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CRESTOR (ROSUVASTATIN) 10MG TBL. N28

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-29
CRESTOR-ROSUVASTATIN-drug/medicine -tablets aproximate price on "CRESTOR (ROSUVASTATIN) 10MG TBL. N28 " in Riga city, Latvia is:
  • 22.92€  24.78$  19.6£  2647Rub  264.2SEK  99PLN  91.22₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  CRESTOR (ROSUVASTATIN) 10MG TBL. N28     Recheck

Reģ. Nr.: 03-0167

ATC codeC10AA07 

Active substances: Rosuvastatinum

 


Vendor, principal: Astra Ab

 Prescription drug (℞) 

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 .

CRESTOR 10MG N28

Package leaflet: information for the user

Crestor, 5 mg film-coated tablets Crestor, 10 mg film-coated tablets Crestor, 20 mg film-coated tablets
Rosuvastatin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor or pharmacist.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are similar to yours.
-   If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Crestor is and what it is used for
2.   What you need to know before you use Crestor
3.   How to take Crestor
4.   Possible side effects
5.   How to store Crestor
6.   Contents of the pack and other information

1. What Crestor is and what it is used for

Crestor (rosuvastatin) belongs to a group of medicines called statins.

You have been prescribed Crestor because

-   You have a high blood cholesterol level. This means that you are at a risk of heart attack or stroke. Crestor is used in adults, adolescents and children aged 6 or older to treat high cholesterol levels.
-   You have been advised to take a statin, because changing your diet and getting more exercise were not enough to lower your high cholesterol levels. You should continue with your cholesterollowering diet and physical exercise while you are taking Crestor.
Or
-   There are other factors that increase your risk of having a heart attack, stroke or other similar health problems.
Heart attack, stroke and other similar health problems are caused by a disease called atherosclerosis. Atherosclerosis is caused by a build-up of fatty deposits in your arteries (blood vessels).

Why is it important to take Crestor consistently?

Crestor is used to lower the levels of fatty compounds in the blood called lipids (mainly cholesterol). The blood contains different types of cholesterol - “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).
-   Crestor reduces the level of “bad” cholesterol and increases the level of “good” cholesterol.
-   It works by helping to block your body’s production of “bad” cholesterol and improves your body’s ability to remove it from your blood.
For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels supplying the whole body with blood, which causes them to narrow over time.
Sometimes, these narrowed blood vessels can get blocked, which can cut off blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, a stroke or other similar health problems.
You need to take Crestor consistently, even after your cholesterol levels have normalised, because it prevents your cholesterol levels from increasing again and causing a build-up of fatty deposits in the walls of your blood vessels. However, stop taking this medicine if your doctor has told you to or you have become pregnant.

2. What you need to know before you use Crestor

Do not take Crestor:

-   If you are allergic (hypersensitive) to rosuvastatin or any of the other ingredients of this medicine.
-   If you are pregnant, trying to have a baby or breast-feeding. If you become pregnant while taking Crestor, stop taking it immediately and talk to your doctor.
-   If you have a liver disease.
-   If you have severe renal failure.
-   If you have repeated or unexplained muscle aches or cramps.
-   If you take a drug called cyclosporine (used, for example, after organ transplants).
If any of the above applies to you, talk to your doctor.

Do not take Crestor at 40 mg doses (the highest dose):

-   If you have moderate kidney damage (if you suspect this, talk to your doctor).
-   If your thyroid gland is not working properly.
-   If you have or have had any repeated or unexplained muscle aches or cramps, a personal or family history of muscle disorders, or a previous history of muscle problems when taking other medicines for lowering lipid content.
-   If you regularly drink large amounts of alcohol.
-   If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
-   If you take other medicines called fibrates to lower your cholesterol.
If any of the above applies to you, talk to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Crestor:
-   If you have kidney problems.
-   If you have liver problems.
-   If you have or have had repeated or unexplained muscle aches or cramps, a personal or family history of muscle disorders, or a previous history of muscle problems when taking other medicines for lowering lipid content (fatty compounds). Talk to your doctor immediately if you have unexplained muscle aches, especially if you also feel unwell or have a fever. Talk to your doctor, if you feel constant muscle weakness. Additional tests and treatment may be necessary for diagnosing and treating it.
-   If you regularly drink large amounts of alcohol.
-   If you take other medicines (called fibrates) to lower your cholesterol. Read all of this leaflet carefully, even if you have taken such medicines before.
-   If you take medicines used to fight infections, including medicines for treating HIV or hepatitis C, e.g. antiviral medicines, such as ritonavir with lopinavir and/or atazanavir or simeprevir. For further information see the section “Other medicines and Crestor”.
-   If you are taking or have taken, orally or by injection, a medicine called fusidic acid (antibacterial medicine) in the last 7 days. Combining fusidic acid and Crestor may lead to a severe muscle disorder (rhabdomyolysis), please see section “Other medicines and Crestor”.
-   If you are over 70, your doctor needs to choose the correct starting dose to suit you.
-   If you have severe respiratory failure.
-   If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian): your doctor needs to choose the correct starting dose to suit you.
If any of the above applies to you (or if you suspect so):
-   Do not take Crestor at 40 mg doses (the highest dose) and talk to your doctor or pharmacist before you start taking the medicine.
In a small number of people, statins can affect liver function. This is identified by a simple test which looks for increased levels of liver enzymes in the blood. For this reason, your doctor may carry out this blood test (liver function test) before and during treatment with Crestor.
While you are taking this medicine, your doctor will periodically check for signs of diabetes or whether you are at risk of developing diabetes. You are likely to be at a risk of developing diabetes if you have high blood sugar or lipid (fats) levels, are overweight and have high blood pressure.

