 mg tablets: pale pink to pink, oval shaped tablets, marked "N" on one side of the tablet and "40" on the other side of the tablet.
Rozuvanor is available in blister packages of 14, 14 x 1, 15, 15 x 1, 20, 20 x 1, 28, 28 x 1, 30, 30 x 1, 56, 56 x 1, 60, 60 x 1, 90, 90 x 1, 98, 98 x 1 100 x 1 and 100 tablets per carton.
Not all pack sizes may be marketed.

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