Crestor (Rosuvastatin) Fort 28 Tablets

In these operating instructions:

1. What is CRESTOR and what is it used for? 2. Cautions before using CRESTOR 3. How to use CRESTOR 4. What are the possible side effects? 5. Header for storage of CRESTOR

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2. Things to consider before using CRESTOR Do not use

CRESTOR

if:

• If you have previously experienced an allergic effect with CRESTOR or any of its substances,

• If you are pregnant or breast-feeding. If you become pregnant while receiving CRESTOR, stop taking the drug immediately and consult your doctor. Women receiving CRESTOR should avoid becoming pregnant using an appropriate method of protection.

• If you have liver disease,If you have

•severe kidney problems,If you have

•recurrent or unexplained muscle pains or pain,If you are taking

•a drug called cyclosporin (eg after organ transplantation).

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If you have any of these conditions listed above, or if you believe that it exists, please contact your doctor.

Also, DO NOT use CRESTOR 40 mg (highest dose) in the following cases

• If you have a moderate kidney problem (consult your doctor if in doubt),

• Your thyroid gland does not work well,

• Your repeated or unexplained muscle pains or pain, personal or familial muscle problems or if you have a history of muscle problems when you have previously taken other cholesterol-lowering medications,If you

•use alcohol continuously,

• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian),

• Fats to lower your cholesterol (gemfibrozil, fenofibrate, etc.) If

you have any of these conditions listed above, or if you think they exist, please contact your doctor.

USE CRESTOR CAREFULLY in the following cases

:

• If you have problems with your kidneys,,

• If you have problems with your liver• If

you have a history of muscular problems, or if you have a history of muscle problems or other cholesterol-lowering drugs in your family or in your family, there is a history of muscle problems. In particular, if you feel unwell or if you have fever, if you feel unexplained muscle aches and pains, you should consult your doctor immediately. You should also tell your doctor or pharmacist if your muscle weakness is constant.

• If you regularly use a large amount of alcohol,

• Your thyroid gland does not work well,

• If you are taking medication from the group called fibrates (such as gemfibrozil, fenofibrate) to lower your cholesterol. Please read these operating instructions carefully, even if you have previously used other drugs against high cholesterol.

• If you are using ritonavir with lopinavir and / or atazanavir, for example drugs used to treat HIV infection. Please refer to the lar Use with other drugs kullanım section of CRESTOR.

• If you are using antibiotics containing fusidic acid, please refer to the section ors Use with CRESTOR and other drugs lütfen.

Children and adolescents:

• If the patient is under 10 years old: CRESTOR should not be given to children under 10 years of age.

• If the patient is under 18 years old: CRESTOR 40 mg tablet is not suitable for use in children and adolescents under 18 years of age.

• If you are over 70 (Your doctor has to decide the appropriate starting dose of CRESTOR for you),

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• If you have severe respiratory failure,

• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor has to decide the appropriate starting dose of CRESTOR.

If you have any of these conditions listed above, or if you think it exists, do not use a dose of 40 mg (the highest dose). Consult your doctor or pharmacist before taking any dose of CRESTOR.

In some people statins affect the liver. Whether such a condition exists or not can be understood by a simple blood test (increase in liver enzyme level). Your doctor will therefore ask for liver function tests to be performed before and during the use of CRESTOR.

If you have diabetes or have a risk of diabetes, your doctor will keep you in close follow-up when you use this medicine. If you have high levels of sugar and fat in your blood, if you are overweight and have high blood pressure, you have the risk of having diabetes.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using CRESTOR with food and drink

You can get CRESTOR open or full.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

Do not use CRESTOR if you are pregnant. If you notice that you are pregnant while using CRESTOR, stop using it immediately and tell your doctor. Women who use CRESTOR should avoid conception with proper protection.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Do not use CRESTOR if you are breastfeeding.

Vehicle and machine useuse

Most peoplecars and machines while receiving CRESTOR; because CRESTOR does not affect the capabilities of these people. However, some people may experience dizziness when using CRESTOR. If you feel dizzy, consult your doctor before using the car or a machine.

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Important information about some of the excipients in the content of CRESTOR

If you have been told by your doctor about some sugar (lactose or milk sugar) that you are unstable about, please contact your doctor before taking this medicinal product. For a complete list of components in this drug, please refer to the “excipients in section.

Use with

other drugs If you use other drugs, including those that can be taken without a prescription, or if you have used it recently, please report this to your doctor or pharmacist.

Report to your doctor if you are taking any of the following drugs:

• Cyclosporine (eg after organ transplantation),

• Warfarin,

• Clopidogrel (or another blood-thinning medication),

• Fibrates (such as gemfibrozil, fenofibrate),

• Other cholesterol-lowering drugs (eg ezetimib) )

• indigestion remedies (used to reduce the gastric acid),

• erythromycin (antibiotic),

• fusidic acid (an antibiotic),

• birth control pill,

• Hormone replacement therapy,

• lopinavir and / or atazanavir and ritonavir as antiviral (treatment of

•infections including HIV or hepatitis C. Please refer to ğı Before using CRESTOR ğı).

CRESTOR may alter the effects of these drugs or may alter the effects of CRESTOR.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medicine or have recently used it.

3. How to use CRESTOR?

Instructions for appropriate use and dose / frequency of administration:

Always take CRESTOR as prescribed by your doctor. If in doubt, ask your doctor or pharmacist.

regular dosesfor adults

If you receiveforhigh cholesterol crestor

starting dose of

your treatmentwithCRESTOR, even if you previously have used high doses of another statin should be started at a dose of 5 mg or 10 mg. Selection depends on your starting dose include:

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• Your cholesterol level,

your risk of having a heart attack or stroke •,

• will cause you to be more sensitive to possible side effects, whether you have a feature.