Children and adolescents

•   If the patient is younger than 6 years: Crestor must not be given to children younger than 6 years.
•   If the patient is younger than 18 years: Crestor 40 mg tablets are not suitable for use in adolescents and children younger than 18 years.

Other medicines and Crestor

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines: cyclosporine (used, for example, after organ transplants), warfarin or clopidogrel (or any other drug used for thinning the blood), fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower lipid content in the blood (such as ezetimibe), antacids or indigestion medicines (used to neutralise acid in your stomach), erythromycin (an antibiotic), fusidic acid (an antibiotic - please see section “Warnings and precautions” and the information below), oral contraceptives, hormone replacement therapy or antiviral medicines, such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to fight infections, including HIV and hepatitis C - please see section “Warnings and precautions”).
If you need to orally take fusidic acid to treat a bacterial infection, you must temporarily stop taking Crestor. Your doctor will tell you on when it is safe to resume taking Crestor. Taking Crestor with fusidic acid may in rare cases lead to muscle weakness, tenderness or pain (rhabdomyolysis). For further information, see section 4.

Crestor with food and drink

You can take Crestor with or without food

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking Crestor, stop taking it immediately and talk to your doctor. Women should avoid becoming pregnant while taking Crestor by using suitable contraception.
Talk to your doctor or pharmacist before using any medicines.

Driving and using machines

Crestor does not affect the ability to drive or use machines for most people. However, some people may feel mildly dizzy during treatment with Crestor. If you feel dizzy, talk to your doctor before attempting to drive or use machines.
Crestor contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (lactose found in milk) consult your doctor before taking Crestor.
For the full list of excipients, see section “Contents of the pack and other information”.

3. How to take Crestor

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

If you are taking Crestor for high cholesterol:

Starting dose
Your treatment with Crestor must start with a 5 mg or 10 mg dose once a day, even if you have taken different dose of a different statin before. The choice of starting dose will depend on:
-   Your cholesterol level.
-   Your level of risk of having a heart attack or stroke.
-   Whether you have a factor that may make you more sensitive to possible side effects.
Please talk to your doctor or pharmacist about which starting dose of Crestor best suits you.
Your doctor may decide to prescribe you the lowest dose (5 mg) if:
-   You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
-   You are over 70 years of age.
-   You have moderate kidney damage.
-   You are at a risk of muscle aches (myopathy).

Increasing the dose and the maximum daily dose

Your doctor may decide to increase your dose. This is done so you would take the amount of Crestor that is right for you. If you started with a 5 mg dose, your doctor may decide to double this to 10 mg, then to 20 mg and finally to 40 mg, if necessary. If you started with a 10 mg dose, your doctor may decide to double this to 20 mg and then to 40 mg, if necessary. There will be a gap of four weeks between every dose adjustment.
The maximum daily dose of Crestor is 40 mg. The highest does is only for patients with high cholesterol levels, who are at a risk of heart attack or stroke and whose cholesterol levels are not lowered enough with a 20 mg dose.

If you are taking Crestor to lower the risk of heart attack, stroke or other similar health problems:

The recommended dose is 20 mg a day. Your doctor may prescribe you a lower dose if any of the following factors applies to you.

Children aged 6...17

The dose range for children and adolescents aged 6...17 is 5...20 mg once a day. The usual starting dose is 5 mg a day and your doctor may increase the dose to find the correct amount of Crestor suitable for you. The maximum daily dose of Crestor for children and adolescents aged 6...17 is 10 mg or 20 mg, depending on the condition to be treated. Take Crestor once a day. The Crestor 40 mg tablet must not be used on children.

Taking your tablets

Swallow the tablet whole with a drink of water.
Take Crestor once a day. You can take it at any time of the day.
Try to take your tablet at the same time every day to help you remember it.

Regular blood cholesterol checks

It is important to see your doctor for regular cholesterol checks to make sure your cholesterol is in the normal range.
Your doctor may decide to increase your dose so that you are taking the amount of Crestor that is suitable for you.

