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ROVASYN 20MG FC TBL N30

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-28
aproximate price on "ROVASYN 20MG FC TBL N30 " in Riga city, Latvia is:
  • 6.13€  6.63$  5.26£  708Rub  70.5SEK  26PLN  24.26₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  ROVASYN 20MG FC TBL N30

ATC codeC10AA07 

Active substances: Rosuvastatinum

 


Vendor, principal: Medochemie Ltd.
...

* This table was compiled fully automatically, independently from any advertisers, transparently and without any modification relaying the open offers available on the mentioned dates.
 .

ROVASYN 20MG N60

Package leaflet: Information for the user ROVASYN 10 mg film-coated tablets ROVASYN 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 ROVASYN is and what it is used for
2.   What you need to know before you take ROVASYN
3.   How to take ROVASYN
4.   Possible side effects
5.   How to store ROVASYN
6.   Contents of the pack and other information

1. What ROVASYN is and what it is used for

ROVASYN belongs to a group of medicines called statins.
You have been prescribed ROVASYN because:
• You have a high cholesterol level. This means you are at risk from a heart attack or stroke. ROVASYN 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 ROVASYN.
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 buildup of fatty deposits in your arteries.

Why is it important to keep taking ROVASYN?

ROVASYN 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).
•   ROVASYN 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 ROVASYN, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing buildup 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 ROVASYN

Do not take ROVASYN:

  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 ROVASYN stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking ROVASYN 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 ROVASYN 40 mg (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 ROVASYN:
  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 cholesterollowering 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 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 ROVASYN can lead to serious muscle problems (rhabdomyolysis).
•   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 ROVASYN.
Children and adolescents
•   If the patient is under 6 years old: ROVASYN should not be given to children younger than 6 years.
•   If the patient is below 18 years of age: The ROVASYN 40 mg tablet 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 ROVASYN 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 ROVASYN to suit you.
If any of the above applies to you (or if you are not sure):
•   Do not take ROVASYN 40 mg (the highest dose) and check with your doctor or pharmacist before you actually start taking any dose of ROVASYN.
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 ROVASYN.
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 ROVASYN

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 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), an oral contraceptive (the pill), hormone replacement therapy or ritonavir with lopinavir and/or atazanavir ( (used to treat the HIV infection - please see Warnings and precautions). The effects of these medicines could be changed by ROVASYN or they could change the effects of ROVASYN.
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 ROVASYN. Taking ROVASYN with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

ROVASYN with food and drink

You can take ROVASYN with or without food.

Pregnancy and breast-feeding

Do not take ROVASYN if you are pregnant or breast-feeding. If you become pregnant while taking ROVASYN stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking ROVASYN 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 ROVASYN - it will not affect their ability. However, some people feel dizzy during treatment with ROVASYN. If you feel dizzy, consult your doctor before attempting to drive or use machines.

ROVASYN contains lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact you doctor before taking this medicinal product.
For a full list of ingredients please see Section 6 Contents of the pack and other information.

3. How to take ROVASYN

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

The recommended dose in adults is:

If you are taking ROVASYN for high cholesterol:
Starting dose
Your treatment with ROVASYN 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 ROVASYN 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 ROVASYN 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 ROVASYN 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 ROVASYN 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 ROVASYN for you. The maximum daily dose of ROVASYN 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. ROVASYN 40 mg tablet should not be used by children.

Taking your tablets

Swallow each tablet whole with a drink of water.
Take ROVASYN once daily. You can take it at any time of the day.
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 ROVASYN that is right for you.

If you take more ROVASYN 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’re taking ROVASYN.

If you forget to take ROVASYN

Don’t 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 ROVASYN

Talk to your doctor if you want to stop taking ROVASYN. Your cholesterol levels might increase again if you stop taking ROVASYN.
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 ROVASYN 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 ROVASYN 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 ROVASYN tablets (only ROVASYN 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 ROVASYN tablets (only ROVASYN 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 ROVASYN and seek medical help immediately.
•   Muscle damage in adults - as a precaution, stop taking ROVASYN 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.
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 not known 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 via www.ravimiamet.ee . By reporting side effects you can help provide more information on the safety of this medicine.
5.   How to store ROVASYN
•   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 and blister after “EXP”. The expiry date refers to the last day of that month.
•   This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
•   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 ROVASYN contains
-   The active substance is rosuvastatin.
Each film-coated tablet contains 10 mg, 20 mg rosuvastatin as rosuvastatin calcium, respectively.
-   The other ingredients are: Cellulose Microcrystalline PH-101, Silica Colloidal Anhydrous, Crospovidone Type A, Cellulose Microcrystalline PH-102, Lactose Monohydrate, Magnesium Stearate.
The tablet coating contains:
ROVASYN 10 mg film-coated tablets: Hypromellose, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Iron oxide red (E172).
ROVASYN 20 mg film-coated tablets: Hypromellose, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Iron oxide red (E172).
What ROVASYN looks like and contents of the pack
ROVASYN 10 mg film-coated tablets: Pink, round, biconvex, coated tablet, embossed ‘ROS’ over ‘10’ on one side and nothing on the other, with diameter 7 mm.
ROVASYN 20 mg film-coated tablets: Pink, round, biconvex, coated tablet, embossed ‘ROS’ over ‘20’ on one side and nothing on the other, with diameter 9 mm.
Tablets are packed in OPA-Al-PVC/Al blisters.
Boxes containing 14, 20, 28, 30, 56, 60, 84, 90 and 100 film coated tablets in blisters are available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder:
Medochemie Ltd
1-10 Constantinoupoleos Str.,
Limassol, 3011, Cyprus

Manufacturer:

Medochemie Ltd- Central Factory 1-10 Constantinoupoleos Str.,
Limassol, 3011, Cyprus
Medochemie Ltd- Factory AZ 2 Michael Erakleous Str.
Ag. Athanassios Industrial Area 4101 Ag. Athanassios, Limassol Cyprus
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Netdoktor OÜ Seebi 3 11316 Tallinn Phone: +372 564 80207

This medicinal product is authorized in the Member States of the EEA under the following names:


2231
2232
Denmark
CELMANTIN 5, 10, 20, 40mg
film coated tablets
ROVASYN 5, 10, 20, 40mg
film coated tablets
Bulgaria
ROVASTA 10, 20mg film coated
tablets

Cyprus
CELMANTIN 5, 10, 20, 40mg
AioKa smKaA,uppsva ps upevio
ROVASYN 5, 10, 20, 40mg
film coated tablets AioKa
smra^uppsva ps upevio
Czech Republic
ROVASYN 10,   20, 40mg
potahovane tablety

Estonia
ROVASYN 10, 20mg Öhukese
polümeerikattega tabletid

Greece
Celmantin 5, 10, 20, 40mg film
coated tablets

Latvia
ROVASYN 5, 10, 20, 40mg
apvalkotās tabletes

Romania
ROVASTAMED 5, 10, 20, 40mg
comprimate filmate

Malta
CELMANTIN 5, 10, 20, 40mg
film coated tablets

This leaflet was last revised in October 2017.






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




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