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ROSUVASTATIN TEVA 20MG 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
ROSUVASTATIN-drug/medicine -tablets aproximate price on "ROSUVASTATIN TEVA 20MG TBL. N28 " in Riga city, Latvia is:
  • 5.32€  5.75$  4.55£  614Rub  61.3SEK  23PLN  21.17₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  ROSUVASTATIN TEVA 20MG TBL. N28     Recheck

ATC codeC10AA07 

Active substances: Rosuvastatinum

 


Vendor, principal: Teva Pharmaceutical
ROSUVASTATIN TEVA 20MG TBL. N28 is compensated medicine in Latvia. 

 Prescription drug (℞) 

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ROSUVASTATIN TEVA 20 MG ÕHUK. POLÜM.KAT. TBL 20MG N28, Rosuvastatiin Rx
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* This table was compiled fully automatically, independently from any advertisers, transparently and without any modification relaying the open offers available on the mentioned dates.Only the distribution of over-the-counter remedies through the website is permitted in Latvia in accordance with national laws and regulations.
 .

ROSUVASTATIN TEVA PHARMA 20MG N28

Package leaflet: Information for the patient

Rosuvastatin Teva Pharma 10 mg film-coated tablets Rosuvastatin Teva Pharma 20 mg film-coated tablets
rosuvastatin

Read all of this leaflet carefully before you start taking 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 signs of illness are the same as yours.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Rosuvastatin Teva Pharma is and what it is used for

Rosuvastatin Teva Pharma belongs to a group of medicines called statins.

You have been prescribed Rosuvastatin Teva Pharma because:

• You have a high cholesterol level. This means you are at risk from a heart attack or stroke.
Rosuvastatin Teva Pharma is used in adults, adolescents and children 6 years or older to treat high cholesterol.
You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking Rosuvastatin Teva Pharma.
Or
•   You have other factors that increase your risk of having a heart attack, stroke or related health problems.
Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Atherosclerosis is due to build up of fatty deposits in your arteries.

Why it is important to keep taking Rosuvastatin Teva Pharma?

Rosuvastatin Teva Pharma is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol.
There are different types of cholesterol found in the blood - ‘bad’ cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C).
•   Rosuvastatin can reduce the “bad” cholesterol and increase the “good” cholesterol.
•   It works by helping to block your body’s production of ‘bad’ cholesterol. It also 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 causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut off the 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 related health problems.
You need to keep taking Rosuvastatin Teva Pharma, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing build up of fatty deposits. However, you should stop if your doctor tells you to do so, or you have become pregnant.

2. What you need to know before you take Rosuvastatin Teva Pharma Do not take Rosuvastatin Teva Pharma

-   if you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6)
-   If you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin Teva Pharma stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Teva Pharma by using suitable contraception.
-   If you have liver disease
-   If you have severe kidney problems
-   If you have repeated or unexplained muscle aches or pains
-   If you take a drug called ciclosporin (used, for example, after organ transplants).
If any of the above applies to you (or you are in doubt), please go back and see your doctor.

In addition, do not take Rosuvastatin 40 mg film-coated tablets (the highest dose):

-   If you have moderate kidney problems (if in doubt, please ask your doctor)
-   If your thyroid gland is not working properly
-   If you have had any repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines
-   If you regularly drink large amounts of alcohol
-   If you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian)
-   If you take other medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or you are in doubt), please go back and see your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rosuvastatin Teva Pharma.

•   If you have problems with your kidneys

•   If you have problems with your liver
•   If you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever. Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
•   If you regularly drink large amounts of alcohol
•   If your thyroid gland is not working properly
•   If you take other medicines called fibrates to lower your cholesterol. Please read this leaflet carefully, even if you have taken other medicines for high cholesterol before
•   If you take medicines used to treat the HIV infection e.g. ritonavir with lopinavir and/or atazanavir, please see Other medicines and Rosuvastatin Teva Pharma
•   If you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Rosuvastatin Teva Pharma can lead to serious muscle problems (rhabdomyolysis).