If you take more Crestor than you should

Contact your doctor or nearest hospital for advice.
If you fall ill or are hospitalised, inform the medical staff that you are taking Crestor.

If you forget to take Crestor

Do not worry about missing a dose, just take your next scheduled dose at the correct time as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Crestor

Talk to your doctor if you want to stop taking Crestor. Your cholesterol levels may increase again if you stop taking Crestor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important for you to be aware of what these side effects may be. These are usually mild and disappear after a short time.
Stop taking Crestor and seek medical help immediately if you develop any of the following allergic reactions:
-   Breathing difficulties, with or without swelling of the face, lips, tongue and/or throat.
-   Swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing.
-   Severe itching of the skin (with raised bumps).
Also stop taking Crestor and talk to your doctor immediately if you experience muscle pain, which persists longer than expected. As with other statins, a very small number of people have experienced unpleasant side effects affecting the muscles and in rare cases these have caused a potentially life-threatening muscle damage condition, known as rhabdomyolysis.

Common side effects (affects more than 1 user in 100 and less than 1 user in 10):

-   Headache.
-   Muscle pain.
-   Abdominal pain.
-   General feeling of weakness.
-   Constipation.
-   Nausea.
-   Dizziness.
-   Feeling unwell.
-   An increase in the amount of protein in the urine (at 40 mg doses) - this usually returns to normal on its own without having to stop taking Crestor.
-   Diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon side effects (affects more than 1 user in 1,000 and less than 1 user in 100):

-   Rash, itching or urticaria.
-   An increase in the amount of protein in the urine (at 5 mg, 10 mg and 20 mg doses) - this usually returns to normal on its own without having to stop taking Crestor.

Rare side effects (affects more than 1 user in 10,000 and less than 1 user in 1,000):

-   Severe allergic reactions - symptoms include swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing and breathing, a severe itching of the skin (with raised bumps). If you think you are having an allergic reaction, stop taking Crestor and seek medical attention immediately.
-   Muscle damage - as a precaution, stop taking Crestor and talk to your doctor immediately if you experience any muscle aches, which persist longer than expected.
-   Severe abdominal pain (pancreatitis).
-   Thrombocytopenia or low levels of thrombocytes (platelets responsible for blood clotting) in the blood.
-   Increase in liver enzyme activity in the blood.

Very rare side effects (less than 1 user in 10,000, including isolated cases):

-   Yellowing of the skin (jaundice).
-   Inflammation of the liver (hepatitis).
-   Traces of blood in urine.
-   Impaired sensitivity in the legs and hands (e.g. numbness).
-   Joint pain.
-   Memory loss.
-   Breast enlargement in men (gynaecomastia).

Side effects of unknown frequency may include:

-   Diarrhoea.
-   Stevens-Johnson syndrome (severe condition characterised by blistering of the skin, mouth, eyes and genitals).
-   Cough.
-   Shortness of breath.
-   Oedema (swelling).
-   Sleep disturbances, including insomnia and nightmares.
-   Sexual difficulties.
-   Depression.
-   Breathing problems, including persistent cough and/or shortness of breath or fever.
-   Tendon damage, including ruptured tendons.
-   Immune mediated necrotising myopathy.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Crestor

Do not store above 30 °C. Store in the original package, protected from moisture.
The bottle must be kept tightly sealed.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister pack and carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.

Contents of the pack and other information

6.

What Crestor contains

-   The active substance is rosuvastatin. Each Crestor tablet contains 5 mg, 10 mg or 20 mg of rosuvastatin (as a calcium salt).
-   The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide, red iron oxide (only in Crestor 10 mg and 20 mg tablets), yellow iron oxide (only in Crestor 5 mg tablets).

What Crestor looks like and contents of the pack

The Crestor 5 mg film-coated tablet is round, yellow and double-convex with the marking “ZD4522” on one side and clear on the other.
The Crestor 10 mg film-coated tablet is round, pink and double-convex with the marking “ZD4522 10” on one side and clear on the other.
The Crestor 20 mg film-coated tablet is round, pink and double-convex with the marking “ZD4522 20” on one side and clear on the other.
The blister pack contains 7, 14, 15, 28, 30, 42, 98 or 100 tablets.
The HDPE jar contains 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
AstraZeneca UK Ltd Silk Road Business Park Charter Way Macclesfield Cheshire SK10 2NA United Kingdom
Manufacturers
Corden Pharma GmbH, Otto-Hahn Strasse, 68723 Plankstadt, Germany AstraZeneca UK Ltd., Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
AstraZeneca Eesti OÜ Järvevana tee 9 11314 Tallinn Phone: +372 6549 600

This leaflet was last revised in January 2017 Other sources of information

Detailed information on this medicine is available on the website of the Estonian State Agency of Medicines.





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia




[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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