Ask your doctor about the optimal starting dose of CRESTOR.

If this is the case, your doctor may recommend you the lowest dose (5 mg):

• If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian),

•are over 70 years of age,

If you• If you have a moderate kidney problem,

• Muscle aches and if you are at risk of experiencing pain (myopathy).

Increasing the dose and the highest daily dose

Your doctor may decide to increase the dose. Thus, you can use the most appropriate dose. If you start with a 5 mg dose, your doctor may double the dose 10 mg, then 20 mg, then 40 mg if necessary. If you start with 10 mg, your doctor may double it to 20 mg and then 40 mg if necessary. There will be a 4-week interval between each dose adjustment.

The highest daily dose of CRESTOR is 40 mg. This dose is only for patients whose cholesterol levels are high and the risk of heart attack or stroke is high, but also does not decrease the cholesterol levels by a dose of 20 mg.

If you take CRESTOR to reduce your risk of heart attack, stroke or related health problems: The

recommended dose is 20 mg per day. However, if you have any of the factors listed above, your doctor may decide to use a lower dose.

Method and method of

administration Swallow the tablet as a whole with water.

Take CRESTOR once a day. You can receive CRESTOR at any time of the day.

Remember to take the CRESTOR tablet at the same time every day to keep in mind.

Regular cholesterol controls

It is very important that you go to your doctor for regular cholesterol controls. Thus, you can be sure that your cholesterol is at the desired level and remains at this level.

Your doctor may decide to increase the dose so that you can use the most appropriate dose of CRESTOR.

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Different age groups:

• Use in children and adolescents between the ages of 6-17: The normal starting dose is 5 mg. Your doctor may increase your dose to find the optimal amount of CRESTOR for you. The highest daily dose of CRESTOR is 10 mg in children 6 to 9 years and 20 mg in those between 10 and 17 years. Take your dose once a day. CRESTOR 40 mg tablets should not be used by children.

• Elderly use: It is recommended as an initial dose of 5 mg in patients over 70 years of age. No further dosage adjustment is required by age.

Special Use Cases: Renal insufficiency: No dosage adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal failure, no dose of CRESTOR should be used. In patients with moderate renal impairment (creatinine clearance <60 mL / min), 5 mg is recommended as the initial dose. The 40 mg dose should not be used in patients with moderate renal impairment.

Liver failure: CRESTOR should not be used in patients with active liver disease.

Talk to your doctor or pharmacist if you have an impression that CRESTOR's effect is too strong or too weak.

If you have used more CRESTOR than you should:

Talk to a doctor or pharmacist if you have used more than you should use from CRESTOR.

When you go to the hospital or receive treatment for any other reason, tell your health care personnel that you are receiving CRESTOR.

If you forget to use CRESTORnot

Doworry, take the next dose in the right time.

Do not take double doses to compensate for the forgotten dose.

Effects after cessation of treatment with

CRESTOR If you want to stop using CRESTOR, talk to your doctor. If you stop using CRESTOR, your cholesterol levels may rise again.

4. What are the possible side effects?

Like all medicines, CRESTOR can cause side effects, although not all. It is important to know what these side effects may be. Side effects are usually mild and disappear soon.

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If you have any of the following, stop using CRESTOR and IMMEDIATELY tell your doctor or contact the emergency department of the hospital nearest you:

• Difficulty in breathing with or without swelling on the lips, lips, and / or throat,

• Percentage, lips, tongue and / or swelling in the throat and the difficulty of swallowing, which may develop,swelling

• Severe itching with skin.

In addition, if your muscles have unusual pain or pain that lasts longer than you expect, stop using CRESTOR and seek medical advice immediately. These symptoms are more common in children and adolescents than in adults. As with other statins, very few people may have disturbing effects on muscles. These effects can rarely progress to life-threatening muscle damage called rhabdomyolysis.

Consult your doctor if you encounter these conditions which may be very serious. All of these very serious side effects are very rare.

Side effects are listed in the following categories:

Common: Less than one in 10 patients, but more than one in 100 patients. Uncommon: Less than one in 100 patients, but more than one in 1,000 patients. Rare: Less than one in 1,000 patients, but more than one in 10,000 patients

. Very rare: less than one in 10,000 patients. Unknown: Frequency cannot be estimated from available data.

If you notice any of the following, contact your doctor.

Common:

• Headache

• Abdominal pain

• Constipation

• Feeling sick

• Pain in muscles

• Feeling weakness

• Dizziness

• Sugar (diabetes) disease. This is more likely to occur in those with high blood sugar and high levels of fat, in overweight and in high blood pressure. Your doctor will keep you under control while taking this medicine.

Uncommon:

• Rash, itching or other skin reactions

• Increase in urine protein. This condition usually returns to its normal state without breaking the CRESTOR.

Rare:

• Severe allergic effects: swelling of the face, lips, tongue and / or throat, difficulty swallowing and breathing, severe skin rash with blisters. Ifan allergic condition

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you think you are facing, IMMEDIATELY use CRESTOR and seek medical attention.

• Muscle damage in adults: If your muscles have unusual pain or pain that last longer than you expect, stop using CRESTOR IMMEDIATELY and consult your doctor.

• Severe abdominal pain (inflamed pancreas)

• Increased liver enzymes in the blood

Very rare:

• Jaundice (yellowing of the skin and eyes)

• Hepatitis (inflammation of the liver)

blood• Blood sign in urine

• Damage of the limb nerves (such as numbness)