Children and adolescents

If the patient is under 6 years old: Rosuvastatin Teva Pharma should not be given to children younger than 6 years.
If the patient is below 18 years of age: Rosuvastatin 40 mg film-coated tablets is not suitable for use in children and adolescents below 18 years of age.
If you are over 70 (as your doctor needs to choose the right start dose of Rosuvastatin Teva Pharma to suit you)

•   If you have severe respiratory failure

•   If you are of Asian origin - that is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor needs to choose the right start dose of Rosuvastatin Teva Pharma to suit you.
If any of the above applies to you (or if you are not sure):
•   Do not take Rosuvastatin 40 mg film-coated tablets (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of Rosuvastatin Teva Pharma.
In a small number of people, statins can affect the liver. This is identified by a simple test which looks for increased 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 Rosuvastatin Teva Pharma.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Other medicines and Rosuvastatin Teva Pharma

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:
•   ciclosporin (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 cholesterol (such as ezetimibe)
•   indigestion remedies (used to neutralise acid in your stomach)
•   erythromycin (an antibiotic)
•   fusidic acid (an antibiotic). 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 restart Rosuvastatin Teva Pharma. Taking Rosuvastatin Teva Pharma with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
•   an oral contraceptive (the pill)
•   hormone replacement therapy
•   anti-viral medicines such as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat infections, including HIV or hepatitis C infection - please see Warnings and precautions).
The effects of these medicines could be changed by Rosuvastatin Teva Pharma or they could change the effect of Rosuvastatin Teva Pharma.

Pregnancy and breast-feeding

Do not take Rosuvastatin Teva Pharma if you are pregnant or breast-feeding. If you become pregnant while taking Rosuvastatin Teva Pharma stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rosuvastatin Teva Pharma by using suitable contraception.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Most people can drive a car and operate machinery while using Rosuvastatin Teva Pharma - it will not affect their ability. However, some people feel dizzy during treatment with Rosuvastatin Teva Pharma. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatin Teva Pharma contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Rosuvastatin Teva Pharma

Always take this medicine as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual doses in adults
If you are taking Rosuvastatin Teva Pharma for high cholesterol:
Starting dose
Your treatment with Rosuvastatin Teva Pharma must start with the 5 mg or the 10 mg dose, even if you have taken a higher dose of a different statin before. The choice of your start dose will depend upon:
•   Your cholesterol level
•   The level of risk you have of experiencing a heart attack or stroke
•   Whether you have a factor that may make you more sensitive to possible side effects.
Please check with your doctor or pharmacist which start dose of Rosuvastatin Teva Pharma will best suit you.
Your doctor may decide to give you the lowest dose (5 mg) if:
•   You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian)
•   You are over 70 years of age
•   You have moderate kidney problems
•   You are at risk of muscle aches and pains (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the amount of Rosuvastatin Teva Pharma that is right for you. If you started with a 5 mg dose, your doctor may decide to double this to 10 mg, then 20 mg and then 40 mg if necessary. If you started on 10 mg, your doctor may decide to double this to 20 mg and then 40 mg if necessary. There will be a gap of four weeks between every dose adjustment. The maximum daily dose of Rosuvastatin Teva Pharma is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attacks or stroke whose cholesterol levels are not lowered enough with 20 mg.

If you are taking Rosuvastatin Teva Pharma to reduce your risk of having a heart attack, stroke or related health problems:

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

Use in children and adolescents aged 6-17 years

The usual start dose is 5 mg. Your doctor may increase your dose to find the right amount of Rosuvastatin Teva Pharma for you. The maximum daily dose of Rosuvastatin Teva Pharma is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take your dose once a day. Rosuvastatin 40 mg film-coated tablets should not be used by children.

Taking your tablets

Swallow each tablet whole with a drink of water.
Take Rosuvastatin Teva Pharma once daily. You can take it at any time of the day with or without food. Try to take your tablet at the same time every day to help you to remember it.

Regular cholesterol checks

It is important to go back to your doctor for regular cholesterol checks to make sure your cholesterol has reached and is staying at the correct level.
Your doctor may decide to increase your dose so that you are taking the amount of Rosuvastatin Teva Pharma that is right for you.

If you take more Rosuvastatin Teva Pharma than you should

Contact your doctor or nearest hospital for advice.
If you go into hospital or receive treatment for another condition, tell the medical staff that you are taking Rosuvastatin Teva Pharma.

If you forget to take Rosuvastatin Teva Pharma

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

If you stop taking Rosuvastatin Teva Pharma

Talk to your doctor if you want to stop taking Rosuvastatin Teva Pharma. Your cholesterol levels might increase again if you stop taking Rosuvastatin Teva Pharma.
If you have any further questions on 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.
It is important that you are aware of what these side effects may be. They are usually mild and disappear after a short time.

Stop taking Rosuvastatin Teva Pharma and seek medical help immediately if you have any of the

following allergic reactions:
•   Difficulty in breathing, 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 in swallowing
•   Severe itching of the skin (with raised lumps).
Also, stop taking Rosuvastatin Teva Pharma and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than you might expect. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects and rarely these have gone on to become a potentially life threatening muscle damage known as rhabdomyolysis.

Common possible side effects (may affect up to 1 in 10 people):

•   Headache
•   Stomach pain
•   Constipation
•   Feeling sick
•   Muscle pain
•   Feeling weak
•   Dizziness
•   An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking your Rosuvastatin Teva Pharma (only Rosuvastatin Teva Pharma 40 mg).
•   Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon possible side effects (may affect up to 1 in 100 people):

•   Rash, itching or other skin reactions
•   An increase in the amount of protein in the urine - this usually returns to normal on its own without having to stop taking your Rosuvastatin Teva Pharma (only Rosuvastatin Teva Pharma 5 mg, 10 mg and 20 mg).

Rare possible side effects (may affect up to 1 in 1,000 people):

•   Severe allergic reaction - signs include swelling of the face, lips, tongue and/or throat, difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps). If you think you are having an allergic reaction, then stop taking Rosuvastatin Teva Pharma and seek medical help immediately
•   Muscle damage in adults- as a precaution, stop taking Rosuvastatin Teva Pharma and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected
•   A severe stomach pain (inflamed pancreas)
•   Increase in liver enzymes in the blood
•   Unexpected bleeding and bruising (thrombocytopenia).

Very rare possible side effects (may affect up to 1 in 10,000 people):

•   Jaundice (yellowing of the skin and eyes)
•   Hepatitis (an inflamed liver)
•   Traces of blood in your urine
•   Damage to the nerves of your legs and arms (such as numbness)
•   Joint pain
•   Memory loss
•   Breast enlargement in men (gynaecomastia)

Side effects of unknown frequency may include:

•   Diarrhoea (loose stools)
•   Stevens-Johnson syndrome (serious blistering condition 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 injury
•   Muscle weakness that is constant

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Rosuvastatin Teva Pharma

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 carton after EXP. 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 you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information What Rosuvastatin Teva Pharma contains

The active substance is rosuvastatin.
Rosuvastatin10, 20 mg film-coated tablets contain rosuvastatin calcium equivalent to 10 mg, 20 mg or of rosuvastatin.
The other ingredients are
Tablet core:
Microcrystalline cellulose Lactose monohydrate Crospovidone (type B)
Hydroxypropylcellulose Sodium hydrogen carbonate Magnesium stearate
Film-coating:
Lactose monohydrate Hypromellose 6 Cp Titanium dioxide (E 171)
Triacetin
Iron oxide red (E 172) in Rosuvastatin 10 mg, 20 mg film-coated tablets

What Rosuvastatin Teva Pharma looks like and contents of the pack

Rosuvastatin 10 mg film-coated tablets: round, biconvex, pink tablet with a score line, around 7 mm in diameter.
Rosuvastatin 20 mg film-coated tablets: round, biconvex, pink tablet with a score line, around 9 mm in diameter.
The tablets can be divided into equal halves.
Rosuvastatin film-coated tablets come in blister packs containing 7, 14, 15, 20, 28, 28 (calendar pack), 30, 30 x 1, 42, 50, 50 x 1, 56, 60, 84, 90, 90 x 1, 98, 100 and 100 x 1 film-coated tablets and HDPE bottles containing 30, 100 and 250 film-coated tablets.
The bottle may contain a separate desiccant canister containing silica gel. Do NOT remove it from the bottle. Do NOT eat the canister containing silica gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA B.V.
Swensweg 5 2031GA Haarlem The Netherlands

Manufacturers

Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren 89143 Germany
PLIVA Hrvatska d.o.o.
Prilaz baruna Filipovica 25
Zagreb, 10000
Croatia
TEVA UK Ltd.
Brampton Road, Hampden Park Eastbourne BN22 9AG United Kingdom
Teva Pharma B.V.
Swensweg 5, Haarlem
2031GA
The Netherlands
HBM Pharma s.r.o.
Sklabinska 30 Martin 036 80 Slovakia
TEVA PHARMA S.L.U.
C/ C, n° 4
Poligono Industrial Malpica
50016 Zaragoza
Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Estonian branch UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Phone: +372 6610801

This leaflet was last revised in January 2018.






  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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